OBJECTIVE SMART-GDM examined whether Habits-GDM, a smartphone application (app) coaching program, can prevent excessive gestational weight gain (EGWG) and improve glycemic control and maternal and neonatal outcomes in gestational diabetes mellitus (GDM). RESEARCH DESIGN AND METHODS In this randomized controlled trial, women diagnosed with GDM between 12 and 30 weeks were randomly assigned to usual care (control) or to additional support from Habits-GDM that integrated dietary, physical activity, weight, and glucose monitoring (intervention). The primary outcome was the proportion of participants with EGWG. Secondary outcomes included absolute gestational weight gain (GWG), glycemic control, and maternal, delivery, and neonatal outcomes. RESULTS In total, 340 women were randomized (170 intervention, 170 control; mean ± SD age 32.0 ± 4.2 years; mean BMI 25.6 ± 5.6 kg/m 2 ). There were no statistically significant differences in the proportions of women with EGWG, absolute GWG, or maternal and delivery outcomes between experimental groups. Average glucose readings were lower in the intervention group (mean difference −0.15 mmol/L [95% CI −0.26; −0.03], P = 0.011) as were the proportions of glucose above targets (premeal: 17.9% vs. 23.3%, odds ratio 0.68 [95% CI 0.53; 0.87], P = 0.003; 2-h postmeal: 19.9% vs. 50%, 0.54 [0.42; 0.70], P < 0.001). When regarded as a composite (although not prespecified), the overall neonatal complications (including birth trauma, neonatal hypoglycemia, hyperbilirubinemia, respiratory distress, neonatal intensive care unit admission, and perinatal death) were significantly lower in the intervention group (38.1% vs. 53.7%, 0.53 [0.34; 0.84], P = 0.006). CONCLUSIONS When added to usual care, Habits-GDM resulted in better maternal glycemic control and composite neonatal outcomes (nonprespecified) but did not reduce EGWG among women with GDM.
Electronic-based (e-based) lifestyle interventions provide potential and cost-effective delivery of remote interventions for overweight and obese perinatal women. To date, no meta-analysis has reported the efficacy of maternal and neonatal outcomes. Seven electronic databases were searched from inception up to July 13, 2016, including the Cumulative Index to Nursing and Allied Health Literature, Cochrane Library, EMBASE, ProQuest Dissertations and Theses, PsycINFO, PubMed and Scopus. Among the 1,145 studies retrieved, 14 randomized controlled trials were selected among 17 publications. The Cochrane risk of bias tool was used to appraise the quality assessment. The meta-analyses demonstrated a significant result for limiting gestational weight gain, losing postnatal weight in 1-2 months, increasing self-reported moderate and vigorous physical activity and reducing caloric intake using diet-related software. Our review shows that an e-based lifestyle intervention is an acceptable approach. The findings reveal the variability in intervention methods and provide limited conclusive evidence. Thus, future studies should examine the efficacy and essential components as well as the various approaches using optimal portions of in-person and phone sessions. Further evaluations comparing the effectiveness of different e-based lifestyle intervention approaches toward activity-related and diet-related outcomes are necessary.
