Parent Involvement in Adolescent Obesity Treatment

NCT03851796 | Completed Results DMC

• 2 other identifiers: HM20014304R01HD095910-01A1
• Study Type: interventional
• Target: 418
• Locations: 1 country
• Sites: 1

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

Conditions

Pediatric Obesity

Keywords

Pediatric Obesity; Lifestyle Intervention; Family-based Intervention; Motivational Interviewing

Outcome Measures

Primary Outcomes (2)

• Body Mass Index (BMI) Change

  Body Mass Index (BMI) change (kg/m2; adolescent) during the maintenance phase (4-month to 12-month).

  4 months to 12 month [follow up phase]

• Body Mass Index

  National Health and Nutrition Examination Survey (NHANES) Anthropometry methods were used to measure height and weight to calculate Body Mass Index (BMI). At 0, 2, 4, 8, 12 months, trained staff measured 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.

  Baseline, 2-, 4-, 8-, and 12-months

Secondary Outcomes (21)

• Parent Weight

  Baseline, 2-, 4-, 8-, and 12-months

• Parent Weight Change

  baseline to 4 month [intervention phase] and 4 month to 12 month [maintenance phase]

• Physical Activity

  Baseline, 4-, 8-, and 12-months

• Physical Activity Change

  4-month to 12-month

• Physical Activity Energy Expenditure

  Baseline, 4-, 8-, and 12-months

Other Outcomes (4)

• Autonomy Support

  Baseline, 2-, 4-, 8-, and 12-months

• Parent Child Relationship

  Baseline, 2-, 4-, 8-, and 12-months

• Parent Self-efficacy

  Baseline, 2-, 4-, 8-, and 12-months

Study Arms (2)

TEENS+Parents as Coaches

ACTIVE COMPARATOR

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

TEENS+Parent Weight Loss

ACTIVE COMPARATOR

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

Interventions

TEENS+Parents as Coaches 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.

Also known as: Parents as Champions for TEENS (PACT)

TEENS+Parents as Coaches

TEENS+Parent Weight Loss 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.

Also known as: Healthy You!

TEENS+Parent Weight Loss

Eligibility Criteria

• Age: 12 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• University of North Carolina: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• University of Tennessee: collaborator

Study Sites (1)

Children's Hospital of Richmond at VCU Healthy Lifestyles Center

Henrico, Virginia, 23239, United States

Location

Related Publications (2)

• 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.

  PMID: 38404649 DERIVED

• 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.

  PMID: 37537548 DERIVED

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Melanie K Bean
• Organization: Virginia Commonwealth University

melanie.bean@vcuhealth.org

804-527-4756

Study Officials

• Melanie K Bean, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Assessors and the PI will be blind to treatment group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Control Trial

Study Record Dates

• First Submitted: December 12, 2018
• First Posted: February 22, 2019
• Study Start: May 23, 2019
• Primary Completion: October 26, 2024
• Study Completion: October 26, 2024
• Last Updated: December 12, 2025
• Results First Posted: December 12, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)