Recruiting
Phase 2

Observational Study

Sponsor:

Pro-Change Behavior Systems

Code:

NCT02755636

Conditions

Risk Behavior

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Accepted

Interventions

PCPHC

Usual care

Study Details

Brief summary:

Patients with co-occurring health risk behaviors suffer greater morbidity, disability, and premature death. The Pro-Change Population Health Solution (PCPHS) is a suite of mobile tools designed to assist patients and primary care providers (PCPs) in applying evidence-based principles of health behavior change to reduce four cancer risk behaviors-cigarette smoking, risky drinking, noncompliance with national guidelines for physical activity, and overweight and obesity-and depression among at-risk patients. The intervention is based on the Transtheoretical Model of Behavior Change (TTM, the "stage model") and includes computer-tailored interventions and text messages for patients and a clinical dashboard for providers. The efficacy of the intervention will be assessed in a cluster-randomized trial involving 780 patients recruited from 12 federally qualified health centers randomly assigned to intervention or usual care.

Conditions

Risk Behavior

Study ID

NCT02755636

Start date

May, 2016

Status verified date

May, 2016

Completion date

Jul, 2017

Anticipated

Primary completion date

Jul, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

Has at least one of the following behavioral risk factors for cancer:

1. Cigarette smoker
2. Exceeds recommended limits for alcohol intake
3. Does not meet national guidelines for physical activity
4. Overweight or obese

Exclusion Criteria:

1. Currently pregnant
2. Currently undergoing cancer treatment
3. Serious medical condition that could prevent participation in the study for a full year
4. History of mania, schizophrenia, or other psychoses
5. Admitted to an inpatient mental health facility within the previous 2 years
6. Currently enrolled in the In It to Quit Study at the Community Health Center, Inc.
7. Unable to read English or Spanish
8. Unable to receive text messages

Note: Risky drinkers who screen positive for alcohol dependence will not be eligible for the intervention's risky drinking program, which focuses on limiting drinking to national guidelines. Treatment and control participants who screen positive for alcohol dependence and who are not engaging in any of the other targeted cancer risk behaviors will screen out of the study.

Study Design

Enrollment

780 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: PCPHC intervention

PCPHC intervention during 6-month intervention period plus study assessments at baseline, 6, and 12 months

active comparator: Usual care

Usual primary care plus study assessments at baseline, 6, and 12 months

Interventions

PCPHC

Mobile-delivered health risk intervention (HRI), computer-tailored interventions (CTIs), text messages; provider-delivered one-on-one session guided by clinical dashboard

Usual care

Primary care as usual

Primary outcome measure

  • Change in number of cancer risk behaviors [ Time Frame: Baseline, 12 months ]

Central Contacts and Locations

Central contacts

Deborah A Levesque, Ph.D

401-360-2975dlevesque@prochange.com

Deborah Van Marter, M.P.H.

401-360-2981dvanmarter@prochange.com

Locations

Connecticut Health Center, Inc.

Recruiting

Middletown, Connecticut, United States, 06457

Contacts

Daren Anderson, MD

860-347-6971AndersD@chc1.com

Bridget Teevan, MPH

860-416-3088TeevanB@chc1.com

Pro-Change Behavior Systems, Inc.

Recruiting

South Kingstown, Rhode Island, United States, 02879

Contacts

Deborah A Levesque, Ph.D.

401-360-2975dlevesque@prochange.com

Deborah Van Marter, M.P.H.

401-360-2981dvanmarter@prochange.com

Principal Investigator:

Deborah A Levesque, Ph.D.

More Information

Sponsor

Pro-Change Behavior Systems

Last update posted

Jun 2, 2016

Last verified

May, 2016

Keywords

  • Health Behavior Change
  • Primary Health Care
  • Patient Participation
  • Provider-Patient Communication
  • Cluster-Randomized Trial
  • Mobile Health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Pro-Change Behavior Systems on 2016-06-02.