SMARTer Weight Loss Management for Obesity
(SMARTer Trial)
Recruiting in Palo Alto (17 mi)
Overseen byAngela Pfammatter, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Northwestern University
Must not be taking: Weight loss medications
Disqualifiers: Diabetes, Pregnancy, Suicidal ideation, others
No Placebo Group
Trial Summary
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.
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.
12345Is 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.
16789How 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.
1571011Eligibility 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)
+2 more
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
+3 more
Trial 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
Participant Groups
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.
3Treatment groups
Experimental Treatment
Active Control
Group I: Diabetes Prevention Program Participants (DPP)Experimental Treatment1 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 Treatment1 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 Control1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Northwestern UniversityChicago, IL
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Who Is Running the Clinical Trial?
Northwestern UniversityLead Sponsor
References
Weight loss success in metabolic syndrome by telephone interventions: results from the SHINE Study. [2022]The Diabetes Prevention Program (DPP) intensive lifestyle intervention resulted in significant weight loss, reducing the development of diabetes, but needs to be adapted to primary care provider (PCP) practices.
Barriers and Facilitators to Real-world Implementation of the Diabetes Prevention Program in Large Healthcare Systems: Lifestyle Coach Perspectives. [2021]Group-based lifestyle change programs based on the Diabetes Prevention Program (DPP) are associated with clinically significant weight loss and decreases in cardiometabolic risk factors. However, these benefits depend on successful real-world implementation. Studies have examined implementation in community settings, but less is known about integration in healthcare systems, and particularly in large, multi-site systems with the potential for extended reach.
The Diabetes Prevention Program (DPP): description of lifestyle intervention. [2022]The purpose of the present article is to provide a detailed description of the highly successful lifestyle intervention administered to 1,079 participants, which included 45% racial and ethnic minorities and resulted in a 58% reduction in the incidence rate of diabetes (2). The two major goals of the Diabetes Prevention Program (DPP) lifestyle intervention were a minimum of 7% weight loss/weight maintenance and a minimum of 150 min of physical activity similar in intensity to brisk walking. Both goals were hypothesized to be feasible, safe, and effective based on previous clinical trials in other countries (3-7). The methods used to achieve these lifestyle goals include the following key features: 1) individual case managers or "lifestyle coaches;" 2) frequent contact with participants; 3) a structured, state-of-the-art, 16-session core-curriculum that taught behavioral self-management strategies for weight loss and physical activity; 4) supervised physical activity sessions; 5) a more flexible maintenance intervention, combining group and individual approaches, motivational campaigns, and "restarts;" 6) individualization through a "toolbox" of adherence strategies; 7) tailoring of materials and strategies to address ethnic diversity; and finally 8) an extensive network of training, feedback, and clinical support.
Implications of the diabetes prevention program and Look AHEAD clinical trials for lifestyle interventions. [2022]The Diabetes Prevention Program (DPP) and Look AHEAD (Action for Health in Diabetes) trials are long-term randomized clinical trials that have the potential to direct diabetes care and medical nutrition therapy for obesity, prediabetes, and type 2 diabetes both now and in the future. This article summarizes and compares the important evidence-based results of these diabetes and obesity clinical trials and reviews the similarities and differences in lifestyle interventions that were designed for these trials. Although there were many similarities in the features of the DPP and Look AHEAD interventions, the Look AHEAD lifestyle intervention was more ambitious in several ways: higher individual weight-loss goals, lower calorie and fat-gram targets based on initial body weight, more intensive intervention frequency, combining closed group and individual session format, and use of more structured nutrition intervention strategies from the outset, including meal replacements, structured menus, and combined fat and calorie counting. Evidence, knowledge, and insights gained from working on these clinical trials will be very important in determining the strategies, methods, and approaches needed to make sure that the results of these trials will be fully applied in real-world practice settings for obesity, prediabetes, and type 2 diabetes.
Usefulness of a Novel Mobile Diabetes Prevention Program Delivery Platform With Human Coaching: 65-Week Observational Follow-Up. [2019]It is widely recognized that the prevalence of obesity and comorbidities including prediabetes and type 2 diabetes continue to increase worldwide. Results from a 24-week Diabetes Prevention Program (DPP) fully mobile pilot intervention were previously published showing promising evidence of the usefulness of DPP-based eHealth interventions on weight loss.
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]The National Health Service (NHS) Diabetes Prevention Program (DPP) is a nationally implemented behavioral intervention for adults at high risk of developing Type 2 diabetes in England, based on a program specification that stipulates inclusion of 19 specific behavior change techniques (BCTs). Previous work has identified drift in fidelity from these NHS England specifications through providers' program manuals, training, and delivery, especially in relation to BCTs targeting self-regulatory processes.
Adapting the Diabetes Prevention Program lifestyle intervention for delivery in the community: the YMCA model. [2022]The Diabetes Prevention Program (DPP) demonstrated that a structured diet and physical activity intervention that achieves and maintains modest weight loss for overweight adults with impaired glucose tolerance can significantly reduce the development of diabetes. Although tens of millions of American adults could benefit from access to the DPP lifestyle intervention, there currently is no available model for nationwide dissemination of this highly beneficial and cost-effective approach to diabetes prevention. In this article, the authors describe the evolution of adaptations to improve DPP lifestyle intervention implementation and dissemination by a strong community partner, the YMCA. They also provide information about early field research and an ongoing clinical trial that will provide information about the feasibility and effectiveness of applying this new model on a national scale.
Background and recruitment data for the U.S. Diabetes Prevention Program. [2018]The objective of the Diabetes Prevention Program (DPP) is to prevent or delay the development of type 2 diabetes in those high-risk individuals who have tested positive for impaired glucose tolerance on an oral glucose tolerance test. The DPP is a multicenter randomized clinical trial in the U.S. with three intervention arms--lifestyle, metformin, and placebo--with 1,000 participants in each arm who will be recruited over a 3-year recruitment period and will be followed for 3 years after the study-wide closing date for recruitment, resulting in a 3- to 6-year participant follow-up interval. The primary outcome is the development of diabetes according to the revised American Diabetes Association criteria, confirmed with a repeat test. Recruitment ended in the spring of 1999. As of 14 October 1998, the DPP had screened 133,683 individuals, of whom 26,518 had an oral glucose tolerance test, resulting in 3,048 randomized participants (585 of who were former troglitazone arm participants). Of the randomized participants, approximately 45% belong to an ethnic minority group, 67% are women, and 10% are > or = 65 years old. In conclusion, recruitment of subjects for the DPP has been highly successful, particularly with respect to recruitment of minority participants.
Modification of the diabetes prevention program for the treatment of nonalcoholic fatty liver disease: A pilot study. [2023]The Diabetes Prevention Program (DPP) is the gold standard lifestyle modification program that reduces incident type 2 diabetes mellitus. Patients with prediabetes and patients with non-alcoholic fatty liver disease (NAFLD) often share metabolic features; we hypothesized that the DPP could be adapted and used to improve outcomes in patients with NAFLD.
One-year results of a community-based translation of the Diabetes Prevention Program: Healthy-Living Partnerships to Prevent Diabetes (HELP PD) Project. [2022]Although the Diabetes Prevention Program (DPP) and the Finnish Diabetes Prevention Study (FDPS) demonstrated that weight loss from lifestyle change reduces type 2 diabetes incidence in patients with prediabetes, the translation into community settings has been difficult. The objective of this study is to report the first-year results of a community-based translation of the DPP lifestyle weight loss (LWL) intervention on fasting glucose, insulin resistance, and adiposity.
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]Low- and middle-income countries (LMICs) are experiencing major increases in diabetes and cardiovascular conditions linked to overweight and obesity. Lifestyle interventions such as the United States National Diabetes Prevention Program (DPP) developed in high-income countries require adaptation and cultural tailoring for LMICs. The objective of this study was to evaluate the efficacy of "Lifestyle Africa," an adapted version of the DPP tailored for an underresourced community in South Africa compared to usual care.