Dietary AssessmentFFQ RwandaNCT04202107
Dietary Assessment in Rwanda - Food Frequency Questionnaire
An observational study of Dietary Assessment, run by University Ghent at 1 site in Rwanda.
Trial summary
The burden of non-communicable diseases (NCDs) in Rwanda is adding to the health burden in the country which is facing the nutritional transition and the double burden of malnutrition. Read more about this study
- Who is it for?
- Ages 18 to 49 years
- Conditions the study is for
- Dietary Assessment
- What is being tested?
- Food Frequency Questionnaire and 24 Hour food recall
- How many people
- 200 participants
- Where
- 1 siteRwanda
- Study dates
- 30 Jan 2020to 31 Dec 2021
- 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 18 to 49 years
- All sexes
- Adult
Study population: In total, 100 participants will be selected from 100 households (one per household) in urban villages (mainly in Kigali) and the same number of participants from rural communities of Rwanda will be recruited in the validation study.
Who may be able to join
- Permanent residence of the selected urban or rural villages
- Holding a valid health insurance card
- Aged between 18 and 49 years
- Signing informed consent form
- Familiar with the diet and cooking practices
- Registration in city demographic system, since study participants will be selected from population registration cards at village level,
- Accept enumerators for home visit and data collection for one year
Who cannot join
- Mental disorders such as clinically diagnosed depression, anxiety disorders, eating disorders and addictive behaviors
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Evaluation of a Semi-quantitative Food Frequency Questionnaire for Use in Urban and Rural Communities of Rwanda
The burden of non-communicable diseases (NCDs) in Rwanda is adding to the health burden in the country which is facing the nutritional transition and the double burden of malnutrition. Diet is an established risk factor in NCDs, hence the importance to assess accurately the changes in dietary habits occurring in the population. The objective is to develop and validate a food frequency questionnaire in Rwanda.
Read the detailed description
In many developing countries, including Rwanda, the lack of developed and validated questionnaires is among major challenges for dietary assessment in nutritional surveys. Questionnaires are mostly borrowed from other communities. This can increase the error range due to low adaptation to local context, especially when they are not validated and may not have similar objectives. One Food Frequency Questionnaire (FFQ) does not capture dietary history in two different countries or regions, unless their diets are similar. Besides, the diet changes with time, where new foods are introduced in diet and others may disappear. In Rwanda, one FFQ has been developed to cover only the eastern part of the country, but none for the entire country (Cade et al., 2001; FAO, 2018). It is then very important to develop and validate an update and general FFQ that can be used across the country to measure the dietary intake to have a better interpretation of the study findings from the Rwandan context.
The overall objective is to develop and validate a semi-quantitative FFQ that can be used to assess the food and nutrient intake in urban and rural communities of Rwanda.
Specific objectives include:
- To collect data on diet intake of selected participants by using a 24-H recall questionnaire that includes pictures on the approximate quantities consumed in each occasion.
- To develop a list of food items from commonly consumed food by study participants using the compiled 24-h recall questionnaire to use for an FFQ development. Additionally, an open question format to collect information on foods consumed during social gathering and festivals will be used to include unreported foods. FFQ shall include additionally the food portion size, and the frequency of intake over a reference period of one year.
- To assess the accuracy of the developed FFQ in estimating energy and nutrient intake using the 24-H dietary recall as a benchmark of accuracy.
- Conditions
- Dietary Assessment
- Being tested
- Food Frequency Questionnaire, 24 Hour food recall
- Keywords
- Dietary assessment, Food Frequency Questionnaire, multi-pass 24 hour food recall, semi-quantitative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food Frequency QuestionnaireOther
Food frequency questionnaires (FFQs) are a common method for measuring dietary intake in large epidemiological studies, in particular in low literacy settings were diaries and food history would not be viable.
24 Hour food recallOther
Standardized and validated approach of collecting all foods, beverages, and supplements consumed during the past 24 hours
| Study group | Role | What they receive |
|---|---|---|
| Urban | Men and women between 18 and 49 years of age living in the selected urban communities in Rwanda and who are familiar with the diet.
