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

Primary Purpose

Pediatric Obesity, Impact of Parent Intervention on Adolescent Weight Loss

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lifestyle Intervention
Parent Motivational Interviewing
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediatric Obesity focused on measuring pediatric obesity, motivational interviewing, lifestyle intervention

Eligibility Criteria

11 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

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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Sites / Locations

  • CHoR at VCU Healthy Lifestyles Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lifestyle Intervention plus Parent Motivational Interviewing

Lifestyle Intervention alone

Arm Description

Lifestyle intervention + Parent MI

lifestyle intervention alone

Outcomes

Primary Outcome Measures

Change in BMI z-scores

Secondary Outcome Measures

Changes in body composition
Changes in BMI
Changes in insulin sensitivity
Changes in blood pressure
Changes in serum lipids
Changes in fitness measures
Changes in ECG parameters
Changes I dietary intake
Changes in quality of life scores
Changes in BMI of participating parents
Changes in body composition of participating parents

Full Information

First Posted
February 7, 2014
Last Updated
February 10, 2016
Sponsor
Virginia Commonwealth University
Collaborators
Children's Hospital Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02086851
Brief Title
Study of a Structured Parent Intervention on Adolescent Weight Loss Modification Program.
Official Title
Impact of a Structured Parent Intervention on Weight Loss and Behavioral Change in Overweight Adolescents Enrolled in a Lifestyle Modification Program
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
Children's Hospital Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obesity, Impact of Parent Intervention on Adolescent Weight Loss
Keywords
pediatric obesity, motivational interviewing, lifestyle intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lifestyle Intervention plus Parent Motivational Interviewing
Arm Type
Experimental
Arm Description
Lifestyle intervention + Parent MI
Arm Title
Lifestyle Intervention alone
Arm Type
Active Comparator
Arm Description
lifestyle intervention alone
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle Intervention
Intervention Type
Behavioral
Intervention Name(s)
Parent Motivational Interviewing
Primary Outcome Measure Information:
Title
Change in BMI z-scores
Time Frame
12 weeks, 6 months and 12 months
Secondary Outcome Measure Information:
Title
Changes in body composition
Time Frame
12 weeks, 6 months and 1 year
Title
Changes in BMI
Time Frame
12 weeks, 6 months and 12 months
Title
Changes in insulin sensitivity
Time Frame
12 weeks, 6 months and 12 months
Title
Changes in blood pressure
Time Frame
12 weeks, 6 months and 12 months
Title
Changes in serum lipids
Time Frame
12 weeks, 6 months and 12 months
Title
Changes in fitness measures
Time Frame
12 weeks, 6 months and 12 months
Title
Changes in ECG parameters
Time Frame
12 weeks and 6 months
Title
Changes I dietary intake
Time Frame
12 weeks, 6 months and 12 months
Title
Changes in quality of life scores
Time Frame
12 weeks, 6 months and 12 months
Title
Changes in BMI of participating parents
Time Frame
12 weeks, 6 months and 12 months
Title
Changes in body composition of participating parents
Time Frame
12 weeks, 6 months and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edmond P Wickham, MD, MPH
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHoR at VCU Healthy Lifestyles Center
City
Henrico
State/Province
Virginia
ZIP/Postal Code
23229
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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