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

NCT ID: NCT02086851

Last Updated: 2016-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2015-08-31

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.

Conditions

Pediatric Obesity; Impact of Parent Intervention on Adolescent Weight Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lifestyle Intervention plus Parent Motivational Interviewing

Lifestyle intervention + Parent MI

Group Type: EXPERIMENTAL

Lifestyle Intervention

Intervention Type: BEHAVIORAL

Parent Motivational Interviewing

Intervention Type: BEHAVIORAL

Lifestyle Intervention alone

lifestyle intervention alone

Group Type: ACTIVE_COMPARATOR

Lifestyle Intervention

Intervention Type: BEHAVIORAL

Interventions

Lifestyle Intervention

Intervention Type: BEHAVIORAL

Parent Motivational Interviewing

Intervention Type: BEHAVIORAL

Eligibility Criteria

Exclusion Criteria

-

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Children's Hospital Foundation

OTHER

Sponsor Role: collaborator

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Edmond P Wickham, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

CHoR at VCU Healthy Lifestyles Center

Henrico, Virginia, United States

Countries

United States

Other Identifiers

HM13833

Identifier Type: -

Identifier Source: org_study_id