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?

Black Americans are disproportionately affected by diabetes, with nearly double the rates of type 2 diabetes mellitus (T2DM), compared to non-Hispanic White adults. Though numerous factors affect these disparities, one modifiable risk factor may be that of binge eating (BE), which increases risk for binge-eating disorder (BED), which is associated with severe obesity, and often precedes a T2DM diagnosis, beginning in childhood or adolescence. Nearly 30% of Black women with obesity report binge eating episodes. Furthermore, given that binge and overeating may disparately increase the odds of obesity in Black adults (15-fold increase vs. 6-fold increase in White adults), reducing this behavior will be critical to prevent continued disparities in T2DM diagnosis. Given that Black women have the highest rates of obesity in the nation (57%), report disparate rates of weight gain between young adulthood and mid adulthood, and report disparate rates of emotional eating in adolescence, which is a risk factor for BE, one pathway to reducing disparities in T2DM risk in Black women may be to reduce binge eating and prevent weight gain in emerging adulthood (ages 18-25).

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 Appetite Awareness Training + Diabetes Prevention safe for humans?

Incretin-based therapies, which include DPP-4 inhibitors, are generally considered safe with few side effects and are weight neutral. Sitagliptin, a DPP-4 inhibitor, has been shown to be safe in clinical studies and does not cause a higher rate of low blood sugar compared to other treatments. ^{1 2 3 4 5}

How does the Appetite Awareness Training + Diabetes Prevention treatment differ from other treatments for type 2 diabetes?

This treatment is unique because it combines Appetite Awareness Training (AAT), which helps individuals recognize and respond to their body's hunger and fullness signals, with the Diabetes Prevention Program (DPP), a lifestyle intervention focusing on diet and exercise. Unlike standard drug treatments, this approach emphasizes behavioral changes to manage weight and prevent diabetes. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Appetite Awareness Training + Diabetes Prevention Program for Type 2 Diabetes?

The Diabetes Prevention Program (DPP) is a proven lifestyle change program that can reduce the risk of developing type 2 diabetes by 58% over three years. It has been successfully adapted for other conditions like non-alcoholic fatty liver disease, suggesting its potential flexibility and effectiveness in various health contexts. ^{11 12 13 14 15}

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 1 Intervention

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+

Published Research Related to This Trial

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]

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 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]

Citations

1. England 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). [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Modification of the diabetes prevention program for the treatment of nonalcoholic fatty liver disease: A pilot study. [2023]

3. Canada pubmed.ncbi.nlm.nih.gov

Usefulness of a Novel Mobile Diabetes Prevention Program Delivery Platform With Human Coaching: 65-Week Observational Follow-Up. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Practical Tips for Implementing the Diabetes Prevention Program in Clinical Practice. [2019]

5. United States 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. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

DPP-4 inhibitor therapy: new directions in the treatment of type 2 diabetes. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Is there a place for incretin therapies in obesity and prediabetes? [2015]

8. United States pubmed.ncbi.nlm.nih.gov

Role of the incretin pathway in the pathogenesis of type 2 diabetes mellitus. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Dipeptidyl peptidase-4 inhibitors in triple oral therapy regimens in patients with type 2 diabetes mellitus. [2018]

10. Spain pubmed.ncbi.nlm.nih.gov

Sitagliptin: Profile of a novel DPP-4 inhibitor for the treatment of type 2 diabetes. [2017]

11. England pubmed.ncbi.nlm.nih.gov

Weight loss-induced increase in fasting ghrelin concentration is a predictor of weight regain: Evidence from the Diabetes Remission Clinical Trial (DiRECT). [2020]

12. England pubmed.ncbi.nlm.nih.gov

Weight loss induced increase in fasting ghrelin concentration is a predictor of weight regain: evidence from the Diabetes Remission Clinical Trial. [2020]

13. England 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. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

Glucagon-like peptide-1 promotes satiety and reduces food intake in patients with diabetes mellitus type 2. [2019]

15. Japan pubmed.ncbi.nlm.nih.gov

Effects of ipragliflozin on glycemic control, appetite and its related hormones: A prospective, multicenter, open-label study (SOAR-KOBE Study). [2023]