Study of a Structured Parent Intervention on Adolescent Weight Loss Modification Program.
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 11 - 16 |
| Updated: | 4/21/2016 |
| Start Date: | September 2011 |
| End Date: | August 2015 |
Impact of a Structured Parent Intervention on Weight Loss and Behavioral Change in Overweight Adolescents Enrolled in a Lifestyle Modification Program
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.
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.
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.
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.
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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