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Preventing American Indian Children From Becoming Overweight
This study is not yet open for participant recruitment.
Verified by National Heart, Lung, and Blood Institute (NHLBI), April 2006
Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00245180
  Purpose

The purpose of this study is to establish an intervention to keep American Indian/Alaskan Native (AI/AN) children from becoming overweight.


Condition Intervention
Cardiovascular Diseases
Heart Diseases
Obesity
Behavioral: Diet
Behavioral: Exercise

MedlinePlus related topics: Heart Diseases Obesity Obesity in Children
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention
Official Title: Primordial Prevention of Overweight in American Indian Children

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

Primary Outcome Measures:
  • BMI (measured at birth and Months 6, 12, 18, 24, and 30)

Estimated Enrollment: 600
Study Start Date: May 2006
Detailed Description:

BACKGROUND:

AI/AN children have overweight rates that are 18 to 30 percent higher than the general American population of children. Adult obesity has early antecedents, and data 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 AI/AN 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.

  Eligibility

Ages Eligible for Study:   15 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women who have had uncomplicated pregnancies
  • Women who agree to have their child enrolled in the study and followed for 30 months
  • Women who are not planning to leave their area within 2 years of study start

Exclusion Criteria:

  • Women whose children have a serious illness known to affect normal growth
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00245180

Sponsors and Collaborators
Investigators
Principal Investigator: Njeri Karanja Kaiser Foundation Hospitals
  More Information

Study ID Numbers: 239, U01 HL81624
Study First Received: October 26, 2005
Last Updated: April 26, 2006
ClinicalTrials.gov Identifier: NCT00245180  
Health Authority: United States: Federal Government

Study placed in the following topic categories:
Body Weight
Signs and Symptoms
Obesity
Heart Diseases
Nutrition Disorders
Overnutrition
Overweight

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009