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

NCT ID: NCT05741125

Last Updated: 2025-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-22

Study Completion Date

2026-02-01

Brief Summary

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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

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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.

Conditions

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Type 2 Diabetes Binge Eating

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

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 Type EXPERIMENTAL

DSME + ASE intervention (Centering Appetite)

Intervention Type BEHAVIORAL

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.

Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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DSME + ASE intervention (Centering Appetite)

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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

Eligibility Criteria

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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 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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American Diabetes Association

OTHER

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rachel Goode, PhD, MPH, LCSW

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina at Chapel Hil

Locations

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Rachel W. Goode

Kannapolis, North Carolina, United States

Site Status NOT_YET_RECRUITING

UNC Nutrition Research Institute

Kannapolis, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Ramine Alexander, PhD, MPH

Role: CONTACT

704-250-5093

Rachel Goode, PhD, MPH, LCSW

Role: CONTACT

919-962-6429

Facility Contacts

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Rachel Goode, PhD, MPH, LCSW

Role: primary

919-962-6429

Tyisha Harper-Cooks, MBA

Role: primary

7042505093

Ramine Alexander, PhD, MPH

Role: backup

Other Identifiers

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22-2237

Identifier Type: -

Identifier Source: org_study_id

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