Pro-Change Smoking Cessation Intervention

August 11, 2017 updated by: VAL Health, LLC

Software to Translate Behavioral Economics Insights to Improve Health (Phase 2b)

The purpose of this study is to determine whether a behavioral economics solution impacts smoking cessation program engagement and quit rates.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The behavioral economics solution is a weekly regret contest in which participants can win or miss out on money based on their behavior.

Study Type

Interventional

Enrollment (Actual)

422

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Old Greenwich, Connecticut, United States, 06870
        • VAL Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Be current tobacco users (specifically smokers)
  • Be 18 years old or over

Exclusion Criteria:

  • Pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Usual care with minimal incentives
Participants in this arm receive usual care from the Pro-Change smoking cessation program, and receive compensation for enrolling and completing a survey at the end of the study.
Other: Minimal incentives
Minimal financial incentives to promote engagement and outcomes in a smoking cessation intervention.
Active Comparator: Usual care with BE incentives
Participants in this arm receive usual care from the Pro-Change smoking cessation program, the chance to win money based on their behavior (behavioral economics incentives), and receive compensation for enrolling and completing a survey at the end of the study.
Behavioral: Behavioral economics incentives
Behavioral economics-informed incentives to promote engagement and outcomes in a smoking cessation intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Number of Completed Sessions Per Participant
Time Frame: Every 30 days for up to 6 months post-enrollment
Engagement rates for the intervention will be higher relative to the control arm. Engagement is measured by the number of complete tobacco cessation sessions per participant.
Every 30 days for up to 6 months post-enrollment
Outcome of Smoking Cessation Intervention
Time Frame: Every 30 days for up to 6 months post-enrollment
Quit levels for the intervention will be higher relative to the control arm. Quit level is defined as a participant who progresses to the stage in the tobacco cessation program where they quit smoking. The quit stages are levels 4 and 5 of the tobacco cessation program.
Every 30 days for up to 6 months post-enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VAL Health, LLC

Collaborators

National Institute on Aging (NIA)
Pro-Change Behavior Systems
Rhode Island Primary Care Physicians Corporation

Investigators

  • Principal Investigator: Karen Horgan, MBA, President
  • Study Director: Kevin Volpp, MD, PhD, Scientific Advisory Board
  • Study Director: David Asch, MD, Scientific Advisory Board

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

November 17, 2014

First Submitted That Met QC Criteria

November 19, 2014

First Posted (Estimate)

November 24, 2014

Study Record Updates

Last Update Posted (Actual)

October 2, 2017

Last Update Submitted That Met QC Criteria

August 11, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 5R44AG044872-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Individual participant data will not be made available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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