Clinical trial NCT02086851: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Obesity
Impact of Parent Intervention on Adolescent Weight Loss
Keywords: pediatric obesity
motivational interviewing
lifestyle intervention
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: Children's Hospital Foundation
First posted: 2014-03-13
Enrollment: 110
Sex: ALL
Minimum age (years): 11
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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Primary outcomes:
measure: Change in BMI z-scores
timeFrame: 12 weeks, 6 months and 12 months
Secondary outcomes:
measure: Changes in body composition
timeFrame: 12 weeks, 6 months and 1 year
measure: Changes in BMI
timeFrame: 12 weeks, 6 months and 12 months
measure: Changes in insulin sensitivity
timeFrame: 12 weeks, 6 months and 12 months
measure: Changes in blood pressure
timeFrame: 12 weeks, 6 months and 12 months
measure: Changes in serum lipids
timeFrame: 12 weeks, 6 months and 12 months
measure: Changes in fitness measures
timeFrame: 12 weeks, 6 months and 12 months
measure: Changes in ECG parameters
timeFrame: 12 weeks and 6 months
measure: Changes I dietary intake
timeFrame: 12 weeks, 6 months and 12 months
measure: Changes in quality of life scores
timeFrame: 12 weeks, 6 months and 12 months
measure: Changes in BMI of participating parents
timeFrame: 12 weeks, 6 months and 12 months
measure: Changes in body composition of participating parents
timeFrame: 12 weeks, 6 months and 12 months
Other outcomes:
Locations:
city: Henrico
country: United States
facility: CHoR at VCU Healthy Lifestyles Center
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Edmond P Wickham, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: