Clinical Trial: Evaluation of a Family-based Pediatric Obesity Program: TEENS+

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Evaluation of a Family-based Pediatric Obesity Program: TEENS+

Brief Summary: Investigators propose to pilot an adolescent obesity intervention, TEENS+, to examine the feasibility of this dietary intervention strategy and preliminary effectiveness of two models of parental involvement within adolescent obesity treatment.

Detailed Summary:

Investigators will recruit overweight or obese adolescents (BMI >85th percentile) and parent(s) (BMI >25 kg/m2). Families will participate in one of two 6-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, lab work, psychological surveys, and nutritional evaluations. Assessments will be completed at baseline, 3 months, 6 months (post-intervention), and 9 months.


Sponsor: Virginia Commonwealth University

Current Primary Outcome: Change in BMI z-scores (adolescents and parents) [ Time Frame: 3 months, 6 months, 9 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Changes in Insulin Sensitivity [ Time Frame: 6 months, 9 months ]
    Insulin, Glucose, HbA1c
  • Changes in Serum Lipids [ Time Frame: 6 months, 9 months ]
  • Changes in Energy Balance [ Time Frame: 6 months, 9 months ]
    Adipokines, Cytokines
  • Changes in Blood Pressure [ Time Frame: 3 months, 6 months, 9 months ]
  • Changes in Psychosocial Measures [ Time Frame: 3 months, 6 months, 9 months ]
  • Changes in Dietary Intake [ Time Frame: 3 months, 6 months, 9 months ]


Original Secondary Outcome: Same as current

Information By: Virginia Commonwealth University

Dates:
Date Received: October 7, 2014
Date Started: January 2015
Date Completion:
Last Updated: February 8, 2017
Last Verified: February 2017