Smartphone App vs. Diabetes Prevention Program for Obesity

(EVO Trial)

Overseen By Angela Pfammatter, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Must not be taking: Anti-obesity, Weight-gain

Disqualifiers: Diabetes, Crohn's, Sleep apnea, others

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

Compensation: Varies

Number of Visits: 3

Duration: 24 weeks

524 Participants Needed

Trial Summary

What is the purpose of this trial?

The overall objective of this study is to evaluate the first rigorously optimized, remotely delivered treatment for obesity against the current gold standard treatment in a head-to-head randomized controlled trial. The investigators will be comparing the previously developed and optimized behavioral weight loss intervention (APP) to the Diabetes Prevention Program (DPP), to evaluate program weight-loss success and cost-effectiveness.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking anti-obesity medications or medications that may cause weight gain.

What data supports the effectiveness of the treatment in the clinical trial 'Smartphone App vs. Diabetes Prevention Program for Obesity'?

The Diabetes Prevention Program (DPP) has been shown to help people lose weight and lower their risk of developing diabetes. Studies suggest that similar lifestyle change programs can be effective, and using technology like smartphone apps or text messages might help more people participate and succeed. ^{1 2 3 4 5}

Is the Diabetes Prevention Program safe for humans?

The Diabetes Prevention Program (DPP) has been widely studied and is considered safe for humans, as it focuses on lifestyle changes to prevent diabetes, which have been shown to result in significant weight loss and reduced risk of developing diabetes. ^{1 2 6 7 8}

How does the Smartphone App vs. Diabetes Prevention Program for Obesity treatment differ from other treatments for obesity?

This treatment is unique because it compares a traditional in-person lifestyle change program (DPP) with a smartphone app intervention, making it potentially more accessible and easier to distribute than standard in-person programs. ^{3 6 7 9 10}

Research Team

Angela Pfammatter, PhD

Principal Investigator

Northwestern University

Eligibility Criteria

This trial is for adults with obesity, having a BMI between 30-45, who own and can use a smartphone. Participants should be willing to install an app and do video calls with the study team. It's not for those on weight loss programs, insulin-treated diabetes, recent psychiatric hospitalizations, moderate exercise-induced cardiovascular symptoms, pregnant or lactating women, Crohn's Disease sufferers, bulimia or binge eating disorders patients.

Inclusion Criteria

I am willing to do video calls with the study team.

I am willing to do video calls with the study team.

I own a smartphone and agree to install the required app.

Exclusion Criteria

Pregnancy, trying to get pregnant, or lactating.

I am currently taking medication for weight loss.

You have a medical condition that is not well-controlled or keeps changing.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either the APP or DPP program for a 24-week active intervention phase

24 weeks

Biweekly remote sessions

Follow-up

Participants are monitored for weight change and cost-effectiveness of the treatment

6 months

Remote assessments at 3, 6, and 12 months

Treatment Details

Interventions

• Diabetes Prevention Program Participants (DPP)
• Smartphone App Participants (APP)

Trial Overview The study compares two methods to treat obesity: one group uses a specially designed smartphone app (APP) while the other follows the Diabetes Prevention Program (DPP). The goal is to see which method helps people lose more weight effectively and affordably.

Participant Groups

Group I: Smartphone App Participants (APP) Experimental Treatment 1 Intervention

Smartphone application, diet and activity goals, online lessons, brief remote sessions with a Health Promotionist

Group II: Diabetes Prevention Program Participants (DPP) Experimental Treatment 1 Intervention

Participant program manual, diet and activity logs, hour long remote sessions with a Health Promotionist

Diabetes Prevention Program Participants (DPP) is already approved in United States for the following indications:

Approved in United States as Diabetes Prevention Program for:

• Type 2 Diabetes Prevention

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Washington University School of Medicine

Collaborator

Trials

2,027

Recruited

2,353,000+

Findings from Research

The study involved 33 interviews with lifestyle coaches across 20 clinic sites, identifying six key factors that influence the successful implementation of the Diabetes Prevention Program (DPP) in large healthcare systems.

