NCT05525429

Brief 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. 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. 1.characterize these barriers in detail
  2. 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,873

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 1, 2022

Completed
1.8 years until next milestone

Study Start

First participant enrolled

June 8, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2025

Completed
Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

1.2 years

First QC Date

May 21, 2022

Last Update Submit

February 5, 2026

Conditions

Outcome Measures

Primary Outcomes (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.

    ~1 year

Secondary Outcomes (3)

  • Change in height-for-age z score from baseline to endline for children 6-60 months

    ~1 year

  • Change in head circumference-for-age z score from baseline to endline for children 6-60 months

    ~1 year

  • Change in BMI from baseline to endline for adolescent girls

    ~1 year

Study Arms (2)

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).

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.

Interventions

Multidimensional nutrition education will be provided.

Nutrition Education

Eligibility Criteria

Age6 Months - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heifer Project International Nepal

Kathmandu, Nepal, Nepal

Location

MeSH Terms

Conditions

Malnutrition

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics

Study Record Dates

First Submitted

May 21, 2022

First Posted

September 1, 2022

Study Start

June 8, 2024

Primary Completion

August 10, 2025

Study Completion

August 10, 2025

Last Updated

February 6, 2026

Record last verified: 2026-02

Locations