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Parent Involvement in Adolescent Obesity Treatment (TEENS+)

Primary Purpose

Pediatric Obesity

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TEENS+Parents as Coaches
TEENS+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 - 16 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Adolescent Inclusion Criteria:

  • BMI ≥ 85th percentile for age and gender according to the CDC Growth Charts
  • Age 12 to 16
  • Must reside with the primary participating parent

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
  • Diabetes mellitus
  • Use of oral glucocorticoids, atypical antipsychotics, weight loss medications, or an investigational medication within 3 months of study participation
  • Use of a GLP-1 within 6 months of study participation
  • Use of Depo-Provera within 6 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 HM20010365, HM20003076, HM20005235 or HM20014304
  • Current participation in another weight loss program
  • Personal history of weight loss surgery
  • Clinically significant depression
  • Clinically significant eating disorder
  • Change in dose of metformin, tricyclic antidepressants, selective serotonin uptake inhibitors, or stimulant medications within 3 months of study participation
  • 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 an investigational medication within 3 months of study participation
  • Use of a GLP-1 within 6 months of study participation with no T2D diagnosis; if T2D diagnosis, change in dose GLP-1 within 3 months of study participation
  • Use of Depo-Provera within 6 months of study participation
  • 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, lactation, less than 6 months post-partum, or plan to become pregnant during study period
  • Previous participation in HM20010365, HM20003076, HM20005235 or HM20014304
  • Current participation in another weight loss program
  • Personal history of weight loss surgery
  • Clinically significant depression
  • Clinically significant eating disorder
  • Change in dose of diabetes medications, tricyclic antidepressants, selective serotonin uptake inhibitors, or stimulant medications within 3 months of study participation
  • Admission to a psychiatric hospital within the past year

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

TEENS+Parents as Coaches

TEENS+Parent Weight Loss

Arm Description

Parents are taught strategies to support and facilitate child weight management via family-based change. Each visit includes group psychoeducation and discussion, focused on strategies to facilitate healthy weight management in their child(ren). Topics include role modeling, strategies for healthy lifestyle changes, and how to be a coach to your teen. They receive personalized feedback throughout the program. All adolescents participate in a group-based empirically supported behavioral weight management treatment, that includes dietary and physical activity goals, and instructions to self-monitor key information. Adolescents will receive training in core behavioral weight loss strategies (e.g. goal setting, stimulus control) and techniques to help them achieve these goals. They also receive personalized feedback throughout the program.

Parents are given a weight loss goal of 1-2 lbs/week, and specific calorie and fat prescriptions, PA goals, and instructions to self-monitor key information. Parents receive training in core behavioral weight loss strategies (e.g. goal setting, stimulus control) and techniques to help them achieve these goals. They also receive personalized feedback throughout the program. All adolescents participate in a group-based empirically supported behavioral weight management treatment, that includes dietary and physical activity goals, and instructions to self-monitor key information. Adolescents receive training in core behavioral weight loss strategies (e.g. goal setting, stimulus control) and techniques to help them achieve these goals. They also receive personalized feedback throughout the program.

Outcomes

Primary Outcome Measures

Adolescent weight loss maintenance
Primary pre-specified outcome is BMI change (kg/m2; adolescent) during the maintenance phase. At 0, 2, 4, 8, 12 months, trained staff will measure adolescent height and weight (in light clothing and after a 12 hour fast) to the nearest 0.1cm and 0.1kg using a precision stadiometer and digital scale, respectively. BMI will be calculated (kg/m2); Adolescent BMI Z-scores will be determined using Epi Info software.

Secondary Outcome Measures

Parent weight loss
trained staff will measure parent height and weight (in light clothing and after a 12 hour fast) to the nearest 0.1cm and 0.1kg using a precision stadiometer and digital scale, respectively, at 0, 2, 4, 8, 12 months. Percent weight loss and weight change (kg) from baseline to 4 months is the primary parent weight loss outcome interval.
Physical activity
Accelerometers will be worn for 1 week by adolescents and parents for each assessment period (0, 4, 8, and 12 months) to assess adolescent and parent physical activity objectively. Total time (min/wk) spent in moderate/vigorous activity and mean total daily physical activity energy expenditure (kcal/d) estimated via accelerometer will be examined. The Seven-Day Physical Activity Recall (PAR) will also be administered to participants in person at the same timepoints. This measure asks them to report the approximate number of hours they slept and engaged in moderate, hard and very hard activity for each day of the preceding week. Parent and adolescent change in physical activity from 4-12 months during the maintenance period is the primary PA outcome.
Dietary intake
Adolescent and parent participants will complete a 3-day food record to track dietary intake for 2 weekdays and 1 weekend day in the week prior to their assessment (0, 4, 8, 12m). Parent and adolescent average total energy intake (kcal/d) from 4-12 months will be the primary dietary outcome.
Parenting Style
The Authoritative Parenting Index (API) will assess adolescent-report of authoritative parenting style and the Parenting Styles and Dimension Questionnaire (PSDQ) will be administered to parents to assess parent self-report of parenting style. Both measures will be administered at 0, 2, 4, 8, 12 months.
Role Modeling
At 0, 2, 4, 8, 12 months, adolescents will complete the Family Experiences Related to Food Questionnaire (FERFQ) is an 8 or 9-item measure (father and mother version, respectively) that will assess family commentary about weight and shape as well as family modeling of diet and weight concerns.
Child Feeding
At 0, 2, 4, 8, 12 months, parents will complete the Child Feeding Questionnaire (CFQ; Adolescent version) to assess parent feeding style,
Home Environment
The Home Food Inventory (HFI) and Exercise Environment Questionnaire (EEQ) will assess availability of types of food or exercise equipment, respectively, in the home. Measures will be completed at 0, 2, 4, 8, 12 months.
Weight control practices
Adolescents and parents will complete the Weight Control Strategies Scale (WCSS) which will assess the use of healthy weight control practices (e.g., dietary choices, self-monitoring, and physical activity) at 0, 2, 4, 8, 12 months.

Full Information

First Posted
December 12, 2018
Last Updated
February 8, 2023
Sponsor
Virginia Commonwealth University
Collaborators
University of North Carolina, University of Tennessee, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT03851796
Brief Title
Parent Involvement in Adolescent Obesity Treatment
Acronym
TEENS+
Official Title
The Role of Parents in Adolescent Obesity Treatment: Randomized Control Trial of TEENS+
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 23, 2019 (Actual)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
University of North Carolina, University of Tennessee, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A randomized control trial to compare the efficacy of two distinct parent treatments on weight loss maintenance for adolescents with obesity participating in a lifestyle intervention including nutrition education, exercise and behavioral support. Funding support from NIH via 1R01HD095910
Detailed Description
Investigators will recruit adolescents with overweight or obesity (BMI>85th percentile) and a parent (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 adolescents, the intervention will consist of weekly behavioral weight management group sessions and weekly 1 hour exercise sessions. Each adolescent also has a monthly individual session with a behavior coach. Parent groups meet weekly for 1 hour according to treatment arm (PAC or PWL). All PWL sessions are separate from their adolescent. Bi-weekly sessions in the PAC arm are combined with parents and adolescent. Assessments will consist of anthropometric measures, psychological surveys and dietary and PA evaluations. Assessments will be completed at baseline, 2 months, 4 months (post-test), 8 months and 1 year.

