Shape Up Somerville: Eat Smart Play Hard

Childhood Obesity Clinical Trial

Official title:

Shape Up Somerville: Eat Smart Play Hard

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00153322
• Other study ID #: CDC-OPHR-121519
• Secondary ID: R06 CCR 121519
• Status: Completed
• Phase: N/A
• First received: September 7, 2005
• Last updated: September 7, 2005
• Start date: November 2002
• Est. completion date: June 2005

Study information

• Verified date: September 2005
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

Community-based environmental approach to obesity prevention targeting first, second, and third grade students in Somerville, MA.

Description:

This study will demonstrate using measures of effectiveness, the feasibility of partnering with the community to create, disseminate, implement and evaluate Shape Up Somerville: Eat Smart. Play Hard., a community-based environmental change intervention to prevent obesity in culturally diverse, high-risk, early elementary school children. Based on formative work with parents, children, teachers, school food service, school officials, and community members, a community-wide campaign will be developed with targeted environmental change strategies for early elementary school children within the before-, during-, and after-school environments reinforced by changes within the home and community to support behavioral action and maintenance. The intervention targeting children will bring the energy equation into balance by offering numerous physical activity options that total up to 125 kcals per day and by improving the composition of the food served and the dietary options, particularly snack foods, available throughout the day. This study will measure awareness and participation of the partners and residents within the community. In addition the temporal change in BMI z-score will be monitored internally in 700 Somerville children and externally in 1000 control children from 2 demographically-matched communities for one year and will be compared to the change in BMI z-score in children participating in Shape Up Somerville with children from control communities over the one-year intervention and for one year of follow up. If successful, Somerville will serve as the model community that paves the way for cost-effective nationwide environmental action to prevent obesity at the community level.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3000
• Est. completion date: June 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 11 Years

Eligibility

Inclusion Criteria:

• Public school students in 1st, 2nd, and 3rd grade in Somerville, MA

Exclusion Criteria:

Study Design

Allocation: Non-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:
• Nurtition and Physical Activity Education

Locations

Country	Name	City	State
United States	Tufts University, Friedman School of Nutrition	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention	Tufts University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI at one year
Primary	Dietary Behavior at one year
Primary	Physical Activity Behavior at one year
Primary	Nutrition Policy and Infrastructure Outcomes
Secondary	Nutrition Policy and Infrastructure Outcomes

External Links

•   Link