Use of a Smartphone-Based Mobile App for Weight Management in Obese Minority Stroke Survivors: Pilot Randomized Controlled Trial With Open Blinded End Point

Abstract

Journal of Medical Internet Research - International Scientific Journal for Medical Research, Information and Communication on the Internet #Preprint #PeerReviewMe: Warning: This is a unreviewed preprint. Readers are warned that the document has not been peer-reviewed by expert/patient reviewers or an academic editor, may contain misleading claims, and is likely to undergo changes before final publication, if accepted, or may have been rejected/withdrawn. Readers with interest and expertise are encouraged to sign up as peer-reviewer, if the paper is within an open peer-review period. Please cite this preprint only for review purposes or for grant applications and CVs (if you are the author). Background: Minorities have an increased incidence of obesity-related cerebrovascular disease. Unfortunately, effective weight management in this vulnerable population has significant barriers. Objective: Determine feasibility and preliminary treatment effects of using a SmartPhone based weight loss intervention versus food journals to monitor dietary patterns in minority acute stroke patients (Swipe out Stroke). Methods: Swipe out Stroke is a pilot Prospective Randomized Controlled Trial with Open Blinded Endpoint (PROBE) study. After written informed consent was obtained, both patients and their caregivers were screened for vascular risk factors using cluster enrollment at a Joint Commission Comprehensive Stroke Center in Houston Texas. Adaptive randomization was used for assignment to one of two groups – 1) behavior intervention with SmartPhone based self-monitoring, 2) behavior intervention with food journal self-monitoring. Caregivers joined the group of the study participant. The SmartPhone group received daily reminder messages during the first 30 days, reminder messages on missed days plus weekly summaries between 31 and 90 days, and weekly summaries only between 91 and 180 days. Both the SmartPhone and food journal groups received four face-to-face visits (baseline, 30 days, 90 days, 180 days), culturally competent counseling by a health care provider of their racial group, cookbooks, measuring cups and educational materials. The SmartPhone group used the app Lose it! to record meals, physical activity and to communicate with the study team. The food journal group used paper diaries. The primary outcome was a reduction in total body weight over a 180 day period. Results: Thirty-six stroke patients (64% African-American, 36% Hispanic) were enrolled, 17 in the SmartPhone group, 19 in the food journal group. Mean age 54 (SD 9) years, BMI 35.7 (SD 5.7) education, employment status and family history of stroke or obesity did not differ between the groups. Baseline rates of depression [median Patient Health Questionnaire-9 (PHQ-9) 5.5; IQR 3.0 – 9.5), cognitive impairment [median Montreal Cognitive Assessment (MOCA) 23.5; IQR 21 – 26] and inability to ambulate (13% with mRS of 3) were similar. Sixty-nine percent of stroke survivors completed Swipe out Stroke (n=25, 13/17 in the SmartPhone group, 12/19 in the food journal group); one participant died in the SmartPhone group. The median weight change at 180 days was 5.7 pounds (IQR -2.4 to 8.0) in the SmartPhone group versus 6.4 pounds in the food journal group (IQR -2.2 to 12.5; P=0.77). Depression was significantly lower at 30 days in the SmartPhone group compared to the food journal group (PHQ-9 of 2 vs 8; P=0.03). Clinically relevant depression rates remained in the “zero to minimal” range for the SmartPhone group compared to “mild to moderate” range in the food journal group at Day 90 (PHQ-9 of 3.5 vs 4.5; P=0.39) and Day 180 (PHQ-9 of 3 vs 6; P=0.12). In patients with depression, the median weight change at 180 days was 3.9 pounds (IQR -10.1 to 14) compared to 6.4 pounds in stroke survivors without depression (IQR -2.4 to 15; P=0.49). Conclusions: In our patient population of obese minority stroke survivors with cognitive impairments, the use of a SmartPhone did not lead to a significant reduction in weight loss compared to a food journal. The presence of baseline depression (53%) was a confounding variable, which improved with SmartPhone engagement. Future studies that include treatment of post-stroke depression may positively influence intervention efficacy. Clinical Trial: NCT02531074