Feasibility and preliminary efficacy of a 12-week primary care-based behavioral counseling intervention among adults with cardiovascular disease risk factors.

Physical activity (PA) and dietary counseling are recommended for adults with cardiovascular disease (CVD) risk factors. However, these programs are seldom implemented in primary care. This study evaluated the feasibility and preliminary efficacy of a 12-week primary care-based behavioral counseling intervention (BCI) for adults with CVD risk factors. Participants were primarily recruited through a novel clinical screening and referral workflow implemented in six local Family Medicine clinics to participate in a single-arm, pre-post study. Participants received a 12-week, theory-based (Multi-Process Action Control), remotely-delivered BCI that included health education, health coaching, and a wearable activity and sleep monitor. Changes in psychosocial mechanisms of action (e.g., habits, identity), behavioral outcomes (PA, diet, sleep), and health outcomes (cardiometabolic and self-reported) were assessed with paired t-tests, and Cohen's d effect sizes were calculated. The relationships between baseline behaviors and observed changes in behaviors from pre-post intervention were tested with simple linear regression. Ninety-seven participants (mean age = 50.6 years, 64% women) completed the BCI. Moderate-large improvements were observed for behavioral regulation skills, health habits, and health identity psychosocial mechanisms of action (d = 0.75-1.03). Muscle-strengthening exercises, daily kilocalories, whole fruit and total protein intake, and several sleep parameters improved to a small-moderate degree (d = 0.23-0.64). Small-moderate improvements in diastolic blood pressure, body weight, total fat mass, depressive symptoms, fatigue, general health, and quality of life were also observed (d = 0.25-0.53). While no significant overall changes in device-based PA were observed, participants not meeting aerobic PA guidelines at baseline showed small-moderate improvements in daily steps and moderate-vigorous PA (d = 0.25-0.53). Participants with lower baseline steps and dietary quality showed greater improvements in these behaviors (r = - 0.54 and - 0.49, respectively), though regression to the mean may also explain these findings. Retention (85%) and adherence (e.g., 98% coaching attendance) were high. Results support the feasibility and preliminary efficacy of a 12-week, remotely-delivered BCI-mediated through primary care-to change targeted psychosocial mechanisms of action, and specific health behaviors and outcomes. Importantly, participants with less favorable behaviors at baseline benefited most. A randomized controlled trial is warranted to confirm these findings.