iACT for Eating Disorders in Type 1 Diabetes

Not Applicable

Recruiting

• Conditions: Eating Disorders; Type 1 Diabetes
• Interventions: Other: Usual Care; Behavioral: iACT

• Registration Number: NCT05540704
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-09
• Study First Submitted QC: 2022-09-09
• Study First Posted: 2022-09-15
• Study Start: 2023-04-04
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-14
• Last Update Posted: 2025-01-16
• Primary Completion: 2026-06-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 128

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	Usual Care	-
iACT Experimental Intervention	iACT	-

Primary Outcome Measures

Name	Time	Method
Change in glycemic control as indexed by hemoglobin A1c (HbA1c)	baseline, 12 weeks, 24 weeks, 36 weeks	Glycated hemoglobin (percentage of red blood cells that are glycated providing an estimate of average blood glucose over 3 months)
Change in eating disorder symptoms as indexed by the Diabetes Eating Problems Survey	baseline, 12 weeks, 24 weeks, 36 weeks	Severity of eating and body image concerns, frequency of engagement in maladaptive eating and weight control behaviors, specifically in the context of diabetes. Scores range from 0-80, with higher scores indicating greater symptom severity (worse outcome).
Change in eating disorder symptoms as indexed by the Eating Disorder Examination Global score	baseline, 12 weeks, 36 weeks	Severity of eating and body image concerns, frequency of engagement in maladaptive eating and weight control behaviors. Global scores range from 0-6, with higher scores indicating greater symptom severity (worse outcome).
Acceptability as measured by meeting the recruitment target for the study	36 months from start of enrollment	recruitment of n=128
Feasibility as measured by participant attrition less than 20%	39 months from start of enrollment	Less than n=26 individuals dropping out of treatment prematurely
Change in glycemic control as indexed by continuous glucose monitoring (CGM)	baseline, 6 weeks, 12 weeks, 36 weeks	CGM indices of time in range, frequency of Level 1 and 2 hyperglycemia and blood glucose variability
Change in diabetes self-management as indexed by the Diabetes Self-Management Questionnaire	baseline, 12 weeks, 24 weeks, 36 weeks	Engagement in activities necessary to manage diabetes, including checking blood sugar and administering insulin. Scores range from 0-10 with higher scores indicating better self-management.

Secondary Outcome Measures

Name	Time	Method
Change in NIH PROMIS Scale - Anxiety	baseline, 12 weeks, 36 weeks	8 items assessing anxious affect, scored 1-5 and t-score normed (mean of 50, standard deviation of 10). Higher scores indicating greater symptoms (worse outcome).
Change in NIH PROMIS Scale - Depression	baseline, 12 weeks, 36 weeks	8 items assessing depressive affect, scored 1-5 and t-score normed (mean of 50, standard deviation of 10). Higher scores indicating greater symptoms (worse outcome).
Change in diabetes distress as indexed by the Type 1 - Diabetes Distress Scale	baseline, 12 weeks, 24 weeks, 36 weeks	Feelings of stress or overwhelm with the burden of living with diabetes and diabetes management. Scores range from 1-6, with higher scores indicating greater distress (worse outcome)

Trial Locations

Locations (2)

Duke University; 🇺🇸 Durham, North Carolina, United States

Brown University; 🇺🇸 Providence, Rhode Island, United States