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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.
ClinicalTrials.gov Identifier: NCT00245180
Recruitment Status : Completed
First Posted : October 27, 2005
Last Update Posted : March 12, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Cardiovascular Diseases Heart Diseases Obesity 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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 577 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Primordial Prevention of Overweight in American Indian Children
Study Start Date : May 2006
Primary Completion Date : September 2012
Study Completion Date : September 2012
Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. BMI [ Time Frame: birth, 6,12,18, and 24 months ]

Secondary Outcome Measures :
  1. feeding [ Time Frame: 0-24 months ]
    Breastfeeding, (initiation and maintenance), introduction of solids.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 ( U.S. NIH Grant/Contract )
First Posted: October 27, 2005    Key Record Dates
Last Update Posted: March 12, 2014
Last Verified: April 2006

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