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

Primary Purpose

Pediatric Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Parents as Coaches
Parent Weight Loss
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediatric Obesity focused on measuring Pediatric Obesity, Lifestyle Intervention, Family-based Intervention, Motivational Interviewing

Eligibility Criteria

12 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 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.

Sites / Locations

  • Children's Hospital of Richmond at VCU Healthy Lifestyles Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Parents as Coaches

Parent Weight Loss

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in BMI z-scores (adolescents and parents)

Secondary Outcome Measures

Changes in Insulin Sensitivity
Insulin, Glucose, HbA1c
Changes in Serum Lipids
Changes in Energy Balance
Adipokines, Cytokines
Changes in Blood Pressure
Changes in Psychosocial Measures
Changes in Dietary Intake

Full Information

First Posted
October 7, 2014
Last Updated
February 8, 2017
Sponsor
Virginia Commonwealth University
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1. Study Identification

Unique Protocol Identification Number
NCT02262013
Brief Title
Evaluation of a Family-based Pediatric Obesity Program: TEENS+
Official Title
Evaluation of a Family-based Pediatric Obesity Program: TEENS+
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obesity
Keywords
Pediatric Obesity, Lifestyle Intervention, Family-based Intervention, Motivational Interviewing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Parents as Coaches
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Parent Weight Loss
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Parents as Coaches
Other Intervention Name(s)
TEENS+PAC
Intervention Description
Adolescents will receive lifestyle intervention (TEENS) and parents will receive parents as coaches (PAC) intervention.
Intervention Type
Behavioral
Intervention Name(s)
Parent Weight Loss
Other Intervention Name(s)
TEENS+PWL
Intervention Description
Adolescents will receive lifestyle intervention (TEENS) and parents will receive parent weight loss (PWL) intervention.
Primary Outcome Measure Information:
Title
Change in BMI z-scores (adolescents and parents)
Time Frame
3 months, 6 months, 9 months
Secondary Outcome Measure Information:
Title
Changes in Insulin Sensitivity
Description
Insulin, Glucose, HbA1c
Time Frame
6 months, 9 months
Title
Changes in Serum Lipids
Time Frame
6 months, 9 months
Title
Changes in Energy Balance
Description
Adipokines, Cytokines
Time Frame
6 months, 9 months
Title
Changes in Blood Pressure
Time Frame
3 months, 6 months, 9 months
Title
Changes in Psychosocial Measures
Time Frame
3 months, 6 months, 9 months
Title
Changes in Dietary Intake
Time Frame
3 months, 6 months, 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edmond P Wickham, MD, MPH
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Richmond at VCU Healthy Lifestyles Center
City
Henrico
State/Province
Virginia
ZIP/Postal Code
23239
Country
United States

12. IPD Sharing Statement

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