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
Model Description
Randomized Control Trial
Masking
InvestigatorOutcomes Assessor
Masking Description
Assessors and the PI will be blind to treatment group.
Allocation
Randomized
Enrollment
420 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TEENS+Parents as Coaches
Arm Type
Active Comparator
Arm Description
Parents are taught strategies to support and facilitate child weight management via family-based change. Each visit includes group psychoeducation and discussion, focused on strategies to facilitate healthy weight management in their child(ren). Topics include role modeling, strategies for healthy lifestyle changes, and how to be a coach to your teen. They receive personalized feedback throughout the program. All adolescents participate in a group-based empirically supported behavioral weight management treatment, that includes dietary and physical activity goals, and instructions to self-monitor key information. Adolescents will receive training in core behavioral weight loss strategies (e.g. goal setting, stimulus control) and techniques to help them achieve these goals. They also receive personalized feedback throughout the program.
Arm Title
TEENS+Parent Weight Loss
Arm Type
Active Comparator
Arm Description
Parents are given a weight loss goal of 1-2 lbs/week, and specific calorie and fat prescriptions, PA goals, and instructions to self-monitor key information. Parents receive training in core behavioral weight loss strategies (e.g. goal setting, stimulus control) and techniques to help them achieve these goals. They also receive personalized feedback throughout the program. All adolescents participate in a group-based empirically supported behavioral weight management treatment, that includes dietary and physical activity goals, and instructions to self-monitor key information. Adolescents receive training in core behavioral weight loss strategies (e.g. goal setting, stimulus control) and techniques to help them achieve these goals. They also receive personalized feedback throughout the program.
Intervention Type
Behavioral
Intervention Name(s)
TEENS+Parents as Coaches
Other Intervention Name(s)
Parents as Champions for TEENS (PACT)
Intervention Description
Parents as Coaches teaches parenting strategies to facilitate healthy weight loss in adolescent children; adolescents are in a group based behavioral weight management treatment.
Intervention Type
Behavioral
Intervention Name(s)
TEENS+Parent Weight Loss
Other Intervention Name(s)
Healthy You!
Intervention Description
Parent Weight loss teaches core behavioral weight loss strategies and techniques for parent weight loss; adolescents are in a group based behavioral weight management treatment.
Primary Outcome Measure Information:
Title
Adolescent weight loss maintenance
Description
Primary pre-specified outcome is BMI change (kg/m2; adolescent) during the maintenance phase. At 0, 2, 4, 8, 12 months, trained staff will measure adolescent height and weight (in light clothing and after a 12 hour fast) to the nearest 0.1cm and 0.1kg using a precision stadiometer and digital scale, respectively. BMI will be calculated (kg/m2); Adolescent BMI Z-scores will be determined using Epi Info software.
Time Frame
8 months [4 month - 12 month follow up]
Secondary Outcome Measure Information:
Title
Parent weight loss
Description
trained staff will measure parent height and weight (in light clothing and after a 12 hour fast) to the nearest 0.1cm and 0.1kg using a precision stadiometer and digital scale, respectively, at 0, 2, 4, 8, 12 months. Percent weight loss and weight change (kg) from baseline to 4 months is the primary parent weight loss outcome interval.
Time Frame
4 months [0 - 4 month]
Title
Physical activity
Description
Accelerometers will be worn for 1 week by adolescents and parents for each assessment period (0, 4, 8, and 12 months) to assess adolescent and parent physical activity objectively. Total time (min/wk) spent in moderate/vigorous activity and mean total daily physical activity energy expenditure (kcal/d) estimated via accelerometer will be examined. The Seven-Day Physical Activity Recall (PAR) will also be administered to participants in person at the same timepoints. This measure asks them to report the approximate number of hours they slept and engaged in moderate, hard and very hard activity for each day of the preceding week. Parent and adolescent change in physical activity from 4-12 months during the maintenance period is the primary PA outcome.
Time Frame
8 months [4 months - 12 months]
Title
Dietary intake
Description
Adolescent and parent participants will complete a 3-day food record to track dietary intake for 2 weekdays and 1 weekend day in the week prior to their assessment (0, 4, 8, 12m). Parent and adolescent average total energy intake (kcal/d) from 4-12 months will be the primary dietary outcome.
Time Frame
8 months [4 months - 12 months]
Title
Parenting Style
Description
The Authoritative Parenting Index (API) will assess adolescent-report of authoritative parenting style and the Parenting Styles and Dimension Questionnaire (PSDQ) will be administered to parents to assess parent self-report of parenting style. Both measures will be administered at 0, 2, 4, 8, 12 months.
Time Frame
4 months [0-4 month]
Title
Role Modeling
Description
At 0, 2, 4, 8, 12 months, adolescents will complete the Family Experiences Related to Food Questionnaire (FERFQ) is an 8 or 9-item measure (father and mother version, respectively) that will assess family commentary about weight and shape as well as family modeling of diet and weight concerns.
Time Frame
4 months [0-4 month]
Title
Child Feeding
Description
At 0, 2, 4, 8, 12 months, parents will complete the Child Feeding Questionnaire (CFQ; Adolescent version) to assess parent feeding style,
Time Frame
4 months [0-4 month]
Title
Home Environment
Description
The Home Food Inventory (HFI) and Exercise Environment Questionnaire (EEQ) will assess availability of types of food or exercise equipment, respectively, in the home. Measures will be completed at 0, 2, 4, 8, 12 months.
Time Frame
4 months [0-4 month]
Title
Weight control practices
Description
Adolescents and parents will complete the Weight Control Strategies Scale (WCSS) which will assess the use of healthy weight control practices (e.g., dietary choices, self-monitoring, and physical activity) at 0, 2, 4, 8, 12 months.
Time Frame
12 months [0-4 mo; 4-12 mo]
Other Pre-specified Outcome Measures:
Title
Autonomy Support
Description
At 0, 2, 4, 8, 12 months, adolescents will complete the Perceived Parental Autonomy Support Scale (P-PASS) to assess adolescent perception of 1) autonomy-supportive parenting behaviors and 2) controlling parenting behaviors.
Time Frame
4 months [0-4 month]
Title
Parent Child Relationship
Description
The Conflict Behavior Questionnaire (CBQ; Parent and Adolescent Versions) will assess parent and adolescent report of parent-child relational factors at 0, 2, 4, 8, 12 mo.
Time Frame
4 months [0-4 month]
Title
Parent Self-efficacy
Description
The Parent Efficacy for Child Healthy Weight Behavior (PECHWB) will assess parent self-efficacy in promoting healthy weight behaviors in their adolescents. This measure will be completed at 0, 2, 4, 8, 12 months.
Time Frame
4 months [0-4 month]
Title
Social Support
Description
At 0, 2, 4, 8, 12 months, adolescents will complete family and friend social support scales from the Patient-based Assessment and Counseling for Physical Activity and Nutrition (PACE+) questionnaires to assess adolescent report of family and friend social support across 3 domains: 1) fruit and vegetable intake, 2) fat intake, and 3) physical activity
Time Frame
4 months [0-4 month]

