Improving Appetite Self-Regulation in African American Adults With Type 2 Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of North Carolina, Chapel Hill
About this trial
The purpose of this 6-month randomized clinical trial is to examine the feasibility of recruitment, attendance, retention, program adherence, and satisfaction of a digital application designed, Centering Appetite to improve glucose scores (HbA1c) and binge eating in African American adults with type 2 diabetes. Intervention participants will receive type 2 diabetes education and web-based lessons on appetite self-regulation. Participants will also receive a Fitbit to monitor daily physical activity. The investigators will follow up with participants at six months.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
identify as a Non-Hispanic, AA
are over 18 years of age
have an A1c value > 7.5
have a working Smartphone
Disqualifiers
have major end-organ type 2 diabetes mellitus complications
have a history of weight loss surgery
are currently pregnant
in substance use treatment or are involved in another weight reduction program.
Trial design
Design model
Parallel
Treatments tested in this trial
DSME + ASE intervention (Centering Appetite)
BehavioralThe intervention 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: DSMES + ASE intervention Appetite Self-Regulation (Centering Appetite)Experimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Feasibility (Recruitment): The Percentage of Participants Who Were Eligible and Enrolled in the Study at Baseline
The number of potential participants screened for study eligibility versus the number of persons who enrolled in the study.
Time frame
Baseline2
Feasibility (Recruitment): The Percentage of Participants Who Were Eligible and Enrolled in the Study at Month 6
The number of potential participants screened for study eligibility versus the number of persons who enrolled in the study.
Time frame
Month 63
Feasibility (Attendance): The Percentage of Participants who Enrolled and Attended Each Intervention Session
The number of potential participants who attended intervention sessions versus the number of persons who enrolled in the study and did not attend intervention sessions.
Time frame
Month 64
Feasibility (Retention): The Percentage of Participants Retained in the Study at Month 6
Percentage of participants retained in the study following enrollment.
Time frame
Month 6Secondary outcomes
1
Changes in HbA1C
Participant HbA1C will be measured using a glycohemoglobin analyzer.
Time frame
Baseline, Month 62
Changes in Weight
Participant body weight will be measured by trained research staff using a calibrated digital scale.
Time frame
Baseline, Month 63
Changes in Blood Pressures (Systolic and Diastolic pressure)
Participant blood pressures will be measured by trained research staff using a calibrated sphygmomanometer.
Time frame
Baseline, Month 64
Changes in Binge Eating Episodes
Participant binge eating episodes will be measured using the Binge Eating Scale (BES). This is a 16-item psychological self-assessment tool used to assess the severity of binge eating behavior. Minimum values are: 0-17 which indicates non-binge eating, and the maximum values are anything greater than 27, which indicates severe binge eating.
Time frame
Baseline, Month 6Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of North Carolina, Chapel Hill
Lead sponsor
American Diabetes Association
Collaborator
Source ClinicalTrials.gov