SDSU MOVE/Me Muevo Project

Childhood Obesity Clinical Trial

Official title:

Obesity Prevention and Control in Community Recreation Centers

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00381069
• Other study ID #: DK72994
• Secondary ID: R01DK072994
• Status: Active, not recruiting
• Phase: N/A
• First received: September 26, 2006
• Last updated: January 19, 2010
• Start date: October 2006
• Est. completion date: August 2010

Study information

• Verified date: January 2010
• Source: San Diego State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to design, implement, and evaluate a recreation site-based obesity prevention & control intervention for 7-9 year old children and their families by targeting physical activity and dietary behaviors.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 541
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 10 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Childhood Obesity
• Pediatric Obesity

Intervention

Behavioral:
• Family & Community Recreation Center Intervention
The two year intervention involves changing the environment and policies in community recreation centers to promote physical activity and healthy eating choices. The Recreation Specialist will meet with recreation center staff monthly to create action plans that work towards this goal. Family Health Coaches will be in contact with intervention families twice a month either through a phone consultation, workshop at the recreation center,or home visit. Intervention families will receive a monthly mailing highlighting tips for healthy eating and physical activity. MOVE families will be encouraged to utilize the recreation center as a resource in supporting their child's physical activity and healthy eating behaviors.

Locations

Country	Name	City	State
United States	Sdsu Move	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
San Diego State University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI (height & weight) at baseline, 1 year of intervention, and post intervention		February 2010-August 2010	No
Secondary	Child physical activity measured by wearing the ActiGraph accelerometer in a subsample of 1/3 of participants from each center		February 2010-August 2010	No
Secondary	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.		February 2010-August 2010	No