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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
Tufts University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Malnutrition focused on measuring Nepal, child growth, nutrition education, community development

Eligibility Criteria

1 Month - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

    First Posted
    April 9, 2018
    Last Updated
    July 14, 2020
    Sponsor
    Tufts University
    Collaborators
    Heifer Project International
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    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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