- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03516396
Community Development and Nutrition Education in Banke District, Nepal: Effect on Child Health and Growth
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Laurie C Miller, MD, Tufts University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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