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App & Fitbit Monitoring for Type 2 Diabetes

N/A

Waitlist Available

Led By Rachel Goode, PhD, MPH, LCSW

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Are over 18 years of age

Be older than 18 years old

Must not have

Have major end-organ T2DM complications

Have a history of weight loss surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 6

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if an app & Fitbit can help African Americans with type 2 diabetes lower glucose and binge eating. They'll receive online lessons and be monitored for 6 months.

Who is the study for?

This trial is for African American adults with type 2 diabetes who experience binge eating. They must be over 18, have an HbA1c level above 7.5, and own a working smartphone. It's not for those with major diabetes complications, substance use treatment, involvement in other weight programs, history of weight loss surgery or current pregnancy.

What is being tested?

The study tests a digital app called Centering Appetite combined with diabetes education to improve blood sugar control and reduce binge eating. Participants will also use a Fitbit to track physical activity and follow up after six months.

What are the potential side effects?

Since the intervention involves educational content and lifestyle monitoring rather than medication, typical medical side effects are not expected. However, participants may experience stress or frustration related to adherence to the program.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have serious complications from type 2 diabetes.

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I have had weight loss surgery in the past.

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I am currently in a substance use treatment or a weight loss program.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability (Satisfaction): The Percentage of Participants Who Were Satisfied with the Delivery and Content of the Intervention

Feasibility (Attendance): The Percentage of Participants who Enrolled and Attended Each Intervention Session

Feasibility (Recruitment): The Percentage of Participants Who Were Eligible and Enrolled in the Study at Baseline

+3 more

Secondary study objectives

Changes in Binge Eating Episodes

Changes in Blood Pressures (Systolic and Diastolic pressure)

Changes in HbA1C

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: DSMES + ASE intervention Appetite Self-Regulation (Centering Appetite)Experimental Treatment1 Intervention

The Diabetes Self-Management Education and Support (DSMES) + Appetite Self-Regulation (ASE) intervention includes two, 45-60-minute group sessions delivered via telehealth. These sessions will enable participants to relearn their stomach's hunger and fullness signals and monitor their appetite. Participants will also learn strategies for glucose monitoring and carbohydrate management. Monthly booster sessions will be devoted to problem-solving, addressing barriers to emotion management, and self-monitoring type 2 diabetes mellitus symptoms. Participants will also receive weekly lessons with interactive activities delivered via a digital app.

Group II: ControlActive Control1 Intervention

Control group participants will attend two remotely delivered DSMES sessions that will offer content commonly. They will also receive weekly emails providing content from the American Association of Diabetes Educators.

0 / 4Eligibility criteria met