Preventing American Indian Children From Becoming Overweight

Obesity Clinical Trial

Official title:

Primordial Prevention of Overweight in American Indian Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00245180
• Other study ID #: 239
• Secondary ID: U01HL081624
• Status: Completed
• Phase: N/A
• First received: October 26, 2005
• Last updated: March 10, 2014
• Start date: May 2006
• Est. completion date: September 2012

Study information

• Verified date: April 2006
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 577
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years to 40 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Heart Diseases
• Obesity

Intervention

Behavioral:
• Diet

• Exercise

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	National Heart, Lung, and Blood Institute (NHLBI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI		birth, 6,12,18, and 24 months	Yes
Secondary	feeding	Breastfeeding, (initiation and maintenance), introduction of solids.	0-24 months	No