Mobile health intervention for eating disorders in type 1 diabetes
Changing the T1DE (Type 1 Diabetes Eating Disorders): A Randomized Controlled Trial Comparing Acceptance and Commitment Therapy (ACT) to Supportive Diabetes Counseling and a Waitlist Control
NA · Duke University · NCT05540704
This study is testing a new mobile health program to see if it can help young adults with type 1 diabetes who have binge-purge eating disorders feel better and manage their diabetes more effectively.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 235 (estimated) |
| Ages | 16 Years to 50 Years |
| Sex | All |
| Sponsor | Duke University (other) |
| Locations | 2 sites (Durham, North Carolina and 1 other locations) |
| Trial ID | NCT05540704 on ClinicalTrials.gov |
What this trial studies
This project is a randomized controlled trial evaluating a novel mobile health intervention (iACT) aimed at treating eating disorders in patients with type 1 diabetes. The study will involve 128 participants aged 16-45 who have binge-purge eating disorders, and they will be randomly assigned to receive either iACT or usual care. Assessments will be conducted at baseline and every three months over a nine-month period, focusing on glycemic control, eating disorder symptoms, and diabetes management. The study also aims to explore the biobehavioral mechanisms of change and predictors of treatment response.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 16-50 with type 1 diabetes and binge-purge eating disorders who can independently manage their diabetes.
Not a fit: Patients with current suicidal ideation, anorexia nervosa, or those who are non-English speaking may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve glycemic control and eating disorder symptoms in patients with type 1 diabetes.
How similar studies have performed: While this approach is innovative, similar interventions in related areas have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Primary Cohort Inclusion Criteria: * 16-50 years of age * Diagnosis of Type 1 diabetes * Eating disorder characterized by binge eating and/or problematic weight control behaviors, including withholding insulin (Bulimia Nervosa, Binge Eating and Purging Disorder spectrum diagnoses) * Independently manages diabetes (not reliant on a caregiver) Expansion Cohort Inclusion Criteria: * 16-50 years of age * Diagnosis of Type 1 diabetes * DEPR-R score \>=20 but does not meet criteria for the primary cohort Primary and Expansion Cohort Exclusion Criteria: * Active suicidal ideation * Diagnosis of Avoidant Restrictive Food Intake Disorder or Anorexia Nervosa spectrum diagnoses * Hypoglycemic unawareness as assessed by the Gold Method and multiple severe episodes of hypoglycemia requiring 3rd party assistance in the last 2 years * Current substance abuse disorder or current or past psychotic disorder * NonEnglish speaking
Where this trial is running
Durham, North Carolina and 1 other locations
- Duke University — Durham, North Carolina, United States (RECRUITING)
- Brown University — Providence, Rhode Island, United States (RECRUITING)
Study contacts
- Principal investigator: Rhonda Merwin, PhD — Duke University faculty
- Study coordinator: Dottie R Mayo, BA
- Email: drm72@duke.edu
- Phone: (919) 668-1935
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Type 1 Diabetes, Eating Disorders, Disordered Eating Behaviors, Purging, Binge-Eating Disorder, glycemic control, disordered eating behavior, eating disorders