Preventing American Indian Children From Becoming Overweight

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00245180
Recruitment Status : Completed
First Posted : October 27, 2005
Last Update Posted : March 12, 2014
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Kaiser Permanente

October 26, 2005
October 27, 2005
March 12, 2014
May 2006
September 2012   (Final data collection date for primary outcome measure)
BMI [ Time Frame: birth, 6,12,18, and 24 months ]
Not Provided
Complete list of historical versions of study NCT00245180 on Archive Site
feeding [ Time Frame: 0-24 months ]
Breastfeeding, (initiation and maintenance), introduction of solids.
Not Provided
Not Provided
Not Provided
Preventing American Indian Children From Becoming Overweight
Primordial Prevention of Overweight in American Indian Children
The purpose of this study is to establish an intervention to keep American Indian/Alaskan Native (AI/AN) children from becoming overweight.


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.


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.

Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Cardiovascular Diseases
  • Heart Diseases
  • Obesity
  • Behavioral: Diet
  • Behavioral: Exercise
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Not Provided
September 2012
September 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
15 Years to 40 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
U01HL081624 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
Kaiser Permanente
Kaiser Permanente
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Njeri Karanja Kaiser Foundation Hospitals
Kaiser Permanente
April 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP