Development and Efficacy of an Electronic, Culturally Adapted Lifestyle Counseling Tool for Improving Diabetes-Related Dietary Knowledge: Randomized Controlled Trial Among Ethnic Minority Adults With Type 2 Diabetes Mellitus.

BACKGROUND: Ethnic minority populations exhibit disproportionately high rates of type 2 diabetes mellitus (T2DM). Electronic health tools have the potential to facilitate the cultural adaptation and tailoring of T2DM education to improve the knowledge and management of diabetes mellitus (DM). OBJECTIVE: This study aimed (1) to develop an adaptable Interactive Lifestyle Assessment, Counseling, and Education (I-ACE) software to support dietitian-delivered lifestyle counseling among low-socioeconomic status (SES) ethnic minority patients with T2DM and (2) to evaluate its effect on DM-related dietary knowledge and management compared with standard lifestyle advice (SLA) in a randomized controlled trial (RCT). METHODS: The I-ACE software, developed in consultation with clinical dieticians, incorporates evidence-based dietary and physical activity (PA) recommendations and educational materials. The features and behavioral change techniques include quantitative lifestyle (dietary intake and PA) assessment and simulation, individually tailored education and recommendations, motivational interviewing, and goal setting. For the unblinded pilot RCT, 50 overweight or obese Arab adults (aged 40-62 years) with poorly controlled T2DM were recruited from primary care clinics and randomly assigned to receive 4 in-person, dietician-delivered counseling sessions over 6 months using either (1) the I-ACE tool (experimental arm) or (2) the SLA methods (comparison arm). All outcome assessments were face-to-face. DM-related dietary knowledge (primary outcome) was measured at baseline, 3, 6, and 12 months. Lifestyle and other parameters were measured before, during, and after the intervention. Multiple linear regression and repeated measures linear mixed models were used to compare the changes in study outcomes and explore time trends in between-group and within-group changes. RESULTS: A total of 25 participants were enrolled in each arm, of whom 24 and 21 completed the final assessment of the primary outcome in the I-ACE and SLA arms, respectively. DM-related lifestyle knowledge increased more rapidly in the I-ACE arm than in the SLA arm (P value for study arm×time interaction=.02). Within the I-ACE arm, the mean (SE) differences in added sugar and dietary fiber intakes from baseline to 12 months were -2.6% (SE 1.0%) of total energy (P=.03) and 2.7 (SE 0.0) g/1000 kcal (P=.003), respectively. The odds of engaging in any leisure PA at 12 months tended to be higher in the I-ACE arm versus SLA arm, but did not reach statistical significance (odds ratio 2.8; 95% CI 0.7-11.6; P=.16). Both arms exhibited significant reductions in HbA1c (P value for change over time <.001). CONCLUSIONS: The use of the I-ACE software in a 6-month, 4-session dietician-delivered lifestyle counseling intervention improved the efficiency of lifestyle education, compared with SLA, among low-SES, ethnic minority patients with T2DM. This pilot trial provides justification for conducting a large-scale trial to evaluate its effectiveness and applicability in routine clinical care among ethnically diverse populations. TRIAL REGISTRATION: ClinicalTrials.gov NCT01858506; https://clinicaltrials.gov/ct2/show/NCT01858506.

Lifestyle intervention in obese Arab women: a randomized controlled trial.

BACKGROUND: Few randomized controlled trials on lifestyle interventions have been reported in non-Western populations; none have been reported in Arab populations. METHODS: From 2 Muslim Arab communities in Israel, obese, nondiabetic women aged 35 to 54 years with 1 or more components of the metabolic syndrome were randomized to either an intensive (n = 100) or a moderate (control) (n = 101) 12-month lifestyle intervention. Women in the intensive intervention had 11 individual and 11 group counseling sessions per year with a dietitian and 22 physical activity group sessions per year. Women in the moderate intervention had 3 individual and 2 group dietary counseling sessions per year and no guided physical activity. Cultural issues were addressed in the design and conduct of both interventions. The primary outcome measure was change in the metabolic syndrome and its components. RESULTS: At 12 months, the intensive intervention group had median declines of 3.0 mg/dL (to convert to millimoles per liter, multiply by 0.0555) in fasting plasma glucose and 4.5 mg/dL (to convert to millimoles per liter, multiply by 0.0113) in triglyceride levels compared with median increases of 1 mg/dL in fasting plasma glucose and 5.8 mg/dL in triglyceride levels in the moderate intervention group (P = .01 and P = .02, respectively). The median waist circumference decreased by 5.4 cm in the intensive intervention group and by 3.1 cm in the moderate intervention group (P = .10). The prevalence of the metabolic syndrome decreased by 4.0% in the intensive intervention group and increased by 5.2% in the moderate intervention group (P = .12). CONCLUSION: The 12-month culturally sensitive intensive lifestyle intervention was effective in improving some of the metabolic syndrome components in obese Arab women. Trial Registration clinicaltrials.gov Identifier: NCT00273572.