- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00381069
SDSU MOVE/Me Muevo Project
Obesity Prevention and Control in Community Recreation Centers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The primary aim is to evaluate the effectiveness of a multi-level intervention to prevent the onset of overweight and obesity in 7-9 year old children. The recreation center site intervention emphasizes changes in quantity and quality of physical activity and nutrition-related offerings within the centers. The home site intervention targets the home environment and household rule setting delivered via Family Health Coaches and tailored to the needs of the family. Five hundred forty one (541) families were recruited to participate in this project. Participants were selected in part based on residence in proximity to participating recreation centers. Eighteen (18) families living up to 3 miles from each of the 30 recreation centers involved in the project were be recruited to participate. For each family, one child was recruited between the ages of 5 and 8 years old and this child's primary caregiver was enrolled in the study. The study's primary outcome is Body Mass Index (kg/m2).
Comparisons: Control vs. Intervention
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
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San Diego, California, United States, 92123
- Sdsu Move
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Primary residence within 3 miles of recreation center
- Children ages 5-8 at baseline
- Commit to participate in study for 3 1/2 years
- Participating parent must be a legal guardian of the child
- Parent and child must be able to speak and read English or Spanish
- Willing to be randomly assigned to control or intervention
Exclusion Criteria:
- Child has a medical/health/psychological condition or is taking a medication that may impact the child's physical activity, diet or weight to confound BMI
- Parent or child is unable to read and speak English or Spanish
- Family plans to move during the next 3 1/2 years
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
BMI (height & weight) at baseline, 1 year of intervention, and post intervention
Time Frame: February 2010-August 2010
|
February 2010-August 2010
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Child physical activity measured by wearing the ActiGraph accelerometer in a subsample of 1/3 of participants from each center
Time Frame: February 2010-August 2010
|
February 2010-August 2010
|
|
Questionnaire to assess Parent-reported nutrition and eating behaviors,rules about physical activity & nutrition in the home, and physical activity & sedentary behavior at baseline, 2 years, 3 years.
Time Frame: February 2010-August 2010
|
February 2010-August 2010
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: John P Elder, PhD, MPH, San Diego State University Graduate School of Public Health
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DK72994
- R01DK072994 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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