Clinical trial NCT01814072: Opt-IN: Optimization of Remotely Delivered Intensive Lifestyle Treatment for Obesity
Official title: Opt-IN: Optimization of Remotely Delivered Intensive Lifestyle Treatment for Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Weight Loss
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Penn State University
First posted: 2013-03-19
Enrollment: 562
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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 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.

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 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).

Eligibility criteria: 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

Primary outcomes:
measure: Weight Change (kg) From Baseline to Month 6, Main Effect of Time
timeFrame: From Baseline to Month 6
measure: Weight Change (kg) From Baseline to Month 6, Time by Factor Interaction
timeFrame: From Baseline to Month 6
Secondary outcomes:
measure: Intervention for <$500
timeFrame: 6 months
Other outcomes:
measure: Treatment Adherence
timeFrame: 6 months
measure: Self-monitoring Adherence
timeFrame: 6 months
measure: Self-efficacy
timeFrame: 6 months
measure: Self-Regulation
timeFrame: 6 months
measure: Supportive Accountability
timeFrame: 6 months
measure: Facilitation
timeFrame: 6 months
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Bonnie Spring, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Penn State University
name: Linda Collins, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Nahum-Shani I, Smith SN, Spring BJ, Collins LM, Witkiewitz K, Tewari A, Murphy SA. Just-in-Time Adaptive Interventions (JITAIs) in Mobile Health: Key Components and Design Principles for Ongoing Health Behavior Support. Ann Behav Med. 2018 May 18;52(6):446-462. doi: 10.1007/s12160-016-9830-8.
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citation: Booth JN 3rd, Allen NB, Calhoun D, Carson AP, Deng L, Goff DC Jr, Redden DT, Reis JP, Shimbo D, Shikany JM, Sidney S, Spring B, Lewis CE, Muntner P. Racial Differences in Maintaining Optimal Health Behaviors Into Middle Age. Am J Prev Med. 2019 Mar;56(3):368-375. doi: 10.1016/j.amepre.2018.10.020.
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citation: Pfammatter AF, Marchese SH, Pellegrini C, Daly E, Davidson M, Spring B. Using the Preparation Phase of the Multiphase Optimization Strategy to Develop a Messaging Component for Weight Loss: Formative and Pilot Research. JMIR Form Res. 2020 May 13;4(5):e16297. doi: 10.2196/16297.