EVO: Elements Vital to Treat Obesity Study

Sponsor
Northwestern University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04708769
Collaborator
Washington University School of Medicine (Other)
524
1
2
50.5
10.4

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Smartphone App Participants (APP)
  • Behavioral: Diabetes Prevention Program Participants (DPP)
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
524 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Evaluating the EVO Treatment Optimized for Resource Constraints: Elements Vital to Treat Obesity.
Actual Study Start Date :
Mar 16, 2021
Anticipated Primary Completion Date :
Jun 1, 2025
Anticipated Study Completion Date :
Jun 1, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Weight [Baseline to 6-Months]

    Participant change in weight, in kilograms, from baseline to 6-months.

Secondary Outcome Measures

  1. Costs of treatment [12 Months]

    Costs of EVO versus DPP implementation

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Northwestern University Chicago Illinois United States 60611

Sponsors and Collaborators

  • Northwestern University
  • Washington University School of Medicine

Investigators

  • Principal Investigator: Angela Pfammatter, PhD, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Angela Fidler Pfammatter, PhD, Assistant Professor, Northwestern University
ClinicalTrials.gov Identifier:
NCT04708769
Other Study ID Numbers:
  • STU00212742
First Posted:
Jan 14, 2021
Last Update Posted:
May 5, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Angela Fidler Pfammatter, PhD, Assistant Professor, Northwestern University
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 5, 2022