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Active, Not Recruiting

NCT Number: NCT04708769

Elements Vital to Treat Obesity Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Obesity Behavior Body Weight Body Weight Changes Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Smartphone App Participants (APP)

Behavioral

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)

Behavioral

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 outcomes

  1. Weight

    Time frame: Baseline to 6-Months

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

Secondary outcomes

  1. Costs of treatment

    Time frame: 12 Months

    Costs of EVO versus DPP implementation

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Washington University School of Medicine

Registry information

Official study title

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

Acronym: EVO

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Jan 14, 2021
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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