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

Completed · Not applicable

Conditions studied: Pediatric Obesity

In brief

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.

Key facts

Study ID

NCT02262013

Run by

Virginia Commonwealth University

People needed

25

Starts

2015-01-01

Expected to finish

2016-09-01

Last updated by the study team

2017-02-10

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• Adolescents and parents will be ineligible for study participation under the following conditions: 1) non-English speaking; 2) medical condition(s) that may be associated with unintentional weight change (e.g., hypothalamic injury, Prader-Willi, or malignancy); 3) diabetes mellitus diagnosed by history or a fasting glucose ≥126 mg/dl (subjects with glucose intolerance or "pre-diabetes" will eligible for study participation); 4) use of oral glucocorticoids, atypical antipsychotics, weight loss medications, or an investigational medication within 3 months of study participation; 5) medical condition(s) that may be negatively impacted by exercise; 6) physical limitation affected the ability to exercise, 7) psychiatric, cognitive or developmental conditions that would impair the adolescent's ability to complete assessments or participate in a group; 8) reports of compensatory behaviors (i.e., vomiting, laxative abuse, excessive exercise) in the past 3 months; 9) current pregnancy or plan to become pregnant during study period; 10) previous participation in TEENS or NOURISH; 11) current participation in another weight loss program; or 12) personal history of weight loss surgery.
• Adolescents and parents taking metformin, oral contraceptives, tricyclic antidepressants (TCAs), selective serotonin reuptake inhibitors (SSRIs), or stimulant medications may be eligible for participation; however, subjects must be on a stable dose of medication for at least 3 months prior to study participation.
• In addition, adolescents will be excluded from participation (and referred for further evaluation) based on the results of baseline psychological assessments under the following circumstances: 1) clinically significant depression, evidenced by elevations (>20) on CDI; 2) suicidality as reported on CDI or during screening / behavioral interview; 3) psychosis, 4) clinical impairment in Activities of Daily Living and Functional Communication (i.e., expressive and receptive communication; and 3) clinically significant eating disorder based on EDE-Q.

Where it is running

• Children's Hospital of Richmond at VCU Healthy Lifestyles Center — Henrico, Virginia, United States

Full record on ClinicalTrials.gov

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