SMARTer Weight Loss Management for Obesity

(SMARTer Trial)

Overseen By Keri A Gladhill, 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests different methods to help people lose weight effectively and affordably. It compares three approaches: a flexible plan using a smartphone app, a structured program with a manual, and self-guided lifestyle changes. The goal is to determine if the app-based plan, known as the Adaptive SMARTer intervention (SMARTer), can achieve similar weight loss results at a lower cost compared to the other methods. The trial seeks participants with a body mass index (BMI) of 25 or higher, who are not part of another formal weight loss program, and are comfortable using a smartphone app. As an unphased trial, this study offers a unique opportunity to explore innovative weight loss methods and contribute to research that could benefit many others.

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.

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

Earlier studies tested the Adaptive SMARTer program on adults with obesity and showed promising results. These studies did not identify any serious safety issues. The program combines a smartphone app, dietary advice, and remote health support, with most participants requiring only minimal assistance. If weight loss is insufficient, meal replacements can be added.

The Diabetes Prevention Program (DPP) has a long history of safety and effectiveness. It aids in weight loss and reduces the risk of developing type 2 diabetes. Over many years, research has consistently shown that changes in diet and exercise can greatly improve health without major safety concerns.

Both treatments have been well-tolerated in past research, indicating they are safe options for managing weight. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to manage obesity using personalized and technology-driven approaches. The Adaptive SMARTer intervention stands out by using a smartphone app to set personalized diet and activity goals, with data monitored through a WiFi-connected scale. This dynamic method allows for adjustments, like adding meal replacement products if weight loss isn't progressing as planned. In contrast, the Diabetes Prevention Program offers a more structured approach with fixed sessions and materials, providing a consistent support framework. Both methods aim to enhance the effectiveness of weight loss strategies by combining digital tools with human interaction, potentially offering more tailored and responsive care than traditional options.

What evidence suggests that this trial's treatments could be effective for weight loss?

Research has shown that the Diabetes Prevention Program (DPP), one of the treatment arms in this trial, effectively manages obesity. Participants in the DPP lost 5% to 7% of their body weight, a significant reduction. They also reduced their risk of developing type 2 diabetes by 58%.

Another treatment arm in this trial, the Adaptive SMARTer intervention, aims to achieve similar success as the DPP but at a lower cost. It employs a step-by-step approach, beginning with simple methods and adding more support if needed. This strategy enables many people to lose weight without expensive treatments. ^{1 2 4 6 7}

Who Is on the Research Team?

Bonnie Spring, PhD

Principal Investigator

Florida State University

Are You a Good Fit for This Trial?

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

Pregnancy, lactation, or intended pregnancy

I need help to walk or move around.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Fixed intervention using 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 (SMARTer) Experimental Treatment 1 Intervention

Smartphone application, diet and activity goals, online lessons, brief remote sessions with a Health Promotionist. Data from a wifi scale will be monitored. Individuals losing less than .5 lb per week will be stepped up to also be given meal replacement products. Will have physical measures taken at baseline, 3 months, 6 months, 9 months, and 12 months.

Group III: Self-Guided Treatment (Self-Guided) Active Control 1 Intervention

Provides paper and internet resources tailored to geographic area, educating on leading a healthier lifestyle, including information on wellness and physical activity. Will have physical measures taken 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+

Florida State University

Collaborator

Trials

234

Recruited

41,100+

Published Research Related to This Trial

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) 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]

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) 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]

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]

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 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 '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]

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) 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05861973

Study Details | NCT05861973 | SMARTer Weight Loss ... The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02997943

Study Details | NCT02997943 | SMART Weight Loss ... The proposed study seeks to develop an effective, resource-sensitive strategy to manage weight loss treatment for obesity.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6624080/

SMART: Study Protocol for a Sequential Multiple ... A sequential multiple assignment randomization trial (SMART) will be conducted to inform the development of an empirically based stepped care intervention.

4. trial.medpath.com trial.medpath.com/clinical-trial/594d2299b5d71ae2/nct05861973-smarter-weight-loss-management

SMARTer Weight Loss Management | MedPath 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.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7269678/

The SMARTER Trial: Design of a trial testing tailored mHealth ... The SMARTER trial addresses two major gaps in the mHealth field – the absence of efficacy data on the use of commercially-available self-monitoring smartphone ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11094642/

An Adaptive Behavioral Intervention for Weight Loss ... In an adaptive, noninferiority randomized clinical trial of 400 adults with overweight or obesity, mean 6-month weight change was −2.8 (95 ...

7. withpower.com withpower.com/trial/phase-weight-loss-2024-f4edb

SMARTer Weight Loss Management for Obesity The SMARTer trial will be a three-arm, randomized controlled non-inferiority trial that compares the optimized, adaptive SMARTer intervention, fixed DPP, ...