Child MalnutritionNCT03886467
Strategies to Increase Milk Consumption by Young Nepali Children
A study testing Community-based nutrition education in people with Child Malnutrition, run by Tufts University at 1 site in Nepal.
Trial summary
Dairy animals are an important source of income, food and nutrition security at the household level. However, substandard animal husbandry practices and limited understanding of disease prevention and control may limit dairy animal productivity. Read more about this study
- Who is it for?
- Ages 6 to 66 months
- Conditions the study is for
- Child Malnutrition
- What is being tested?
- Community-based nutrition education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 368 participants
- Where
- 1 siteNepal
- Study dates
- 1 Nov 2019to 30 Apr 2022
- Phase
- Interventional
- 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 6 to 66 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 6-66 months of age, parent willing to participate in research activity
Who cannot join
- unwillingness to participate in the research activity, plans to leave the area within the next 12 months, or child with physical or other special needs that prevent the ingestion of a normal diet-for-age.
Trial locations and contacts
1 site in 1 country.
About this study
Dairy animals are an important source of income, food and nutrition security at the household level. However, substandard animal husbandry practices and limited understanding of disease prevention and control may limit dairy animal productivity. Interventions to address these issues may enhance milk production, substantially improving the well-being of smallholder farmers. In addition to increasing household income, greater milk production may improve the diet quality of household members, particularly children.
Previously, the investigators implemented a program in rural Nepal promoting enhanced animal husbandry practices (GHP), focusing on mastitis control. Concurrently, the investigators found child milk intake was strongly linked to better growth and development. However, milk intake was limited and its availability was not examined. The investigators now propose to build on these prior activities and examine strategies to increase child milk consumption. The investigators plan to introduce a nutrition education program into 200 households (with young children) which previously received GHP training. A comparison group of 200 households will serve as the control. Household surveys will be conducted at baseline and endline to assess (1) household milk production and the sustainability of adoption of GHP routines, (2) the relationship of household milk production to child milk consumption, (3) household factors influencing child milk consumption (participation in nutrition education, mother's education, socioeconomic status, etc.), and (4) longitudinal child growth and development. In addition, a pilot study will determine if households can accurately record milk production and child milk intake.
The project is designed to enhance understanding of the links between milk availability and child milk consumption in rural Nepal. It aims to explore whether milk consumption is limited by availability or other factors (nutrition awareness, socioeconomic status, maternal education). Additionally, the investigators will examine if optimization of milk consumption by young children can further boost their growth and development, and whether instruction in good animal husbandry practice and mastitis control is sustainable. These findings could more appropriately and efficiently direct resources to improve child nutrition and development and household dairy practices.
Read the detailed description
The study will be conducted in close collaboration with Heifer International Nepal, a well-established branch of Heifer International, an international non-government organization based in Little Rock, Arkansas. Heifer specializes in community development activities and livestock management training; as part of Heifer's activities, participating households receive 1 or more dairy animals. The proposed study will take place in 3 districts in western Nepal (Bardiya, Surkhet, and Dang) where Heifer has been active and dairy animals have been distributed. Households (n=400) will be eligible for participation if there is at least one child between the ages of 6-66 months and at least one dairy animal. Household clusters (separated geographically) will be randomly assigned to receive either nutrition education or to control status (no education). Households assigned to control status will be offered the nutrition education after completion of data collection for the proposed project (12 months later).
The participants will be one adult in each household (usually the child's mother), and any children in the household between the ages of 6-66 months.
The study design involves 3 household visits, spaced over 12 months (thus: baseline, 6 months, and endline). In addition, information about household dairy animal milk production will be collected on a monthly basis.
At the baseline and endline household visits, the mother (or other caretaker) of the target child will be asked to respond to a questionnaire. The questionnaire will be based on standardized tools developed by "Measure Demographic and Health survey (DHS)", specifically the version used in the "2016 Nepal Demographic and Health Survey" conducted by the Government of Nepal (Ministry of Health et al. 2017) (Ministry of Health and Population Nepal et al. 2012). The questionnaire will address (A) household attributes, (B) child diet, (C) child growth, and (D) child development.
