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

NCT02262013 | Completed DMC

• 1 other identifier: HM20003076
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Obesity

Keywords

Pediatric Obesity; Lifestyle Intervention; Family-based Intervention; Motivational Interviewing

Outcome Measures

Primary Outcomes (1)

• Change in BMI z-scores (adolescents and parents)

  3 months, 6 months, 9 months

Secondary Outcomes (6)

• Changes in Insulin Sensitivity

  6 months, 9 months

• Changes in Serum Lipids

  6 months, 9 months

• Changes in Energy Balance

  6 months, 9 months

• Changes in Blood Pressure

  3 months, 6 months, 9 months

• Changes in Psychosocial Measures

  3 months, 6 months, 9 months

Study Arms (2)

Parents as Coaches

ACTIVE COMPARATOR

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.

Behavioral: Parents as Coaches

Parent Weight Loss

EXPERIMENTAL

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.

Behavioral: Parent Weight Loss

Interventions

Parents as Coaches BEHAVIORAL

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

Also known as: TEENS+PAC

Parents as Coaches

Parent Weight Loss BEHAVIORAL

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

Also known as: TEENS+PWL

Parent Weight Loss

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Children's Hospital of Richmond at VCU Healthy Lifestyles Center

Henrico, Virginia, 23239, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Edmond P Wickham, MD, MPH

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2014
• First Posted: October 10, 2014
• Study Start: January 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: February 10, 2017

Record last verified: 2017-02

Locations

US (1)