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Sensible Treatment of Obesity in Rural Youth . . .

NCT00248677 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2011-12-13

No results posted yet for this study

Summary

Project STORY (Sensible Treatment of Obesity in Rural Youth) will entail a three-arm randomized controlled trial to test the effectiveness of interventions designed to promote successful weight management in an important population, overweight children and their parents in medically underserved, rural settings. The current feasibility study will provide pilot data to develop and support a full-scale trial that will be implemented across multiple rural counties. In this pilot program, participants will be randomly assigned to one of two, 4-month long intervention programs that will be delivered in rural communities through Cooperative Extension Offices, or to a Wait List Control (WLC) group. The Behavioral Family-Based Intervention (BFI) will involve simultaneous, but separate treatment groups for both the child and their parent(s). The Behavioral Parent-Based Intervention (BPI) will involve groups for only the parent(s). Both programs will take a behavioral lifestyle approach to gradually modify dietary and physical activity patterns. The aims of the trial and its principal hypotheses are listed below.

AIMS:

* Evaluate the effects on child's standardized body mass index (BMI-z) of BPI and BFI delivered via group contacts to overweight children and/or their overweight parents in rural counties.
* Examine changes in children's dietary intake, physical activity, self-esteem, and body image.
* Compare the cost-effectiveness of the BPI and BFI.
* Evaluate the effects of the BPI and BFI on parent BMI.

Conditions

Interventions

BEHAVIORAL

Behavioral Family-Based Intervention

Behavioral family intervention

BEHAVIORAL

Behavioral Parent-Based Intervention

Behavioral Parent-Only Intervention

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • University of Florida

    lead OTHER

Principal Investigators

  • David M. Janicke, Ph.D. · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2008-08-31
Completion
2008-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00248677 on ClinicalTrials.gov