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Trial record 1 of 1 for:    NCT05540704
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iACT for Eating Disorders in Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT05540704
Recruitment Status : Not yet recruiting
First Posted : September 15, 2022
Last Update Posted : March 16, 2023
Sponsor:
Collaborator:
The Miriam Hospital
Information provided by (Responsible Party):
Duke University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Eating Disorders Behavioral: iACT Other: Usual Care Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of iACT, a Novel mHealth Intervention for Eating Disorders in Type 1 Diabetes
Estimated Study Start Date : April 1, 2023
Estimated Primary Completion Date : June 1, 2026
Estimated Study Completion Date : June 1, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arms and Interventions
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Arm Intervention/treatment
Experimental: iACT Experimental Intervention Behavioral: iACT
Treatment is based on Acceptance and Commitment Therapy (ACT), a contemporary cognitive behavioral therapy (CBT) that improves human functioning and adaptability by increasing psychological flexibility. Individual therapy sessions are paired with mobile phone delivered interventions.
Active Comparator: Usual Care Other: Usual Care
Usual care for problems in Type 1 diabetes management


Outcome Measures
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Primary Outcome Measures :
  1. Change in glycemic control as indexed by continuous glucose monitoring (CGM) [ Time Frame: baseline, 6 weeks, 12 weeks, 36 weeks ]
    CGM indices of time in range, frequency of Level 1 and 2 hyperglycemia and blood glucose variability

  2. Change in glycemic control as indexed by hemoglobin A1c (HbA1c) [ Time Frame: 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)

  3. Change in eating disorder symptoms as indexed by the Eating Disorder Examination Global score [ Time Frame: 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).

  4. Change in eating disorder symptoms as indexed by the Diabetes Eating Problems Survey [ Time Frame: 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).

  5. Change in diabetes self-management as indexed by the Diabetes Self-Management Questionnaire [ Time Frame: 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.

  6. Acceptability as measured by meeting the recruitment target for the study [ Time Frame: 36 months from start of enrollment ]
    recruitment of n=128

  7. Feasibility as measured by participant attrition less than 20% [ Time Frame: 39 months from start of enrollment ]
    Less than n=26 individuals dropping out of treatment prematurely


Secondary Outcome Measures :
  1. Change in diabetes distress as indexed by the Type 1 - Diabetes Distress Scale [ Time Frame: 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)

  2. Change in NIH PROMIS Scale - Depression [ Time Frame: 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).

  3. Change in NIH PROMIS Scale - Anxiety [ Time Frame: 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).


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 16-45 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05540704


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

Sponsors and Collaborators
Duke University
The Miriam Hospital
Investigators
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Principal Investigator: Rhonda Merwin, PhD Duke University faculty
More Information
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT05540704    
Other Study ID Numbers: Pro00111401
4-SRA-2022-1226-M-B ( Other Grant/Funding Number: Juvenile Diabetes Research Foundation (JDRF) )
First Posted: September 15, 2022    Key Record Dates
Last Update Posted: March 16, 2023
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Feeding and Eating Disorders
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Mental Disorders