- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02586090
The Role of Parents in Adolescent Obesity Treatment (TEENS+)
Innovative Approaches to Adolescent Obesity Treatment: Exploring the Role of Parents
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 4-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, psychological surveys, and nutritional evaluations. Assessments will be completed at baseline, post-test and 3-month follow-up.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Virginia
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Henrico, Virginia, United States, 23239
- Children's Hospital of Richmond at VCU Healthy Lifestyles Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Adolescent Inclusion Criteria:
- BMI ≥85% percentile for age and gender according to the CDC Growth Charts
- Age 12 to 16
- must reside with the primary participating parent
- parent must have a BMI ≥25 kg/m 2
- parent must be willing to participate in the protocol
Parent Inclusion Criteria:
- 18-60 years of age
- BMI ≥25 kg/m2
- must reside with the adolescent
Exclusion Criteria:
Adolescent Exclusion Criteria
- non-English speaking
- medical condition(s) that may be associated with unintentional weight change
- use of oral glucocorticoids, atypical antipsychotics, weight loss medications, or an investigational medication within 3 months of study participation;
- medical condition(s) that may be negatively impacted by exercise
- psychiatric, cognitive, physical or developmental conditions that would impair the ability to complete assessments, participate in a group, or conduct physical activity
- reports of compensatory behaviors in the past 3 months
- current pregnancy or plan to become pregnant during study period
- previous participation in HM11113, HM13833, HM20003076, IRB3008, IRB6255, HM11390, HM13468, HM14973 or HM14139
- current participation in another weight loss program; or 11) personal history of weight loss surgery.
- clinically significant depression
- clinically significant eating disorder
- change in dose of metformin, oral contraceptives, tricyclic antidepressants (TCAs), selective serotonin reuptake inhibitors (SSRIs), or stimulant medications within 3 months prior to study participation.
- weight in excess of 400 pounds
- admission to a psychiatric hospital within the past year
Parent Exclusion Criteria
- non-English speaking
- medical condition(s) that may be associated with unintentional weight change
- use of oral glucocorticoids, atypical antipsychotics, weight loss medications, or investigational medications within 3 months of study participation
- psychiatric, cognitive, physical or developmental conditions that would impair the parent's ability to respond to assessments, participate in physical activity or participate in a group
- reports of compensatory behaviors in the past 3 months
- current pregnancy, lactation, less than 6 months post-partum, or plan to become pregnant during the study period
- past participation in IRB3354, HM11113, HM13833, HM20003076, IRB3008, IRB6255, HM11390, HM13468, HM14973 or HM14139
- currently engaged in another weight loss program, or 9) personal history of weight loss surgery.
- Severe depression or endorsing suicidal thoughts
- admission to a psychiatric hospital within the past year.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
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.
|
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.
|
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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Between-group differences in parent weight change.
Time Frame: 4 months (pre-intervention - post-test)
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Weight change (kg; parents)- primary outcome; trial is powered on parent weight change
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4 months (pre-intervention - post-test)
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Within group differences in adolescent changes in BMI
Time Frame: 4 months (pre-intervention - post-test)
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BMI change (kg/m2; adolescent)
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4 months (pre-intervention - post-test)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in parent dietary intake
Time Frame: 4 months (pre-intervention - post-test)
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Average total energy intake (kcal/day) estimated via 3-day food record
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4 months (pre-intervention - post-test)
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Changes in authoritative parenting (API) and parent feeding practices measured via Child Feeding Questionnaire
Time Frame: 4 months (pre-intervention - post-test)
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parenting and feeding style
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4 months (pre-intervention - post-test)
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Changes in child dietary intake
Time Frame: 4 months (pre-intervention - post-test)
|
Average total energy intake (kcal/day) estimated via 3-day food record
|
4 months (pre-intervention - post-test)
|
Changes in parent physical activity
Time Frame: 4 months (pre-intervention - post-test)
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Mean total daily energy expenditure (kcal/day) estimated via accelerometer
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4 months (pre-intervention - post-test)
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Changes in adolescent physical activity
Time Frame: 4 months (pre-intervention - post-test)
|
Mean total daily energy expenditure (kcal/day) estimated via accelerometer
|
4 months (pre-intervention - post-test)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Melanie Bean, PhD, Virginia Commonwealth University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
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
- HM20005235
- 1R21HD084930 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
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