UndernutritionNCT05525429
Enhancing Milk Consumption by Vulnerable Household Members in Rural Nepal
A study testing Nutrition Education in people with Undernutrition, run by Tufts University at 1 site in Nepal.
Trial summary
Diet quality is generally poor in rural Nepal, especially among vulnerable household members. Consumption of milk (and other animal source foods [ASF]) could contribute to improvements in diet quality. Read more about this study
- Who is it for?
- Ages 6 months to 60 years
- Conditions the study is for
- Undernutrition
- What is being tested?
- Nutrition Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,873 participants
- Where
- 1 siteNepal
- Study dates
- 8 Jun 2024to 10 Aug 2025
- 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 months to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Households involved with Heifer Project International activities. Mothers participate in women's self-help group. Household has at least 1 child 6-60 months at baseline. Household is will to participate.
Who cannot join
- unwillingness to participate in the research activity, plans to leave the area within the next 12 months, or child 6-60 months or adolescent girl with physical or other special needs that prevent the ingestion of a normal diet-for-age. For adolescent girls, an additional exclusion criterion is the presence of any issues that interfere with their ability to respond.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Integrated Approach to Enhance Milk Consumption by Vulnerable Household Members in Rural Nepal
Diet quality is generally poor in rural Nepal, especially among vulnerable household members. Consumption of milk (and other animal source foods [ASF]) could contribute to improvements in diet quality. However, multiple cultural, structural and economic barriers constrain the inclusion of ASF in the diet in these households, even though most raise dairy animals. This study will
- characterize these barriers in detail
- conduct a randomized controlled trial to test a multi-dimensional behavior change intervention designed to increase ASF/milk consumption by young children 6-60 months, adolescent girls 10-15 years, and women of child-bearing age (WCBA).
Read more
Matched clusters of villages in Kapilbastu and Nawalparasi districts (Nepal) will be randomized to Intervention or Control status. Household surveys will be conducted at baseline and 12 months later to collect demographic, diet, feeding practices, nutrition knowledge, etc. Fathers and adolescent girls will respond to mini-surveys. Growth parameters of children, adolescent girls, and WCBA will be assessed. The intervention consists of 4 components: 1) didactic training (mothers, fathers, adolescent girls), 2) participatory learning activities (mothers, fathers, adolescent girls), 3) model kitchens (mothers, adolescent girls), and 4) Nutrition Club (adolescent girls).
The primary outcome will be the impact of the intervention on diet, household feeding practices, and nutrition knowledge.
Read the detailed description
Animal-source-foods (ASF) contains nutrients essential to human health. These nutrients are especially important for vulnerable household members (young children, adolescent girls, women of child-bearing age [WCBA]). 1, 2 In developing countries, milk is generally one of the largest sources and most widely consumed animal-based dietary protein 3
Although livestock farmers are more likely than their counterparts to consume ASF 3-5, paradoxically, families that rely on agriculture and livestock production for their livelihoods are significantly food and nutrition insecure households. This is partly due to use of the income earned from livestock for purposes other than improving household diet diversity and quality, and partly due to inadequate knowledge about the importance of doing so. In addition, household food allocation practices and cultural beliefs and taboos impact ASF consumption by individual family members. ASF consumption in Nepal, for example, is often prioritized for the primary household bread winner (usually an adult male) 6. Thus, multiple cultural, structural and economic barriers converge to limit consumption of ASF by vulnerable household memb8rs.
Many governmental and non-governmental organizations attempt to improve diet quality in rural households via nutrition education in hopes of motivating behavior change among participants. However, results of such programs have been inconsistent and generally disappointing 7-9. Even programs which provide a robust agricultural intervention are not always successful in improving diets or child growth 10, 11. Therefore, the study will define the barriers to household ASF consumption in rural Nepal and introduce a package of solutions to overcome these barriers. The design of the intervention builds on prior formative work 1, 12-20 21, and will be tested in a randomized controlled trial. While young children under 5 years of age remain a strong focus of this work, adolescent girls, WCBA and fathers will also be included in the intervention activities.
