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

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ClinicalTrials.gov Identifier: NCT03516396
Recruitment Status : Completed
First Posted : May 4, 2018
Last Update Posted : July 15, 2020
Sponsor:
Collaborator:
Heifer Project International
Information provided by (Responsible Party):
Laurie Miller, MD, Tufts University

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.

Condition or disease Intervention/treatment Phase
Malnutrition Behavioral: Training Plus Behavioral: Training Only Behavioral: No Inputs then Community development and training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1500 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: 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
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Community Development and Nutrition Education in Banke District, Nepal: Effect on Child Health and Growth
Actual Study Start Date : July 1, 2013
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Training Plus

Intervention: Community Development

Training plus enhanced community development activities

Behavioral: Training Plus
Training plus enhanced community development activities

Active Comparator: Control
No inputs
Behavioral: No Inputs then Community development and training
No inputs for 24 months then add community development and training

Experimental: Training Only

Intervention: Training

Training Only (livestock management and child nutrition)

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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".

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03516396


Sponsors and Collaborators
Tufts University
Heifer Project International
Investigators
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Principal Investigator: Laurie C Miller, MD Tufts University
  Study Documents (Full-Text)

Documents provided by Laurie Miller, MD, Tufts University:
Study Protocol  [PDF] October 2, 2014
Statistical Analysis Plan  [PDF] October 2, 2014

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Laurie Miller, MD, Professor of Pediatrics, Tufts University
ClinicalTrials.gov Identifier: NCT03516396    
Other Study ID Numbers: AID-OAA-L-1-00006
First Posted: May 4, 2018    Key Record Dates
Last Update Posted: July 15, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Laurie Miller, MD, Tufts University:
Nepal
child growth
nutrition education
community development
Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders