TRUST Study of Adolescent Weight Self-Management (TRUST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03016247
Recruitment Status : Recruiting
First Posted : January 10, 2017
Last Update Posted : July 10, 2018
Case Western Reserve University
Information provided by (Responsible Party):
Heather K Hardin, Case Western Reserve University

Brief Summary:
The purpose of this pilot study is to evaluate the effect of the Trust-building weight Self-management Together (TRUST) intervention on weight self-management behaviors and neural processing in overweight/obese adolescents. Study aims include comparing the effects of the TRUST intervention with Enhanced Usual Care on BMI and quality of life in overweight/obese early adolescents and exploring differences in neural processing (DMT/TPN switching and reward activation).

Condition or disease Intervention/treatment Phase
Adolescent Obesity Behavioral: TRUST Intervention Behavioral: Enhanced Usual Care Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study Evaluating the Effects of a Trust-Building Intervention on Adolescent Weight Self-Management Behaviors
Actual Study Start Date : January 15, 2018
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Active Comparator: Enhanced Usual Care
Group will receive a single visit with a Nutritionist for dietary and physical activity counseling
Behavioral: Enhanced Usual Care
Single meeting with a Nutritionist for physical activity and eating counseling.

Experimental: TRUST intervention
Group will receive parent-adolescent trust-building and weight self-management training.
Behavioral: TRUST Intervention
The TRUST intervention will be guided by Rotenberg's Framework of Interpersonal Trust 3. The TRUST group will meet with an interventionist trained in weight self-management for eight 90-minute weekly sessions. Each session will include adolescent/parent trust-building exercises (honesty, reliability, emotional connection), didactic content, experiential skills developing (nutrition label reading), behavior-change goal-setting, and problem-solving.
Other Name: Trust-building weight Self-management Together

Primary Outcome Measures :
  1. Body Mass Index [ Time Frame: 6 months ]
    Statistically significant change in BMI from baseline to 3 months and 6 months

Secondary Outcome Measures :
  1. Eating [ Time Frame: 6 months ]
    Change in Nutrient Data Systems Report data

  2. Physical Activity [ Time Frame: 6 months ]
    Change in accelerometer data

  3. Sleep [ Time Frame: 6 months ]
    Change in PROMIS-Sleep 4 scale score and Pediatric Daytime Sleepiness Scale score

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   10 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 10-12 year old Cleveland Metropolitan School District student
  • identified as overweight or obese (BMI >85th percentile for age/sex during school screenings)
  • able to read, speak, and understand the English language
  • able to complete a self-administered questionnaire

Exclusion Criteria:

  • taking medications that alter appetite or weight
  • stage 2 hypertension or stage 1 hypertension with end organ damage
  • severe behavioral problems that preclude group participation (as reported by parent/guardian)
  • child involvement in another weight management program
  • pregnancy
  • family expectation to move from the region within 1 year

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03016247

Contact: Heather K Hardin, PhD 216-368-5129
Contact: Shirley Moore, PhD 216-368-5978

United States, Ohio
Case Western Reserve University Recruiting
Cleveland, Ohio, United States, 44106
Contact: Heather K Hardin, PhD    216-368-5129   
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
Case Western Reserve University
Principal Investigator: Heather K Hardin, PhD Case Western Reserve University

Responsible Party: Heather K Hardin, Assistant Professor, Case Western Reserve University Identifier: NCT03016247     History of Changes
Other Study ID Numbers: 09-16-49
First Posted: January 10, 2017    Key Record Dates
Last Update Posted: July 10, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data will be shared for further analysis after main results are published.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Heather K Hardin, Case Western Reserve University:
magnetic resonance imaging, trust, reward

Additional relevant MeSH terms:
Pediatric Obesity
Nutrition Disorders
Body Weight
Signs and Symptoms