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

NCT ID: NCT02262013

Last Updated: 2017-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2016-09-30

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 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 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.

Conditions

Pediatric Obesity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Parents as Coaches

PAC (modeled after NIH-funded NOURISH) focuses on parenting strategies to support and facilitate their child's weight management via family-based change. Each visit includes group psychoeducation and discussion, focused on parenting strategies to facilitate healthy weight management in their child(ren). Topics include focus such as role modeling, strategies for healthy lifestyle changes, and how to be a coach to your teen.

Group Type: ACTIVE_COMPARATOR

Parents as Coaches

Intervention Type: BEHAVIORAL

Adolescents will receive lifestyle intervention (TEENS) and parents will receive parents as coaches (PAC) intervention.

Parent Weight Loss

In PWL parents will be given a weight loss goal of 1-2 lbs/week, as well as specific calorie and fat prescriptions, PA goals, and instructions to self-monitor key information. Parents will receive training in core behavioral weight loss strategies (e.g., goal setting, stimulus control) and techniques to help them achieve these goals and will also receive personalized feedback throughout the program.

Group Type: EXPERIMENTAL

Parent Weight Loss

Intervention Type: BEHAVIORAL

Adolescents will receive lifestyle intervention (TEENS) and parents will receive parent weight loss (PWL) intervention.

Interventions

Parents as Coaches

Adolescents will receive lifestyle intervention (TEENS) and parents will receive parents as coaches (PAC) intervention.

Intervention Type: BEHAVIORAL

Parent Weight Loss

Adolescents will receive lifestyle intervention (TEENS) and parents will receive parent weight loss (PWL) intervention.

Intervention Type: BEHAVIORAL

Other Intervention Names

TEENS+PAC; TEENS+PWL

Eligibility Criteria

Exclusion Criteria

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Edmond P Wickham, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Children's Hospital of Richmond at VCU Healthy Lifestyles Center

Henrico, Virginia, United States

Countries

United States

Other Identifiers

HM20003076

Identifier Type: -

Identifier Source: org_study_id