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SMARTer Weight Loss Management for Obesity (SMARTer Trial)
N/A
Waitlist Available
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
SMARTer Trial 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.Check my eligibility
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.See study design
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.
SMARTer Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Weight
Secondary outcome measures
Cost
SMARTer 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.
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Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,585 Previous Clinical Trials
916,739 Total Patients Enrolled
32 Trials studying Obesity
10,840 Patients Enrolled for Obesity
Angela Pfammatter, PhDPrincipal InvestigatorUniversity of Tennesse-Knoxville
1 Previous Clinical Trials
524 Total Patients Enrolled
1 Trials studying Obesity
524 Patients Enrolled for Obesity
Bonnie Spring, PhDPrincipal InvestigatorNorthwestern University
9 Previous Clinical Trials
5,044 Total Patients Enrolled
1 Trials studying Obesity
3,000 Patients Enrolled for Obesity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had a stroke or heart attack in the last six months.I manage my diabetes with insulin.I need help to walk or move around.I am currently having thoughts about harming myself.I own a Smartphone and agree to install the SMARTer app.I am over 18 years old.I have a history of anorexia or bulimia.My BMI is 25 or higher and I weigh less than 396 lbs.
Research Study Groups:
This trial has the following groups:- Group 1: Diabetes Prevention Program Participants (DPP)
- Group 2: Adaptive SMARTer intervention (
- Group 3: Assessments-Only (Control)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research project currently recruiting new participants?
"Unfortunately, this research trial is not currently recruiting. According to the data posted on clinicaltrials.gov which was last updated in May of 2023, no new patients are being accepted at present; however, there are 1,092 other active studies for people to consider participating in."
Answered by AI
Who else is applying?
What site did they apply to?
Northwestern University
What portion of applicants met pre-screening criteria?
Met criteria
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