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Sensible Treatment of Obesity in Rural Youth . . .

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00248677
First Posted: November 4, 2005
Last Update Posted: December 13, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Florida
  Purpose

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.

Condition Intervention Phase
Obesity Behavioral: Behavioral Family-Based Intervention Behavioral: Behavioral Parent-Based Intervention Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sensible Treatment of Obesity in Rural Youth

Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Change in Child BMI Z-score [ Time Frame: Sept 2005 - Aug 2008 ]

Secondary Outcome Measures:
  • Change in parent BMI [ Time Frame: Sept 2005 - Aug 2008 ]
  • Change in child dietary intake [ Time Frame: Sept 2005 - Aug 2008 ]
  • Change in child's physical activity and steps per day [ Time Frame: Sept 2005 - Aug 2008 ]

Enrollment: 93
Study Start Date: September 2005
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   8 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00248677


Locations
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: David M. Janicke, Ph.D. University of Florida
  More Information

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00248677     History of Changes
Other Study ID Numbers: DK71555
R34DK071555 ( U.S. NIH Grant/Contract )
1R34DK071555-01 ( U.S. NIH Grant/Contract )
First Submitted: November 3, 2005
First Posted: November 4, 2005
Last Update Posted: December 13, 2011
Last Verified: February 2011

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms