ABSTRACT
BACKGROUND: Walking therapy improves functional outcomes in patients with peripheral artery disease (PAD). Less is known about the additive benefit of a dietary intervention. OBJECTIVE: Our objectives were to develop a smartphone app and, as a pilot, explore its potential efficacy as compared to motivational interviewing (MI) to increase walking distance and promote weight loss in overweight/obese adults with PAD. METHODS: We conducted a 3-month, 2-arm randomized pilot study at the University of Kansas. Inclusion criteria were BMI >27 kg/m2 and symptomatic PAD, defined by an ankle-brachial index <0.9. Patients were randomized into 2 groups: MI, delivered through in-person and telephone counseling, and app, a mobile smartphone app. Both interventions encouraged walking for exercise and healthy dietary habits (increasing fruits and vegetables and whole grains while reducing fat and sugary drinks). We assessed medical history at baseline. At baseline and 3 months, participants completed an assessment of 6-minute walking distance, weight, quality of life, exercise behaviors, and dietary habits. The primary outcome was 3-month change in walking distance. Secondary outcomes were changes in weight, quality of life, exercise behaviors, and dietary habits. We used a Wilcoxon rank-sum test to analyze the primary and secondary outcomes at 3 months within the MI and app groups and to compare the changes between the groups with adjustment for baseline. RESULTS: We randomized 29 participants with a mean age of 66.03 (SD 8.12) years; 25 participants completed the trial. At baseline, mean walking distance among completers was 260.40 (SD 94.32) meters and 326.15 (SD 69.28) meters for MI and app participants, respectively. At 3 months, the mean walking distance was 298.67 (SD 101.20) meters and 331.19 (SD 58.63) meters for MI and app participants, respectively (group difference P=.03, adjusting for baseline). Increase in walking distance at 3 months was 40.5 meters (95% CI 6.77 to 61.34; P=.02) in MI group. At baseline, mean body weight was 253.10 (SD 59.45) lbs and 225.13 (SD 58.93) lbs for MI and app participants, respectively. At 3 months, mean body weight was 242.14 (SD 58.54) lbs and 223.44 (SD 59.54) lbs for MI and app, respectively (group difference P=.006, adjusting for baseline). Pre-post study decrease in weight was 10.1 lbs (95% CI -17.9 to -3.0) and 2.3 lbs (95% CI -3.4 to -0.7) in MI and app group, respectively. Comparing baseline to 3 months, there were no statistically significant differences in quality of life, exercise behaviors, or dietary habits. CONCLUSIONS: Our study demonstrates that MI can promote walking and weight loss in overweight/obese adults with PAD. The smartphone app showed a small weight loss but no statistically significant increase in walking distance. As this was a pilot study, future large-scale studies are needed to replicate the efficacy of MI to promote weight loss in overweight or obese adults with PAD. TRIAL REGISTRATION: ClinicalTrials.gov NCT03694652; https://clinicaltrials.gov/ct2/show/NCT03694652.