Participants in this study should be acquainted with cooking practices to be able to cite all the ingredients that are used in the preparation of the dishes/ meals Receives: Other: Food Frequency Questionnaire; Other: 24 Hour food recall | |
| Rural | Men and women between 18 and 49 years of age living in the selected urban communities in Rwanda and who are familiar with the diet.
Participants in this study should be acquainted with cooking practices to be able to cite all the ingredients that are used in the preparation of the dishes/ meals Receives: Other: Food Frequency Questionnaire; Other: 24 Hour food recall |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median proportion of energy intake from carbohydrates assessed by the 24 hour recalls
Median proportion of energy intake from carbohydrates (starch from grains and tubers such as corn, pasta, rice, potatoes, breads), natural sugars from fruits and juices, and added sugars found in soft drinks, candy, fruit drinks, and desserts) assessed by the 24 hour recalls Adults should get 45 percent to 65 percent of their calories from carbohydrates
Measured: One year
Median proportion of energy intake from carbohydrates assessed by the Food Frequency Questionnaire
Median proportion of energy intake from carbohydrates (starch from grains and tubers such as corn, pasta, rice, potatoes, breads), natural sugars from fruits and juices, and added sugars found in soft drinks, candy, fruit drinks, and desserts) assessed by the Food Frequency Questionnaire.
Adults should get 45 percent to 65 percent of their calories from carbohydrates
Measured: One year
Median proportion of energy intake from fat assessed by the 24 hour recalls
Median proportion of energy intake from fat (Butter, margarine, vegetable oils, whole milk, visible fat on meat and poultry products, invisible fat in fish, shellfish, some plant products such as seeds and nuts, and bakery products) assessed by the 24 hour recalls.
Adults should get 20 percent to 35 percent of their calories from fat
Measured: One year
Median proportion of energy intake from fat assessed by the Food Frequency Questionnaire
Median proportion of energy intake from fat (Butter, margarine, vegetable oils, whole milk, visible fat on meat and poultry products, invisible fat in fish, shellfish, some plant products such as seeds and nuts, and bakery products) assessed by the Food Frequency Questionnaire.
Adults should get 20 percent to 35 percent of their calories from fat
Measured: One year
Median proportion of energy intake from proteins assessed by the 24 hour recalls
Median proportion of energy intake from proteins (from animal sources, such as meat, poultry, fish, eggs, milk, cheese, and yogurt; and proteins from plants, legumes, grains, nuts, seeds, and vegetables) assessed by the 24 hour recalls.
Adults should get 10 to 35 percent of their calories from protein
Measured: One year
Median proportion of energy intake from proteins assessed by the Food Frequency Questionnaire
Median proportion of energy intake from proteins (from animal sources, such as meat, poultry, fish, eggs, milk, cheese, and yogurt; and proteins from plants, legumes, grains, nuts, seeds, and vegetables) assessed by the Food Frequency Questionnaire.
Adults should get 10 to 35 percent of their calories from protein
Measured: One year
Median daily intake of fibers assessed by the 24 hour recalls
Median daily intake of fibers (in gram; Includes dietary fiber naturally present in grains, such as found in oats, wheat, or unmilled rice; and functional fiber synthesized or isolated from plants or animals) assessed by the 24 hour recalls.
The recommended intake for total fiber for adults 50 years and younger is set at 38 grams for men and 25 grams for women
Measured: One year
Median daily intake of fibers assessed by the Food Frequency Questionnaire
Median daily intake of fibers (in gram; Includes dietary fiber naturally present in grains, such as found in oats, wheat, or unmilled rice; and functional fiber synthesized or isolated from plants or animals) assessed by the Food Frequency Questionnaire.
