A randomized comparative effectiveness study of Healthy Directions 2--a multiple risk behavior intervention for primary care

Abstract

Objective: To evaluate the effectiveness of the Healthy Directions 2 (HD2) intervention in the primary care setting.

Methods: HD2 was a cluster randomized trial (conducted 3/09-11/11). The primary sampling unit was provider (n=33), with secondary sampling of patients within provider (n=2440). Study arms included: 1) usual care (UC); 2) HD2--a patient self-guided intervention targeting 5 risk behaviors; and 3) HD2 plus 2 brief telephone coaching calls (HD2+CC). The outcome measure was the proportion of participants with a lower multiple risk behavior (MRB) score by follow-up.

Results: At baseline, only 4% of the participants met all behavioral recommendations. Both HD2 and HD2+CC led to improvements in MRB score, relative to UC, with no differences between the two HD2 conditions. Twenty-eight percent of the UC participants had improved MRB scores at 6 months, vs. 39% and 43% in HD2 and HD2+CC, respectively (ps≤.001); results were similar at 18 months (p≤.05). The incremental cost of one risk factor reduction in MRB score was $310 for HD2 and $450 for HD2+CC.

Conclusions: Self-guided and coached intervention conditions had equivalent levels of effect in reducing multiple chronic disease risk factors, were relatively low cost, and thus are potentially useful for routine implementation in similar health settings.

Trial registration: ClinicalTrials.gov NCT01415492.

Keywords: Cancer prevention; Multimorbidities; Physical activity; Primary care intervention; Red meat; Smoking cessation.

Conflict of interest statement

Conflict of Interest: None of the authors have conflict of interest to report.

Copyright © 2014 Elsevier Inc. All rights reserved.

Figures

Figure 1

Healthy Directions 2 Study Design—CONSORT Figure

Figure 2

Change in Multiple Risk Behavior Score by Intervention Condition at end of Intervention (6 mos.) and at 18 mos. Post-Baseline, Controlling for Baseline