NCT03516396

Brief Summary

Heifer Project International is a globally active NGO with more than 400 projects in over 30 countries. The organization uses the introduction of livestock and related training in the development of social capital as tools for poverty alleviation, citizen empowerment, and community development. In a pilot project conducted in 2009-2012, these activities were found to promote some improvement in child health and nutritional status. However, robust enhancement of these important indicators was not observed. Heifer now intends to investigate the efficacy of a nutrition and child health education program in amplifying these effects.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2013

Longer than P75 for not_applicable

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

April 9, 2018

Completed
25 days until next milestone

First Posted

Study publicly available on registry

May 4, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

July 15, 2020

Status Verified

July 1, 2020

Enrollment Period

6.5 years

First QC Date

April 9, 2018

Last Update Submit

July 14, 2020

Conditions

Keywords

Nepalchild growthnutrition educationcommunity development

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in prevalence of child wasting

    measurement of child's weight in kg and height in cm. These measurements will be converted respectively to weight z scores, height z scores and then weight-for-height z scores using World Health Organization standards. The proportion of wasted children (z score \<-2) will be determined.

    baseline, and then at each study visit (every 6 months over 36 months)

Secondary Outcomes (3)

  • child health

    at each study visit (every 6 months over 36 months)

  • household socioeconomic (SES) status

    at each study visit (every 6 months over 36 months)

  • child developmental status

    at one study visit each year, starting 12 months after randomization, then annually

Study Arms (3)

Training Plus

EXPERIMENTAL

Intervention: Community Development Training plus enhanced community development activities

Behavioral: Training Plus

Control

ACTIVE COMPARATOR

No inputs

Behavioral: No Inputs then Community development and training

Training Only

EXPERIMENTAL

Intervention: Training Training Only (livestock management and child nutrition)

Behavioral: Training Only

Interventions

Training PlusBEHAVIORAL

Training plus enhanced community development activities

Training Plus
Training OnlyBEHAVIORAL

Training Only (livestock management and child nutrition) for 24 months then add community development inputs

Training Only

No inputs for 24 months then add community development and training

Control

Eligibility Criteria

Age1 Month - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • child in household in designated study area of Nepal, age 1 month to 12 years
  • family agrees to enrollment

You may not qualify if:

  • parent refuse to enroll child

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Miller LC, Neupane S, Joshi N, Lohani M, Rogers BL, Neupane S, Ghosh S, Webb P. Multisectoral community development in Nepal has greater effects on child growth and diet than nutrition education alone. Public Health Nutr. 2020 Jan;23(1):146-161. doi: 10.1017/S136898001900260X. Epub 2019 Sep 23.

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Laurie C Miller, MD

    Tufts University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SEQUENTIAL
Model Details: Randomized cluster design of households in rural Nepal. Groups will be randomized to receive either: (a) Training Only (livestock management and child nutrition), (b) Training plus enhanced community development activities, or (c) no inputs (Control). After 24 months, groups A and C will receive community development inputs
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics

Study Record Dates

First Submitted

April 9, 2018

First Posted

May 4, 2018

Study Start

July 1, 2013

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

July 15, 2020

Record last verified: 2020-07