The recommended intake for total fiber for adults 50 years and younger is set at 38 grams for men and 25 grams for women
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2019
- Study start30 Jan 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Dietary AssessmentStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rwanda, Institut de Recherche en Sciences de la Sante, Burkina Faso
- Responsible party
- Sponsor
- Investigators
- Stefaan De Henauw, Md. PhD, Principal investigator, University GhentSouheila Abbeddou, MSc. PhD, Principal investigator, UGentJerome Some, Md. PhD, Principal investigator, Institut de Recherche en Sciences de la Sante, Ouagadougou, Burkina FasoHilda Vasanthakaalam, PhD, Principal investigator, University of Rwanda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04202107
- Sponsor's protocol ID
- EC/2019/1578
- Acronym
- FFQ Rwanda
- Status last verified
- Nov 2022
- First submitted
- 27 Nov 2019
- Last updated
- 15 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bowen L, Bharathi AV, Kinra S, Destavola B, Ness A, Ebrahim S. Development and evaluation of a semi-quantitative food frequency questionnaire for use in urban and rural India. Asia Pac J Clin Nutr. 2012;21(3):355-60.
PubMed 22705424Cade J, Thompson R, Burley V, Warm D. Development, validation and utilisation of food-frequency questionnaires - a review. Public Health Nutr. 2002 Aug;5(4):567-87. doi: 10.1079/PHN2001318.
PubMed 12186666Aglago EK, Landais E, Nicolas G, Margetts B, Leclercq C, Allemand P, Aderibigbe O, Agueh VD, Amuna P, Annor GA, El Ati J, Coates J, Colaiezzi B, Compaore E, Delisle H, Faber M, Fungo R, Gouado I, El Hamdouchi A, Hounkpatin WA, Konan AG, Labzizi S, Ledo J, Mahachi C, Maruapula SD, Mathe N, Mbabazi M, Mirembe MW, Mizehoun-Adissoda C, Nzi CD, Pisa PT, El Rhazi K, Zotor F, Slimani N. Evaluation of the international standardized 24-h dietary recall methodology (GloboDiet) for potential application in research and surveillance within African settings. Global Health. 2017 Jun 19;13(1):35. doi: 10.1186/s12992-017-0260-6.
PubMed 28629424Shridhar K, Satija A, Dhillon PK, Agrawal S, Gupta R, Bowen L, Kinra S, Bharathi AV, Prabhakaran D, Srinath Reddy K, Ebrahim S; Indian Migration Study group. Association between empirically derived dietary patterns with blood lipids, fasting blood glucose and blood pressure in adults - the India migration study. Nutr J. 2018 Feb 8;17(1):15. doi: 10.1186/s12937-018-0327-0.
PubMed 29422041
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of a Semi-quantitative Food Frequency Questionnaire for Use in Urban and Rural Communities of Rwanda
- ClinicalTrials.gov ID
- NCT04202107
- Acronym / sponsor ID
- FFQ Rwanda / EC/2019/1578
- Conditions
- Dietary Assessment
- Keywords
- Dietary assessment, Food Frequency Questionnaire, multi-pass 24 hour food recall, semi-quantitative
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- University of Rwanda, Institut de Recherche en Sciences de la Sante, Burkina Faso
- Study start
- 30 Jan 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 17 Dec 2019 (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.
The burden of non-communicable diseases (NCDs) in Rwanda is adding to the health burden in the country which is facing the nutritional transition and the double burden of malnutrition. Diet is an established risk factor in NCDs, hence the importance to assess accurately the changes in dietary habits occurring in the population. The objective is to develop and validate a food frequency questionnaire in Rwanda.
Detailed description
In many developing countries, including Rwanda, the lack of developed and validated questionnaires is among major challenges for dietary assessment in nutritional surveys. Questionnaires are mostly borrowed from other communities. This can increase the error range due to low adaptation to local context, especially when they are not validated and may not have similar objectives. One Food Frequency Questionnaire (FFQ) does not capture dietary history in two different countries or regions, unless their diets are similar. Besides, the diet changes with time, where new foods are introduced in diet and others may disappear. In Rwanda, one FFQ has been developed to cover only the eastern part of the country, but none for the entire country (Cade et al., 2001; FAO, 2018). It is then very important to develop and validate an update and general FFQ that can be used across the country to measure the dietary intake to have a better interpretation of the study findings from the Rwandan context.
