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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
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiovascular Diseases

Eligibility Criteria

15 Years - 40 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    October 26, 2005
    Last Updated
    March 10, 2014
    Sponsor
    Kaiser Permanente
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)
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    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

    Learn more about this trial

    Preventing American Indian Children From Becoming Overweight

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