Elements Vital to Treat Obesity Study (EVO)

Evaluating the EVO Treatment Optimized for Resource Constraints: Elements Vital to Treat Obesity.

The overall objective of this study is to evaluate the first rigorously optimized, remotely delivered treatment for obesity against the current gold standard treatment in a head-to-head randomized controlled trial. The investigators will be comparing the previously developed and optimized behavioral weight loss intervention (APP) to the Diabetes Prevention Program (DPP), to evaluate program weight-loss success and cost-effectiveness.

Study Overview

• Status: Recruiting
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Smartphone App Participants (APP); Behavioral: Diabetes Prevention Program Participants (DPP)

Detailed Description

The proposed study seeks to determine if the APP program is an effective, resource-sensitive strategy to manage weight for obesity, as compared to the DPP program. During the 24-week active intervention phase, participants will be randomized to one of two treatments: 1) APP, wherein participants receive calorie, fat, and physical activity goals via a Smartphone application for self-monitoring, online educational readings, and biweekly sessions with a Health Promotionist; or 2) DPP, wherein participants are guided to self-monitor their physical activity, food intake, and weight via a participant log, and are guided through 16 sessions by a Health Promotionist. Assessments to track progress will occur remotely at the 3-month, 6-month, and 12-month time points of the program.

• Study Type: Interventional
• Enrollment (Estimated): 524
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Angela Pfammatter, PhD; Phone Number: 5 865-974-9126; Email: angela@northwestern.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern University
      • Contact: Angela Pfammatter, PhD; Phone Number: 5 865-974-9126; Email: angela@northwestern.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• BMI 30-45
• Weight stable
• Own a Smartphone and be willing to install our Smartphone app
• Willing to conduct video conference calls with study staff

Exclusion Criteria:

• Enrolled in any formal weight loss program
• Taking anti-obesity medications
• Not taking medications that may cause weight gain
• Unstable medical conditions
• Diabetes requiring insulin supplementation
• Crohn's Disease
• Diagnosis of obstructive sleep apnea requiring intervention (i.e., CPAP)
• Assistive devices for mobility
• Hospitalizations for a psychiatric disorder within the past 5 years
• Cardiovascular disease symptoms while performing moderate intensity exercise
• Pregnancy, trying to get pregnant, or lactating.
• Bulimia or binge eating disorder
• Reports of active suicidal ideation
• Current substance abuse or dependence besides nicotine dependence

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Smartphone App Participants (APP); Smartphone application, diet and activity goals, online lessons, brief remote sessions with a Health Promotionist	Behavioral: Smartphone App Participants (APP); Participants will receive calorie, fat, and physical activity goals, a Smartphone application for self-monitoring their diet, activity and weight, online educational readings, and brief bi-weekly remote health sessions with a Health Promotionist. They will also be provided with a wireless bluetooth scale and portable blood pressure machine.
Experimental: Diabetes Prevention Program Participants (DPP); Participant program manual, diet and activity logs, hour long remote sessions with a Health Promotionist	Behavioral: Diabetes Prevention Program Participants (DPP); In accordance with the Center for Disease Control curriculum, participants will receive a participant log for tracking physical activity, food intake, and weight, a paper participant guide with worksheets, logs, and psycho-educational materials, and 16 hour long remote sessions with a Health Promotionist. They will also be provided with a wireless bluetooth scale and portable blood pressure machine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	Participant change in weight, in kilograms, from baseline to 6-months.	Baseline to 6-Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Costs of treatment	Costs of EVO versus DPP implementation	12 Months

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: Washington University School of Medicine
• Investigators: Principal Investigator: Angela Pfammatter, PhD, Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2021
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: January 12, 2021
• First Submitted That Met QC Criteria: January 12, 2021
• First Posted (Actual): January 14, 2021

Study Record Updates

• Last Update Posted (Actual): May 31, 2024
• Last Update Submitted That Met QC Criteria: May 29, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Physical Activity; Mobile Health; Weight Loss; Diet; Self Monitoring
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: STU00212742

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No