Randomised Controlled Trial of a Customised Text Messaging and Activity Monitor Program for Lifestyle Improvement after Gestational Diabetes.

Gestational diabetes (GDM) is associated with a long-term risk of diabetes. We aimed to determine whether a text-messaging-based lifestyle support program would improve diabetes risk factors following GDM. Women with GDM were randomised following delivery to receive four text messages per week supporting a healthy lifestyle and parenting for 6 months, with feedback from an activity monitor (intervention), or to receive the activity monitor only (control). The primary outcome was a composite of weight, physical activity and dietary goals. There were 177 women randomised, with 88 intervention and 89 control participants. All the participants experienced COVID-19 lockdowns during the study. Six-month primary outcome data were obtained for 57 intervention participants and 56 controls. There were 7/57 (12%) intervention and 6/56 (11%) control participants who met the primary outcome (relative risk, 1.08; 95%CI, 0.63-1.85; p = 0.79). Two intervention participants met the dietary goals compared to none of the control participants (p = NS). The intervention participants were more likely to record >1000 steps/day (on 102 ± 59 vs. 81 ± 59 days, p = 0.03). When analysed monthly, this was not initially different but became significant 3-6 months post-partum. Interviews and surveys indicated that with the Intervention, healthier choices were made, but these were negatively impacted by COVID-19 restrictions. Participants found the messages motivational (74%) and the activity monitor useful (71%). In conclusion, no improvement in the diabetes risk factors occurred among the women receiving the text messaging intervention when affected by COVID-19 restrictions.

Effectiveness of a customised mobile phone text messaging intervention supported by data from activity monitors for improving lifestyle factors related to the risk of type 2 diabetes among women after gestational diabetes: protocol for a multicentre randomised controlled trial (SMART MUMS with smart phones 2).

INTRODUCTION: Gestational diabetes (GDM) contributes substantially to the population burden of type 2 diabetes (T2DM), with a high long-term risk of developing T2DM. This study will assess whether a structured lifestyle modification programme for women immediately after a GDM pregnancy, delivered via customised text messages and further individualised using data from activity monitors, improves T2DM risk factors, namely weight, physical activity (PA) and diet. METHODS AND ANALYSIS: This multicentre randomised controlled trial will recruit 180 women with GDM attending Westmead, Campbelltown or Blacktown hospital services in Western Sydney. They will be randomised (1:1) on delivery to usual care with activity monitor (active control) or usual care plus activity monitor and customised education, motivation and support delivered via text messaging (intervention). The intervention will be customised based on breastfeeding status, and messages including their step count achievements to encourage PA. Messages on PA and healthy eating will encourage good lifestyle habits. The primary outcome of the study is healthy lifestyle composed of weight, dietary and PA outcomes, to be evaluated at 6 months. The secondary objectives include the primary objective components, body mass index, breastfeeding duration and frequency, postnatal depression, utilisation of the activity monitor, adherence to obtaining an oral glucose tolerance test post partum and the incidence of dysglycaemia at 12 months. Relative risks and their 95% CIs will be presented for the primary objective and the appropriate regression analysis, adjusting for the baseline outcome results, will be done for each outcome. ETHICS AND DISSEMINATION: Ethics approval has been received from the Western Sydney Local Health District Human Research Ethics Committee (2019/ETH13240). All patients will provide written informed consent. Study results will be disseminated via the usual channels including peer-reviewed publications and presentations at national and international conferences. TRIAL REGISTRATION NUMBER: ACTRN12620000615987; Pre-results.

Evaluation of Methylphenidate Safety and Maximum-Dose Titration Rationale in Attention-Deficit/Hyperactivity Disorder: A Meta-analysis.

Importance: Evidence on the titration of stimulant medications for attention-deficit/hyperactivity disorder (ADHD) is lacking. However, this lack of evidence has not prevented medication guidelines from specifying apparently arbitrary dose limitations, which could discourage clinicians from titrating methylphenidate to higher and, perhaps for some patients, more efficacious doses. Objective: To determine the evidence on dose titration and adverse events associated with dose titration of stimulants for ADHD. Data Sources: MEDLINE from 1946, Embase from 1974, and PsycINFO from 1806 through April 1, 2019, were searched to identify relevant articles. Study Selection: The inclusion criteria were that (1) the study was conducted on children up to 18 years of age; (2) children had a diagnosis of ADHD according to the Diagnostic and Statistical Manual of Mental Disorders, or hyperkinetic disorder according to the International Classification of Diseases codes; and (3) the dose of methylphenidate was determined by titration. Data Extraction and Synthesis: The PRISMA guidelines for abstracting data and assessing data quality and validity were followed. Quality assessment was undertaken using the Jadad scoring system. Statistical analysis was undertaken using a random-effects model. Main Outcomes and Measures: The outcomes of interest were (1) the doses used in published clinical trials, (2) the clinical justification given by researchers for their selected dose range, and (3) the adverse effects associated with methylphenidate when the dose is established by titration. Results: A total of 11 randomized clinical trials and 38 cohort studies were analyzed. The randomized clinical trials involved 1304 participants treated with methylphenidate and 887 controls; the 38 cohort studies included 5524 participants. Maximum doses of methylphenidate ranged from 0.8 to 1.8 mg/kg/d. Some studies detailed their method of titration, including starting dose, titration interval, increment dose, and maximum dose. Not all of these studies reported justification for the chosen dose range. Common adverse effects of methylphenidate included insomnia (odds ratio, 4.66; 95% CI, 1.99-10.92; P < .001), anorexia (5.11 higher than for those who took placebo; 95% CI, 1.99-13.14; P < .001), abdominal pain (1.9 times more likely; 95% CI, 0.77-4.77; P = .16), and headache (14% of participants; 95% CI, 10%-20%; P < .001). Conclusions and Relevance: A range of maximum doses for methylphenidate was recommended in clinical studies; no discernable scientific justification for any particular dose was given. Reports of life-threatening adverse events were absent; further studies of the efficacy, tolerability, and safety of methylphenidate titrated purely on clinical grounds, without reference to any set maximum dose, are needed.