HealthyNCT03394963
Developing and Validating Food-based Dietary Guidelines and a Healthy Eating Index
An observational study of Healthy, run by Ethiopian Public Health Institute at 1 site in Ethiopia.
Trial summary
Among several factors contributing to the occurrence of undernutrition, micronutrient deficiencies, overnutrition, and chronic disease, unhealthy diet is one of the most important factors that need to be addressed to tackle the burden in low- and middle-income countries. Read more about this study
- Who is it for?
- Ages 2 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Food-based dietary guidelines for healthier diet
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 500 participants
- Where
- 1 siteEthiopia
- Study dates
- 1 Nov 2019to 30 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 65 years
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The FBDGs validation, a HEI and FFQ tools development and validation will target women of reproductive age (15-49 years), are not planning to move from the study and do not have a severe illness at the time of enrolment. Exclusion criteria will be a severe illness.
Who may be able to join
- General population above 2 years of FBDGs development
- Women of reproductive age (15-49 years) for FBDGs validation
- Women of reproductive age (15-49 years) for HEI development and validation
Who cannot join
- population groups other than women of reproductive age for FBDGs validation, and HEI development and validation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Scientific Foundations for Developing and Validating Food-based Dietary Guidelines and a Healthy Eating Index for Ethiopia
Among several factors contributing to the occurrence of undernutrition, micronutrient deficiencies, overnutrition, and chronic disease, unhealthy diet is one of the most important factors that need to be addressed to tackle the burden in low- and middle-income countries. To maintain healthy eating in a population, it is crucial to develop and implement country-specific food-based dietary guidelines as well as monitor the adherence of the population with the guidelines. The aim of this study is to generate evidence that will help the development and validation of food-based dietary guidelines and a healthy eating index for Ethiopia. The method to develop Ethiopian food-based dietary guidelines is adapted from the 2015 Dutch food-based dietary guidelines and the Dutch healthy diet index development and validation process, and the 1998 FAO/WHO preparation and use of food-based dietary guidelines. A multidisciplinary technical working will be established to develop FBDGs. The working group will identify key messages for the guidelines that can address priority diet-related public health problems in Ethiopia based on the evidence that will be generated by the PhD student from Wageningen University and Research. The evidence generation will begin by identifying top ten diet-related diseases that lead to high morbidity and mortality in 2016. The nutrition situation (nutritional status, dietary pattern, and nutrient gaps) analysis will be conducted to define the objectives of FBDGs. A systematic review will be conducted by formulating research questions to address the objectives of the FBDGs. The FBDGs will be translated for a specific population subgroup using linear mathematical programming and validated for cultural appropriateness, acceptability, consumer understanding and practicality of the messages. Focus group discussions and key informant interviews will be conducted to validate the FBDGs. The most recent Ethiopian national food consumption survey data collected in 2011 will be used to develop a healthy eating index (HEI). The selection of a healthy eating component of HEI will be done based on the FBDGs. Validation of a healthy eating index will be conducted by comparing the HEI score based on 24-hour recall with the HEI score based on food frequency questionnaire for population characteristics and association with micronutrient intake with or without adjusting for energy and anthropometric measurement. Developing short food frequency questionnaire (FFQ) that can be scored with the index for dietary counseling and public health practice as well as dietary gap assessment for policy recommendation will be part of the study. Validation of FFQ will be conducted by collecting primary data among women of reproductive age in 500 households in rural and urban areas of Ethiopia. The data will be analyzed using the latest version of STATA, SPSS, and NVIVO software. Correlations and other appropriate advanced statistical technique will be applied as needed to answer the objectives of the study. Ethical approval will be received from the medical ethical committee of Wageningen University and Research and scientific and ethical review office of Ethiopian Public Health Institute. This Ph.D. research is supported by the Food Systems for Healthier Diets flagship of the CGIAR- Agriculture for Nutrition and Health Programme coordinated by International Food Policy Research Institute. Food and Agriculture Organization (FAO) and Ethiopian Public Health Institute are collaborators of this project to develop the FBDGs.
Read the detailed description
Triple burden of malnutrition (i.e. protein-energy malnutrition including micronutrient deficiency and overnutrition) is a current global problem. In 2017, 155 out of 677 million children in the world under the age of 5 years were stunted (height for age < -2 SD of the WHO Child Growth Standards median), 52 million wasted (weight for height < -2 SD of the WHO child growth standards median) and 41 million overweight (weight for height > 2 SD of the WHO child growth standards median) with 93 million children at risk of overweight. Out of 5 billion adults worldwide, nearly 2 billion are overweight (BMI > 25 kg/m2) or obese (BMI > 30 kg/m2) and one in 12 has a type -2 diabetes mellitus. The mean prevalence of adult obesity in the WHO data set was 7.5 ± 6.0% while adult overweight was much higher at 21.8 ± 10.2% and adult underweight was 13.4 ± 7.0%. The median ratio of overweight to underweight among women age 20 - 49 years was 5.8 in urban and 2.1 in rural areas of low- and middle-income countries (LMICs). Even many poor countries, countries in which underweight persists as a significant problem, had a fairly high prevalence of rural overweight. As compared to the overall Sub-Saharan Africa (SSA), urban prevalence of adult obesity and overweight were higher (12.5 ± 7.0% and 31.8 ± 12.8% respectively), child undernutrition was generally lower (30.4 ± 8.4% for stunting < -2SD from median height for age,15.5 ± 7.0% for underweight < -2SD from median weight for age and 12.0 ± 5.0% for wasting < -2SD from median weight for height) and adult underweight (BMI < 18.5 kg/m2) was also 10.5%. In addition to this, two billion people living in developing and developed countries are micronutrients deficient; they lack the vital vitamins and minerals needed to grow properly and live healthily. Iron, iodine, vitamin A, zinc, and folate separately or in combination are the priority micronutrient deficiencies for populations in most countries of the world. Micronutrient deficiencies have consequences throughout an individual's lifespan and are perpetuated across the generations. Thus, maternal and child malnutrition in low- and middle-income countries encompasses undernutrition and micronutrient deficiency, with a growing problem of overweight and obesity. The problem of triple burden of malnutrition is especially increasing in low- and middle-income countries mainly due to urbanization, fast economic growth, and changes in dietary pattern and lifestyle.
Ethiopia has a fast growing economy over the past 10 years, and a changing food environment, with declining shares of food expenditures and increased access to non-staples, processed foods, and sugary beverages. Stunting among young children has reduced from 57% in 2000, to 40% in 2014. Nevertheless, levels of stunting are still among the highest in the world and the contribution starts from underweight mothers whose birth outcome is a child with low birth weight. According to 2016 demographic and health survey report, the prevalence of stunting among under 5 children is 38%, wasting 9.9% and underweight 23.6%. The national nutrition survey conducted by Ethiopian Public Health Institute (EPHI) in 2015 also indicated that the prevalence of underweight (BMI<18.5 kg/m2) and overweight among women of reproductive age are 20% and 13% respectively. Overweight had increased by 10% between 2009 and 2015 according to the national nutrition survey results and other studies. The national micronutrient survey also showed that anemia, vitamin A, zinc, iodine, folate and vitamin B12 are public health problems among all population in Ethiopia. This indicates that, like other LMICs, Ethiopia is suffering from the triple burden of malnutrition.
The unhealthy diet is one of the most important risk factors that need to be addressed to tackle the triple burden of malnutrition in LMICs. The changes in the pattern of dietary risk factors in low- and middle-income countries is characterized by increases in the consumption of animal fat and protein, refined grains, and added sugar. In middle-income countries, from1989 to 2011, the percentage of individuals with consumption frequency of fish 5 + per week has decreased from 93% to 74%, that with consumption frequency of meat 5 + per week has increased from 25% to 51%, consumption frequency of fruits 1 + per week has increased from 48% to 94%, consumption frequency of salty snacks 1 + per week has increase from 22% to 64%, consumption frequency of sweet snacks has increased from 38% to 67%, and from 2004 to 2011, consumption frequency of poultry has increased from 86% to 96%. On the other hand, in Sub-Saharan African (SSA) countries, dietary micronutrient density index (average micronutrient density of the food supply based on 14 micronutrients: calcium, copper, iron, folate, magnesium, niacin, phosphorus, riboflavin, thiamin, vitamin A, vitamin B12, vitamin B6, vitamin C, and zinc using the 2011 global population-weighted Recommended Dietary Allowance [RDA]) has declined over the past 50 years. This indicates that there is a policy gap in terms of improving dietary quality for better health, prevention of diet-related diseases, and triple burden of malnutrition in LMICs setting. Promoting healthy eating in low- and middle-income countries can reduce the social inequality among the poor and rich, especially when it targets the disadvantaged population group. In general, healthy global diet can reduce global mortality by 6 - 10%, and greenhouse emission by 29-70%, reduce biodiversity loss and economic benefit up to 31 trillion US dollar and adoption of global dietary guidelines would result in 5.1 million avoided deaths per year [95% confidence interval (CI), 4.8-5.5 million] and 79 million years of life saved (CI, 75-83 million).
Besides this, lack of a healthy diet also contributes to the burden of diet-related diseases. Intakes of a diet low in fruits and vegetables and high in sodium are the leading dietary risks factors for non-communicable diseases (NCDs) burden in Ethiopia. Evidence from animal, clinical and epidemiological studies also showed that specific dietary patterns are associated with reduced risk of specific disease. Fruits and vegetables are associated with a reduction of the incidence of an esophagus, lung, stomach, and colorectum cancer and coronary heart diseases. In addition, by promoting a healthy diet, it is also possible to prevent different forms of malnutrition and micronutrient deficiencies.
A healthy diet means eating a variety of foods that can give the nutrients needed to maintain or improve health, feel good, and have adequate energy content. The nutrients include protein, carbohydrates, fat, water, vitamins, and minerals. To maintain healthy eating in a population, it is crucial to develop and implement country-specific food-based dietary guidelines and to enable tracking the adherence of the population to the food-based dietary guidelines.
Indications for dietary transitions are observed in several overall trends of Ethiopian eating habits such as increased energy intake, declining but still a dominant share of cereals in diets, and more purchased foods. Whether diets as a whole are changing towards healthier or unhealthier patterns, and how this differs between and within regions and population subgroups, is unclear. The increase in consumption of unhealthier components might be faster than that of healthy components as in many (187 countries) other countries of the world. In addition, Ethiopia's food production and supply are very vulnerable to climate change and variability (droughts in 2015-2016), which leads to temporal high levels of severe food insecurity and malnutrition which can easily affect the dietary pattern of the population. A national food consumption study conducted by EPHI sheds light on some major dietary gaps, including inadequate intake of vitamin A, calcium, folate and zinc. However, the heterogeneity of dietary patterns and dietary nutrient gaps concerns among the large diversity of consumers remain to be investigated and this heterogeneity currently limits efficient targeting of food-based interventions. Filling this knowledge gap was identified among the priorities of the nutrition research agenda of the country. Research could then support the development of food-based dietary guidelines for the general population above the age of 2 years.
Food-based dietary guidelines is a set of simple advisory statements that gives direction to consumers on healthy eating patterns to promote better nutrition and well-being and to address diet-related conditions. They provide advice on the type of food or food groups that need attention to promote more optimal nutrition and health outcomes for a target population in the country. The overall aim of food-based dietary guidelines is to promote overall health, contribute to the management of specific diet-related diseases and prevention of the risk factors, and to improve micronutrient deficiency and protein-energy malnutrition. Food-based dietary guidelines can be used for dietary advice regarding national food supply planning, better health status, reduced healthcare cost and improve work, growth and learning capacity for different population groups.
Food-based dietary guidelines should be specific to a given country, should be appropriate in terms of socio-demographic profile, nutritional status, health status, and dietary pattern to provide a framework for a healthy diet based on current nutrition recommendations. Country-specific food-based dietary guidelines are relevant due to foods that makeup diet are more than just a collection of nutrients. The nutrients in food interact differently when present as a food and the method of food preparation, processing, and cooking (i.e. food culture) influence the nutritional values of food. Food-based dietary guidelines should target the total diet, including all foods in daily meals and snacks, be based on food commonly consumed and all type of foods. The list of food groups used in FBDGs should be recognizable by consumers, permit the maximum flexibility in food choice to accommodate different eating tradition in a country and the description of food serving size should be in terms of commonly used household measures. Out of 58, only 7 African countries have FBDGs at the moment. Ethiopia is one of those African countries which do not have food-based dietary guidelines. In collaboration with FAO and other key local partners, Wageningen University and Research (WUR) and EPHI planned to develop food-based dietary guidelines for Ethiopian population above 2 years in the coming 4 years (until 2021).
The process for the development of the food-based dietary guidelines will have two major parts; the first part is developing the guidelines and advising how to use it at individual and HH level to improve dietary practice. To do this, establishing a national multidisciplinary technical working group composed of multiple concerned sectors such as ministry of health, ministry of agriculture and natural resources, ministry of livestock and fisheries, ministry of education, universities, research institute and development partners will be crucial to take into account different issues into consideration during the development and translation of the key messages in the FBDGs. The technical committee will agree on the key messages that have to be addressed on the FBDGs for the general population above 2 years based on evidence generated by WUR and EPHI on the wealth of foods, nutrients and health information, and other diet-related evidence and diet modeling. The general guidelines will translate into every day healthy dietary choices for specific population subgroups (women of reproductive age, school-age children, adolescent girls, adults and elderly) based on their dietary reference values. Food guide will be designed using the most commonly consumed foods in different regions of the country. In addition, dietary gap assessment will be done to see how far the FBDGs implementation can be possible in Ethiopia by comparing the current food supply with recommended healthy eating by the population. This will lead additional recommendations for policymakers and technical experts to set agriculture, trade and health target based on the demand formulated on Ethiopian food-based dietary guidelines. During the second part of the process, a healthy eating index will be developed which will be a measure of diet quality and relevant to evaluate the adherence to FBDGs. It is also relevant to determine the risk of diet-related diseases such as arthritis, diverticulitis, CVD, diabetes, common epithelial cancers, with colorectal cancer and mortality risk in Ethiopia for any future research. Therefore, the aim of this study is generating supportive evidence that will be useful for the development and validation of food-based dietary guidelines and a healthy eating index to Ethiopia.
- Conditions
- Healthy
- Being tested
- Food-based dietary guidelines for healthier diet
- Keywords
- Food-Based Dietary guideline, Healthy Eating Index, Healthy Diet, Protocol, Ethiopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food-based dietary guidelines for healthier dietBehavioural
Develop and validate food-based dietary guideline and a healthy eating index
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of foods in gram per day from different food groups
Country-specific food-based dietary guidelines
Measured: From June 2018 - October 2021
Healthy Eating Index
Selection of the healthy eating components will be based on the food-based dietary guidelines developed for all Ethiopian above two years. Each component of a healthy eating index will have a minimum score of zero and maximum score between 5 to 20. The components will be scored in a way that a higher value indicates better adherence to the guidelines. The total healthy eating index score will not estimate an absolute energy intake rather it represents an intake per certain energy content. The total healthy eating index score (the sum of each components) ranges from 0 to 100, with higher scores indicating higher diet quality. The healthy eating index components will be categorized into adequacy, optimum, moderation, and ratio based on the healthier options provided in the food group of food-based dietary guidelines.
Measured: From June 2018 - October 2021
Calorie gap from different food groups
Estimating the dietary gap in different food groups mentioned in the food based dietary guidelines by comparing with world health organization nutrient reference intake for different population group.
Measured: From June 2018 - October 2021
Secondary outcomes (9)
Top 10 diseases based on total number of disability-adjusted life-years (DALYs) among all age and sex in Ethiopia
Secondary data analysis from global burden of disease data
Measured: From June 2018 - October 2021
Top 10 diseases based on total number of death among all age and sex in Ethiopia
Secondary data analysis from global burden of disease data
Measured: From June 2018 - October 2021
Current dietary assessment among different population group
Secondary data analysis from the national food consumption survey. Estimate inadequate intake of nutrients (vitamin A, zinc, calcium and ...) and calories.
Measured: From June 2018 - October 2021
Trend in nutritional status: body mass index (weight in kilogram/ height in meter square)
Nutrition trend analysis using demographic and health survey, other national nutrition and health surveys and desktop review of published journals
Measured: From June 2018 - October 2021
Height in meter
Nutritional status trend analysis such as stunting (height for age < -2 SD of the WHO Child Growth Standards median) analysis using demographic and health survey, other national nutrition and health surveys and desktop review of published journals
Measured: From June 2018 - October 2021
Weight in kilogram
Nutritional status trend analysis such as wasting (weight for height < -2 SD of the WHO child growth standards median) and underweight (weight for height < -2 SD of the WHO child growth standards median) using demographic and health survey, other national nutrition and health surveys and desktop review of published journals
Measured: From June 2018 - October 2021
Cultural acceptability of food-based dietary guidelines
Qualitative study
Measured: From June 2018 - October 2021
Consumer understanding of food-based dietary guidelines
Qualitative study
Measured: From June 2018 - October 2021
Implementation feasibility of food-based dietary guidelines
Qualitative study
Measured: From June 2018 - October 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2018
- Study start1 Nov 2019
- Primary completion30 Oct 2021
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (77)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethiopian Public Health Institute
- Sponsor type
- Other government
- Collaborators
- Wageningen University, Food and Agriculture Organization (FAO), International Food Policy Research Institute
- Responsible party
- Principal investigator, Tesfaye Hailu, Ethiopian Public Health Institute
- Investigators
- Inge D Brouwer, PhD, Study director, Wageningen UniversityEdith Feskens, Prof., PhD, Study chair, Wageningen UniversityJeanne de Vries, PhD, Study chair, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03394963
- Sponsor's protocol ID
- A4NH-FP1-CoA1
- Status last verified
- Oct 2023
- First submitted
- 8 Dec 2017
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Once the protocol finalized and published, it will be shared.
Publications
Muthuri SK, Francis CE, Wachira LJ, Leblanc AG, Sampson M, Onywera VO, Tremblay MS. Evidence of an overweight/obesity transition among school-aged children and youth in Sub-Saharan Africa: a systematic review. PLoS One. 2014 Mar 27;9(3):e92846. doi: 10.1371/journal.pone.0092846. eCollection 2014.
PubMed 24676350Ng M, Fleming T, Robinson M, Thomson B, Graetz N, Margono C, Mullany EC, Biryukov S, Abbafati C, Abera SF, Abraham JP, Abu-Rmeileh NM, Achoki T, AlBuhairan FS, Alemu ZA, Alfonso R, Ali MK, Ali R, Guzman NA, Ammar W, Anwari P, Banerjee A, Barquera S, Basu S, Bennett DA, Bhutta Z, Blore J, Cabral N, Nonato IC, Chang JC, Chowdhury R, Courville KJ, Criqui MH, Cundiff DK, Dabhadkar KC, Dandona L, Davis A, Dayama A, Dharmaratne SD, Ding EL, Durrani AM, Esteghamati A, Farzadfar F, Fay DF, Feigin VL, Flaxman A, Forouzanfar MH, Goto A, Green MA, Gupta R, Hafezi-Nejad N, Hankey GJ, Harewood HC, Havmoeller R, Hay S, Hernandez L, Husseini A, Idrisov BT, Ikeda N, Islami F, Jahangir E, Jassal SK, Jee SH, Jeffreys M, Jonas JB, Kabagambe EK, Khalifa SE, Kengne AP, Khader YS, Khang YH, Kim D, Kimokoti RW, Kinge JM, Kokubo Y, Kosen S, Kwan G, Lai T, Leinsalu M, Li Y, Liang X, Liu S, Logroscino G, Lotufo PA, Lu Y, Ma J, Mainoo NK, Mensah GA, Merriman TR, Mokdad AH, Moschandreas J, Naghavi M, Naheed A, Nand D, Narayan KM, Nelson EL, Neuhouser ML, Nisar MI, Ohkubo T, Oti SO, Pedroza A, Prabhakaran D, Roy N, Sampson U, Seo H, Sepanlou SG, Shibuya K, Shiri R, Shiue I, Singh GM, Singh JA, Skirbekk V, Stapelberg NJ, Sturua L, Sykes BL, Tobias M, Tran BX, Trasande L, Toyoshima H, van de Vijver S, Vasankari TJ, Veerman JL, Velasquez-Melendez G, Vlassov VV, Vollset SE, Vos T, Wang C, Wang X, Weiderpass E, Werdecker A, Wright JL, Yang YC, Yatsuya H, Yoon J, Yoon SJ, Zhao Y, Zhou M, Zhu S, Lopez AD, Murray CJ, Gakidou E. Global, regional, and national prevalence of overweight and obesity in children and adults during 1980-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2014 Aug 30;384(9945):766-81. doi: 10.1016/S0140-6736(14)60460-8. Epub 2014 May 29.
PubMed 24880830Gernand AD, Schulze KJ, Stewart CP, West KP Jr, Christian P. Micronutrient deficiencies in pregnancy worldwide: health effects and prevention. Nat Rev Endocrinol. 2016 May;12(5):274-89. doi: 10.1038/nrendo.2016.37. Epub 2016 Apr 1.
PubMed 27032981Haddad, L.J., et al., Global Nutrition Report 2015: Actions and accountability to advance nutrition and sustainable development. 2015: Intl Food Policy Res Inst.
Tzioumis E, Adair LS. Childhood dual burden of under- and overnutrition in low- and middle-income countries: a critical review. Food Nutr Bull. 2014 Jun;35(2):230-43. doi: 10.1177/156482651403500210.
PubMed 25076771Initiatives, D., Global Nutrition Report 2017: Nourishing the SDGs. 2017.
Mendez MA, Monteiro CA, Popkin BM. Overweight exceeds underweight among women in most developing countries. Am J Clin Nutr. 2005 Mar;81(3):714-21. doi: 10.1093/ajcn/81.3.714.
PubMed 15755843Wojcicki JM. The double burden household in sub-Saharan Africa: maternal overweight and obesity and childhood undernutrition from the year 2000: results from World Health Organization Data (WHO) and Demographic Health Surveys (DHS). BMC Public Health. 2014 Oct 31;14:1124. doi: 10.1186/1471-2458-14-1124.
PubMed 25361562Beal T, Massiot E, Arsenault JE, Smith MR, Hijmans RJ. Global trends in dietary micronutrient supplies and estimated prevalence of inadequate intakes. PLoS One. 2017 Apr 11;12(4):e0175554. doi: 10.1371/journal.pone.0175554. eCollection 2017.
PubMed 28399168Bailey RL, West KP Jr, Black RE. The epidemiology of global micronutrient deficiencies. Ann Nutr Metab. 2015;66 Suppl 2:22-33. doi: 10.1159/000371618. Epub 2015 Jun 2.
PubMed 26045325Ahmed T, Hossain M, Sanin KI. Global burden of maternal and child undernutrition and micronutrient deficiencies. Ann Nutr Metab. 2012;61 Suppl 1:8-17. doi: 10.1159/000345165. Epub 2013 Jan 21.
PubMed 23343943Nguyen PH, Gonzalez-Casanova I, Young MF, Truong TV, Hoang H, Nguyen H, Nguyen S, DiGirolamo AM, Martorell R, Ramakrishnan U. Preconception Micronutrient Supplementation with Iron and Folic Acid Compared with Folic Acid Alone Affects Linear Growth and Fine Motor Development at 2 Years of Age: A Randomized Controlled Trial in Vietnam. J Nutr. 2017 Aug;147(8):1593-1601. doi: 10.3945/jn.117.250597. Epub 2017 Jun 14.
PubMed 28615372Black RE, Victora CG, Walker SP, Bhutta ZA, Christian P, de Onis M, Ezzati M, Grantham-McGregor S, Katz J, Martorell R, Uauy R; Maternal and Child Nutrition Study Group. Maternal and child undernutrition and overweight in low-income and middle-income countries. Lancet. 2013 Aug 3;382(9890):427-451. doi: 10.1016/S0140-6736(13)60937-X. Epub 2013 Jun 6.
PubMed 23746772Popkin BM, Gordon-Larsen P. The nutrition transition: worldwide obesity dynamics and their determinants. Int J Obes Relat Metab Disord. 2004 Nov;28 Suppl 3:S2-9. doi: 10.1038/sj.ijo.0802804.
PubMed 15543214Tebekaw Y, Teller C, Colon-Ramos U. The burden of underweight and overweight among women in Addis Ababa, Ethiopia. BMC Public Health. 2014 Nov 1;14:1126. doi: 10.1186/1471-2458-14-1126.
PubMed 25361603
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scientific Foundations for Developing and Validating Food-based Dietary Guidelines and a Healthy Eating Index for Ethiopia
- ClinicalTrials.gov ID
- NCT03394963
- Acronym / sponsor ID
- A4NH-FP1-CoA1
- Conditions
- Healthy
- Keywords
- Food-Based Dietary guideline, Healthy Eating Index, Healthy Diet, Protocol, Ethiopia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Ethiopian Public Health InstituteOther government
- Collaborators
- Wageningen University, Food and Agriculture Organization (FAO), International Food Policy Research Institute
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 9 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Among several factors contributing to the occurrence of undernutrition, micronutrient deficiencies, overnutrition, and chronic disease, unhealthy diet is one of the most important factors that need to be addressed to tackle the burden in low- and middle-income countries. To maintain healthy eating in a population, it is crucial to develop and implement country-specific food-based dietary guidelines as well as monitor the adherence of the population with the guidelines. The aim of this study is to generate evidence that will help the development and validation of food-based dietary guidelines and a healthy eating index for Ethiopia. The method to develop Ethiopian food-based dietary guidelines is adapted from the 2015 Dutch food-based dietary guidelines and the Dutch healthy diet index development and validation process, and the 1998 FAO/WHO preparation and use of food-based dietary guidelines. A multidisciplinary technical working will be established to develop FBDGs. The working group will identify key messages for the guidelines that can address priority diet-related public health problems in Ethiopia based on the evidence that will be generated by the PhD student from Wageningen University and Research. The evidence generation will begin by identifying top ten diet-related diseases that lead to high morbidity and mortality in 2016. The nutrition situation (nutritional status, dietary pattern, and nutrient gaps) analysis will be conducted to define the objectives of FBDGs. A systematic review will be conducted by formulating research questions to address the objectives of the FBDGs. The FBDGs will be translated for a specific population subgroup using linear mathematical programming and validated for cultural appropriateness, acceptability, consumer understanding and practicality of the messages. Focus group discussions and key informant interviews will be conducted to validate the FBDGs. The most recent Ethiopian national food consumption survey data collected in 2011 will be used to develop a healthy eating index (HEI). The selection of a healthy eating component of HEI will be done based on the FBDGs. Validation of a healthy eating index will be conducted by comparing the HEI score based on 24-hour recall with the HEI score based on food frequency questionnaire for population characteristics and association with micronutrient intake with or without adjusting for energy and anthropometric measurement. Developing short food frequency questionnaire (FFQ) that can be scored with the index for dietary counseling and public health practice as well as dietary gap assessment for policy recommendation will be part of the study. Validation of FFQ will be conducted by collecting primary data among women of reproductive age in 500 households in rural and urban areas of Ethiopia. The data will be analyzed using the latest version of STATA, SPSS, and NVIVO software. Correlations and other appropriate advanced statistical technique will be applied as needed to answer the objectives of the study. Ethical approval will be received from the medical ethical committee of Wageningen University and Research and scientific and ethical review office of Ethiopian Public Health Institute. This Ph.D. research is supported by the Food Systems for Healthier Diets flagship of the CGIAR- Agriculture for Nutrition and Health Programme coordinated by International Food Policy Research Institute. Food and Agriculture Organization (FAO) and Ethiopian Public Health Institute are collaborators of this project to develop the FBDGs.
Detailed description
Triple burden of malnutrition (i.e. protein-energy malnutrition including micronutrient deficiency and overnutrition) is a current global problem. In 2017, 155 out of 677 million children in the world under the age of 5 years were stunted (height for age < -2 SD of the WHO Child Growth Standards median), 52 million wasted (weight for height < -2 SD of the WHO child growth standards median) and 41 million overweight (weight for height > 2 SD of the WHO child growth standards median) with 93 million children at risk of overweight. Out of 5 billion adults worldwide, nearly 2 billion are overweight (BMI > 25 kg/m2) or obese (BMI > 30 kg/m2) and one in 12 has a type -2 diabetes mellitus. The mean prevalence of adult obesity in the WHO data set was 7.5 ± 6.0% while adult overweight was much higher at 21.8 ± 10.2% and adult underweight was 13.4 ± 7.0%. The median ratio of overweight to underweight among women age 20 - 49 years was 5.8 in urban and 2.1 in rural areas of low- and middle-income countries (LMICs). Even many poor countries, countries in which underweight persists as a significant problem, had a fairly high prevalence of rural overweight. As compared to the overall Sub-Saharan Africa (SSA), urban prevalence of adult obesity and overweight were higher (12.5 ± 7.0% and 31.8 ± 12.8% respectively), child undernutrition was generally lower (30.4 ± 8.4% for stunting < -2SD from median height for age,15.5 ± 7.0% for underweight < -2SD from median weight for age and 12.0 ± 5.0% for wasting < -2SD from median weight for height) and adult underweight (BMI < 18.5 kg/m2) was also 10.5%. In addition to this, two billion people living in developing and developed countries are micronutrients deficient; they lack the vital vitamins and minerals needed to grow properly and live healthily. Iron, iodine, vitamin A, zinc, and folate separately or in combination are the priority micronutrient deficiencies for populations in most countries of the world. Micronutrient deficiencies have consequences throughout an individual's lifespan and are perpetuated across the generations. Thus, maternal and child malnutrition in low- and middle-income countries encompasses undernutrition and micronutrient deficiency, with a growing problem of overweight and obesity. The problem of triple burden of malnutrition is especially increasing in low- and middle-income countries mainly due to urbanization, fast economic growth, and changes in dietary pattern and lifestyle.
