American Indian |
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Clinical Trial: Primordial Prevention of Overweight in American Indian Children
This study is not yet open for patient recruitment.
Verified by National Heart, Lung, and Blood Institute (NHLBI) October 2005
Purpose
| Condition | Intervention |
|---|---|
| Cardiovascular Diseases Heart Diseases Obesity | Behavior: diet Behavior: exercise |
MedlinePlus related topics: Heart Diseases; Obesity; Vascular Diseases
Genetics Home Reference related topics: Heart Diseases
Study Type: Interventional
Study Design: Prevention
Study start: September 2005; Expected completion: July 2010
BACKGROUND:
American Indian/Alaskan native (AI/AN) children have overweight rates that are 18-30% higher than the general American population of children. Adult obesity has early antecedents, and date show that eating and physical activity behaviors are formed and set as early as 3 years of age, through primary socialization within families. Yet there are few, if any, obesity prevention programs that target children younger than 3 years of age.
DESIGN NARRATIVE:
This is a community-partnered randomized study to prevent early childhood overweight in American Indian (AI) children. A birth cohort of about 780 children from six Indian communities born over a period 18 months will be randomized by community to either a control (3 communities) or intervention condition (3 communities). The intervention comprises a community-wide intervention coupled with individualized family counseling to improve nutrition and physical activity in infants and toddlers. Nutrition goals are to increase breastfeeding initiation and sustainability, limit sugared beverages for infants and toddlers, and make healthful choices during weaning and solid food introduction. Physical activity goals include promoting motor development, limiting video/TV viewing and creating play opportunities for infants and toddlers. Intervention approaches and methods used in the pilot study on which this project is based will be combined with new formative data collected at the beginning of the project to enhance the intervention''''s feeding and physical activity components. Each component in the community-wide interventions will be collaboratively designed with the tribes, and tailored to each community''''s needs. Trained peer counselors will deliver the family interventions, during a series of 12 cluster visits, each covering a different developmental stage of the infant/toddler. The primary outcome is body mass index (BMI) Z scores at ages 24-30 months.
Eligibility
Location and Contact Information
Njeri Karanja, Kaiser Foundation Hospitals
More Information
Last Updated: December 8, 2005
Record first received: October 26, 2005
ClinicalTrials.gov Identifier: NCT00245180
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2006-01-10
Resources
- American Indian (National Women's Health Information Center)

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