Status:
COMPLETED
Opt-IN: Optimization of Remotely Delivered Intensive Lifestyle Treatment for Obesity
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Penn State University
Conditions:
Weight Loss
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
PHASE3
Brief Summary
The overall objective of the proposed research is to use an innovative methodological framework, the Multiphase Optimization Strategy (MOST), to design, for the first time, an optimized, scalable vers...
Detailed Description
The goal of the proposed study is to determine the optimal composition of a technology supported intervention for obesity that minimizes expense and burden to participants, while achieving 6 month wei...
Eligibility Criteria
Inclusion
- 18 and 60 years old
- BMI 25-40 kg/m2
- Weight stable (no loss or gain \>25 lbs for the past 6 months)
- Not enrolled in any formal weight loss program or taking anti-obesity medications, but interested in losing weight.
- Own a Smartphone and be willing to install the Opt-IN app
- Able to use the app to record dietary intake and weight onto the Smartphone
- "Buddy" participants must:
- 18 years of age or older
- Have access to a computer and internet
- Be willing to undergo "Buddy Training" and participate in 4 webinars
- Be willing to provide support and encouragement to the participant
Exclusion
- Unstable medical conditions (uncontrolled hypertension, diabetes, unstable angina pectoris, myocardial infarction, transient ischemic attack, cancer undergoing active treatment, or cerebrovascular accident within the past six months)
- History of diabetes requiring insulin supplementation, Crohn's Disease, or a diagnosis of obstructive sleep apnea requiring intervention (i.e. CPAP)
- Use an assistive device for mobility (e.g., wheelchair, walker, cane)
- Plantar fasciitis
- Hospitalization for a psychiatric disorder within the past 5 years
- At risk for adverse cardiovascular (CVD) events with moderate intensity activity
- Cannot read the study questionnaires
- Committed to following an incompatible dietary regimen
- Not be pregnant, trying to get pregnant, or lactating
- Bulimia, binge eating disorder, current substance abuse or dependence (besides nicotine dependence) or report active suicidal ideation
- Low motivation to change
- Cannot live with a current or past Opt-IN participant
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 20 2017
Estimated Enrollment :
562 Patients enrolled
Trial Details
Trial ID
NCT01814072
Start Date
September 1 2013
End Date
September 20 2017
Last Update
February 1 2023
Active Locations (1)
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1
Northwestern University
Chicago, Illinois, United States, 60611