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SMARTer Weight Loss Management for Obesity (SMARTer Trial)

N/A

Recruiting

Led By Angela Pfammatter, PhD

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare 3 approaches to weight loss to see which is most effective and cost-efficient. It will compare a new, adaptive approach with a gold-standard and usual care to see which works best.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this study involves behavioral interventions like lifestyle changes rather than medication, side effects are minimal but may include stress or frustration related to new diet or exercise routines.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Weight

Secondary study objectives

Cost

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Do I qualify?Apply below to find out