NCT03016247

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 10, 2017

Completed
1 year until next milestone

Study Start

First participant enrolled

January 15, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

December 2, 2019

Status Verified

November 1, 2019

Enrollment Period

1.4 years

First QC Date

January 6, 2017

Last Update Submit

November 26, 2019

Conditions

Adolescent Obesity

Keywords

magnetic resonance imaging, trust, reward

Outcome Measures

Primary Outcomes (1)

  • Body Mass Index

    Statistically significant change in BMI from baseline to 3 months and 6 months

    6 months

Secondary Outcomes (3)

  • Eating

    6 months

  • Physical Activity

    6 months

  • Sleep

    6 months

Study Arms (2)

Enhanced Usual Care

ACTIVE COMPARATOR

Group will receive a single visit with a Nutritionist for dietary and physical activity counseling

Behavioral: Enhanced Usual Care

TRUST intervention

EXPERIMENTAL

Group will receive parent-adolescent trust-building and weight self-management training.

Behavioral: TRUST Intervention

Interventions

TRUST InterventionBEHAVIORAL

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.

Also known as: Trust-building weight Self-management Together
TRUST intervention
Enhanced Usual CareBEHAVIORAL

Single meeting with a Nutritionist for physical activity and eating counseling.

Enhanced Usual Care

Eligibility Criteria

Age10 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Related Publications (4)

  • Heinberg LJ, Kutchman EM, Berger NA, Lawhun SA, Cuttler L, Seabrook RC, Horwitz SM. Parent involvement is associated with early success in obesity treatment. Clin Pediatr (Phila). 2010 May;49(5):457-65. doi: 10.1177/0009922809337531. Epub 2009 Jun 1.

    PMID: 19487764BACKGROUND

  • Steinberg L. A Social Neuroscience Perspective on Adolescent Risk-Taking. Dev Rev. 2008 Mar;28(1):78-106. doi: 10.1016/j.dr.2007.08.002.

    PMID: 18509515BACKGROUND

  • Jack AI, Dawson AJ, Begany KL, Leckie RL, Barry KP, Ciccia AH, Snyder AZ. fMRI reveals reciprocal inhibition between social and physical cognitive domains. Neuroimage. 2013 Feb 1;66:385-401. doi: 10.1016/j.neuroimage.2012.10.061. Epub 2012 Oct 27.

    PMID: 23110882BACKGROUND

  • Moore SM, Musil CM, Alder ML, Pignatiello G, Higgins P, Webel A, Wright KD. Building a Research Data Repository for Chronic Condition Self-Management Using Harmonized Data. Nurs Res. 2020 Jul/Aug;69(4):254-263. doi: 10.1097/NNR.0000000000000435.

    PMID: 32205788DERIVED

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Heather K Hardin, PhD

    Case Western Reserve University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 6, 2017

First Posted

January 10, 2017

Study Start

January 15, 2018

Primary Completion

June 24, 2019

Study Completion

July 31, 2019

Last Updated

December 2, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will share

De-identified data will be shared for further analysis after main results are published.

Locations

US(1)