Status:
COMPLETED
Sensible Treatment of Obesity in Rural Youth . . .
Lead Sponsor:
University of Florida
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Obesity
Eligibility:
All Genders
8-13 years
Phase:
EARLY_PHASE1
Brief 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 manage...
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 manage...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT00248677
Start Date
September 1 2005
End Date
August 1 2008
Last Update
December 13 2011
Active Locations (1)
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1
University of Florida
Gainesville, Florida, United States, 32610