Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01814072 · ClinicalTrials.gov registry record · Phase 2
Opt-IN: Optimization of Remotely Delivered Intensive Lifestyle Treatment for Obesity
A Phase 2 study, sponsored by Northwestern University.
- Completed
- Registry status
- Phase 2
- Development phase
- 562
- Enrollment target
NCT01814072: Completed Phase 2 study, sponsored by Northwestern University.
NCT01814072 is a Phase 2 study that has completed, run by Northwestern University. The registered enrollment target is 562 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (323% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01814072, a Phase 2 study, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 562 participants
- Enrollment target
Study 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.
Primary Outcome
Estimated mean change from Baseline to Month 6 were obtained from a linear mixed models analysis of variance to account for missing data. All randomized participants were utilized in the model (ITT analysis).
Interventions
- BEHAVIORAL Text Messages
- BEHAVIORAL 12 Telephone Coaching Sessions
- BEHAVIORAL 24 Telephone Coaching Sessions
- BEHAVIORAL Report to Primary Care Physician
- BEHAVIORAL Recommendations to use meal replacements
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 562 participants |
| Start Date | 2013-09 |
| Est. Completion | 2017-09-20 |
| Phase | Phase 2 |
What the finished NCT01814072 record still lists
NCT01814072 is an interventional study that assigns participants to a tested intervention. The registered 562 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (323% higher).
The record links to 0 conditions, and to 5 interventions - of which Text Messages is the first listed.
NCT01814072 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01814072 about?
NCT01814072 is a clinical study titled "Opt-IN: Optimization of Remotely Delivered Intensive Lifestyle Treatment for Obesity". 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 hig...
What is the current status of trial NCT01814072?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 562 participants. The study started on 2013-09. Estimated completion is 2017-09-20.
What interventions are being tested in trial NCT01814072?
The interventions under investigation include: Text Messages (BEHAVIORAL), 12 Telephone Coaching Sessions (BEHAVIORAL), 24 Telephone Coaching Sessions (BEHAVIORAL), Report to Primary Care Physician (BEHAVIORAL), Recommendations to use meal replacements (BEHAVIORAL).
Who is sponsoring clinical trial NCT01814072?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01814072's enrollment target sits among peer trials
562 60th of 2000 higher than 1,941 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT07007065 · 561 participants · Phase 3
Study to Assess the Injection Burden, Adverse Events, Change in Disease Activity, and Long-Term Preservation of Visual Acuity of Surabgene Lomparvovec in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD)
- NCT06146725 · 564 participants
The RESBIOP-study: Resection Versus Biopsy in High-grade Glioma Patients (ENCRAM 2202)
- NCT06188520 · 564 participants · Phase 1
A First-in-human Dose Escalation and Expansion Study to Evaluate the Safety, and Tolerability of AZD8421 Alone or in Combination in Participants With Selected Advanced or Metastatic Solid Tumors
- NCT06628453 · 564 participants · NA
CGM for Management of Type 2 Diabetes in Pregnancy
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia