Parent Involvement in Adolescent Obesity Treatment

NCT ID: NCT03851796

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 418 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-23
• Study Completion Date: 2024-10-26

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.

Conditions

Pediatric Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

TEENS+Parents as Coaches

Intervention Type: BEHAVIORAL

Parents as Coaches teaches parenting strategies to facilitate healthy weight loss in adolescent children; adolescents are in a group based behavioral weight management treatment.

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.

Group Type: ACTIVE_COMPARATOR

TEENS+Parent Weight Loss

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Parents as Champions for TEENS (PACT); Healthy You!

Eligibility Criteria

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

• ≥18
• BMI ≥ 25 kg/m2
• Must reside with the 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

• 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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of North Carolina

OTHER

Sponsor Role: collaborator

University of Tennessee

OTHER

Sponsor Role: collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Melanie K Bean, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Children's Hospital of Richmond at VCU Healthy Lifestyles Center

Henrico, Virginia, United States

Countries

United States

References

Brown KL, LaRose JG, Raynor HA, Gorin AA, Thornton LM, Farthing S, Tatum K, Bean MK. Study design and rationale for TEENS+REACH: Evaluating ripple effects of a family-based lifestyle intervention to untreated family members. Contemp Clin Trials Commun. 2024 Feb 15;38:101276. doi: 10.1016/j.conctc.2024.101276. eCollection 2024 Apr.

Reference Type: DERIVED

PMID: 38404649 (View on PubMed)

Bean MK, LaRose JG, Wickham EP 3rd, Raynor HA, Caccavale L, Evans RK, Thornton LM, Farthing S, Mendoza A, Mazzeo SE. The role of parents in behavioral treatment for adolescent obesity: design and rationale for the TEENS+ randomized clinical trial. BMC Public Health. 2023 Aug 4;23(1):1484. doi: 10.1186/s12889-023-16421-0.

Reference Type: DERIVED

PMID: 37537548 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R01HD095910-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HM20014304

Identifier Type: -

Identifier Source: org_study_id