Clinical trial NCT05540704: iACT for Eating Disorders in Type 1 Diabetes
Official title: A Randomized Controlled Trial of iACT, a Novel mHealth Intervention for Eating Disorders in Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 1 Diabetes
Eating Disorders
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: The Miriam Hospital
First posted: 2022-09-15
Enrollment: 128
Sex: ALL
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: 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)

Exclusion Criteria:

* Current suicidal ideation or self-harming behavior
* Diagnosis of Avoidant Restrictive Food Intake Disorder or Anorexia Nervosa spectrum diagnoses
* Hypoglycemic unawareness as assessed by the Gold Method
* Current substance abuse disorder or current or past psychotic disorder
* NonEnglish speaking

Primary outcomes:
measure: Change in glycemic control as indexed by continuous glucose monitoring (CGM)
timeFrame: baseline, 6 weeks, 12 weeks, 36 weeks
measure: Change in glycemic control as indexed by hemoglobin A1c (HbA1c)
timeFrame: baseline, 12 weeks, 24 weeks, 36 weeks
measure: Change in eating disorder symptoms as indexed by the Eating Disorder Examination Global score
timeFrame: baseline, 12 weeks, 36 weeks
measure: Change in eating disorder symptoms as indexed by the Diabetes Eating Problems Survey
timeFrame: baseline, 12 weeks, 24 weeks, 36 weeks
measure: Change in diabetes self-management as indexed by the Diabetes Self-Management Questionnaire
timeFrame: baseline, 12 weeks, 24 weeks, 36 weeks
measure: Acceptability as measured by meeting the recruitment target for the study
timeFrame: 36 months from start of enrollment
measure: Feasibility as measured by participant attrition less than 20%
timeFrame: 39 months from start of enrollment
Secondary outcomes:
measure: Change in diabetes distress as indexed by the Type 1 - Diabetes Distress Scale
timeFrame: baseline, 12 weeks, 24 weeks, 36 weeks
measure: Change in NIH PROMIS Scale - Depression
timeFrame: baseline, 12 weeks, 36 weeks
measure: Change in NIH PROMIS Scale - Anxiety
timeFrame: baseline, 12 weeks, 36 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Providence
country: United States
facility: Brown University
state: Rhode Island
Study officials:
affiliation: Duke University faculty
name: Rhonda Merwin, PhD
role: PRINCIPAL_INVESTIGATOR
References: