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Behavioural Intervention
Smartphone App vs. Diabetes Prevention Program for Obesity (EVO 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
BMI 30-45
Be older than 18 years old
Must not have
Taking anti-obesity medications
Not taking medications that may cause weight gain
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will compare a new weight-loss program to the current gold standard to see which is more effective and cost-efficient.
Who is the study for?
This trial is for adults with obesity, having a BMI between 30-45, who own and can use a smartphone. Participants should be willing to install an app and do video calls with the study team. It's not for those on weight loss programs, insulin-treated diabetes, recent psychiatric hospitalizations, moderate exercise-induced cardiovascular symptoms, pregnant or lactating women, Crohn's Disease sufferers, bulimia or binge eating disorders patients.
What is being tested?
The study compares two methods to treat obesity: one group uses a specially designed smartphone app (APP) while the other follows the Diabetes Prevention Program (DPP). The goal is to see which method helps people lose more weight effectively and affordably.
What are the potential side effects?
Since this trial involves lifestyle interventions rather than medications, side effects are minimal but may include potential stress or frustration from dietary changes or new exercise routines.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My BMI is between 30 and 45.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently taking medication for weight loss.
Select...
I am not on medications that can cause weight gain.
Select...
I need insulin for my diabetes.
Select...
I have Crohn's Disease.
Select...
I have sleep apnea and need treatment like CPAP.
Select...
I use devices like canes or walkers to help me move around.
Select...
I have not been hospitalized for a mental health issue in the last 5 years.
Select...
I experience heart problems when doing moderate exercise.
Select...
I have thoughts of harming myself.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
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
Costs of treatment
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Smartphone App Participants (APP)Experimental Treatment1 Intervention
Smartphone application, diet and activity goals, online lessons, brief remote sessions with a Health Promotionist
Group II: Diabetes Prevention Program Participants (DPP)Experimental Treatment1 Intervention
Participant program manual, diet and activity logs, hour long remote sessions with a Health Promotionist
Find a Location
Who is running the clinical trial?
Washington University School of MedicineOTHER
2,000 Previous Clinical Trials
2,343,786 Total Patients Enrolled
84 Trials studying Obesity
14,278 Patients Enrolled for Obesity
Northwestern UniversityLead Sponsor
1,652 Previous Clinical Trials
960,991 Total Patients Enrolled
33 Trials studying Obesity
10,938 Patients Enrolled for Obesity
Angela Pfammatter, PhDPrincipal InvestigatorNorthwestern University
1 Previous Clinical Trials
492 Total Patients Enrolled
1 Trials studying Obesity
492 Patients Enrolled for Obesity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing to do video calls with the study team.I am currently taking medication for weight loss.You have a medical condition that is not well-controlled or keeps changing.I have Crohn's Disease.I have sleep apnea and need treatment like CPAP.I have thoughts of harming myself.I am willing to do video calls with the study team.I own a smartphone and agree to install the required app.You are currently addicted to or regularly use drugs (excluding nicotine).I need insulin for my diabetes.I experience heart problems when doing moderate exercise.Your weight has remained consistent.Your body mass index (BMI) is between 30 and 45.Your weight has been consistent and not changing.I own a smartphone and agree to install the required app.I have not been hospitalized for a mental health issue in the last 5 years.You have a condition called bulimia or binge eating disorder.My BMI is between 30 and 45.I am not on medications that can cause weight gain.I use devices like canes or walkers to help me move around.
Research Study Groups:
This trial has the following groups:- Group 1: Smartphone App Participants (APP)
- Group 2: Diabetes Prevention Program Participants (DPP)
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.
Obesity Patient Testimony for trial: Trial Name: NCT04708769 — N/A