A holistic lifestyle mobile health intervention for the prevention of type 2 diabetes and common mental disorders in Asian women with a history of gestational diabetes: a randomised control trial with 3-year follow-up protocol.

BACKGROUND: Women with a history of gestational diabetes mellitus (GDM) are 12-fold more likely to develop type 2 diabetes (T2D) 4-6 years after delivery than women without GDM. Similarly, GDM is associated with the development of common mental disorders (CMDs) (e.g. anxiety and depression). Evidence shows that holistic lifestyle interventions focusing on physical activity (PA), dietary intake, sleep, and mental well-being strategies can prevent T2D and CMDs. This study aims to assess the effectiveness of a holistic lifestyle mobile health intervention (mHealth) with post-GDM women in preventing T2D and CMDs in a community setting in Singapore. METHODS: The study consists of a 1-year randomised controlled trial (RCT) with a 3-year follow-up period. Post-GDM women with no current diabetes diagnosis and not planning to become pregnant will be eligible for the study. In addition, participants will complete mental well-being questionnaires (e.g. depression, anxiety, sleep) and their child's socio-emotional and cognitive development. The participants will be randomised to either Group 1 (Intervention) or Group 2 (comparison). The intervention group will receive the "LVL UP App", a smartphone-based, conversational agent-delivered holistic lifestyle intervention focused on three pillars: Move More (PA), Eat Well (Diet), and Stress Less (mental wellbeing). The intervention consists of health literacy and psychoeducational coaching sessions, daily "Life Hacks" (healthy activity suggestions), slow-paced breathing exercises, a step tracker (including brisk steps), a low-burden food diary, and a journaling tool. Women from both groups will be provided with an Oura ring for tracking physical activity, sleep, and heart rate variability (a proxy for stress), and the "HAPPY App", a mHealth app which provides health promotion information about PA, diet, sleep, and mental wellbeing, as well as display body mass index, blood pressure, and results from the oral glucose tolerance tests. Short-term aggregate effects will be assessed at 26/27 weeks (midpoint) and a 1-year visit, followed by a 2, 3, and 4-year follow-up period. DISCUSSION: High rates of progression of T2D and CMDs in women with post-GDM suggest an urgent need to promote a healthy lifestyle, including diet, PA, sleep, and mental well-being. Preventive interventions through a holistic, healthy lifestyle may be the solution, considering the inextricable relationship between physical and psychological health. We expect that holistic lifestyle mHealth may effectively support behavioural changes among women with a history of GDM to prevent T2D and CMDs. TRIAL STATUS: The protocol study was approved by the National Healthcare Group in Singapore, Domain Specific Review Board (DSRB) [2023/00178]; June 2023. Recruitment began on October 18, 2023. TRIAL REGISTRATION: ClinicalTrials.gov NCT05949957. The first submission date is June 08, 2023.

Folic acid fortified milk increases blood folate to concentrations associated with a very low risk of neural tube defects in Singaporean women of childbearing age.

BACKGROUND AND OBJECTIVES: Folic acid (400 µg/d) taken during the periconceptional period reduces neural tube defect (NTD) risk by >75%. Achieving red cell folate (RCF) or plasma folate (PF) >905 nmol/L and >35 nmol/L, respectively, has been associated with a low risk of NTDs. We determined whether daily consumption of folic acid fortified milk increases blood folate concentrations to levels associated with a low risk of NTDs in Singaporean women of childbearing age. METHODS AND STUDY DESIGN: In this double-blind placebo-controlled trial, 70 non-pregnant women (21-35 y) were randomly assigned to receive fortified milk (FM) powder providing 400 µg folic acid per day or unfortified placebo milk (PM) powder for 12 weeks. Blood samples were collected at baseline and at 6 and 12 weeks. RESULTS: At 12 weeks, mean (95% CI) RCF and PF concentrations were 376 (240, 512) and 39 (26, 51) nmol/L higher in the FM group compared with the PM group (p<0.001). Of the women receiving FM, 71% (n=25) and 86% (n=30) achieved a RCF and PF associated with a very low risk of NTDs, respectively. CONCLUSION: Folic acid fortified milk increased blood folate concentrations in women of childbearing age to levels associated with a reduced risk of an NTD-affected pregnancy.