Parent Involvement in Adolescent Obesity Treatment (TEENS+)

Virginia Commonwealth University (VCU)

Status: Completed

Conditions: Pediatric Obesity

Treatments: Behavioral: TEENS+Parents as Coaches; Behavioral: TEENS+Parent Weight Loss

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03851796

R01HD095910-01A1 (U.S. NIH Grant/Contract)

HM20014304

Details and patient eligibility

About

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

Full 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.

Enrollment: 418 patients

Sex: All

Ages: 12 to 16 years old

Volunteers: Accepts 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
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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418 participants in 2 patient groups

TEENS+Parents as Coaches

Active Comparator group

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.

Treatment:

Behavioral: TEENS+Parents as Coaches

TEENS+Parent Weight Loss

Active Comparator group

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.

Treatment:

Behavioral: TEENS+Parent Weight Loss