Clinical trial NCT03516396: 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
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Keywords: Nepal
child growth
nutrition education
community development
Lead sponsor: Tufts University
Sponsor class: OTHER
Collaborators: name: Heifer Project International
First posted: 2018-05-04
Enrollment: 1500
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
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
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Change from baseline in prevalence of child wasting
timeFrame: baseline, and then at each study visit (every 6 months over 36 months)
Secondary outcomes:
measure: child health
timeFrame: at each study visit (every 6 months over 36 months)
measure: household socioeconomic (SES) status
timeFrame: at each study visit (every 6 months over 36 months)
measure: child developmental status
timeFrame: at one study visit each year, starting 12 months after randomization, then annually
Other outcomes:
Locations:
Study officials:
affiliation: Tufts University
name: Laurie C Miller, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.