Sensible Treatment of Obesity in Rural Youth . . .

Sensible Treatment of Obesity in Rural Youth

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Behavioral Family-Based Intervention; Behavioral: Behavioral Parent-Based Intervention

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 93
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 13 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Ethnicity: all ethnic groups.
• Sex/Gender of Child Participant: Males and females.
• Age of Child Participant: 8 - 12 years.
• Child's Body-Mass Index: BMI above the 85th percentile for sex and age.
• Participating Parent or Legal Guardian: Must have participating parent or legal guardian (male or female) with BMI > 25 kg/m2. Participants (children and parents) must weigh less than 159 kg (350 pounds) in order to allow weight measurement on a standard balance beam scale.
• Physician Authorization: Letter signed by a physician medically clearing individuals (children and adults) to participate in weight management program. For families who are not able to access physician care, we will arrange for an appointment with a health care provider.
• Place of Residence: Child and participating parents must live in a rural county and within the same house.

Exclusion Criteria:

• Child or participating parent has dietary or exercise restrictions, or a medical condition that contraindicates mild energy restriction or moderate physical activity: history of musculo-skeletal condition that limits walking; heart condition; diabetes; chronic lung diseases limiting physical activity; uncontrolled high blood pressure or uncontrolled exercise induced-asthma as determined by a physician.
• Participating parent pregnant or plans on becoming pregnant within the next year.
• Medication exclusions: Child or participating parent on antipsychotic agents; systemic corticosteroids; or current use of prescription weight-loss drugs, insulin, or other diabetic medications.
• Child or participating parent currently engaged in another weight control program.
• Conditions or behaviors likely to affect the conduct of the trial: unwilling or unable to give informed consent; parent or legal guardian unable to read English at the 5th grade level; unwilling to accept random assignment; unable to travel to extension office for intervention sessions; likely to move out of the county within the next 18 months; child or parent with major psychiatric disorder; child with major cognitive or developmental delay; children with a current pattern of aggressive or oppositional behavior; or any other condition/situation which in the opinion of staff would adversely affect participation in Project STORY.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: No Contact Control
EXPERIMENTAL: Behavior Family Intervention	Behavioral: Behavioral Family-Based Intervention; Behavioral family intervention
EXPERIMENTAL: Behavioral Parent-Only Intervention	Behavioral: Behavioral Parent-Based Intervention; Behavioral Parent-Only Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Child BMI Z-score	Sept 2005 - Aug 2008

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in parent BMI	Sept 2005 - Aug 2008
Change in child dietary intake	Sept 2005 - Aug 2008
Change in child's physical activity and steps per day	Sept 2005 - Aug 2008

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: David M. Janicke, Ph.D., University of Florida

Study record dates

Study Major Dates

• Study Start: September 1, 2005
• Primary Completion (ACTUAL): August 1, 2008
• Study Completion (ACTUAL): August 1, 2008

Study Registration Dates

• First Submitted: November 3, 2005
• First Submitted That Met QC Criteria: November 3, 2005
• First Posted (ESTIMATE): November 4, 2005

Study Record Updates

• Last Update Posted (ESTIMATE): December 13, 2011
• Last Update Submitted That Met QC Criteria: December 9, 2011
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: DK71555; R34DK071555 (NIH); 1R34DK071555-01 (NIH)