Preventing American Indian Children From Becoming Overweight

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Cardiovascular Diseases; Heart Diseases; Obesity	Behavioral: Diet; Behavioral: Exercise	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	577 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	Primordial Prevention of Overweight in American Indian Children
Study Start Date :	May 2006
Actual Primary Completion Date :	September 2012
Actual Study Completion Date :	September 2012

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
No Intervention: control; Primary and secondary data collected as in intervention arm. Dental screenings will be done once a year as a service.	Behavioral: Diet Behavioral: Exercise

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. BMI [ Time Frame: birth, 6,12,18, and 24 months ]

Secondary Outcome Measures :

1. feeding [ Time Frame: 0-24 months ]
   Breastfeeding, (initiation and maintenance), introduction of solids.

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	15 Years to 40 Years (Child, Adult)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Sponsors and Collaborators

Kaiser Permanente

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Principal Investigator:	Njeri Karanja	Kaiser Foundation Hospitals

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Kaiser Permanente
ClinicalTrials.gov Identifier:	NCT00245180 History of Changes
Other Study ID Numbers:	239; U01HL081624 ( U.S. NIH Grant/Contract )
First Posted:	October 27, 2005
Last Update Posted:	March 12, 2014
Last Verified:	April 2006

Additional relevant MeSH terms:

Cardiovascular Diseases; Heart Diseases; Overweight; Body Weight; Signs and Symptoms