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

NCT01814072 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 562

Last updated 2023-02-01

Study results available
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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.

Conditions

Interventions

BEHAVIORAL

12 Telephone Coaching Sessions

Participants will receive 12 telephone coaching sessions

BEHAVIORAL

24 Telephone Coaching Sessions

Participants will receive 24 telephone coaching sessions

BEHAVIORAL

Report to Primary Care Physician

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

BEHAVIORAL

Text Messages

Participants will receive regular text messages

BEHAVIORAL

Recommendations to use meal replacements

Participants will receive recommendations from their coach to use meal replacements

BEHAVIORAL

Buddy Training

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

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH
  • Penn State University

    collaborator OTHER
  • Northwestern University

    lead OTHER

Principal Investigators

  • Bonnie Spring, PhD · Northwestern University

  • Linda Collins, PhD · Penn State University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2017-09-20
Completion
2017-09-20

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01814072 on ClinicalTrials.gov