Parent Involvement in Adolescent Obesity Treatment (TEENS+)

The Role of Parents in Adolescent Obesity Treatment: Randomized Control Trial of TEENS+

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

Study Overview

• Status: Active, not recruiting
• Conditions: Pediatric Obesity
• Intervention / Treatment: Behavioral: TEENS+Parents as Coaches; Behavioral: TEENS+Parent Weight Loss

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.

• Study Type: Interventional
• Enrollment (Actual): 418
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sarah M Farthing, MS; Phone Number: (804) 527-4756; Email: sarah.malone@vcuhealth.org
• Study Contact Backup: Name: Melanie K Bean, PhD; Phone Number: (804) 527-4765; Email: melanie.bean@vcuhealth.org

Study Locations

• United States
  • Virginia
    • Henrico, Virginia, United States, 23239
      • Children's Hospital of Richmond at VCU Healthy Lifestyles Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 16 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TEENS+Parents as Coaches; 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.	Behavioral: TEENS+Parents as Coaches; Parents as Coaches teaches parenting strategies to facilitate healthy weight loss in adolescent children; adolescents are in a group based behavioral weight management treatment.; Other Names: Parents as Champions for TEENS (PACT)
Active Comparator: TEENS+Parent Weight Loss; 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.	Behavioral: TEENS+Parent Weight Loss; 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.; Other Names: Healthy You!

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	8 months [4 month - 12 month follow up]

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 months [0 - 4 month]
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.	8 months [4 months - 12 months]
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.	8 months [4 months - 12 months]
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.	4 months [0-4 month]
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.	4 months [0-4 month]
Child Feeding	At 0, 2, 4, 8, 12 months, parents will complete the Child Feeding Questionnaire (CFQ; Adolescent version) to assess parent feeding style,	4 months [0-4 month]
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.	4 months [0-4 month]
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.	12 months [0-4 mo; 4-12 mo]

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Autonomy Support	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.	4 months [0-4 month]
Parent Child Relationship	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.	4 months [0-4 month]
Parent Self-efficacy	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.	4 months [0-4 month]
Social Support	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	4 months [0-4 month]

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); University of Tennessee; University of North Carolina
• Investigators: Principal Investigator: Melanie K Bean, PhD, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2019
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): October 31, 2024

Study Registration Dates

• First Submitted: December 12, 2018
• First Submitted That Met QC Criteria: February 21, 2019
• First Posted (Actual): February 22, 2019

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Motivational Interviewing; Lifestyle Intervention; Pediatric Obesity; Family-based Intervention
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: HM20014304; R01HD095910-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No