Elements Vital to Treat Obesity Study

Obesity Clinical Trial

— EVO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04708769
• Other study ID #: STU00212742
• Status: Recruiting
• Phase: N/A
• Start date: March 16, 2021
• Est. completion date: June 30, 2027

Study information

• Verified date: May 2024
• Source: Northwestern University
• Contact: Angela Pfammatter, PhD
• Phone: 865-974-9126
• Email: angela[@]northwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 524
• Est. completion date: June 30, 2027
• Est. primary completion date: November 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight	Participant change in weight, in kilograms, from baseline to 6-months.	Baseline to 6-Months
Secondary	Costs of treatment	Costs of EVO versus DPP implementation	12 Months