(A) Household attributes: basic demographics, possessions (used to determine wealth score by standard principal components analysis), hygiene practices, animal ownership, mother's knowledge/attitudes/practices related to child nutrition.
(B) Child diet: Consumption of animal source foods (ASFs: meat, fish, offal, eggs, or dairy) in the past 24 hours by all children in the household (ages 12-60 months) will be recorded (Ruel 2003, Steyn et al. 2007), along with the frequency of intake. The quantity of milk and other dairy foods ingested will also be determined. In addition, 16 specific foods/food groups will be documented (Kennedy et al. 2013). Milk and "other dairy products" (yogurt, paneer, cheese, etc.) will be recorded separately. In addition, the number of times in the previous week that the child consumed each of the 16 individual food items will be recorded. A diet diversity score (DDS) will be constructed by aggregating the food groups into 8 categories: starchy staples (grains and white potatoes); vitamin-A rich fruits and vegetables; other fruits and vegetables; offal, meat, and fish; eggs; legumes, nuts, and seeds; milk and dairy products; oils (Swindale et al. 2006).
(C) Child growth will also be assessed by standard anthropometric techniques (see (Miller et al. 2017) for details) using Seca scales and stadiometers and paper measuring tapes (for head and mid-upper arm circumferences).
(D) Child development: relevant sections of the Multiple Indicator Cluster Survey (UNICEF 2015), a standardized questionnaire developed by UNICEF (and validated in Nepal (Government of Nepal 2014)) to assess early child development, will be administered by the enumerator. The child's parent (usually the mother), will respond to questions related to child literacy/numeracy, gross and fine motor skills, social-emotional development, and learning skills. In addition, the age-appropriate version of the Ages and Stages Questionnaire will be administered. This simple assessment serves as a screen test for developmental issues by asking the child (or if the child is unable or unwilling to participate) to engage in developmentally appropriate activities such as completing a puzzle, jumping, scribbling with a crayon, or answering simple questions ("How old are you").
The midline visit will include only child anthropometry and child diet record.
- Conditions
- Child Malnutrition
- Being tested
- Community-based nutrition education
- Keywords
- Nepal, ASF consumption
- Medical subject headings
- Child Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community-based nutrition educationOther
Nutrition education will be included in community development training. The nutrition education will target child nutrition, particularly consumption of animal-source foods and especially milk. The importance of dietary diversity will also be emphasized. Demonstrations of food preparation techniques will also be included in the training.
| Study group | Role | What they receive |
|---|---|---|
| Nutrition Education | Active comparator | Households will participate in community-based nutrition education program specifically targeting child nutrition and milk consumption, in addition to general community development activities Receives: Other: Community-based nutrition education |
| Control | No intervention | community development activities only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in child height from baseline to midline
Height of children will be measured, and converted to z scores. The difference from baseline to midline will be assessed.
Measured: baseline, midline (0, 6 months)
Change in child height from baseline to endline
Height of children will be measured, and converted to z scores. The difference from baseline to endline will be assessed.
Measured: baseline, endline (0, 12 months)
Change in child weight from baseline to midline
Weight of children will be measured, and converted to z scores. The difference from baseline to midline will be assessed.
Measured: baseline, midline (0, 6 months)
Change in child weight from baseline to endline
Weight of children will be measured, and converted to z scores. The difference from baseline to midline will be assessed.
Measured: baseline, endline (0, 12 months)
Change in child head circumference from baseline to midline
Head circumference will be measured, and converted to z scores
Measured: baseline, midline (0, 6 months)
Change in child head circumference from baseline to endline
Head circumference will be measured, and converted to z scores
Measured: baseline, endline (0, 12 months)
Change in child development standardized score from baseline to endline
Developmental performance on standardized test, the Ages and Stages Questionnaire. The change in scores from baseline to endline will be assessed.
Measured: baseline and endline (0, 12 months)
Secondary outcomes (1)
Milk consumption by children
Amount of milk consumed by children will be measured daily, using standardized measuring cups. The information will be recorded by their mothers. The daily consumption will be compiled into monthly total consumption for later analysis.
Measured: daily for up to 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2019
- Study start1 Nov 2019
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child MalnutritionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Household clusters (separated geographically) will be randomly assigned to receive either nutrition education or to control status (no education).
