SMARTer Weight Loss Management for Obesity

(SMARTer Trial)

Overseen By Bonnie Spring, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Must not be taking: Weight loss medications

Disqualifiers: Diabetes, Pregnancy, Suicidal ideation, others

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

Compensation: Varies

Number of Visits: 12

492 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking weight loss medications, such as GLP-1 agonists, to participate.

What data supports the effectiveness of the treatment SMARTer Weight Loss Management for Obesity?

The Diabetes Prevention Program (DPP) lifestyle intervention, which is a component of the SMARTer Weight Loss Management, has been shown to significantly reduce the incidence of diabetes by 58% through weight loss and increased physical activity. Additionally, group-based lifestyle change programs based on the DPP are linked to meaningful weight loss and reduced health risks, indicating potential effectiveness for the SMARTer intervention. ^{1 2 3 4 5}

Is the SMARTer Weight Loss Management program safe for humans?

The Diabetes Prevention Program (DPP), which is related to the SMARTer Weight Loss Management program, has been widely studied and is considered safe for humans. It involves lifestyle changes like diet and exercise, which are generally safe and beneficial for most people. ^{1 6 7 8 9}

How is the SMARTer Weight Loss Management treatment different from other obesity treatments?

The SMARTer Weight Loss Management treatment is unique because it adapts the Diabetes Prevention Program (DPP) lifestyle intervention, which combines structured diet and physical activity, for broader community delivery, making it more accessible and potentially more effective for weight loss and diabetes prevention. ^{1 5 7 10 11}

What is the purpose of this trial?

The SMARTer trial will be a three-arm, randomized controlled non-inferiority trial that compares the optimized, adaptive SMARTer intervention, fixed DPP, and usual care assessment-only (Control). The trial will address whether a scalable, stepped-care intervention can stand up to gold-standard DPP by achieving comparable weight loss at a lower cost. Alongside evaluation of clinical non-inferiority, a comprehensive economic evaluation will inform relative affordability. Cost information is important to inform treatment policy and change standard of care, but is sorely lacking for behavioral interventions. The SMARTer intervention reduces costs by initially offering minimal intervention to all and stepping up to offer more costly treatment components only to non-responders who fail to attain the target weight loss. A rigorous economic evaluation planned and designed alongside the SMARTer trial will provide an accurate, robust head-to-head comparison of costs, cost-effectiveness, and projected lifetime health care costs between the three arms.

Research Team

Bonnie Spring, PhD

Principal Investigator

Northwestern University

Eligibility Criteria

The SMARTer Weight Loss Management trial is for adults over 18 with a BMI of ≥25 and weight under 396 lbs. Participants must own a smartphone, be willing to install the SMARTer app, and stay in the Chicagoland area for 12 months. It's not open to those already in a weight loss program.

Inclusion Criteria

I own a Smartphone and agree to install the SMARTer app.

I am over 18 years old.

Participants must plan to reside in the Chicagoland area for the duration of their participation (i.e., 12 months)

Exclusion Criteria

I have not had a stroke or heart attack in the last six months.

I manage my diabetes with insulin.

Pregnancy, lactation, or intended pregnancy

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Active Intervention

Participants are randomized to one of three first-line treatments: adaptive SMARTer intervention, fixed DPP, or usual care assessment-only (control).

24 weeks

Physical measures at baseline, 3 months, 6 months

Follow-up

Participants are monitored for weight loss and cost-effectiveness at 9-month and 12-month timepoints.

6 months

Physical measures at 9 months, 12 months

Treatment Details

Interventions

• Adaptive SMARTer intervention (SMARTer)
• Diabetes Prevention Program Participants (DPP)

Trial Overview This trial compares three approaches: an adaptive intervention called SMARTer, a fixed Diabetes Prevention Program (DPP), and usual care without active intervention (Control). The goal is to see if SMARTer can match DPP's effectiveness at lower cost by escalating treatment only for those who need it.

Participant Groups

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

Participant program manual, diet and activity logs, hour long remote sessions with a Health Promotionist. Will have physical measures taken at baseline, 3 months, 6 months, 9 months, and 12 months.

Group II: Adaptive SMARTer intervention ( Experimental Treatment 1 Intervention

Smartphone application, diet and activity goals, online lessons, brief remote sessions with a Health Promotionist. Will have physical measures taken at baseline, 3 months, 6 months, 9 months, and 12 months.

Group III: Assessments-Only (Control) Active Control 1 Intervention

Resources educating on leading a healthier lifestyle, including information on wellness and physical activity. Will have physical measures taken or extracted from the medical record at baseline, 3 months, 6 months, 9 months, and 12 months.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Findings from Research

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 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]

The Diabetes Prevention Program (DPP) lifestyle intervention, involving 1,079 participants (45% racial and ethnic minorities), achieved a remarkable 58% reduction in diabetes incidence through targeted weight loss and physical activity goals.

Key features of the intervention included personalized coaching, frequent participant contact, a structured curriculum, and tailored strategies to accommodate ethnic diversity, all contributing to its effectiveness and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Diabetes Prevention Program (DPP): description of lifestyle intervention. [2022]

The Diabetes Prevention Program (DPP) and Look AHEAD trials provide crucial evidence for managing obesity, prediabetes, and type 2 diabetes through lifestyle interventions, with Look AHEAD featuring more ambitious weight-loss goals and structured nutrition strategies.

Insights from these trials will help shape future diabetes care and medical nutrition therapy, ensuring that effective strategies are implemented in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implications of the diabetes prevention program and Look AHEAD clinical trials for lifestyle interventions. Delahanty, LM., Nathan, DM.[2022]

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]

A qualitative study involving 20 participants from the NHS Diabetes Prevention Program revealed significant variation in understanding self-regulatory behavior change techniques (BCTs), particularly in techniques like action planning and problem solving, which many participants found challenging without additional support.

Participants generally understood and valued BCTs focused on outcomes, such as self-monitoring behaviors and goal setting, indicating that while some techniques are effective, others may require more structured guidance to enhance comprehension and application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How is the Behavior Change Technique Content of the NHS Diabetes Prevention Program Understood by Participants? A Qualitative Study of Fidelity, With a Focus on Receipt. Miles, LM., Hawkes, RE., French, DP.[2022]

The Diabetes Prevention Program (DPP) showed that a structured diet and exercise plan can significantly lower the risk of developing diabetes in overweight adults with impaired glucose tolerance.

The YMCA is adapting the DPP lifestyle intervention for broader implementation, and ongoing research will assess the feasibility and effectiveness of this model for nationwide diabetes prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adapting the Diabetes Prevention Program lifestyle intervention for delivery in the community: the YMCA model. Ackermann, RT., Marrero, DG.[2022]

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]

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 involving 301 overweight and obese participants, a community-based lifestyle weight loss intervention significantly reduced fasting glucose levels, insulin resistance, and body weight compared to usual care, demonstrating its efficacy in preventing type 2 diabetes.

Participants in the lifestyle intervention lost an average of 7.1 kg and experienced a notable decrease in waist circumference, indicating that community health workers can effectively implement diabetes prevention strategies in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-year results of a community-based translation of the Diabetes Prevention Program: Healthy-Living Partnerships to Prevent Diabetes (HELP PD) Project. Katula, JA., Vitolins, MZ., Rosenberger, EL., et al.[2022]

The 'Lifestyle Africa' intervention, adapted for a South African community, showed a significant reduction in hemoglobin A1c levels compared to usual care, indicating potential benefits for managing diabetes despite no significant weight loss differences.

The program was successfully delivered by community health workers using video-based sessions, demonstrating feasibility for scaling lifestyle interventions in low- and middle-income countries, with no serious adverse events reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of an adapted version of the Diabetes Prevention Program for low- and middle-income countries: A cluster randomized trial to evaluate "Lifestyle Africa" in South Africa. Catley, D., Puoane, T., Tsolekile, L., et al.[2023]

References

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

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

2. 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]

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

The Diabetes Prevention Program (DPP): description of lifestyle intervention. [2022]

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

Implications of the diabetes prevention program and Look AHEAD clinical trials for lifestyle interventions. [2022]

5. 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]

6. England pubmed.ncbi.nlm.nih.gov

How is the Behavior Change Technique Content of the NHS Diabetes Prevention Program Understood by Participants? A Qualitative Study of Fidelity, With a Focus on Receipt. [2022]

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

Adapting the Diabetes Prevention Program lifestyle intervention for delivery in the community: the YMCA model. [2022]

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

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

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

One-year results of a community-based translation of the Diabetes Prevention Program: Healthy-Living Partnerships to Prevent Diabetes (HELP PD) Project. [2022]

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

Evaluation of an adapted version of the Diabetes Prevention Program for low- and middle-income countries: A cluster randomized trial to evaluate "Lifestyle Africa" in South Africa. [2023]