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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 6
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I am over 18 years old.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Changes in Binge Eating Episodes
Changes in Blood Pressures (Systolic and Diastolic pressure)
Changes in HbA1C
+1 more

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.

Find a Location

Who is running the clinical trial?

American Diabetes AssociationOTHER
137 Previous Clinical Trials
99,442 Total Patients Enrolled
University of North Carolina, Chapel HillLead Sponsor
1,506 Previous Clinical Trials
4,190,501 Total Patients Enrolled
Rachel Goode, PhD, MPH, LCSWPrincipal InvestigatorUniversity of North Carolina at Chapel Hil

Media Library

DSME + ASE intervention (Centering Appetite) Clinical Trial Eligibility Overview. Trial Name: NCT05741125 — N/A
Type 2 Diabetes Research Study Groups: Control, DSMES + ASE intervention Appetite Self-Regulation (Centering Appetite)
Type 2 Diabetes Clinical Trial 2023: DSME + ASE intervention (Centering Appetite) Highlights & Side Effects. Trial Name: NCT05741125 — N/A
DSME + ASE intervention (Centering Appetite) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05741125 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the participant demographic for this study limited to those over 25 years of age?

"This medical study is open to patients aged 18 - 75. Conversely, there are 208 clinical trials for minors and 1125 studies specifically designed for elderly patients."

Answered by AI

Are there any openings for involvement in this research?

"Clinicaltrials.gov indicates that this medical trial is not currently recruiting, although it was originally posted on September 1st, 2024 and last updated February 13th 2023. Luckily for patients looking to participate in clinical trials, there are 1490 other studies actively enrolling at the moment."

Answered by AI

What characteristics make a person an ideal candidate for this trial?

"The parameters for admission to this diabetes trial are strict. Individuals must be Non-Hispanic African American and aged 18 or over, present with an A1c value exceeding 7.5%, possess a working Smartphone, pass the binge eating screening test and fall between 18–75 years of age."

Answered by AI

What tangible goals has this research endeavor set out to achieve?

"The primary goal of this experiment, to be tracked over a predetermined baseline period, is determining the recruitment feasibility. Additional objectives include evaluating changes in bodyweight with calibrated digital scales, checking blood pressure using sphygmomanometers, and assessing binge eating episodes through psychological self-assessment tools."

Answered by AI

Who else is applying?

What site did they apply to?
Rachel W. Goode
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Improving Appetite Self-Regulation in African American Adults With Type 2 Diabetes
2024. "Improving Appetite Self-Regulation in African American Adults With Type 2 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05741125.
All > Binge Eating
~30 spots leftby Sep 2024
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