The overall objective is to develop and validate a semi-quantitative FFQ that can be used to assess the food and nutrient intake in urban and rural communities of Rwanda.
Specific objectives include:
- To collect data on diet intake of selected participants by using a 24-H recall questionnaire that includes pictures on the approximate quantities consumed in each occasion.
- To develop a list of food items from commonly consumed food by study participants using the compiled 24-h recall questionnaire to use for an FFQ development. Additionally, an open question format to collect information on foods consumed during social gathering and festivals will be used to include unreported foods. FFQ shall include additionally the food portion size, and the frequency of intake over a reference period of one year.
- To assess the accuracy of the developed FFQ in estimating energy and nutrient intake using the 24-H dietary recall as a benchmark of accuracy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Urban | – | Other: Food Frequency Questionnaire, Other: 24 Hour food recallMen and women between 18 and 49 years of age living in the selected urban communities in Rwanda and who are familiar with the diet. Participants in this study should be acquainted with cooking practices to be able to cite all the ingredients that are used in the preparation of the dishes/ meals |
| Rural | – | Other: Food Frequency Questionnaire, Other: 24 Hour food recallMen and women between 18 and 49 years of age living in the selected urban communities in Rwanda and who are familiar with the diet. Participants in this study should be acquainted with cooking practices to be able to cite all the ingredients that are used in the preparation of the dishes/ meals |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Age groups
- Adult
- Study population
- In total, 100 participants will be selected from 100 households (one per household) in urban villages (mainly in Kigali) and the same number of participants from rural communities of Rwanda will be recruited in the validation study.
Key inclusion criteria (7 listed)
- Permanent residence of the selected urban or rural villages
- Holding a valid health insurance card
- Aged between 18 and 49 years
- Signing informed consent form
- Familiar with the diet and cooking practices
Key exclusion criteria (1 listed)
- Mental disorders such as clinically diagnosed depression, anxiety disorders, eating disorders and addictive behaviors
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 Frequency QuestionnaireFood frequency questionnaires (FFQs) are a common method for measuring dietary intake in large epidemiological studies, in particular in low literacy settings were diaries and food history would not be viable. | Other | Rural, Urban |
| 24 Hour food recallStandardized and validated approach of collecting all foods, beverages, and supplements consumed during the past 24 hours | Other | Rural, Urban |
Primary outcome
Median proportion of energy intake from carbohydrates assessed by the 24 hour recalls
Time frame: One year
Median proportion of energy intake from carbohydrates (starch from grains and tubers such as corn, pasta, rice, potatoes, breads), natural sugars from fruits and juices, and added sugars found in soft drinks, candy, fruit drinks, and desserts) assessed by the 24 hour recalls Adults should get 45 percent to 65 percent of their calories from carbohydrates
Median proportion of energy intake from carbohydrates assessed by the Food Frequency Questionnaire
Time frame: One year
Median proportion of energy intake from carbohydrates (starch from grains and tubers such as corn, pasta, rice, potatoes, breads), natural sugars from fruits and juices, and added sugars found in soft drinks, candy, fruit drinks, and desserts) assessed by the Food Frequency Questionnaire. Adults should get 45 percent to 65 percent of their calories from carbohydrates
Median proportion of energy intake from fat assessed by the 24 hour recalls
Time frame: One year
Median proportion of energy intake from fat (Butter, margarine, vegetable oils, whole milk, visible fat on meat and poultry products, invisible fat in fish, shellfish, some plant products such as seeds and nuts, and bakery products) assessed by the 24 hour recalls. Adults should get 20 percent to 35 percent of their calories from fat
Median proportion of energy intake from fat assessed by the Food Frequency Questionnaire
Time frame: One year
Median proportion of energy intake from fat (Butter, margarine, vegetable oils, whole milk, visible fat on meat and poultry products, invisible fat in fish, shellfish, some plant products such as seeds and nuts, and bakery products) assessed by the Food Frequency Questionnaire. Adults should get 20 percent to 35 percent of their calories from fat
Median proportion of energy intake from proteins assessed by the 24 hour recalls
Time frame: One year
Median proportion of energy intake from proteins (from animal sources, such as meat, poultry, fish, eggs, milk, cheese, and yogurt; and proteins from plants, legumes, grains, nuts, seeds, and vegetables) assessed by the 24 hour recalls. Adults should get 10 to 35 percent of their calories from protein
Median proportion of energy intake from proteins assessed by the Food Frequency Questionnaire
Time frame: One year
Median proportion of energy intake from proteins (from animal sources, such as meat, poultry, fish, eggs, milk, cheese, and yogurt; and proteins from plants, legumes, grains, nuts, seeds, and vegetables) assessed by the Food Frequency Questionnaire. Adults should get 10 to 35 percent of their calories from protein
Median daily intake of fibers assessed by the 24 hour recalls
Time frame: One year
Median daily intake of fibers (in gram; Includes dietary fiber naturally present in grains, such as found in oats, wheat, or unmilled rice; and functional fiber synthesized or isolated from plants or animals) assessed by the 24 hour recalls. The recommended intake for total fiber for adults 50 years and younger is set at 38 grams for men and 25 grams for women
Median daily intake of fibers assessed by the Food Frequency Questionnaire
Time frame: One year
Median daily intake of fibers (in gram; Includes dietary fiber naturally present in grains, such as found in oats, wheat, or unmilled rice; and functional fiber synthesized or isolated from plants or animals) assessed by the Food Frequency Questionnaire. The recommended intake for total fiber for adults 50 years and younger is set at 38 grams for men and 25 grams for women
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 15 Nov 2022.
- Background: PubMed 22705424Bowen L, Bharathi AV, Kinra S, Destavola B, Ness A, Ebrahim S. Development and evaluation of a semi-quantitative food frequency questionnaire for use in urban and rural India. Asia Pac J Clin Nutr. 2012;21(3):355-60.
- Background: PubMed 12186666Cade J, Thompson R, Burley V, Warm D. Development, validation and utilisation of food-frequency questionnaires - a review. Public Health Nutr. 2002 Aug;5(4):567-87. doi: 10.1079/PHN2001318.
- Background: PubMed 28629424Aglago EK, Landais E, Nicolas G, Margetts B, Leclercq C, Allemand P, Aderibigbe O, Agueh VD, Amuna P, Annor GA, El Ati J, Coates J, Colaiezzi B, Compaore E, Delisle H, Faber M, Fungo R, Gouado I, El Hamdouchi A, Hounkpatin WA, Konan AG, Labzizi S, Ledo J, Mahachi C, Maruapula SD, Mathe N, Mbabazi M, Mirembe MW, Mizehoun-Adissoda C, Nzi CD, Pisa PT, El Rhazi K, Zotor F, Slimani N. Evaluation of the international standardized 24-h dietary recall methodology (GloboDiet) for potential application in research and surveillance within African settings. Global Health. 2017 Jun 19;13(1):35. doi: 10.1186/s12992-017-0260-6.
- Background: PubMed 29422041Shridhar K, Satija A, Dhillon PK, Agrawal S, Gupta R, Bowen L, Kinra S, Bharathi AV, Prabhakaran D, Srinath Reddy K, Ebrahim S; Indian Migration Study group. Association between empirically derived dietary patterns with blood lipids, fasting blood glucose and blood pressure in adults - the India migration study. Nutr J. 2018 Feb 8;17(1):15. doi: 10.1186/s12937-018-0327-0.
- The International Dietary Data Expansion (INDDEX) ProjectLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Stefaan De Henauw, Md. PhD principal investigator
University Ghent
Souheila Abbeddou, MSc. PhD principal investigator
UGent
Jerome Some, Md. PhD principal investigator
Institut de Recherche en Sciences de la Sante, Ouagadougou, Burkina Faso
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 Dietary Assessment, run by University Ghent at 1 site in Rwanda.
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 7 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 15 Nov 2022. 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 Rwanda. 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?
Median proportion of energy intake from carbohydrates assessed by the 24 hour recalls (time frame: One year). The study lists 8 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 NCT04202107, which also lists 4 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 15 Nov 2022.