Opt-IN: Optimization of Remotely Delivered Intensive Lifestyle Treatment for Obesity
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 11/16/2017 |
| Start Date: | September 2013 |
| End Date: | September 20, 2017 |
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 version of a technology-supported intensive lifestyle intervention (INLI)
for obesity. MOST involves highly efficient randomized experimentation to assess the effects
of individual treatment components, and thereby identify which components and component
levels make important contributions to the overall program effect on weight loss. This
information then guides assembly of an optimized treatment package that achieves target
outcomes with least resource consumption and participant burden. Because the intervention
strategies being tested minimize in-person coaching and leverage technology that participants
already own, the new optimized intervention, to be called Opt-IN, will be more scalable than
traditional INLIs. Opt-IN will thus enjoy greatly increased reach, and enable significant
progress in the fight against obesity.
framework, the Multiphase Optimization Strategy (MOST), to design, for the first time, an
optimized, scalable version of a technology-supported intensive lifestyle intervention (INLI)
for obesity. MOST involves highly efficient randomized experimentation to assess the effects
of individual treatment components, and thereby identify which components and component
levels make important contributions to the overall program effect on weight loss. This
information then guides assembly of an optimized treatment package that achieves target
outcomes with least resource consumption and participant burden. Because the intervention
strategies being tested minimize in-person coaching and leverage technology that participants
already own, the new optimized intervention, to be called Opt-IN, will be more scalable than
traditional INLIs. Opt-IN will thus enjoy greatly increased reach, and enable significant
progress in the fight against obesity.
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 weight loss outcomes comparable or superior to those achieved by the
current full cost, full burden form of INLIs. All intervention components to be examined were
selected based on the Opt-IN model's prediction that they enhance behavioral adherence to
weight regulation via the designated pathways. The five components to be tested will be: (1)
coaching intensity (12 vs. 24 phone sessions), (2) text messaging (No vs. Yes), (3) progress
report to participant's primary care provider (No vs. Yes), (4) recommendation to use meal
replacements (No vs. Yes), (5) training participants' self-selected buddies to be supportive
(No vs. Yes).
supported intervention for obesity that minimizes expense and burden to participants, while
achieving 6 month weight loss outcomes comparable or superior to those achieved by the
current full cost, full burden form of INLIs. All intervention components to be examined were
selected based on the Opt-IN model's prediction that they enhance behavioral adherence to
weight regulation via the designated pathways. The five components to be tested will be: (1)
coaching intensity (12 vs. 24 phone sessions), (2) text messaging (No vs. Yes), (3) progress
report to participant's primary care provider (No vs. Yes), (4) recommendation to use meal
replacements (No vs. Yes), (5) training participants' self-selected buddies to be supportive
(No vs. Yes).
Inclusion Criteria:
- 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 Criteria:
- 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
We found this trial at
1
site
Click here to add this to my saved trials
