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iACT Experimental Intervention for Eating Disorders

Brown University, Providence, RI
Eating Disorders+1 More ConditionsiACT - Behavioral
Eligibility
16 - 50
All Sexes
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Study Summary

This trial tests an mHealth intervention to help people with type 1 diabetes and eating disorders better manage their health and diabetes. Outcomes include glycemic control, eating disorder symptoms and diabetes distress.

Eligible Conditions
  • Eating Disorders
  • Type 1 Diabetes

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

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Study Objectives

7 Primary · 3 Secondary · Reporting Duration: 39 months from start of enrollment

Month 36
Acceptability as measured by meeting the recruitment target for the study
Month 39
Feasibility as measured by participant attrition less than 20%
Week 36
Change in diabetes distress as indexed by the Type 1 - Diabetes Distress Scale
Change in diabetes self-management as indexed by the Diabetes Self-Management Questionnaire
Change in eating disorder symptoms as indexed by the Diabetes Eating Problems Survey
Change in glycemic control as indexed by hemoglobin A1c (HbA1c)
Week 36
Change in NIH PROMIS Scale - Anxiety
Change in NIH PROMIS Scale - Depression
Change in eating disorder symptoms as indexed by the Eating Disorder Examination Global score
Week 36
Change in glycemic control as indexed by continuous glucose monitoring (CGM)

Trial Safety

Phase-Based Safety

1 of 3

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1
Naltrexone
2
GOLO for Life® Plan (G4LP) and Release Supplement
1
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Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Usual Care
1 of 2
iACT Experimental Intervention
1 of 2

Active Control

Experimental Treatment

128 Total Participants · 2 Treatment Groups

Primary Treatment: iACT Experimental Intervention · No Placebo Group · N/A

iACT Experimental Intervention
Behavioral
Experimental Group · 1 Intervention: iACT · Intervention Types: Behavioral
Usual Care
Other
ActiveComparator Group · 1 Intervention: Usual Care · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 39 months from start of enrollment

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,236 Previous Clinical Trials
3,038,929 Total Patients Enrolled
7 Trials studying Eating Disorders
1,302 Patients Enrolled for Eating Disorders
The Miriam HospitalOTHER
233 Previous Clinical Trials
36,610 Total Patients Enrolled
Rhonda Merwin, PhDPrincipal InvestigatorDuke University faculty
4 Previous Clinical Trials
185 Total Patients Enrolled
2 Trials studying Eating Disorders
110 Patients Enrolled for Eating Disorders

Eligibility Criteria

Age 16 - 50 · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have an eating disorder where you frequently eat large amounts of food and have difficulty controlling your weight. This includes disorders such as bulimia nervosa and binge eating disorder.
References

Frequently Asked Questions

May I partake in this clinical experiment?

"To be eligible for this diabetes trial, volunteers must have type 1 diabetes and a chronological age between 16 and 50. A total of 128 individuals are needed to participate in the study." - Anonymous Online Contributor

Unverified Answer

Is this trial actively seeking volunteers?

"This clinical trial, which was initially publicized on April 4th 2023 and updated recently on the 18th of the same month, is currently in search for participants. The information can be found through clinicaltrials.gov." - Anonymous Online Contributor

Unverified Answer

Does this research permit individuals of forty years and older to participate?

"According to the stipulations of this clinical trial, participants must be aged between 16 and 50 years old. For those younger than 16 or older than 65, 263 and 991 trials respectively are available for their consideration." - Anonymous Online Contributor

Unverified Answer

How many participants have taken part in this experiment thus far?

"Affirmative. Clinicaltrials.gov indicates that this clinical trial is recruiting participants at the moment, first being posted on April 4th 2023 and last updated 18 days later. It requires 128 patients to be enrolled between two medical sites." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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