Ethiopia has a fast growing economy over the past 10 years, and a changing food environment, with declining shares of food expenditures and increased access to non-staples, processed foods, and sugary beverages. Stunting among young children has reduced from 57% in 2000, to 40% in 2014. Nevertheless, levels of stunting are still among the highest in the world and the contribution starts from underweight mothers whose birth outcome is a child with low birth weight. According to 2016 demographic and health survey report, the prevalence of stunting among under 5 children is 38%, wasting 9.9% and underweight 23.6%. The national nutrition survey conducted by Ethiopian Public Health Institute (EPHI) in 2015 also indicated that the prevalence of underweight (BMI<18.5 kg/m2) and overweight among women of reproductive age are 20% and 13% respectively. Overweight had increased by 10% between 2009 and 2015 according to the national nutrition survey results and other studies. The national micronutrient survey also showed that anemia, vitamin A, zinc, iodine, folate and vitamin B12 are public health problems among all population in Ethiopia. This indicates that, like other LMICs, Ethiopia is suffering from the triple burden of malnutrition.
The unhealthy diet is one of the most important risk factors that need to be addressed to tackle the triple burden of malnutrition in LMICs. The changes in the pattern of dietary risk factors in low- and middle-income countries is characterized by increases in the consumption of animal fat and protein, refined grains, and added sugar. In middle-income countries, from1989 to 2011, the percentage of individuals with consumption frequency of fish 5 + per week has decreased from 93% to 74%, that with consumption frequency of meat 5 + per week has increased from 25% to 51%, consumption frequency of fruits 1 + per week has increased from 48% to 94%, consumption frequency of salty snacks 1 + per week has increase from 22% to 64%, consumption frequency of sweet snacks has increased from 38% to 67%, and from 2004 to 2011, consumption frequency of poultry has increased from 86% to 96%. On the other hand, in Sub-Saharan African (SSA) countries, dietary micronutrient density index (average micronutrient density of the food supply based on 14 micronutrients: calcium, copper, iron, folate, magnesium, niacin, phosphorus, riboflavin, thiamin, vitamin A, vitamin B12, vitamin B6, vitamin C, and zinc using the 2011 global population-weighted Recommended Dietary Allowance [RDA]) has declined over the past 50 years. This indicates that there is a policy gap in terms of improving dietary quality for better health, prevention of diet-related diseases, and triple burden of malnutrition in LMICs setting. Promoting healthy eating in low- and middle-income countries can reduce the social inequality among the poor and rich, especially when it targets the disadvantaged population group. In general, healthy global diet can reduce global mortality by 6 - 10%, and greenhouse emission by 29-70%, reduce biodiversity loss and economic benefit up to 31 trillion US dollar and adoption of global dietary guidelines would result in 5.1 million avoided deaths per year [95% confidence interval (CI), 4.8-5.5 million] and 79 million years of life saved (CI, 75-83 million).
Besides this, lack of a healthy diet also contributes to the burden of diet-related diseases. Intakes of a diet low in fruits and vegetables and high in sodium are the leading dietary risks factors for non-communicable diseases (NCDs) burden in Ethiopia. Evidence from animal, clinical and epidemiological studies also showed that specific dietary patterns are associated with reduced risk of specific disease. Fruits and vegetables are associated with a reduction of the incidence of an esophagus, lung, stomach, and colorectum cancer and coronary heart diseases. In addition, by promoting a healthy diet, it is also possible to prevent different forms of malnutrition and micronutrient deficiencies.
A healthy diet means eating a variety of foods that can give the nutrients needed to maintain or improve health, feel good, and have adequate energy content. The nutrients include protein, carbohydrates, fat, water, vitamins, and minerals. To maintain healthy eating in a population, it is crucial to develop and implement country-specific food-based dietary guidelines and to enable tracking the adherence of the population to the food-based dietary guidelines.
Indications for dietary transitions are observed in several overall trends of Ethiopian eating habits such as increased energy intake, declining but still a dominant share of cereals in diets, and more purchased foods. Whether diets as a whole are changing towards healthier or unhealthier patterns, and how this differs between and within regions and population subgroups, is unclear. The increase in consumption of unhealthier components might be faster than that of healthy components as in many (187 countries) other countries of the world. In addition, Ethiopia's food production and supply are very vulnerable to climate change and variability (droughts in 2015-2016), which leads to temporal high levels of severe food insecurity and malnutrition which can easily affect the dietary pattern of the population. A national food consumption study conducted by EPHI sheds light on some major dietary gaps, including inadequate intake of vitamin A, calcium, folate and zinc. However, the heterogeneity of dietary patterns and dietary nutrient gaps concerns among the large diversity of consumers remain to be investigated and this heterogeneity currently limits efficient targeting of food-based interventions. Filling this knowledge gap was identified among the priorities of the nutrition research agenda of the country. Research could then support the development of food-based dietary guidelines for the general population above the age of 2 years.
Food-based dietary guidelines is a set of simple advisory statements that gives direction to consumers on healthy eating patterns to promote better nutrition and well-being and to address diet-related conditions. They provide advice on the type of food or food groups that need attention to promote more optimal nutrition and health outcomes for a target population in the country. The overall aim of food-based dietary guidelines is to promote overall health, contribute to the management of specific diet-related diseases and prevention of the risk factors, and to improve micronutrient deficiency and protein-energy malnutrition. Food-based dietary guidelines can be used for dietary advice regarding national food supply planning, better health status, reduced healthcare cost and improve work, growth and learning capacity for different population groups.
