The Role of Parents in Adolescent Obesity Treatment

NCT ID: NCT02586090

Last Updated: 2023-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 162 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-06
• Study Completion Date: 2018-02-19

Brief Summary

The study will pilot a randomized control trial to investigate the feasibility and preliminary efficacy of two distinct parent treatments on a dietary intervention for overweight and obese adolescents.

Detailed Description

Investigators will recruit overweight or obese adolescents (BMI >85th percentile) and parent(s) (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 the adolescents, intervention will consist of weekly 1 hour exercise sessions and alternating weekly 1 hour behavioral and nutrition group sessions. Parents will also attend the nutrition sessions and participate in a behavioral parent-only biweekly group. Parent behavioral group sessions will be specific to the treatment arm (e.g. PAC or PWL). Assessments will consist of anthropometric measures, psychological surveys, and nutritional evaluations. Assessments will be completed at baseline, post-test and 3-month follow-up.

Conditions

Pediatric Obesity

Study Design

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

Study Groups

Parents as Coaches

PAC (modeled after NIH-funded NOURISH) focuses on parenting strategies to support and facilitate their child's weight management via family-based change. Each visit includes group psychoeducation and discussion, focused on parenting strategies to facilitate healthy weight management in their child(ren). Topics include focus such as role modeling, strategies for healthy lifestyle changes, and how to be a coach to your teen.

Group Type: ACTIVE_COMPARATOR

Parents as Coaches

Intervention Type: BEHAVIORAL

PAC (modeled after NIH-funded NOURISH) focuses on parenting strategies to support and facilitate their child's weight management via family-based change. Each visit includes group psychoeducation and discussion, focused on parenting strategies to facilitate healthy weight management in their child(ren). Topics include focus such as role modeling, strategies for healthy lifestyle changes, and how to be a coach to your teen.

Parent Weight Loss

In PWL parents will be given a weight loss goal of 1-2 lbs/week, as well as specific calorie and fat prescriptions, PA goals, and instructions to self-monitor key information. Parents will receive training in core behavioral weight loss strategies (e.g., goal setting, stimulus control) and techniques to help them achieve these goals and will also receive personalized feedback throughout the program

Group Type: EXPERIMENTAL

Parent Weight Loss

Intervention Type: BEHAVIORAL

In PWL parents will be given a weight loss goal of 1-2 lbs/week, as well as specific calorie and fat prescriptions, PA goals, and instructions to self-monitor key information. Parents will receive training in core behavioral weight loss strategies (e.g., goal setting, stimulus control) and techniques to help them achieve these goals and will also receive personalized feedback throughout the program

Interventions

Parents as Coaches

PAC (modeled after NIH-funded NOURISH) focuses on parenting strategies to support and facilitate their child's weight management via family-based change. Each visit includes group psychoeducation and discussion, focused on parenting strategies to facilitate healthy weight management in their child(ren). Topics include focus such as role modeling, strategies for healthy lifestyle changes, and how to be a coach to your teen.

Intervention Type: BEHAVIORAL

Parent Weight Loss

In PWL parents will be given a weight loss goal of 1-2 lbs/week, as well as specific calorie and fat prescriptions, PA goals, and instructions to self-monitor key information. Parents will receive training in core behavioral weight loss strategies (e.g., goal setting, stimulus control) and techniques to help them achieve these goals and will also receive personalized feedback throughout the program

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• BMI ≥85% percentile for age and gender according to the CDC Growth Charts
• Age 12 to 16
• must reside with the primary participating parent
• parent must have a BMI ≥25 kg/m 2
• parent must be willing to participate in the protocol

• 18-60 years of age
• 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
• use of oral glucocorticoids, atypical antipsychotics, weight loss medications, or an investigational medication within 3 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 HM11113, HM13833, HM20003076, IRB3008, IRB6255, HM11390, HM13468, HM14973 or HM14139
• current participation in another weight loss program; or 11) personal history of weight loss surgery.
• clinically significant depression
• clinically significant eating disorder
• change in dose of metformin, oral contraceptives, tricyclic antidepressants (TCAs), selective serotonin reuptake inhibitors (SSRIs), or stimulant medications within 3 months prior to study participation.
• weight in excess of 400 pounds
• 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 investigational medications within 3 months of study participation
• psychiatric, cognitive, physical or developmental conditions that would impair the parent's ability to respond to assessments, participate in physical activity or participate in a group
• reports of compensatory behaviors in the past 3 months
• current pregnancy, lactation, less than 6 months post-partum, or plan to become pregnant during the study period
• past participation in IRB3354, HM11113, HM13833, HM20003076, IRB3008, IRB6255, HM11390, HM13468, HM14973 or HM14139
• currently engaged in another weight loss program, or 9) personal history of weight loss surgery.
• Severe depression or endorsing suicidal thoughts
• 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

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 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

Provided Documents

Document Type: Informed Consent Form: Consent Form

View Document

Document Type: Informed Consent Form: Assent Form

View Document

Other Identifiers

1R21HD084930

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HM20005235

Identifier Type: -

Identifier Source: org_study_id