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Preventing American Indian Children From Becoming Overweight

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
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
History of Changes
  Purpose
The purpose of this study is to establish an intervention to keep American Indian/Alaskan Native (AI/AN) children from becoming overweight.

Condition Intervention
Cardiovascular Diseases
Heart Diseases
Obesity
 Behavioral: Diet
Behavioral: Exercise

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Primordial Prevention of Overweight in American Indian Children

Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • BMI [ Time Frame: birth, 6,12,18, and 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • feeding [ Time Frame: 0-24 months ] [ Designated as safety issue: No ]
    Breastfeeding, (initiation and maintenance), introduction of solids.
Enrollment: 577
Study Start Date: May 2006
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility
Ages Eligible for Study:   15 Years to 40 Years   (Child, Adult)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00245180

Sponsors and Collaborators
Kaiser Permanente
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Njeri Karanja Kaiser Foundation Hospitals
  More Information

Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT00245180     History of Changes
Other Study ID Numbers: 239  U01HL081624 
Study First Received: October 26, 2005
Last Updated: March 10, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 23, 2016