Appetite Awareness Training + Diabetes Prevention for Type 2 Diabetes

Overseen By Tyisha Harper- Cooks, MBA

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Type 2 diabetes, Pregnancy, Bariatric surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if reducing binge eating can lower the risk of type 2 diabetes in Black women. The study will test two programs: one focuses on recognizing hunger and fullness cues (Appetite Awareness Training, AAT), and the other on preventing diabetes (Diabetes Prevention Program, DPP). Participants will receive training in both programs or only the diabetes prevention program for a year. Black women aged 18-25 with a BMI over 25 who experience binge eating at least once a week may be suitable for this trial. As an unphased trial, this study offers participants the chance to contribute to important research that could improve health outcomes for Black women.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Appetite Awareness Training (AAT) can help reduce binge eating episodes and the urge to eat when not hungry. AAT is generally safe and well-tolerated for individuals with these behaviors, with no harmful effects reported in the data.

For the Diabetes Prevention Program (DPP), studies have confirmed its safety and effectiveness. Participants in the DPP lifestyle change program reduced their risk of developing type 2 diabetes by 58% through diet and exercise changes, which are typically safe. The program has been used for years without reports of major negative effects.

Both treatments appear safe for those considering joining the trial. They focus on behavior and lifestyle changes, which usually do not carry the risks associated with medication or surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Appetite Awareness Training (AAT) combined with the Diabetes Prevention Program (DPP) because this approach offers a unique angle on managing Type 2 Diabetes. Unlike standard treatments that often focus solely on medication or dietary changes, AAT encourages individuals to become more mindful of their hunger cues and eating habits, potentially leading to sustainable lifestyle changes. The combination with DPP, a well-established program for diabetes prevention, could enhance the overall effectiveness by integrating behavioral insights with proven prevention strategies. This holistic approach might not only help in preventing diabetes but also promote a healthier relationship with food, making it an innovative strategy in diabetes care.

What evidence suggests that this trial's treatments could be effective for type 2 diabetes?

Studies have shown that the Diabetes Prevention Program (DPP), one of the treatments in this trial, can reduce the risk of developing type 2 diabetes by 58% over about three years. This program emphasizes lifestyle changes such as healthier eating and increased exercise. Research indicates that nearly 38% of people in a similar program returned to normal blood sugar levels after one year. Participants often lose weight, which can help prevent diabetes. In this trial, some participants will receive both Appetite Awareness Training (AAT) and DPP. The combination of AAT and DPP aims to reduce binge eating, which is linked to obesity—a major risk factor for diabetes. Together, these strategies could effectively lower diabetes risk, especially in communities with higher rates of the disease. ^{1 6 7 8 9}

Who Is on the Research Team?

Rachel Goode, PhD,MPH,LCSW

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

This trial is for Black emergent adults who may be at risk of developing type 2 diabetes due to factors like obesity and binge eating. Participants should have a history or current issue with binge eating but not yet diagnosed with diabetes. It's aimed at preventing the onset of type 2 diabetes by addressing modifiable behaviors.

Inclusion Criteria

Black women

Have access to a smartphone

I am prediabetic.

Exclusion Criteria

I have type 2 diabetes.

Have no internet access

Currently pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Adaptation

Utilize community-engaged and user-centered design methods to adapt a mobile intervention to prevent T2DM in Black women at risk for BED

12 months

Treatment

Participants receive the adapted AAT and DPP intervention for 12 months

12 months

Follow-up

Participants are monitored for changes in binge eating episodes, weight regain, and inflammatory biomarkers

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Appetite Awareness Training (AAT)
• Diabetes Prevention Program (DPP)

Trial Overview

The study tests Appetite Awareness Training (AAT) combined with the Diabetes Prevention Program (DPP). These interventions are designed to help participants manage their eating habits, reduce binge eating episodes, and ultimately lower their risk of developing type 2 diabetes.

How Is the Trial Designed?