This intervention addresses implementation gaps identified in the investigators' prior work and incorporates findings in recent literature regarding the effectiveness of specific behavior change interventions on nutrition outcomes 22. The investigators' previous work demonstrated that barriers to improving child nutrition are not overcome by increased income, nutrition education, or enhanced household milk production. Recent work has highlighted the value of specific components of behavior change programs: (1) demonstrations of how to perform the behavior, (2) cooking/recipe demonstrations, (3) restructuring the social environment (e.g., women's groups) and engaging with fathers and other groups not typically included, (4) providing households with prompts/cues, (5) action planning, goal-setting and problem-solving, (6) providing information about health consequences, (7) offering strategies to families to self-monitor behaviors. This planned multi-faceted intervention incorporates these elements to augment the effectiveness of behavior change messaging provided to household members, while strengthening community involvement, fostering sustainability and facilitating scaling-up activities.
- Conditions
- Undernutrition
- Being tested
- Nutrition Education
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition EducationBehavioural
Multidimensional nutrition education will be provided.
| Study group | Role | What they receive |
|---|---|---|
| Nutrition Education | Active comparator | Households in this arm will participate in a multidimensional nutrition education intervention, including (1) didactic training on family nutrition (mothers, fathers, adolescent girls), (2) participatory learning activities (mothers, fathers, adolescent girls), (3) model kitchens (mothers, adolescent girls), and (4) Nutrition Club (adolescent girls). Receives: Behavioral: Nutrition Education |
| Control | No intervention | No intervention will be provided. After the research period is complete, the Control group will receive all inputs described above, but no data will be collected during this time period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Animal Source Foods Consumed in prior 24 hours (diet recall survey), baseline to endline
Impact of nutrition education on diet of mothers, children 6-60 months, and adolescent girls will compared between baseline and endline.
Measured: ~1 year
Secondary outcomes (3)
Change in height-for-age z score from baseline to endline for children 6-60 months
Child height in centimeters will be measured at baseline and endline. Results will be converted to z scores using World Health Organization standards. Changes in height-for-age z score between baseline and endline will be compared, and related to child consumption of animal source foods.
Measured: ~1 year
Change in head circumference-for-age z score from baseline to endline for children 6-60 months
Child head circumference in centimeters will be measured at baseline and endline. Results will be converted to z scores using World Health Organization standards. Changes in head circumference-for-age z score between baseline and endline will be compared, and related to child consumption of animal source foods.
Measured: ~1 year
Change in BMI from baseline to endline for adolescent girls
Height in centimeters and weight in kilograms will be measured in adolescent girls 10-15 years of age at baseline and endline. Results will be converted to BMI (kg/m^2) using World Health Organization standards. Changes in BMI between baseline and endline will be compared, and related to adolescent consumption of animal source foods.
Measured: ~1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start8 Jun 2024
- Primary completion10 Aug 2025
- Study completion10 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UndernutritionStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,873 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- Heifer Project International
- Responsible party
- Principal investigator, Laurie Miller, MD, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05525429
- Sponsor's protocol ID
- STUDY00002768
- Status last verified
- Feb 2026
- First submitted
- 21 May 2022
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Approach to Enhance Milk Consumption by Vulnerable Household Members in Rural Nepal
- ClinicalTrials.gov ID
- NCT05525429
- Acronym / sponsor ID
- STUDY00002768
- Conditions
- Undernutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,873 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- Heifer Project International
- Study start
- 8 Jun 2024 (actual)
- Primary completion
- 10 Aug 2025 (actual)
- Study completion
- 10 Aug 2025 (actual)
- First posted
- 1 Sep 2022 (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.
Diet quality is generally poor in rural Nepal, especially among vulnerable household members. Consumption of milk (and other animal source foods [ASF]) could contribute to improvements in diet quality. However, multiple cultural, structural and economic barriers constrain the inclusion of ASF in the diet in these households, even though most raise dairy animals. This study will
- characterize these barriers in detail
- conduct a randomized controlled trial to test a multi-dimensional behavior change intervention designed to increase ASF/milk consumption by young children 6-60 months, adolescent girls 10-15 years, and women of child-bearing age (WCBA).
Matched clusters of villages in Kapilbastu and Nawalparasi districts (Nepal) will be randomized to Intervention or Control status. Household surveys will be conducted at baseline and 12 months later to collect demographic, diet, feeding practices, nutrition knowledge, etc. Fathers and adolescent girls will respond to mini-surveys. Growth parameters of children, adolescent girls, and WCBA will be assessed. The intervention consists of 4 components: 1) didactic training (mothers, fathers, adolescent girls), 2) participatory learning activities (mothers, fathers, adolescent girls), 3) model kitchens (mothers, adolescent girls), and 4) Nutrition Club (adolescent girls).
The primary outcome will be the impact of the intervention on diet, household feeding practices, and nutrition knowledge.