These factors include broader and institutional contexts, program provision, recruitment processes, characteristics of lifestyle coaches, and group dynamics, all of which are interconnected and can either facilitate or hinder the program's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers and Facilitators to Real-world Implementation of the Diabetes Prevention Program in Large Healthcare Systems: Lifestyle Coach Perspectives. Halley, MC., Petersen, J., Nasrallah, C., et al.[2021]

A randomized clinical trial involving 257 obese patients with metabolic syndrome showed that a group conference call (CC) intervention led to significantly greater weight loss (-5.6%) compared to individual calls (IC) (-1.8%) over 2 years, indicating that group support may enhance weight loss outcomes.

Participants in the CC group not only lost more weight but also continued to lose weight between the first and second year, while those in the IC group began to regain weight, highlighting the importance of ongoing support in lifestyle interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight loss success in metabolic syndrome by telephone interventions: results from the SHINE Study. Weinstock, RS., Trief, PM., Cibula, D., et al.[2022]

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]

In a study of 163 patients with prediabetes, those who received text message support alongside invitations to Diabetes Prevention Program (DPP) classes lost an average of 2.6 pounds, compared to only 0.6 pounds in the control group, indicating that text support can enhance weight loss efforts.

The intervention group also had a higher percentage of participants achieving a 3% weight loss (38.5%) compared to the control group (21.5%), suggesting that text message support is effective in promoting weight loss in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Text Message Support for Weight Loss in Patients With Prediabetes: A Randomized Clinical Trial. Fischer, HH., Fischer, IP., Pereira, RI., et al.[2022]

The Diabetes Prevention Program (DPP) is a large clinical trial involving 3,234 participants aimed at evaluating interventions to prevent type 2 diabetes in individuals at high risk, with a diverse demographic including various ethnic backgrounds and age groups.

The study will assess the effectiveness of three treatment approaches: intensive lifestyle modification, standard care with metformin, and standard care with placebo, to determine their impact on delaying or preventing diabetes development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Diabetes Prevention Program: baseline characteristics of the randomized cohort. The Diabetes Prevention Program Research Group. [2022]

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 Diabetes Prevention Program (DPP) is a large-scale clinical trial aimed at preventing type 2 diabetes in high-risk individuals, with 3,048 participants recruited from a pool of over 133,000 screened, highlighting its extensive reach.

The trial includes diverse participants, with 45% from ethnic minority groups and 67% being women, ensuring a representative sample for evaluating the effectiveness of lifestyle changes and metformin in diabetes prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Background and recruitment data for the U.S. Diabetes Prevention Program. Fujimoto, WY.[2018]

Technology-assisted diabetes prevention programs (DPP), including mobile text messaging, apps, and telehealth, have shown potential for clinically meaningful weight loss and cost-effectiveness in preventing type 2 diabetes.

These interventions can be widely distributed and sustained, making them accessible options for individuals at risk for diabetes, although further research is needed to identify the most effective combination of features for these programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Review of Technology-Assisted Interventions for Diabetes Prevention. Grock, S., Ku, JH., Kim, J., et al.[2022]

The modified Diabetes Prevention Program (DPP) lifestyle intervention, implemented as a 12-session Group Lifestyle Balance program, effectively reduced weight, waist circumference, and BMI in 93 nondiabetic participants over a 3-month period, with an average weight loss of 7.4 pounds (3.5% relative loss).

Participants in the program also showed significant improvements in cardiovascular risk factors, including reductions in total cholesterol and blood pressure, with over 80% of those achieving a 7% weight loss maintaining it at 6 months post-intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translating the Diabetes Prevention Program: a comprehensive model for prevention training and program delivery. Kramer, MK., Kriska, AM., Venditti, EM., et al.[2022]

References

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

Barriers and Facilitators to Real-world Implementation of the Diabetes Prevention Program in Large Healthcare Systems: Lifestyle Coach Perspectives. [2021]

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

Weight loss success in metabolic syndrome by telephone interventions: results from the SHINE Study. [2022]

3. 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]

4. 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]

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

Text Message Support for Weight Loss in Patients With Prediabetes: A Randomized Clinical Trial. [2022]

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

The Diabetes Prevention Program: baseline characteristics of the randomized cohort. The Diabetes Prevention Program Research Group. [2022]

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

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

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

Background and recruitment data for the U.S. Diabetes Prevention Program. [2018]

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

A Review of Technology-Assisted Interventions for Diabetes Prevention. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Translating the Diabetes Prevention Program: a comprehensive model for prevention training and program delivery. [2022]