Study of a Structured Parent Intervention on Adolescent Weight Loss Modification Program.

Overview

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.

Full Title of Study: “Impact of a Structured Parent Intervention on Weight Loss and Behavioral Change in Overweight Adolescents Enrolled in a Lifestyle Modification Program”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2015

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.

Interventions

  • Behavioral: Lifestyle Intervention
  • Behavioral: Parent Motivational Interviewing

Arms, Groups and Cohorts

  • Experimental: Lifestyle Intervention plus Parent Motivational Interviewing
    • Lifestyle intervention + Parent MI
  • Active Comparator: Lifestyle Intervention alone
    • lifestyle intervention alone

Clinical Trial Outcome Measures

Primary Measures

  • Change in BMI z-scores
    • Time Frame: 12 weeks, 6 months and 12 months

Secondary Measures

  • Changes in body composition
    • Time Frame: 12 weeks, 6 months and 1 year
  • Changes in BMI
    • Time Frame: 12 weeks, 6 months and 12 months
  • Changes in insulin sensitivity
    • Time Frame: 12 weeks, 6 months and 12 months
  • Changes in blood pressure
    • Time Frame: 12 weeks, 6 months and 12 months
  • Changes in serum lipids
    • Time Frame: 12 weeks, 6 months and 12 months
  • Changes in fitness measures
    • Time Frame: 12 weeks, 6 months and 12 months
  • Changes in ECG parameters
    • Time Frame: 12 weeks and 6 months
  • Changes I dietary intake
    • Time Frame: 12 weeks, 6 months and 12 months
  • Changes in quality of life scores
    • Time Frame: 12 weeks, 6 months and 12 months
  • Changes in BMI of participating parents
    • Time Frame: 12 weeks, 6 months and 12 months
  • Changes in body composition of participating parents
    • Time Frame: 12 weeks, 6 months and 12 months

Participating in This Clinical Trial

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. -

Gender Eligibility: All

Minimum Age: 11 Years

Maximum Age: 16 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Virginia Commonwealth University
  • Collaborator
    • Children’s Hospital Foundation
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Edmond P Wickham, MD, MPH, Principal Investigator, Virginia Commonwealth University

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.