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 ≥ 85th percentile for age and gender according to the CDC Growth Charts Age 12 to 16 Must reside with the primary participating parent Parent Inclusion Criteria: ≥18 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 Diabetes mellitus Use of oral glucocorticoids, atypical antipsychotics, weight loss medications, or an investigational medication within 3 months of study participation Use of a GLP-1 within 6 months of study participation Use of Depo-Provera within 6 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 HM20010365, HM20003076, HM20005235 or HM20014304 Current participation in another weight loss program Personal history of weight loss surgery Severe depression Clinically significant eating disorder Change in dose of metformin, tricyclic antidepressants, selective serotonin uptake inhibitors, or stimulant medications within 3 months of study participation 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 an investigational medication within 3 months of study participation Use of a GLP-1 within 6 months of study participation with no T2D diagnosis; if T2D diagnosis, change in dose GLP-1 within 3 months of study participation Use of Depo-Provera within 6 months of study participation 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, lactation, less than 6 months post-partum, or plan to become pregnant during study period Previous participation in HM20010365, HM20003076, HM20005235 or HM20014304 Current participation in another weight loss program Personal history of weight loss surgery Severe depression Clinically significant eating disorder Change in dose of diabetes medications, tricyclic antidepressants, selective serotonin uptake inhibitors, or stimulant medications within 3 months of study participation Admission to a psychiatric hospital within the past year
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah M Farthing, MS
Phone
(804) 527-4756
Email
sarah.malone@vcuhealth.org
First Name & Middle Initial & Last Name or Official Title & Degree
Melanie K Bean, PhD
Phone
(804) 527-4765
Email
melanie.bean@vcuhealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melanie K 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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah M Farthing, MS
Phone
804-527-4756
Email
sarah.malone@vcuhealth.org
First Name & Middle Initial & Last Name & Degree
Melanie K Bean, Ph.D.
Phone
(804) 527-4765
Email
melanie.bean@vcuhealth.org

12. IPD Sharing Statement

Plan to Share IPD
No

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Parent Involvement in Adolescent Obesity Treatment

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