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Sensible Treatment of Obesity in Rural Youth . . .

NCT ID: NCT00248677

Last Updated: 2011-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2008-08-31

Brief Summary

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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.

Detailed Description

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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

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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No Contact Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Behavior Family Intervention

Group Type EXPERIMENTAL

Behavioral Family-Based Intervention

Intervention Type BEHAVIORAL

Behavioral family intervention

Behavioral Parent-Only Intervention

Group Type EXPERIMENTAL

Behavioral Parent-Based Intervention

Intervention Type BEHAVIORAL

Behavioral Parent-Only Intervention

Interventions

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Behavioral Family-Based Intervention

Behavioral family intervention

Intervention Type BEHAVIORAL

Behavioral Parent-Based Intervention

Behavioral Parent-Only Intervention

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

8 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

NIH

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David M. Janicke, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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University of Florida

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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R34DK071555

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1R34DK071555-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DK71555

Identifier Type: -

Identifier Source: org_study_id