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OpenTrials
Completed

NCT Number: NCT02086851

Study of a Structured Parent Intervention on Adolescent Weight Loss 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.

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Key information

Age range

11 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHoR at VCU Healthy Lifestyles Center

Henrico, Virginia, 23229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

Lifestyle Intervention

Behavioral

Parent Motivational Interviewing

Behavioral

Primary outcomes

  1. Change in BMI z-scores

    Time frame: 12 weeks, 6 months and 12 months

Secondary outcomes

  1. Changes in body composition

    Time frame: 12 weeks, 6 months and 1 year

  2. Changes in BMI

    Time frame: 12 weeks, 6 months and 12 months

  3. Changes in insulin sensitivity

    Time frame: 12 weeks, 6 months and 12 months

  4. Changes in blood pressure

    Time frame: 12 weeks, 6 months and 12 months

  5. Changes in serum lipids

    Time frame: 12 weeks, 6 months and 12 months

  6. Changes in fitness measures

    Time frame: 12 weeks, 6 months and 12 months

  7. Changes in ECG parameters

    Time frame: 12 weeks and 6 months

  8. Changes I dietary intake

    Time frame: 12 weeks, 6 months and 12 months

  9. Changes in quality of life scores

    Time frame: 12 weeks, 6 months and 12 months

  10. Changes in BMI of participating parents

    Time frame: 12 weeks, 6 months and 12 months

  11. Changes in body composition of participating parents

    Time frame: 12 weeks, 6 months and 12 months

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • Children's Hospital Foundation

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Mar 13, 2014
Registry last updated
Feb 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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