Group I: Diabetes Prevention Program (DPP) only Experimental Treatment 1 Intervention

Participants are randomized into the DPP group and will be able to access the program's content.

Group II: Appetite Awareness Training (AAT) and Diabetes Prevention Program (DPP) Experimental Treatment 2 Interventions

Participants are randomized into the AAT and DPP groups and receive content from both programs for 12 months.

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

American Diabetes Association

Collaborator

Trials

148

Recruited

102,000+

Published Research Related to This Trial

A fully mobile Diabetes Prevention Program (DPP) led to significant weight loss among participants, with an average loss of 6.15% to 8.98% depending on engagement levels, over a 65-week period.

High participant engagement was observed, with 80% completing 9 or more lessons, and self-monitoring actions were key predictors of weight loss, suggesting that mobile interventions can effectively support long-term weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usefulness of a Novel Mobile Diabetes Prevention Program Delivery Platform With Human Coaching: 65-Week Observational Follow-Up. Michaelides, A., Major, J., Pienkosz, E., et al.[2019]

The Diabetes Prevention Program (DPP) can reduce the incidence of diabetes by 58% over three years for individuals with prediabetes, yet most patients are unaware of their condition.

With Medicare coverage starting in 2018, the DPP has become more accessible for patients over 65, highlighting the need for healthcare providers to implement screening and referral processes for prediabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practical Tips for Implementing the Diabetes Prevention Program in Clinical Practice. Jasik, CB., Joy, E., Brunisholz, KD., et al.[2019]

The Veterans Affairs Diabetes Prevention Program (VA-DPP) showed higher fidelity in delivery compared to the usual MOVE! program, indicating it may be more effectively implemented in clinical settings.

Participant satisfaction was generally higher in the VA-DPP, suggesting that this program not only has better implementation but also resonates more positively with participants, which is crucial for long-term success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation findings from a hybrid III implementation-effectiveness trial of the Diabetes Prevention Program (DPP) in the Veterans Health Administration (VHA). Damschroder, LJ., Reardon, CM., AuYoung, M., et al.[2022]

In a modified Diabetes Prevention Program (DPP) for patients with non-alcoholic fatty liver disease (NAFLD), 79% of participants completed the program, leading to significant weight loss and improvements in liver health indicators over 12 months.

Key improvements included reduced hepatic steatosis and liver enzymes, indicating enhanced liver function, although there was a noted increase in low-density lipoprotein levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modification of the diabetes prevention program for the treatment of nonalcoholic fatty liver disease: A pilot study. Hershman, M., Torbjornsen, K., Pang, D., et al.[2023]

The Intensive Lifestyle Intervention (ILI) in the Diabetes Prevention Program (DPP) effectively helped approximately 3800 high-risk adults with prediabetes achieve weight loss through dietary and exercise modifications, demonstrating a practical approach to delaying or preventing type 2 diabetes.

The DPP and its follow-up, the DPP Outcomes Study (DPPOS), highlight the importance of lifestyle changes in managing prediabetes, particularly in a diverse population, suggesting that these interventions can be tailored to various ethnic backgrounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of Diabetes Through the Lifestyle Intervention: Lessons Learned from the Diabetes Prevention Program and Outcomes Study and its Translation to Practice. Hoskin, MA., Bray, GA., Hattaway, K., et al.[2019]

In a study involving 68 adults with type 2 diabetes, empagliflozin (25 mg daily) combined with dietary energy restriction led to the most significant weight loss of 5.74 kg over 24 weeks, compared to other groups.

Despite the weight loss, the changes in appetite-regulating peptides like PYY and GLP-1 did not show significant differences between the treatment groups and the placebo, suggesting that these peptides may not explain the observed weight loss with empagliflozin therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of empagliflozin, dietary energy restriction, or both on appetite-regulatory gut peptides in individuals with type 2 diabetes and overweight or obesity: The SEESAW randomized, double-blind, placebo-controlled trial. Sargeant, JA., King, JA., Yates, T., et al.[2022]

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