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Background: Mental health problems are common among people with diabetes. However, evidence-based strategies for the prevention and early intervention of emotional problems in people with diabetes are lacking. Our aim is to assess the real-world effectiveness, cost-effectiveness, and implementation of a Low-Intensity mental health Support via a Telehealth Enabled Network (LISTEN), facilitated by diabetes health professionals (HPs). Methods: A hybrid type I effectiveness-implementation trial, including a two-arm parallel randomised controlled trial, alongside mixed methods process evaluation. Recruited primarily via the National Diabetes Services Scheme, Australian adults with diabetes (N = 454) will be eligible if they are experiencing elevated diabetes distress. Participants are randomised (1:1 ratio) to LISTEN—a brief, low-intensity mental health support program based on a problem-solving therapy framework and delivered via telehealth (intervention) or usual care (web-based resources about diabetes and emotional health). Data are collected via online assessments at baseline (T0), 8 weeks (T1) and 6 months (T2, primary endpoint) follow-up. The primary outcome is between-group differences in diabetes distress at T2. Secondary outcomes include the immediate (T1) and longer-term (T2) effect of the intervention on psychological distress, general emotional well-being, and coping self-efficacy. A within-trial economic evaluation will be conducted. Implementation outcomes will be assessed using mixed methods, according to the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. Data collection will include qualitative interviews and field notes. Discussion: It is anticipated that LISTEN will reduce diabetes distress among adults with diabetes. The pragmatic trial results will determine whether LISTEN is effective, cost-effective, and should be implemented at scale. Qualitative findings will be used to refine the intervention and implementation strategies as required. Trial registration: This trial has been registered with the Australian New Zealand Clinical Trials Registry (ACTRN: ACTRN12622000168752) on 1 February, 2022. [ABSTRACT FROM AUTHOR]

Background: Obesity in pregnancy is a growing problem worldwide, with excessive gestational weight gain (GWG) occurring in the majority of pregnancies. This significantly increases risks to both mother and child. A major contributor to both prepregnancy obesity and excessive GWG is physical inactivity; however, past interventions targeting maternal weight gain and activity levels during the antenatal period have been ineffective in women who are already overweight. Pedometer-guided activity may offer a novel solution for increasing activity levels in this population., Objective: This initial feasibility randomized controlled trial aimed to test a pedometer-based intervention to increase activity and reduce excessive GWG in pregnant women., Methods: We supplied 30 pregnant women with obesity a Fitbit Zip pedometer and randomized them into 1 of 3 groups: control (pedometer only), app (pedometer synced to patients' personal smartphone, with self-monitoring of activity), or app-coach (addition of a health coach-delivered behavioral change program). Feasibility outcomes included participant compliance with wearing pedometers (days with missing pedometer data), data syncing, and data integrity. Activity outcomes (step counts and active minutes) were analyzed using linear mixed models and generalized estimating equations., Results: A total of 30 participants were recruited within a 10-week period, with a dropout rate of 10% (3/30; 2 withdrawals and 1 stillbirth); 27 participants thus completed the study. Mean BMI in all groups was ≥35 kg/m 2 . Mean (SD) percentage of missing data days were 23.4% (20.6%), 39.5% (32.4%), and 21.1% (16.0%) in control, app group, and app-coach group patients, respectively. Estimated mean baseline activity levels were 14.5 active min/day and 5455 steps/day, with no significant differences found in activity levels between groups, with mean daily step counts in all groups remaining in the sedentary (5000 steps/day) or low activity (5000-7499 steps/day) categories for the entire study duration. There was a mean decrease of 7.8 steps/day for each increase in gestation day over the study period (95% CI 2.91 to 12.69, P=.002)., Conclusions: Activity data syncing with a personal smartphone is feasible in a cohort of pregnant women with obesity. However, our results do not support a future definitive study in its present form. Recruitment and retention rates were adequate, as was activity data syncing to participants' smartphones. A follow-up interventional trial seeking to reduce GWG and improve activity in this population must focus on improving compliance with activity data recording and behavioral interventions delivered., Trial Registration: Australian and New Zealand Clinical Trials Registry ACTRN12617000038392; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370884., (©Jai N Darvall, Andrew Wang, Mohamed Nusry Nazeem, Cheryce L Harrison, Lauren Clarke, Chennelle Mendoza, Anna Parker, Benjamin Harrap, Glyn Teale, David Story, Elizabeth Hessian. Originally published in JMIR mHealth and uHealth (http://mhealth.jmir.org), 26.05.2020.)