Clinical trial

Elements Vital to Treat Obesity Study

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT04708769

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 70 Years

SexAll

Healthy volunteersAccepted

ConditionObesity

Full registry 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

Treatments and study arms

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

WeightBaseline to 6-Months

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

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Northwestern University🇺🇸 Chicago, Illinois, United States

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