Preventing American Indian Children From Becoming Overweight
Primary Purpose
Cardiovascular Diseases, Heart Diseases, Obesity
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Diet
Exercise
Sponsored by
About this trial
This is an interventional prevention trial for Cardiovascular Diseases
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
No Intervention
Arm Label
control
Arm Description
Primary and secondary data collected as in intervention arm. Dental screenings will be done once a year as a service.
Outcomes
Primary Outcome Measures
BMI
Secondary Outcome Measures
feeding
Breastfeeding, (initiation and maintenance), introduction of solids.
Full Information
NCT ID
NCT00245180
First Posted
October 26, 2005
Last Updated
March 10, 2014
Sponsor
Kaiser Permanente
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00245180
Brief Title
Preventing American Indian Children From Becoming Overweight
Official Title
Primordial Prevention of Overweight in American Indian Children
Study Type
Interventional
2. Study Status
Record Verification Date
April 2006
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Heart Diseases, Obesity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
577 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control
Arm Type
No Intervention
Arm Description
Primary and secondary data collected as in intervention arm. Dental screenings will be done once a year as a service.
Intervention Type
Behavioral
Intervention Name(s)
Diet
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Primary Outcome Measure Information:
Title
BMI
Time Frame
birth, 6,12,18, and 24 months
Secondary Outcome Measure Information:
Title
feeding
Description
Breastfeeding, (initiation and maintenance), introduction of solids.
Time Frame
0-24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Njeri Karanja
Organizational Affiliation
Kaiser Foundation Hospitals
Official's Role
Principal Investigator
12. IPD Sharing Statement
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Preventing American Indian Children From Becoming Overweight
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