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

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ClinicalTrials.gov Identifier: NCT02086851
Recruitment Status : Completed
First Posted : March 13, 2014
Last Update Posted : February 11, 2016
Sponsor:
Collaborator:
Children's Hospital Foundation
Information provided by (Responsible Party):
Virginia Commonwealth University

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.

Condition or disease Intervention/treatment Phase
Pediatric Obesity Impact of Parent Intervention on Adolescent Weight Loss Behavioral: Lifestyle Intervention Behavioral: Parent Motivational Interviewing Not Applicable

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.

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Study Type : Interventional
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of a Structured Parent Intervention on Weight Loss and Behavioral Change in Overweight Adolescents Enrolled in a Lifestyle Modification Program
Study Start Date : September 2011
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lifestyle Intervention plus Parent Motivational Interviewing
Lifestyle intervention + Parent MI
Behavioral: Lifestyle Intervention
Behavioral: Parent Motivational Interviewing
Active Comparator: Lifestyle Intervention alone
lifestyle intervention alone
Behavioral: Lifestyle Intervention



Primary Outcome Measures :
  1. Change in BMI z-scores [ Time Frame: 12 weeks, 6 months and 12 months ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   11 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02086851


Locations
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United States, Virginia
CHoR at VCU Healthy Lifestyles Center
Henrico, Virginia, United States, 23229
Sponsors and Collaborators
Virginia Commonwealth University
Children's Hospital Foundation
Investigators
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Principal Investigator: Edmond P Wickham, MD, MPH Virginia Commonwealth University

Additional Information:
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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT02086851     History of Changes
Other Study ID Numbers: HM13833
First Posted: March 13, 2014    Key Record Dates
Last Update Posted: February 11, 2016
Last Verified: February 2016

Keywords provided by Virginia Commonwealth University:
pediatric obesity
motivational interviewing
lifestyle intervention

Additional relevant MeSH terms:
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Body Weight
Weight Loss
Pediatric Obesity
Signs and Symptoms
Body Weight Changes
Obesity
Overnutrition
Nutrition Disorders
Overweight