Food-based dietary guidelines should be specific to a given country, should be appropriate in terms of socio-demographic profile, nutritional status, health status, and dietary pattern to provide a framework for a healthy diet based on current nutrition recommendations. Country-specific food-based dietary guidelines are relevant due to foods that makeup diet are more than just a collection of nutrients. The nutrients in food interact differently when present as a food and the method of food preparation, processing, and cooking (i.e. food culture) influence the nutritional values of food. Food-based dietary guidelines should target the total diet, including all foods in daily meals and snacks, be based on food commonly consumed and all type of foods. The list of food groups used in FBDGs should be recognizable by consumers, permit the maximum flexibility in food choice to accommodate different eating tradition in a country and the description of food serving size should be in terms of commonly used household measures. Out of 58, only 7 African countries have FBDGs at the moment. Ethiopia is one of those African countries which do not have food-based dietary guidelines. In collaboration with FAO and other key local partners, Wageningen University and Research (WUR) and EPHI planned to develop food-based dietary guidelines for Ethiopian population above 2 years in the coming 4 years (until 2021).
The process for the development of the food-based dietary guidelines will have two major parts; the first part is developing the guidelines and advising how to use it at individual and HH level to improve dietary practice. To do this, establishing a national multidisciplinary technical working group composed of multiple concerned sectors such as ministry of health, ministry of agriculture and natural resources, ministry of livestock and fisheries, ministry of education, universities, research institute and development partners will be crucial to take into account different issues into consideration during the development and translation of the key messages in the FBDGs. The technical committee will agree on the key messages that have to be addressed on the FBDGs for the general population above 2 years based on evidence generated by WUR and EPHI on the wealth of foods, nutrients and health information, and other diet-related evidence and diet modeling. The general guidelines will translate into every day healthy dietary choices for specific population subgroups (women of reproductive age, school-age children, adolescent girls, adults and elderly) based on their dietary reference values. Food guide will be designed using the most commonly consumed foods in different regions of the country. In addition, dietary gap assessment will be done to see how far the FBDGs implementation can be possible in Ethiopia by comparing the current food supply with recommended healthy eating by the population. This will lead additional recommendations for policymakers and technical experts to set agriculture, trade and health target based on the demand formulated on Ethiopian food-based dietary guidelines. During the second part of the process, a healthy eating index will be developed which will be a measure of diet quality and relevant to evaluate the adherence to FBDGs. It is also relevant to determine the risk of diet-related diseases such as arthritis, diverticulitis, CVD, diabetes, common epithelial cancers, with colorectal cancer and mortality risk in Ethiopia for any future research. Therefore, the aim of this study is generating supportive evidence that will be useful for the development and validation of food-based dietary guidelines and a healthy eating index to Ethiopia.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 2 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The FBDGs validation, a HEI and FFQ tools development and validation will target women of reproductive age (15-49 years), are not planning to move from the study and do not have a severe illness at the time of enrolment. Exclusion criteria will be a severe illness.
Key inclusion criteria (3 listed)
- General population above 2 years of FBDGs development
- Women of reproductive age (15-49 years) for FBDGs validation
- Women of reproductive age (15-49 years) for HEI development and validation
Key exclusion criteria (1 listed)
- population groups other than women of reproductive age for FBDGs validation, and HEI development and validation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Food-based dietary guidelines for healthier dietDevelop and validate food-based dietary guideline and a healthy eating index | Behavioural | – |
Primary outcome
Amount of foods in gram per day from different food groups
Time frame: From June 2018 - October 2021
Country-specific food-based dietary guidelines
Healthy Eating Index
Time frame: From June 2018 - October 2021
Selection of the healthy eating components will be based on the food-based dietary guidelines developed for all Ethiopian above two years. Each component of a healthy eating index will have a minimum score of zero and maximum score between 5 to 20. The components will be scored in a way that a higher value indicates better adherence to the guidelines. The total healthy eating index score will not estimate an absolute energy intake rather it represents an intake per certain energy content. The total healthy eating index score (the sum of each components) ranges from 0 to 100, with higher scores indicating higher diet quality. The healthy eating index components will be categorized into adequacy, optimum, moderation, and ratio based on the healthier options provided in the food group of food-based dietary guidelines.
Calorie gap from different food groups
Time frame: From June 2018 - October 2021
Estimating the dietary gap in different food groups mentioned in the food based dietary guidelines by comparing with world health organization nutrient reference intake for different population group.
9 secondary outcomes
Top 10 diseases based on total number of disability-adjusted life-years (DALYs) among all age and sex in Ethiopia
Time frame: From June 2018 - October 2021
Top 10 diseases based on total number of death among all age and sex in Ethiopia
Time frame: From June 2018 - October 2021
Current dietary assessment among different population group
Time frame: From June 2018 - October 2021
Trend in nutritional status: body mass index (weight in kilogram/ height in meter square)
Time frame: From June 2018 - October 2021
Height in meter
Time frame: From June 2018 - October 2021
Weight in kilogram
Time frame: From June 2018 - October 2021
Cultural acceptability of food-based dietary guidelines
Time frame: From June 2018 - October 2021
Consumer understanding of food-based dietary guidelines
Time frame: From June 2018 - October 2021
Implementation feasibility of food-based dietary guidelines
Time frame: From June 2018 - October 2021
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Background: PubMed 24676350Muthuri SK, Francis CE, Wachira LJ, Leblanc AG, Sampson M, Onywera VO, Tremblay MS. Evidence of an overweight/obesity transition among school-aged children and youth in Sub-Saharan Africa: a systematic review. PLoS One. 2014 Mar 27;9(3):e92846. doi: 10.1371/journal.pone.0092846. eCollection 2014.
- Background: PubMed 24880830Ng M, Fleming T, Robinson M, Thomson B, Graetz N, Margono C, Mullany EC, Biryukov S, Abbafati C, Abera SF, Abraham JP, Abu-Rmeileh NM, Achoki T, AlBuhairan FS, Alemu ZA, Alfonso R, Ali MK, Ali R, Guzman NA, Ammar W, Anwari P, Banerjee A, Barquera S, Basu S, Bennett DA, Bhutta Z, Blore J, Cabral N, Nonato IC, Chang JC, Chowdhury R, Courville KJ, Criqui MH, Cundiff DK, Dabhadkar KC, Dandona L, Davis A, Dayama A, Dharmaratne SD, Ding EL, Durrani AM, Esteghamati A, Farzadfar F, Fay DF, Feigin VL, Flaxman A, Forouzanfar MH, Goto A, Green MA, Gupta R, Hafezi-Nejad N, Hankey GJ, Harewood HC, Havmoeller R, Hay S, Hernandez L, Husseini A, Idrisov BT, Ikeda N, Islami F, Jahangir E, Jassal SK, Jee SH, Jeffreys M, Jonas JB, Kabagambe EK, Khalifa SE, Kengne AP, Khader YS, Khang YH, Kim D, Kimokoti RW, Kinge JM, Kokubo Y, Kosen S, Kwan G, Lai T, Leinsalu M, Li Y, Liang X, Liu S, Logroscino G, Lotufo PA, Lu Y, Ma J, Mainoo NK, Mensah GA, Merriman TR, Mokdad AH, Moschandreas J, Naghavi M, Naheed A, Nand D, Narayan KM, Nelson EL, Neuhouser ML, Nisar MI, Ohkubo T, Oti SO, Pedroza A, Prabhakaran D, Roy N, Sampson U, Seo H, Sepanlou SG, Shibuya K, Shiri R, Shiue I, Singh GM, Singh JA, Skirbekk V, Stapelberg NJ, Sturua L, Sykes BL, Tobias M, Tran BX, Trasande L, Toyoshima H, van de Vijver S, Vasankari TJ, Veerman JL, Velasquez-Melendez G, Vlassov VV, Vollset SE, Vos T, Wang C, Wang X, Weiderpass E, Werdecker A, Wright JL, Yang YC, Yatsuya H, Yoon J, Yoon SJ, Zhao Y, Zhou M, Zhu S, Lopez AD, Murray CJ, Gakidou E. Global, regional, and national prevalence of overweight and obesity in children and adults during 1980-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2014 Aug 30;384(9945):766-81. doi: 10.1016/S0140-6736(14)60460-8. Epub 2014 May 29.
- Background: PubMed 27032981Gernand AD, Schulze KJ, Stewart CP, West KP Jr, Christian P. Micronutrient deficiencies in pregnancy worldwide: health effects and prevention. Nat Rev Endocrinol. 2016 May;12(5):274-89. doi: 10.1038/nrendo.2016.37. Epub 2016 Apr 1.
- BackgroundHaddad, L.J., et al., Global Nutrition Report 2015: Actions and accountability to advance nutrition and sustainable development. 2015: Intl Food Policy Res Inst.
- Background: PubMed 25076771Tzioumis E, Adair LS. Childhood dual burden of under- and overnutrition in low- and middle-income countries: a critical review. Food Nutr Bull. 2014 Jun;35(2):230-43. doi: 10.1177/156482651403500210.
- BackgroundInitiatives, D., Global Nutrition Report 2017: Nourishing the SDGs. 2017.
- Background: PubMed 15755843Mendez MA, Monteiro CA, Popkin BM. Overweight exceeds underweight among women in most developing countries. Am J Clin Nutr. 2005 Mar;81(3):714-21. doi: 10.1093/ajcn/81.3.714.
- Background: PubMed 25361562Wojcicki JM. The double burden household in sub-Saharan Africa: maternal overweight and obesity and childhood undernutrition from the year 2000: results from World Health Organization Data (WHO) and Demographic Health Surveys (DHS). BMC Public Health. 2014 Oct 31;14:1124. doi: 10.1186/1471-2458-14-1124.
- Background: PubMed 28399168Beal T, Massiot E, Arsenault JE, Smith MR, Hijmans RJ. Global trends in dietary micronutrient supplies and estimated prevalence of inadequate intakes. PLoS One. 2017 Apr 11;12(4):e0175554. doi: 10.1371/journal.pone.0175554. eCollection 2017.
- Background: PubMed 26045325Bailey RL, West KP Jr, Black RE. The epidemiology of global micronutrient deficiencies. Ann Nutr Metab. 2015;66 Suppl 2:22-33. doi: 10.1159/000371618. Epub 2015 Jun 2.
- Background: PubMed 23343943Ahmed T, Hossain M, Sanin KI. Global burden of maternal and child undernutrition and micronutrient deficiencies. Ann Nutr Metab. 2012;61 Suppl 1:8-17. doi: 10.1159/000345165. Epub 2013 Jan 21.
- Background: PubMed 28615372Nguyen PH, Gonzalez-Casanova I, Young MF, Truong TV, Hoang H, Nguyen H, Nguyen S, DiGirolamo AM, Martorell R, Ramakrishnan U. Preconception Micronutrient Supplementation with Iron and Folic Acid Compared with Folic Acid Alone Affects Linear Growth and Fine Motor Development at 2 Years of Age: A Randomized Controlled Trial in Vietnam. J Nutr. 2017 Aug;147(8):1593-1601. doi: 10.3945/jn.117.250597. Epub 2017 Jun 14.
- Individual participant dataSharing planned: No. Once the protocol finalized and published, it will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Inge D Brouwer, PhD study director
Wageningen University
Edith Feskens, Prof., PhD study chair
Wageningen University
Jeanne de Vries, PhD study chair
Wageningen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Ethiopian Public Health Institute at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of foods in gram per day from different food groups (time frame: From June 2018 - October 2021). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03394963, which also lists 77 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.