Detailed description
Animal-source-foods (ASF) contains nutrients essential to human health. These nutrients are especially important for vulnerable household members (young children, adolescent girls, women of child-bearing age [WCBA]). 1, 2 In developing countries, milk is generally one of the largest sources and most widely consumed animal-based dietary protein 3
Although livestock farmers are more likely than their counterparts to consume ASF 3-5, paradoxically, families that rely on agriculture and livestock production for their livelihoods are significantly food and nutrition insecure households. This is partly due to use of the income earned from livestock for purposes other than improving household diet diversity and quality, and partly due to inadequate knowledge about the importance of doing so. In addition, household food allocation practices and cultural beliefs and taboos impact ASF consumption by individual family members. ASF consumption in Nepal, for example, is often prioritized for the primary household bread winner (usually an adult male) 6. Thus, multiple cultural, structural and economic barriers converge to limit consumption of ASF by vulnerable household memb8rs.
Many governmental and non-governmental organizations attempt to improve diet quality in rural households via nutrition education in hopes of motivating behavior change among participants. However, results of such programs have been inconsistent and generally disappointing 7-9. Even programs which provide a robust agricultural intervention are not always successful in improving diets or child growth 10, 11. Therefore, the study will define the barriers to household ASF consumption in rural Nepal and introduce a package of solutions to overcome these barriers. The design of the intervention builds on prior formative work 1, 12-20 21, and will be tested in a randomized controlled trial. While young children under 5 years of age remain a strong focus of this work, adolescent girls, WCBA and fathers will also be included in the intervention activities.
This intervention addresses implementation gaps identified in the investigators' prior work and incorporates findings in recent literature regarding the effectiveness of specific behavior change interventions on nutrition outcomes 22. The investigators' previous work demonstrated that barriers to improving child nutrition are not overcome by increased income, nutrition education, or enhanced household milk production. Recent work has highlighted the value of specific components of behavior change programs: (1) demonstrations of how to perform the behavior, (2) cooking/recipe demonstrations, (3) restructuring the social environment (e.g., women's groups) and engaging with fathers and other groups not typically included, (4) providing households with prompts/cues, (5) action planning, goal-setting and problem-solving, (6) providing information about health consequences, (7) offering strategies to families to self-monitor behaviors. This planned multi-faceted intervention incorporates these elements to augment the effectiveness of behavior change messaging provided to household members, while strengthening community involvement, fostering sustainability and facilitating scaling-up activities.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutrition Education | Active comparator | Behavioral: Nutrition EducationHouseholds in this arm will participate in a multidimensional nutrition education intervention, including (1) didactic training on family nutrition (mothers, fathers, adolescent girls), (2) participatory learning activities (mothers, fathers, adolescent girls), (3) model kitchens (mothers, adolescent girls), and (4) Nutrition Club (adolescent girls). |
| Control | No intervention | –No intervention will be provided. After the research period is complete, the Control group will receive all inputs described above, but no data will be collected during this time period. |
Who may qualify
- Ages
- 6 months to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Households involved with Heifer Project International activities. Mothers participate in women's self-help group. Household has at least 1 child 6-60 months at baseline. Household is will to participate.
Key exclusion criteria (1 listed)
- unwillingness to participate in the research activity, plans to leave the area within the next 12 months, or child 6-60 months or adolescent girl with physical or other special needs that prevent the ingestion of a normal diet-for-age. For adolescent girls, an additional exclusion criterion is the presence of any issues that interfere with their ability to respond.
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 |
|---|---|---|
| Nutrition EducationMultidimensional nutrition education will be provided. | Behavioural | Nutrition Education |
Primary outcome
Number of Animal Source Foods Consumed in prior 24 hours (diet recall survey), baseline to endline
Time frame: ~1 year
Impact of nutrition education on diet of mothers, children 6-60 months, and adolescent girls will compared between baseline and endline.
3 secondary outcomes
Change in height-for-age z score from baseline to endline for children 6-60 months
Time frame: ~1 year
Change in head circumference-for-age z score from baseline to endline for children 6-60 months
Time frame: ~1 year
Change in BMI from baseline to endline for adolescent girls
Time frame: ~1 year
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 6 Feb 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition Education in people with Undernutrition, 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 6 Feb 2026. 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?
Number of Animal Source Foods Consumed in prior 24 hours (diet recall survey), baseline to endline (time frame: ~1 year). 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 6 Feb 2026.