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Clinical Trials/NCT02586090
NCT02586090
Completed
Not Applicable

Innovative Approaches to Adolescent Obesity Treatment: Exploring the Role of Parents

Virginia Commonwealth University1 site in 1 country162 target enrollmentJanuary 6, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pediatric Obesity
Sponsor
Virginia Commonwealth University
Enrollment
162
Locations
1
Primary Endpoint
Between-group differences in parent weight change.
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The study will pilot a randomized control trial to investigate the feasibility and preliminary efficacy of two distinct parent treatments on a dietary intervention for overweight and obese adolescents.

Detailed Description

Investigators will recruit overweight or obese adolescents (BMI \>85th percentile) and parent(s) (BMI \>25 kg/m2). Families will participate in one of two 4-month treatments: 1) TEENS+Parents as Coaches (PAC), engaging parents as helpers in their child's weight management, or 2) TEENS+Parent Weight Loss (PWL), engaging parents in their own weight management. All adolescents will participate in TEENS+, which includes behavioral support, nutrition education, and supervised physical activity. For the adolescents, intervention will consist of weekly 1 hour exercise sessions and alternating weekly 1 hour behavioral and nutrition group sessions. Parents will also attend the nutrition sessions and participate in a behavioral parent-only biweekly group. Parent behavioral group sessions will be specific to the treatment arm (e.g. PAC or PWL). Assessments will consist of anthropometric measures, psychological surveys, and nutritional evaluations. Assessments will be completed at baseline, post-test and 3-month follow-up.

Registry
clinicaltrials.gov
Start Date
January 6, 2016
End Date
February 19, 2018
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Adolescent Inclusion Criteria:
  • BMI ≥85% percentile for age and gender according to the CDC Growth Charts
  • Age 12 to 16
  • must reside with the primary participating parent
  • parent must have a BMI ≥25 kg/m 2
  • parent must be willing to participate in the protocol
  • Parent Inclusion Criteria:
  • 18-60 years of age
  • BMI ≥25 kg/m2
  • must reside with the adolescent

Exclusion Criteria

  • Adolescent Exclusion Criteria
  • non-English speaking
  • medical condition(s) that may be associated with unintentional weight change
  • use of oral glucocorticoids, atypical antipsychotics, weight loss medications, or an investigational medication within 3 months of study participation;
  • medical condition(s) that may be negatively impacted by exercise
  • psychiatric, cognitive, physical or developmental conditions that would impair the ability to complete assessments, participate in a group, or conduct physical activity
  • reports of compensatory behaviors in the past 3 months
  • current pregnancy or plan to become pregnant during study period
  • previous participation in HM11113, HM13833, HM20003076, IRB3008, IRB6255, HM11390, HM13468, HM14973 or HM14139
  • current participation in another weight loss program; or 11) personal history of weight loss surgery.

Outcomes

Primary Outcomes

Between-group differences in parent weight change.

Time Frame: 4 months (pre-intervention - post-test)

Weight change (kg; parents)- primary outcome; trial is powered on parent weight change

Within group differences in adolescent changes in BMI

Time Frame: 4 months (pre-intervention - post-test)

BMI change (kg/m2; adolescent)

Secondary Outcomes

  • Changes in parent dietary intake(4 months (pre-intervention - post-test))
  • Changes in authoritative parenting (API) and parent feeding practices measured via Child Feeding Questionnaire(4 months (pre-intervention - post-test))
  • Changes in child dietary intake(4 months (pre-intervention - post-test))
  • Changes in parent physical activity(4 months (pre-intervention - post-test))
  • Changes in adolescent physical activity(4 months (pre-intervention - post-test))

Study Sites (1)

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