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Preventing American Indian Children From Becoming Overweight

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT00245180
First received: October 26, 2005
Last updated: March 10, 2014
Last verified: April 2006

October 26, 2005
March 10, 2014
May 2006
September 2012   (final data collection date for primary outcome measure)
BMI [ Time Frame: birth, 6,12,18, and 24 months ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00245180 on ClinicalTrials.gov Archive Site
feeding [ Time Frame: 0-24 months ] [ Designated as safety issue: No ]
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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.
Interventions:
  • Behavioral: Diet
  • Behavioral: Exercise
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
577
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
Both
15 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00245180
239, U01HL081624, U01 HL81624
No
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