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

Pediatric Obesity Clinical Trial

Official title:

Impact of a Structured Parent Intervention on Weight Loss and Behavioral Change in Overweight Adolescents Enrolled in a Lifestyle Modification Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02086851
• Other study ID #: HM13833
• Status: Completed
• Phase: N/A
• First received: February 7, 2014
• Last updated: February 10, 2016
• Start date: September 2011
• Est. completion date: August 2015

Study information

• Verified date: February 2016
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 11 Years to 16 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Impact of Parent Intervention on Adolescent Weight Loss
• Pediatric Obesity
• Weight Loss

Intervention

Behavioral:
• Lifestyle Intervention

• Parent Motivational Interviewing

Locations

Country	Name	City	State
United States	CHoR at VCU Healthy Lifestyles Center	Henrico	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	Children's Hospital Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in BMI z-scores		12 weeks, 6 months and 12 months	No
Secondary	Changes in body composition		12 weeks, 6 months and 1 year	No
Secondary	Changes in BMI		12 weeks, 6 months and 12 months	No
Secondary	Changes in insulin sensitivity		12 weeks, 6 months and 12 months	No
Secondary	Changes in blood pressure		12 weeks, 6 months and 12 months	No
Secondary	Changes in serum lipids		12 weeks, 6 months and 12 months	No
Secondary	Changes in fitness measures		12 weeks, 6 months and 12 months	No
Secondary	Changes in ECG parameters		12 weeks and 6 months	No
Secondary	Changes I dietary intake		12 weeks, 6 months and 12 months	No
Secondary	Changes in quality of life scores		12 weeks, 6 months and 12 months	No
Secondary	Changes in BMI of participating parents		12 weeks, 6 months and 12 months	No
Secondary	Changes in body composition of participating parents		12 weeks, 6 months and 12 months	No

External Links

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