- Masking
- None (open label)
- Enrolment
- 368 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laurie Miller, MD, Tufts University
- Investigators
- Shailes Neupane, M.S., Study director, Valley Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03886467
- Sponsor's protocol ID
- STRATEGIES
- Status last verified
- May 2022
- First submitted
- 13 Mar 2019
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategies to Increase Milk Consumption by Young Nepali Children
- ClinicalTrials.gov ID
- NCT03886467
- Acronym / sponsor ID
- STRATEGIES
- Conditions
- Child Malnutrition
- Keywords
- Nepal, ASF consumption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 368 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 22 Mar 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.
Dairy animals are an important source of income, food and nutrition security at the household level. However, substandard animal husbandry practices and limited understanding of disease prevention and control may limit dairy animal productivity. Interventions to address these issues may enhance milk production, substantially improving the well-being of smallholder farmers. In addition to increasing household income, greater milk production may improve the diet quality of household members, particularly children.
Previously, the investigators implemented a program in rural Nepal promoting enhanced animal husbandry practices (GHP), focusing on mastitis control. Concurrently, the investigators found child milk intake was strongly linked to better growth and development. However, milk intake was limited and its availability was not examined. The investigators now propose to build on these prior activities and examine strategies to increase child milk consumption. The investigators plan to introduce a nutrition education program into 200 households (with young children) which previously received GHP training. A comparison group of 200 households will serve as the control. Household surveys will be conducted at baseline and endline to assess (1) household milk production and the sustainability of adoption of GHP routines, (2) the relationship of household milk production to child milk consumption, (3) household factors influencing child milk consumption (participation in nutrition education, mother's education, socioeconomic status, etc.), and (4) longitudinal child growth and development. In addition, a pilot study will determine if households can accurately record milk production and child milk intake.
The project is designed to enhance understanding of the links between milk availability and child milk consumption in rural Nepal. It aims to explore whether milk consumption is limited by availability or other factors (nutrition awareness, socioeconomic status, maternal education). Additionally, the investigators will examine if optimization of milk consumption by young children can further boost their growth and development, and whether instruction in good animal husbandry practice and mastitis control is sustainable. These findings could more appropriately and efficiently direct resources to improve child nutrition and development and household dairy practices.
Detailed description
The study will be conducted in close collaboration with Heifer International Nepal, a well-established branch of Heifer International, an international non-government organization based in Little Rock, Arkansas. Heifer specializes in community development activities and livestock management training; as part of Heifer's activities, participating households receive 1 or more dairy animals. The proposed study will take place in 3 districts in western Nepal (Bardiya, Surkhet, and Dang) where Heifer has been active and dairy animals have been distributed. Households (n=400) will be eligible for participation if there is at least one child between the ages of 6-66 months and at least one dairy animal. Household clusters (separated geographically) will be randomly assigned to receive either nutrition education or to control status (no education). Households assigned to control status will be offered the nutrition education after completion of data collection for the proposed project (12 months later).
The participants will be one adult in each household (usually the child's mother), and any children in the household between the ages of 6-66 months.
The study design involves 3 household visits, spaced over 12 months (thus: baseline, 6 months, and endline). In addition, information about household dairy animal milk production will be collected on a monthly basis.
At the baseline and endline household visits, the mother (or other caretaker) of the target child will be asked to respond to a questionnaire. The questionnaire will be based on standardized tools developed by "Measure Demographic and Health survey (DHS)", specifically the version used in the "2016 Nepal Demographic and Health Survey" conducted by the Government of Nepal (Ministry of Health et al. 2017) (Ministry of Health and Population Nepal et al. 2012). The questionnaire will address (A) household attributes, (B) child diet, (C) child growth, and (D) child development.
(A) Household attributes: basic demographics, possessions (used to determine wealth score by standard principal components analysis), hygiene practices, animal ownership, mother's knowledge/attitudes/practices related to child nutrition.
