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Improving Appetite Self-Regulation in African American Adults With Type 2 Diabetes

Primary Purpose

Type 2 Diabetes, Binge Eating

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DSME + ASE intervention (Centering Appetite)
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Bing Eating, Type 2 Diabetes, African Americans, Digital

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Individuals are eligible if they identify as a Non-Hispanic, AA are over 18 years of age have an A1c value > 7.5 have a working Smartphone complete binge eating screening Exclusion Criteria: Individuals will be excluded if they: have major end-organ T2DM complications have a history of weight loss surgery are currently pregnant in substance use treatment or are involved in another weight reduction program.

Sites / Locations

  • Rachel W. Goode

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

DSMES + ASE intervention Appetite Self-Regulation (Centering Appetite)

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
Feasibility (Retention): The Percentage of Participants Retained in the Study at Month 6
Percentage of participants retained in the study following enrollment.
Feasibility (Treatment Adherence): The Percentage of Participants Who Adhered to Study Protocol
Percentage of participants who adheres to study protocol.
Acceptability (Satisfaction): The Percentage of Participants Who Were Satisfied with the Delivery and Content of the Intervention
Participant satisfaction will be measured using a self-report scale at month 6. The Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM). This is a 4-item scale with 1 being the lowest measure and 5 being the highest measure.

Secondary Outcome Measures

Changes in HbA1C
Participant HbA1C will be measured using a glycohemoglobin analyzer.
Changes in Weight
Participant body weight will be measured by trained research staff using a calibrated digital scale.
Changes in Blood Pressures (Systolic and Diastolic pressure)
Participant blood pressures will be measured by trained research staff using a calibrated sphygmomanometer.
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.

Full Information

First Posted
February 13, 2023
Last Updated
April 6, 2023
Sponsor
University of North Carolina, Chapel Hill
Collaborators
American Diabetes Association
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1. Study Identification

Unique Protocol Identification Number
NCT05741125
Brief Title
Improving Appetite Self-Regulation in African American Adults With Type 2 Diabetes
Official Title
Improving Appetite Self-Regulation in African American Adults With Type 2 Diabetes: A Digital Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 9, 2024 (Anticipated)
Primary Completion Date
September 15, 2024 (Anticipated)
Study Completion Date
September 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
American Diabetes Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
Using a randomized clinical trial design examine the feasibility and acceptability of a 6-month digital diabetes self-management education program plus an appetite self-regulation intervention for (n=60) African Americans (AA) with type 2 diabetes who report uncontrolled eating in North Carolina. Sixty AAs will be randomized to the Centering Appetite intervention or the control group. Over the 6 months, Centering Appetite participants will have two intervention sessions supplemented by monthly booster sessions and weekly messages related to the program. The control group will also receive two intervention sessions and weekly nutrition tutorials. The study will examine the following: recruitment feasibility, attendance/retention, treatment adherence, intervention, HbA1c, and binge eating.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Binge Eating
Keywords
Bing Eating, Type 2 Diabetes, African Americans, Digital

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DSMES + ASE intervention Appetite Self-Regulation (Centering Appetite)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
DSME + ASE intervention (Centering Appetite)
Other Intervention Name(s)
Improving Appetite Self-Regulation in African American Adults with Type 2 Diabetes
Intervention Description
The 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.
Primary Outcome Measure Information:
Title
Feasibility (Recruitment): The Percentage of Participants Who Were Eligible and Enrolled in the Study at Baseline
Description
The number of potential participants screened for study eligibility versus the number of persons who enrolled in the study.
Time Frame
Baseline
Title
Feasibility (Recruitment): The Percentage of Participants Who Were Eligible and Enrolled in the Study at Month 6
Description
The number of potential participants screened for study eligibility versus the number of persons who enrolled in the study.
Time Frame
Month 6
Title
Feasibility (Attendance): The Percentage of Participants who Enrolled and Attended Each Intervention Session
Description
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 6
Title
Feasibility (Retention): The Percentage of Participants Retained in the Study at Month 6
Description
Percentage of participants retained in the study following enrollment.
Time Frame
Month 6
Title
Feasibility (Treatment Adherence): The Percentage of Participants Who Adhered to Study Protocol
Description
Percentage of participants who adheres to study protocol.
Time Frame
Month 6
Title
Acceptability (Satisfaction): The Percentage of Participants Who Were Satisfied with the Delivery and Content of the Intervention
Description
Participant satisfaction will be measured using a self-report scale at month 6. The Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM). This is a 4-item scale with 1 being the lowest measure and 5 being the highest measure.
Time Frame
Month 6
Secondary Outcome Measure Information:
Title
Changes in HbA1C
Description
Participant HbA1C will be measured using a glycohemoglobin analyzer.
Time Frame
Baseline, Month 6
Title
Changes in Weight
Description
Participant body weight will be measured by trained research staff using a calibrated digital scale.
Time Frame
Baseline, Month 6
Title
Changes in Blood Pressures (Systolic and Diastolic pressure)
Description
Participant blood pressures will be measured by trained research staff using a calibrated sphygmomanometer.
Time Frame
Baseline, Month 6
Title
Changes in Binge Eating Episodes
Description
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 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Individuals are eligible if they identify as a Non-Hispanic, AA are over 18 years of age have an A1c value > 7.5 have a working Smartphone complete binge eating screening Exclusion Criteria: Individuals will be excluded if they: have major end-organ T2DM complications have a history of weight loss surgery are currently pregnant in substance use treatment or are involved in another weight reduction program.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ramine Alexander, PhD, MPH
Phone
704-250-5093
Email
raminea@unc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Rachel Goode, PhD, MPH, LCSW
Phone
919-962-6429
Email
rwgoode@email.unc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel Goode, PhD, MPH, LCSW
Organizational Affiliation
University of North Carolina at Chapel Hil
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rachel W. Goode
City
Kannapolis
State/Province
North Carolina
ZIP/Postal Code
28081
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel Goode, PhD, MPH, LCSW
Phone
919-962-6429
Email
rwgoode@email.unc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Improving Appetite Self-Regulation in African American Adults With Type 2 Diabetes

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