Back to resultsThe Role of Parents in Adolescent Obesity Treatment (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
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
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.
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
Between-group differences in parent weight change.
Weight change (kg; parents)- primary outcome; trial is powered on parent weight change
Within group differences in adolescent changes in BMI
BMI change (kg/m2; adolescent)
Secondary Outcome Measures
Changes in parent dietary intake
Average total energy intake (kcal/day) estimated via 3-day food record
Changes in authoritative parenting (API) and parent feeding practices measured via Child Feeding Questionnaire
parenting and feeding style
Changes in child dietary intake
Average total energy intake (kcal/day) estimated via 3-day food record
Changes in parent physical activity
Mean total daily energy expenditure (kcal/day) estimated via accelerometer
Changes in adolescent physical activity
Mean total daily energy expenditure (kcal/day) estimated via accelerometer
Full Information
NCT ID
NCT02586090
First Posted
July 16, 2015
Last Updated
May 26, 2023
Sponsor
Virginia Commonwealth University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT02586090
Brief Title
The Role of Parents in Adolescent Obesity Treatment
Acronym
TEENS+
Official Title
Innovative Approaches to Adolescent Obesity Treatment: Exploring the Role of Parents
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 6, 2016 (Actual)
Primary Completion Date
February 17, 2018 (Actual)
Study Completion Date
February 19, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The study will pilot a randomized control trial to investigate the feasibility and preliminary efficacy of two distinct parent treatments on a dietary intervention for overweight and obese adolescents.
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.
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
Care ProviderOutcomes Assessor
Masking Description
Assessors blind to hypotheses and allocation Interventionsts blinded to hypotheses
Allocation
Randomized
Enrollment
162 (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
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
Parent Weight Loss
Intervention 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
Primary Outcome Measure Information:
Title
Between-group differences in parent weight change.
Description
Weight change (kg; parents)- primary outcome; trial is powered on parent weight change
Time Frame
4 months (pre-intervention - post-test)
Title
Within group differences in adolescent changes in BMI
Description
BMI change (kg/m2; adolescent)
Time Frame
4 months (pre-intervention - post-test)
Secondary Outcome Measure Information:
Title
Changes in parent dietary intake
Description
Average total energy intake (kcal/day) estimated via 3-day food record
Time Frame
4 months (pre-intervention - post-test)
Title
Changes in authoritative parenting (API) and parent feeding practices measured via Child Feeding Questionnaire
Description
parenting and feeding style
Time Frame
4 months (pre-intervention - post-test)
Title
Changes in child dietary intake
Description
Average total energy intake (kcal/day) estimated via 3-day food record
Time Frame
4 months (pre-intervention - post-test)
Title
Changes in parent physical activity
Description
Mean total daily energy expenditure (kcal/day) estimated via accelerometer
Time Frame
4 months (pre-intervention - post-test)
Title
Changes in adolescent physical activity
Description
Mean total daily energy expenditure (kcal/day) estimated via accelerometer
Time Frame
4 months (pre-intervention - post-test)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melanie Bean, PhD
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
Plan to Share IPD
No
Learn more about this trial
The Role of Parents in Adolescent Obesity Treatment
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