Obesity
Conditions
Keywords
Weight Loss, Diet, Physical Activity, Self Monitoring, Mobile Health
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.
Interventions
BEHAVIORALSmartphone 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.
BEHAVIORALDiabetes 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.
Sponsors
Northwestern University
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight | Baseline to 6-Months | Participant change in weight, in kilograms, from baseline to 6-months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Costs of treatment | 12 Months | Costs of EVO versus DPP implementation |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAngela Pfammatter, PhD
Northwestern University
Outcome results
None listed