RECRUITING

Study Comparing Acceptance and Commitment Therapy (ACT) to Supportive Diabetes Counseling for Problematic Eating and Weight Control in Type 1 Diabetes

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this study is to test the effectiveness of two different approaches to treating problematic eating and weight control in type 1 diabetes. Participants are between the ages of 16-50 and complete 12 sessions of either Acceptance and Commitment Therapy (ACT) or Supportive Diabetes Counseling over 16 weeks. They use their mobile phone between sessions to increase engagement and reinforce learning. The main questions are: Do participants show improvements in glycemic levels, eating disorder symptoms, diabetes management and diabetes distress? Does one treatment do better than the other? How do the treatments work, if they work, and for whom? Participants complete assessments that include wearing a continuous glucose sensor and activity watch, and get a blood draw to determine HbA1c. They also complete diagnostic interviews, surveys and computer tests of attention and reactions. These assessments help us better understand the types of changes that are happening and how they might influence health and well-being.

Official Title

Changing the T1DE (Type 1 Disordered Eating): A Randomized Controlled Trial Comparing ACT to Supportive Diabetes Counseling

Quick Facts

Study Start:2023-04-04
Study Completion:2027-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05540704

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:16 Years to 50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * 16-50 years of age
  2. * Diagnosis of Type 1 diabetes
  3. * Eating disorder characterized by binge eating and/or problematic weight control behaviors, including withholding insulin (Bulimia Nervosa, Binge Eating and Purging Disorder spectrum diagnoses)
  4. * Independently manages diabetes (not reliant on a caregiver)
  1. * Active suicidal ideation
  2. * Diagnosis of Avoidant Restrictive Food Intake Disorder or Anorexia Nervosa spectrum diagnoses
  3. * Hypoglycemic unawareness as assessed by the Gold Method and multiple severe episodes of hypoglycemia requiring 3rd party assistance in the last 2 years
  4. * Current substance abuse disorder or current or past psychotic disorder
  5. * NonEnglish speaking

Contacts and Locations

Study Contact

Dottie R Mayo, BA
CONTACT
(919) 668-1935
drm72@duke.edu
Rhonda Merwin, PhD
CONTACT
(919) 681-7231
rhonda.merwin@duke.edu

Principal Investigator

Rhonda Merwin, PhD
PRINCIPAL_INVESTIGATOR
Duke University faculty

Study Locations (Sites)

Duke University
Durham, North Carolina, 27705
United States
Brown University
Providence, Rhode Island, 02903
United States

Collaborators and Investigators

Sponsor: Duke University

  • Rhonda Merwin, PhD, PRINCIPAL_INVESTIGATOR, Duke University faculty

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-04
Study Completion Date2027-09

Study Record Updates

Study Start Date2023-04-04
Study Completion Date2027-09

Terms related to this study

Keywords Provided by Researchers

  • T1DE
  • "diabulimia"
  • glycemic control
  • disordered eating behavior
  • eating disorders
  • type 1 diabetes

Additional Relevant MeSH Terms

  • Type 1 Diabetes
  • Eating Disorders
  • Disordered Eating Behaviors
  • Purging (Eating Disorders)
  • Binge-Eating Disorder