Study of a Structured Parent Intervention on Adolescent Weight Loss Modification Program.
February 10, 2016 updated by: Virginia Commonwealth University
Impact of a Structured Parent Intervention on Weight Loss and Behavioral Change in Overweight Adolescents Enrolled in a Lifestyle Modification Program
The study will enroll 110 overweight and obese adolescents ages 11-16 in a lifestyle modification program focusing on dietary modification and exercise.
Parents will be randomized into control and motivational interviewing-based intervention groups.
The primary hypothesis is that adolescents whose parents are in the intervention group will have improved compliance, weight loss and health outcomes compared with adolescents whose parents do not receive the intervention.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Adolescents will participate in a 6-month intensive lifestyle modification that includes a structured exercise program, nutrition education and dietary modification and behavioral support, followed by a 6-month maintenance phase with monthly booster sessions.
Parents will be randomized to participate in 4 dedicated "pre-treatment" parent psychoeducational sessions vs. control (no psychoeducational sessions).
The sessions will explore parents' feelings about participation in a weight management program, explore their reasons for wanting to make behavioral changes, and enhance motivation.
All parents will participate in monthly parent support groups while their adolescents are participating in the intervention phase of the study.
The 6-month adolescent intervention will include biweekly sessions with a registered dietitian for dietary education; biweekly interactive group discussion sessions on topics pertaining to motivation, strategies for changing health behaviors, setting and keeping goals and dealing with peer pressure; and exercise sessions three times a week with 30 minutes of cardiovascular exercise and 30 minutes of strength training each session.
Comprehensive assessments, including nutrition, behavior and exercise assessments, laboratory work, body composition measurements and medical assessments will be conducted at baseline, 6 months and 12 months.
Study Type
Interventional
Enrollment (Actual)
110
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Virginia
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Henrico, Virginia, United States, 23229
- CHoR at VCU Healthy Lifestyles Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
11 years to 16 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
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.
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Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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
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Active Comparator: Lifestyle Intervention alone
lifestyle intervention alone
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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
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Edmond P Wickham, MD, MPH, Virginia Commonwealth University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2011
Primary Completion (Actual)
August 1, 2015
Study Completion (Actual)
August 1, 2015
Study Registration Dates
First Submitted
February 7, 2014
First Submitted That Met QC Criteria
March 11, 2014
First Posted (Estimate)
March 13, 2014
Study Record Updates
Last Update Posted (Estimate)
February 11, 2016
Last Update Submitted That Met QC Criteria
February 10, 2016
Last Verified
February 1, 2016
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.