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

Not Applicable

Completed

• Conditions: Pediatric Obesity; Impact of Parent Intervention on Adolescent Weight Loss
• Interventions: Behavioral: Lifestyle Intervention; Behavioral: Parent Motivational Interviewing

• Registration Number: NCT02086851
• Lead Sponsor: Virginia Commonwealth University

Brief Summary

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.

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2014-02-07
• Study First Submitted QC: 2014-03-11
• Study First Posted: 2014-03-13
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-10
• Last Update Posted: 2016-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

Age 11 - 16; BMI > 85th percentile; one parent or guardian committed to participate in protocol; -

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lifestyle Intervention plus Parent Motivational Interviewing	Lifestyle Intervention	Lifestyle intervention + Parent MI
Lifestyle Intervention plus Parent Motivational Interviewing	Parent Motivational Interviewing	Lifestyle intervention + Parent MI
Lifestyle Intervention alone	Lifestyle Intervention	lifestyle intervention alone

Primary Outcome Measures

Name	Time	Method
Change in BMI z-scores	12 weeks, 6 months and 12 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHoR at VCU Healthy Lifestyles Center; 🇺🇸 Henrico, Virginia, United States