Background The prevalence of nonalcoholic fatty liver disease (NAFLD) reaches up to 30% in the Asian adult population, with a higher prevalence in obese patients. Weight reduction is typically recommended for patients at high risk or diagnosed with NAFLD, but is a challenge to achieve. Objective We aimed to evaluate the effect of a lifestyle intervention with a mobile app on weight loss in NAFLD patients. Methods This prospective randomized controlled trial included 108 adults with NAFLD confirmed by steatosis on ultrasound and a body mass index ≥23 kg/m2 who were recruited from a fatty liver outpatient clinic. The patients were randomly allocated to either a control group (n=53) receiving standard care, consisting of dietary and lifestyle advice by a trained nurse, or an intervention group (n=55) utilizing the Nutritionist Buddy (nBuddy) mobile app in addition to receiving dietary and lifestyle advice by a dietitian. Body weight, alanine aminotransferase (ALT), aspartate aminotransferase (AST), waist circumference, and blood pressure were measured at baseline, and then at 3 and 6 months. Intention-to-treat and per-protocol analyses were used for statistical comparisons. Results The intervention group had a 5-fold higher likelihood (relative risk 5.2, P=.003, 95% CI 1.8-15.4) of achieving ≥5% weight loss compared to the control group at 6 months. The intervention group also showed greater reductions in weight (mean 3.2, SD 4.1 kg vs mean 0.5, SD 2.9 kg; P<.001), waist circumference (mean 2.9, SD 5.0 cm vs mean –0.7, SD 4.4 cm; P<.001), systolic blood pressure (mean 12.4, SD 14.8 mmHg vs mean 2.4, SD 12.4 mmHg; P=.003), diastolic blood pressure (mean 6.8, SD 8.9 mmHg vs mean –0.9, SD 10.0 mmHg; P=.001), ALT (mean 33.5, SD 40.4 IU/L vs mean 11.5, SD 35.2 IU/L; P=.004), and AST (mean 17.4, SD 27.5 U/L vs mean 7.4, SD 17.6 IU/L, P=.03) at 6 months. Conclusions Lifestyle intervention enabled by a mobile app can be effective in improving anthropometric indices and liver enzymes in patients with NAFLD. This treatment modality has the potential to be extended to a larger population scale. Trial Registration Australian New Zealand Clinical Trials Registry ACTRN12617001001381; https://tinyurl.com/w9xnfmp
IMPORTANCE Lifestyle interventions are effective in diabetes management, with smartphone apps that manage health data and dietary and exercise schedules gaining popularity. However, limited evidence from randomized clinical trials exists regarding the effectiveness of smartphone-based interventions among Asian adults with type 2 diabetes. OBJECTIVE To compare the effects of a culturally contextualized smartphone-based intervention with usual care on weight and metabolic outcomes. DESIGN, SETTING, AND PARTICIPANTS This randomized clinical trial conducted at multiple primary care centers in Singapore included 305 adults with type 2 diabetes and body mass index (BMI) of 23 or greater who had literacy in English and smartphone access. Participants were recruited between October 3, 2017, and September 9, 2019, and were randomly assigned (1:1; stratified by gender, age, and BMI) to intervention (99 participants) or control (105 participants) groups. Participants' data were analyzed using intention-to-treat analysis. INTERVENTIONS Both control and intervention participants received diet and physical activity advice from a dietitian at a baseline face-to-face visit. Intervention participants additionally used a smartphone app to track weight, diet, physical activity, and blood glucose and then communicated with dietitians for 6 months. MAIN OUTCOMES AND MEASURES Primary outcome was change in body weight, while secondary outcomes were changes in hemoglobin A 1c (HbA 1c ), fasting blood glucose, blood pressure, lipids, and diet. Post hoc analyses included glycemic changes in the subgroup with HbA 1c levels of 8% or greater and diabetes medication changes. RESULTS Among the 204 randomized participants (mean [SD] age, 51.2 [9.7] years; 132 [64.7%] men), baseline mean (SD) BMI was 30.6 (4.3). Compared with the control group, intervention participants achieved significantly greater reductions in weight (mean [SD] change, −3.6 [4.7] kg vs −1.2 [3.6] kg) and HbA 1c levels (mean [SD] change, −0.7% [1.2] vs −0.3% [1.0]), with a greater proportion having a reduction in diabetes medications (17 participants [23.3%] vs 4 participants [5.4%]) at 6 months. The intervention led to a greater HbA 1c reduction among participants withHbA 1c levels of 8% or higher (mean [SD] change, −1.8% [1.4] vs −1.0% [1.4]; P = .001). Intergroup differences favoring the intervention were also noted for fasting blood glucose, diastolic blood pressure, and dietary changes. (continued) Key Points Question What is the effect of a culturally contextualized smartphonebased lifestyle intervention on weight change and metabolic outcomes in Asian adults who have overweight or obesity and type 2 diabetes compared with usual care? Findings In this randomized clinical trial of 204 adults with type 2 diabetes, the use of a smartphone app tracking personal health data and using integrated behavioral modification strategies led to significantly greater reductions in weight and hemoglobin A 1c , along with a significantly greater proportion of patients with a reduction i...
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