Preventing American Indian Children From Becoming Overweight

NCT ID: NCT00245180

Last Updated: 2014-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 577 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2012-09-30

Brief Summary

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

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.

Conditions

Cardiovascular Diseases; Heart Diseases; Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

control

Primary and secondary data collected as in intervention arm. Dental screenings will be done once a year as a service.

Group Type: NO_INTERVENTION

Diet

Intervention Type: BEHAVIORAL

Exercise

Intervention Type: BEHAVIORAL

Interventions

Diet

Intervention Type: BEHAVIORAL

Exercise

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Kaiser Permanente

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Njeri Karanja

Role: PRINCIPAL_INVESTIGATOR

Kaiser Foundation Hospitals

Other Identifiers

U01HL081624

Identifier Type: NIH

Identifier Source: secondary_id

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239

Identifier Type: -

Identifier Source: org_study_id