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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03516396
Other study ID # AID-OAA-L-1-00006
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2013
Est. completion date December 31, 2019

Study information

Verified date July 2020
Source Tufts University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1500
Est. completion date December 31, 2019
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group 1 Month to 12 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Training Plus
Training plus enhanced community development activities
Training Only
Training Only (livestock management and child nutrition) for 24 months then add community development inputs
No Inputs then Community development and training
No inputs for 24 months then add community development and training

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Tufts University Heifer Project International

Outcome

Type Measure Description Time frame Safety issue
Primary 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. baseline, and then at each study visit (every 6 months over 36 months)
Secondary 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". at each study visit (every 6 months over 36 months)
Secondary 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. at each study visit (every 6 months over 36 months)
Secondary 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. at one study visit each year, starting 12 months after randomization, then annually
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