- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02262013
Evaluation of a Family-based Pediatric Obesity Program: TEENS+
Study Overview
Status
Conditions
Intervention / 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Virginia
-
Henrico, Virginia, United States, 23239
- Children's Hospital of Richmond at VCU Healthy Lifestyles Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
|
Adolescents will receive lifestyle intervention (TEENS) and parents will receive parents as coaches (PAC) intervention.
Other Names:
|
Experimental: 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.
|
Adolescents will receive lifestyle intervention (TEENS) and parents will receive parent weight loss (PWL) intervention.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in BMI z-scores (adolescents and parents)
Time Frame: 3 months, 6 months, 9 months
|
3 months, 6 months, 9 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Insulin Sensitivity
Time Frame: 6 months, 9 months
|
Insulin, Glucose, HbA1c
|
6 months, 9 months
|
Changes in Serum Lipids
Time Frame: 6 months, 9 months
|
6 months, 9 months
|
|
Changes in Energy Balance
Time Frame: 6 months, 9 months
|
Adipokines, Cytokines
|
6 months, 9 months
|
Changes in Blood Pressure
Time Frame: 3 months, 6 months, 9 months
|
3 months, 6 months, 9 months
|
|
Changes in Psychosocial Measures
Time Frame: 3 months, 6 months, 9 months
|
3 months, 6 months, 9 months
|
|
Changes in Dietary Intake
Time Frame: 3 months, 6 months, 9 months
|
3 months, 6 months, 9 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Edmond P Wickham, MD, MPH, Virginia Commonwealth University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HM20003076
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pediatric Obesity
-
Virginia Commonwealth UniversityActive, not recruitingObesity, PediatricUnited States
-
University of British ColumbiaThe Hospital for Sick Children; Canadian Institutes of Health Research (CIHR); Alberta Health services and other collaboratorsCompleted
-
Hasselt UniversityJessa HospitalCompletedObesity, Pediatric
-
Azienda Ospedaliera Universitaria Integrata VeronaNot yet recruitingObesity, Pediatric
-
University of British ColumbiaHeart and Stroke Foundation of Canada; Public Health Agency of Canada (PHAC); Childhood Obesity Foundation and other collaboratorsCompleted
-
Columbia UniversityCompletedVitamin D Deficiency | Obesity, Morbid | Obesity, Childhood | Obesity, PediatricUnited States
-
University Hospital, Clermont-FerrandAME2P Laboratory, Clermont Auvergne UniversityCompleted
-
Medical College of WisconsinWisconsin Department of Health and Family Services; Children's Health System...TerminatedPediatric Obesity | Pediatric OverweightUnited States
-
Kahramanmaras Sutcu Imam UniversityCompletedPediatric Obesity | Pediatric DentistryTurkey
-
Central Hospital, Nancy, FranceNot yet recruiting
Clinical Trials on Parents as Coaches
-
Virginia Commonwealth UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...Completed
-
Virginia Commonwealth UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsActive, not recruiting
-
New York UniversityNot yet recruitingChild Sexual AbuseUnited States
-
USDA, Delta Human Nutrition Research ProgramCompleted
-
Washington University School of MedicineNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedObesity | Pregnancy | Weight GainUnited States
-
University of Applied Sciences of Special Needs...University of Zurich; Swiss National Science Foundation; Jacobs Foundation; Stiftung... and other collaboratorsUnknown
-
Penn State UniversityCompleted
-
St. Louis UniversityRecruitingKnowledge, Attitudes, PracticeUnited States
-
VIVE - The Danish Center for Social Science ResearchMinistry of Social AffairsUnknown
-
University of Wisconsin, MadisonCompleted