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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Nepal1 site
  • Heifer Project International Nepal

    Kathmandu, Nepal

Other trials in Nepal

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

  1. characterize these barriers in detail
  2. 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 groups in NCT05525429
Study groupRoleWhat they receive
Nutrition EducationActive comparatorHouseholds 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
ControlNo interventionNo 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.

  1. 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)
  1. 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

  2. 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

  3. 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.

  1. First posted1 Sep 2022
  2. Study start8 Jun 2024
  3. Primary completion10 Aug 2025
  4. Study completion10 Aug 2025

Resources

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)
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

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.

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