Development of a Mobile Phone-Based Weight Loss Lifestyle Intervention for Filipino Americans with Type 2 Diabetes: Protocol and Early Results From the PilAm Go4Health Randomized Controlled Trial

摘要

Background Filipino Americans are the second largest Asian subgroup in the United States, and were found to have the highest prevalence of obesity and type 2 diabetes (T2D) compared to all Asian subgroups and non-Hispanic whites. In addition to genetic factors, risk factors for Filipinos that contribute to this health disparity include high sedentary rates and high fat diets. However, Filipinos are seriously underrepresented in preventive health research. Research is needed to identify effective interventions to reduce Filipino diabetes risks, subsequent comorbidities, and premature death. Objective The overall goal of this project is to assess the feasibility and potential efficacy of the Filipino Americans Go4Health Weight Loss Program (PilAm Go4Health). This program is a culturally adapted weight loss lifestyle intervention, using digital technology for Filipinos with T2D, to reduce their risk for metabolic syndrome. Methods This study was a 3-month mobile phone-based pilot randomized controlled trial (RCT) weight loss intervention with a wait list active control, followed by a 3-month maintenance phase design for 45 overweight Filipinos with T2D. Participants were randomized to an intervention group (n=22) or active control group (n=23), and analyses of the results are underway. The primary outcome will be percent weight change of the participants, and secondary outcomes will include changes in waist circumference, fasting plasma glucose, glycated hemoglobin A1c, physical activity, fat intake, and sugar-sweetened beverage intake. Data analyses will include descriptive statistics to describe sample characteristics and a feasibility assessment based on recruitment, adherence, and retention. Chi-square, Fisher's exact tests, t-tests, and nonparametric rank tests will be used to assess characteristics of randomized groups. Primary analyses will use analysis of covariance and linear mixed models to compare primary and secondary outcomes at 3 months, compared by arm and controlled for baseline levels. Results Recruitment was completed in January, 2016, and participant follow-up continued through June, 2016. At baseline, mean age was 57 years, 100% (45/45) of participants self-identified as Filipinos, and the cohort was comprised of 17 males and 28 females. Overall, participants were obese with a baseline mean body mass index of 30.2 kg/m2 (standard deviation 4.9). The majority of participants were immigrants (84%, 38/45), with 47% (21/45) living in the United States for more than 10 years. One third of all participants (33%, 15/45) had previously used a pedometer. Conclusions This study will provide preliminary evidence to determine if the PilAm Go4Health weight loss lifestyle intervention is feasible, and if the program demonstrates potential efficacy to reduce risks for metabolic syndrome in Filipinos with T2D. Positive results will lend support for a larger RCT to evaluate the effectiveness of the PilAm Go4Health intervention for Filipinos. ClinicalTrial ClinicalTrials.gov: {"type":"clinical-trial","attrs":{"text":"NCT02290184","term_id":"NCT02290184"}} NCT02290184 ; https://clinicaltrials.gov/ct2/show/ {"type":"clinical-trial","attrs":{"text":"NCT02290184","term_id":"NCT02290184"}} NCT02290184 (Archived at http://www.webcitation.org/6k1kUqKSP).