The Role of Parents in Adolescent Obesity Treatment

NCT02586090 | Completed DMC

• 2 other identifiers: HM200052351R21HD084930
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Obesity

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Between-group differences in parent weight change.

  Weight change (kg; parents)- primary outcome; trial is powered on parent weight change

  4 months (pre-intervention - post-test)

• Within group differences in adolescent changes in BMI

  BMI change (kg/m2; adolescent)

  4 months (pre-intervention - post-test)

Secondary Outcomes (5)

• Changes in parent dietary intake

  4 months (pre-intervention - post-test)

• Changes in authoritative parenting (API) and parent feeding practices measured via Child Feeding Questionnaire

  4 months (pre-intervention - post-test)

• Changes in child dietary intake

  4 months (pre-intervention - post-test)

• Changes in parent physical activity

  4 months (pre-intervention - post-test)

• Changes in adolescent physical activity

  4 months (pre-intervention - post-test)

Study Arms (2)

Parents as Coaches

ACTIVE COMPARATOR

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.

Behavioral: Parents as Coaches

Parent Weight Loss

EXPERIMENTAL

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

Behavioral: Parent Weight Loss

Interventions

Parents as Coaches 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.

Parents as Coaches

Parent Weight Loss 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

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 ≥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
• years of age
• 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
• 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

Sponsors & Collaborators

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

Study Sites (1)

Children's Hospital of Richmond at VCU Healthy Lifestyles Center

Henrico, Virginia, 23239, United States

Location

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

Study Officials

• Melanie Bean, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Assessors blind to hypotheses and allocation Interventionsts blinded to hypotheses
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2015
• First Posted: October 26, 2015
• Study Start: January 6, 2016
• Primary Completion: February 17, 2018
• Study Completion: February 19, 2018
• Last Updated: May 31, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)