Status:
COMPLETED
Evaluation of a Family-based Pediatric Obesity Program: TEENS+
Lead Sponsor:
Virginia Commonwealth University
Conditions:
Pediatric Obesity
Eligibility:
All Genders
12-17 years
Phase:
NA
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 invo...
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 6-month treatments: 1) TEENS+Parents as Coach...
Eligibility Criteria
Inclusion
- Overweight (BMI ≥85% percentile for age and gender according to the CDC Growth Charts) males and females between the age of 12 and 17 years will be eligible for study participation. In order to be eligible, the adolescent must also reside with the primary participating parent, who has a BMI ≥25 kg/m 2 and is also willing to participate in the study protocol. Eligible families must live within a 30 mile radius of the Healthy Lifestyles Center (HLC) at Children's Hospital of Richmond (CHoR) at VCU where the interventions will be conducted.
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT02262013
Start Date
January 1 2015
End Date
September 1 2016
Last Update
February 10 2017
Active Locations (1)
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1
Children's Hospital of Richmond at VCU Healthy Lifestyles Center
Henrico, Virginia, United States, 23239