Community Development and Nutrition Education in Banke District, Nepal: Effect on Child Health and Growth
Primary Purpose
Malnutrition
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Training Plus
Training Only
No Inputs then Community development and training
Sponsored by
About this trial
This is an interventional other trial for Malnutrition focused on measuring Nepal, child growth, nutrition education, community development
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Experimental
Arm Label
Training Plus
Control
Training Only
Arm Description
Intervention: Community Development Training plus enhanced community development activities
No inputs
Intervention: Training Training Only (livestock management and child nutrition)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
child health
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".
household socioeconomic (SES) status
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.
child developmental status
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.
Full Information
NCT ID
NCT03516396
First Posted
April 9, 2018
Last Updated
July 14, 2020
Sponsor
Tufts University
Collaborators
Heifer Project International
1. Study Identification
Unique Protocol Identification Number
NCT03516396
Brief Title
Community Development and Nutrition Education in Banke District, Nepal: Effect on Child Health and Growth
Official Title
Community Development and Nutrition Education in Banke District, Nepal: Effect on Child Health and Growth
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2013 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tufts University
Collaborators
Heifer Project International
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition
Keywords
Nepal, child growth, nutrition education, community development
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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)
Allocation
Randomized
Enrollment
1500 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Training Plus
Arm Type
Experimental
Arm Description
Intervention: Community Development
Training plus enhanced community development activities
Arm Title
Control
Arm Type
Active Comparator
Arm Description
No inputs
Arm Title
Training Only
Arm Type
Experimental
Arm Description
Intervention: Training
Training Only (livestock management and child nutrition)
Intervention Type
Behavioral
Intervention Name(s)
Training Plus
Intervention Description
Training plus enhanced community development activities
Intervention Type
Behavioral
Intervention Name(s)
Training Only
Intervention Description
Training Only (livestock management and child nutrition) for 24 months then add community development inputs
Intervention Type
Behavioral
Intervention Name(s)
No Inputs then Community development and training
Intervention Description
No inputs for 24 months then add community development and training
Primary Outcome Measure Information:
Title
Change from baseline in prevalence of child wasting
Description
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.
Time Frame
baseline, and then at each study visit (every 6 months over 36 months)
Secondary Outcome Measure Information:
Title
child health
Description
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".
Time Frame
at each study visit (every 6 months over 36 months)
Title
household socioeconomic (SES) status
Description
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.
Time Frame
at each study visit (every 6 months over 36 months)
Title
child developmental status
Description
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.
Time Frame
at one study visit each year, starting 12 months after randomization, then annually
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurie C Miller, MD
Organizational Affiliation
Tufts University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31544735
Citation
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. Erratum In: Public Health Nutr. 2020 Jan;23(1):162-167.
Results Reference
derived
Learn more about this trial
Community Development and Nutrition Education in Banke District, Nepal: Effect on Child Health and Growth
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