(B) Child diet: Consumption of animal source foods (ASFs: meat, fish, offal, eggs, or dairy) in the past 24 hours by all children in the household (ages 12-60 months) will be recorded (Ruel 2003, Steyn et al. 2007), along with the frequency of intake. The quantity of milk and other dairy foods ingested will also be determined. In addition, 16 specific foods/food groups will be documented (Kennedy et al. 2013). Milk and "other dairy products" (yogurt, paneer, cheese, etc.) will be recorded separately. In addition, the number of times in the previous week that the child consumed each of the 16 individual food items will be recorded. A diet diversity score (DDS) will be constructed by aggregating the food groups into 8 categories: starchy staples (grains and white potatoes); vitamin-A rich fruits and vegetables; other fruits and vegetables; offal, meat, and fish; eggs; legumes, nuts, and seeds; milk and dairy products; oils (Swindale et al. 2006).
(C) Child growth will also be assessed by standard anthropometric techniques (see (Miller et al. 2017) for details) using Seca scales and stadiometers and paper measuring tapes (for head and mid-upper arm circumferences).
(D) Child development: relevant sections of the Multiple Indicator Cluster Survey (UNICEF 2015), a standardized questionnaire developed by UNICEF (and validated in Nepal (Government of Nepal 2014)) to assess early child development, will be administered by the enumerator. The child's parent (usually the mother), will respond to questions related to child literacy/numeracy, gross and fine motor skills, social-emotional development, and learning skills. In addition, the age-appropriate version of the Ages and Stages Questionnaire will be administered. This simple assessment serves as a screen test for developmental issues by asking the child (or if the child is unable or unwilling to participate) to engage in developmentally appropriate activities such as completing a puzzle, jumping, scribbling with a crayon, or answering simple questions ("How old are you").
The midline visit will include only child anthropometry and child diet record.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Household clusters (separated geographically) will be randomly assigned to receive either nutrition education or to control status (no education).
| Arm | Type | Receives |
|---|---|---|
| Nutrition Education | Active comparator | Other: Community-based nutrition educationHouseholds will participate in community-based nutrition education program specifically targeting child nutrition and milk consumption, in addition to general community development activities |
| Control | No intervention | –community development activities only. |
Who may qualify
- Ages
- 6 to 66 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 6-66 months of age, parent willing to participate in research activity
Key exclusion criteria (1 listed)
- unwillingness to participate in the research activity, plans to leave the area within the next 12 months, or child with physical or other special needs that prevent the ingestion of a normal diet-for-age.
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 |
|---|---|---|
| Community-based nutrition educationNutrition education will be included in community development training. The nutrition education will target child nutrition, particularly consumption of animal-source foods and especially milk. The importance of dietary diversity will also be emphasized. Demonstrations of food preparation techniques will also be included in the training. | Other | Nutrition Education |
Primary outcome
Change in child height from baseline to midline
Time frame: baseline, midline (0, 6 months)
Height of children will be measured, and converted to z scores. The difference from baseline to midline will be assessed.
Change in child height from baseline to endline
Time frame: baseline, endline (0, 12 months)
Height of children will be measured, and converted to z scores. The difference from baseline to endline will be assessed.
Change in child weight from baseline to midline
Time frame: baseline, midline (0, 6 months)
Weight of children will be measured, and converted to z scores. The difference from baseline to midline will be assessed.
Change in child weight from baseline to endline
Time frame: baseline, endline (0, 12 months)
Weight of children will be measured, and converted to z scores. The difference from baseline to midline will be assessed.
Change in child head circumference from baseline to midline
Time frame: baseline, midline (0, 6 months)
Head circumference will be measured, and converted to z scores
Change in child head circumference from baseline to endline
Time frame: baseline, endline (0, 12 months)
Head circumference will be measured, and converted to z scores
Change in child development standardized score from baseline to endline
Time frame: baseline and endline (0, 12 months)
Developmental performance on standardized test, the Ages and Stages Questionnaire. The change in scores from baseline to endline will be assessed.
1 secondary outcome
Milk consumption by children
Time frame: daily for up to 365 days
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 23 May 2022.
- 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.
Shailes Neupane, M.S. study director
Valley Research Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community-based nutrition education in people with Child Malnutrition, run by Tufts University at 1 site in Nepal.
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 1 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 23 May 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 Nepal. 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?
Change in child height from baseline to midline (time frame: baseline, midline (0, 6 months)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 May 2022.