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Primordial Prevention of Overweight in American Indian Children - Article


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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

Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00245180

Purpose

To prevent early childhood overweight in American Indian (AI) children.
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

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

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

Genders Eligible for Study:  Both
Criteria
600 women, age 15-40 years, uncomplicated pregnancy, not planning to leave area within 2 years 600 children, recruited before birth, followed for 30 months, term births, no serious illness known to affect normal growth

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00245180


Study chairs or principal investigators

Njeri Karanja,  Kaiser Foundation Hospitals   

More Information

Study ID Numbers:  239
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



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Page Updated: November 5, 2004
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