Clinical trial NCT00381069: SDSU MOVE/Me Muevo Project
Official title: Obesity Prevention and Control in Community Recreation Centers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Keywords: Recreation Centers
Families
Obesity Prevention
Lead sponsor: San Diego State University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2006-09-27
Enrollment: 541
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: BMI (height & weight) at baseline, 1 year of intervention, and post intervention
timeFrame: February 2010-August 2010
Secondary outcomes:
measure: Child physical activity measured by wearing the ActiGraph accelerometer in a subsample of 1/3 of participants from each center
timeFrame: February 2010-August 2010
measure: 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.
timeFrame: February 2010-August 2010
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Sdsu Move
state: California
Study officials:
affiliation: San Diego State University Graduate School of Public Health
name: John P Elder, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: