- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02086851
Study of a Structured Parent Intervention on Adolescent Weight Loss Modification Program.
Impact of a Structured Parent Intervention on Weight Loss and Behavioral Change in Overweight Adolescents Enrolled in a Lifestyle Modification Program
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Virginia
-
Henrico, Virginia, United States, 23229
- CHoR at VCU Healthy Lifestyles Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria: Age 11 - 16; BMI > 85th percentile; one parent or guardian committed to participate in protocol; -
Exclusion Criteria: Previous enrollment in IRB3354, IRB3008 or HM11113; Underlying genetic, neurological, endocrine or metabolic condition that preclude weight loss with conventional diet and exercise programs; Weight greater than 400 pounds, Pregnancy in female subjects; Inability to understand study instructions due to language barrier or mental disability; Primary residence outside a 30 mile radius of study location.
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lifestyle Intervention plus Parent Motivational Interviewing
Lifestyle intervention + Parent MI
|
|
Active Comparator: Lifestyle Intervention alone
lifestyle intervention alone
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in BMI z-scores
Time Frame: 12 weeks, 6 months and 12 months
|
12 weeks, 6 months and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in body composition
Time Frame: 12 weeks, 6 months and 1 year
|
12 weeks, 6 months and 1 year
|
Changes in BMI
Time Frame: 12 weeks, 6 months and 12 months
|
12 weeks, 6 months and 12 months
|
Changes in insulin sensitivity
Time Frame: 12 weeks, 6 months and 12 months
|
12 weeks, 6 months and 12 months
|
Changes in blood pressure
Time Frame: 12 weeks, 6 months and 12 months
|
12 weeks, 6 months and 12 months
|
Changes in serum lipids
Time Frame: 12 weeks, 6 months and 12 months
|
12 weeks, 6 months and 12 months
|
Changes in fitness measures
Time Frame: 12 weeks, 6 months and 12 months
|
12 weeks, 6 months and 12 months
|
Changes in ECG parameters
Time Frame: 12 weeks and 6 months
|
12 weeks and 6 months
|
Changes I dietary intake
Time Frame: 12 weeks, 6 months and 12 months
|
12 weeks, 6 months and 12 months
|
Changes in quality of life scores
Time Frame: 12 weeks, 6 months and 12 months
|
12 weeks, 6 months and 12 months
|
Changes in BMI of participating parents
Time Frame: 12 weeks, 6 months and 12 months
|
12 weeks, 6 months and 12 months
|
Changes in body composition of participating parents
Time Frame: 12 weeks, 6 months and 12 months
|
12 weeks, 6 months and 12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Edmond P Wickham, MD, MPH, Virginia Commonwealth University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HM13833
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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