Clinical trial NCT04708769: Elements Vital to Treat Obesity Study
Official title: Evaluating the EVO Treatment Optimized for Resource Constraints: Elements Vital to Treat Obesity.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Keywords: Weight Loss
Diet
Physical Activity
Self Monitoring
Mobile Health
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Washington University School of Medicine
First posted: 2021-01-14
Enrollment: 524
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Weight
timeFrame: Baseline to 6-Months
Secondary outcomes:
measure: Costs of treatment
timeFrame: 12 Months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Angela Pfammatter, PhD
role: PRINCIPAL_INVESTIGATOR
References: