A Randomized Controlled Trial of iACT, a Novel mHealth Intervention for Eating Disorders in Type 1 Diabetes

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This project is a randomized controlled trial of iACT, a novel mHealth intervention for eating disorders in type 1 diabetes (ED-T1DM). Participants will be 128 T1DM patients between the ages of 16-45 with binge-purge EDs, including threshold and subthreshold bulimia nervosa, binge eating disorder and purging disorder. Participants will be randomized to either iACT or Usual Care, and complete assessments at baseline and every 3 months for 9 months. The primary outcome of interest is glycemic control as assessed by continuous glucose monitoring. Other outcomes include HbA1c, eating disorder symptoms, diabetes self-management and diabetes distress. In addition to examining clinical outcomes, this study tests biobehavioral mechanisms of change and predictors of treatment response. Process of change assessments focus on flexible responding to pathology-relevant stimuli and early improvement in glycemic control affecting executive function. The primary site is Duke University Medical Center. The Miriam Hospital is a secondary site.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Maximum Age: 50
Healthy Volunteers: f
View:

• 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)

Locations
United States
North Carolina
Duke University
RECRUITING
Durham
Rhode Island
Brown University
RECRUITING
Providence
Contact Information
Primary
Dottie R Mayo, BA
drm72@duke.edu
(919) 668-1935
Backup
Rhonda Merwin, PhD
rhonda.merwin@duke.edu
(919) 681-7231
Time Frame
Start Date: 2023-04-04
Estimated Completion Date: 2026-06-01
Participants
Target number of participants: 128
Treatments
Experimental: iACT Experimental Intervention
Active_comparator: Usual Care
Related Therapeutic Areas
Sponsors
Collaborators: The Miriam Hospital
Leads: Duke University

This content was sourced from clinicaltrials.gov