Elements Vital to Treat Obesity Study

NCT ID: NCT04708769

Last Updated: 2025-07-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 524 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-16
• Study Completion Date: 2026-06-30

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Smartphone App Participants (APP)

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

Group Type: EXPERIMENTAL

Smartphone App Participants (APP)

Intervention Type: 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)

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

Group Type: EXPERIMENTAL

Diabetes Prevention Program Participants (DPP)

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Angela Fidler Pfammatter, PhD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Angela Pfammatter, PhD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern University

Chicago, Illinois, United States

Countries

United States

References

Metzendorf MI, Wieland LS, Richter B. Mobile health (m-health) smartphone interventions for adolescents and adults with overweight or obesity. Cochrane Database Syst Rev. 2024 Feb 20;2(2):CD013591. doi: 10.1002/14651858.CD013591.pub2.

Reference Type: DERIVED

PMID: 38375882 (View on PubMed)

Other Identifiers

STU00212742

Identifier Type: -

Identifier Source: org_study_id