Community Development and Nutrition Education in Banke District, Nepal: Effect on Child Health and Growth

July 14, 2020 updated by: Laurie Miller, MD, Tufts University
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.

Study Overview

Detailed Description

Child health and survival remain significant challenges in Nepal. Nepal is ranks 63rd highest in the world for "under 5 mortality" rate, with 54/1000 children dying before their 5th birthdays and 46/1000 infants dying before their first birthdays. Annually, more than 47,000 children die before reaching age 5 years. At these mortality levels, one in every 22 Nepalese children dies before reaching age 1, and one in every 19 does not survive to his or her fifth birthday. Nutritional status of children is extremely poor, with ~29% of children underweight and 41% stunted (respectively, weight and height <-2 SD from median) (UNICEF, 2011) (Ministry of Health and Population et al., 2012).

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. Heifer International recognizes the links between poverty, child malnutrition, and disease. However, improving economic indicators is not always sufficient to improve child outcomes. Thus, the organization now wishes to conduct a systematic assessment to evaluate the effects of introducing a child health and nutrition component into their work, and to clarify the links (if any) between social capital training and child growth and health. In doing so, Heifer International expects to develop a model which could be adapted for use in other regions of the world. The interaction of Heifer community development activities, specific child and family characteristics, and child health and nutritional status will also be explored.

Study Type

Interventional

Enrollment (Actual)

1500

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • parent refuse to enroll child

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Training Plus

Intervention: Community Development

Training plus enhanced community development activities

Training plus enhanced community development activities
Active Comparator: Control
No inputs
No inputs for 24 months then add community development and training
Experimental: Training Only

Intervention: Training

Training Only (livestock management and child nutrition)

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in prevalence of child wasting
Time Frame: baseline, and then at each study visit (every 6 months over 36 months)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
child health
Time Frame: at each study visit (every 6 months over 36 months)
Mothers will report the frequency that their child experienced respiratory infection, diarrhea, and/or fever within the 2 weeks prior to the study visit. The presence or absence of each of these symptoms will be scored as either "0" or "1", respectively. These totals will be summed to provide a "health score".
at each study visit (every 6 months over 36 months)
household socioeconomic (SES) status
Time Frame: at each study visit (every 6 months over 36 months)
Household possessions will be enumerated (e.g., the presence or absence of such items as refrigerator, telephone, car, computer, radio, television). Using principal components analysis, a household SES score will be calculated.
at each study visit (every 6 months over 36 months)
child developmental status
Time Frame: at one study visit each year, starting 12 months after randomization, then annually
Developmental status of children 66 months of age will be ascertained using the Ages and Stages Questionnaire (for ages 24-66 months). This test combines observation and parent report.
at one study visit each year, starting 12 months after randomization, then annually

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Laurie C Miller, MD, Tufts University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2013

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

April 9, 2018

First Submitted That Met QC Criteria

May 3, 2018

First Posted (Actual)

May 4, 2018

Study Record Updates

Last Update Posted (Actual)

July 15, 2020

Last Update Submitted That Met QC Criteria

July 14, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AID-OAA-L-1-00006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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