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Elements Vital to Treat Obesity Study (EVO)

Primary Purpose

Obesity

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Smartphone App Participants (APP)
Diabetes Prevention Program Participants (DPP)
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Weight Loss, Diet, Physical Activity, Self Monitoring, Mobile Health

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Northwestern UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Smartphone App Participants (APP)

Diabetes Prevention Program Participants (DPP)

Arm Description

Smartphone application, diet and activity goals, online lessons, brief remote sessions with a Health Promotionist

Participant program manual, diet and activity logs, hour long remote sessions with a Health Promotionist

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Costs of treatment
Costs of EVO versus DPP implementation

Full Information

First Posted
January 12, 2021
Last Updated
May 19, 2023
Sponsor
Northwestern University
Collaborators
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04708769
Brief Title
Elements Vital to Treat Obesity Study
Acronym
EVO
Official Title
Evaluating the EVO Treatment Optimized for Resource Constraints: Elements Vital to Treat Obesity.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 16, 2021 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
Washington University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Weight Loss, Diet, Physical Activity, Self Monitoring, Mobile Health

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
524 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Smartphone App Participants (APP)
Arm Type
Experimental
Arm Description
Smartphone application, diet and activity goals, online lessons, brief remote sessions with a Health Promotionist
Arm Title
Diabetes Prevention Program Participants (DPP)
Arm Type
Experimental
Arm Description
Participant program manual, diet and activity logs, hour long remote sessions with a Health Promotionist
Intervention Type
Behavioral
Intervention Name(s)
Smartphone App Participants (APP)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Diabetes Prevention Program Participants (DPP)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Weight
Description
Participant change in weight, in kilograms, from baseline to 6-months.
Time Frame
Baseline to 6-Months
Secondary Outcome Measure Information:
Title
Costs of treatment
Description
Costs of EVO versus DPP implementation
Time Frame
12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Angela Pfammatter, PhD
Phone
865-974-9126
Ext
5
Email
angela@northwestern.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angela Pfammatter, PhD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angela Pfammatter, PhD
Phone
865-974-9126
Ext
5
Email
angela@northwestern.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Elements Vital to Treat Obesity Study

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