CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 562 enrolled
Drug / intervention
12 Telephone Coaching Sessions +5 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01814072
NCT01814072Phase 3Completed

Opt-IN: Optimization of Remotely Delivered Intensive Lifestyle Treatment for Obesity

Northwestern University·interventional·Posted Mar 19, 2013·Updated Feb 1, 2023

In Brief

A Phase 3 clinical trial evaluating 12 Telephone Coaching Sessions, 24 Telephone Coaching Sessions, and 4 other interventions for Weight Loss. Completed, enrolled 562 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsWeight Loss
CountriesUnited States

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 19, 2013
Enrollment StartSep 1, 2013
Primary CompletionSep 20, 2017
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 13.3 years ago

Interventions

12 Telephone Coaching Sessionsbehavioral

Participants will receive 12 telephone coaching sessions

24 Telephone Coaching Sessionsbehavioral

Participants will receive 24 telephone coaching sessions

Report to Primary Care Physicianbehavioral

Participants will have a report detailing their weight loss progress sent to their primary care physician

Text Messagesbehavioral

Participants will receive regular text messages

Recommendations to use meal replacementsbehavioral

Participants will receive recommendations from their coach to use meal replacements

Buddy Trainingbehavioral

Participants will have a buddy that will be trained via webinars to be a supportive buddy