Pro-Change Population Health Solution

Status unconfirmed · Phase 2

Conditions studied: Risk Behavior

In brief

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.

Key facts

Study ID

NCT02755636

Run by

Pro-Change Behavior Systems

People needed

780

Starts

2016-05-01

Expected to finish

2017-07-01

Last updated by the study team

2016-06-02

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Has at least one of the following behavioral risk factors for cancer:
• Cigarette smoker
• Exceeds recommended limits for alcohol intake
• Does not meet national guidelines for physical activity
• Overweight or obese

You may not qualify if…

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

Where it is running

• Connecticut Health Center, Inc. — Middletown, Connecticut, United States (enrolling)
• Pro-Change Behavior Systems, Inc. — South Kingstown, Rhode Island, United States (enrolling)

Full record on ClinicalTrials.gov

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