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

Abstract

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.

Keywords: Anxiety; Behaviour change; Depression; Digital health; Gestational diabetes mellitus; Preventive healthcare; Sleep; Type 2 diabetes; Women.

Fig. 1

Participant flow consort

Fig. 2

Schedule for enrolment, intervention, and assessments for the trial. OGTT, 2-h 75 g Oral Glucose Tolerance Test; BIA, Bioelectrical impedance analysis, SF-36, short-form health survey; STAI, The Stare-Trait Anxiety Inventory; BDI-II, Beck Depression Inventory; CERQ, Cognitive Emotion Regulation Questionnaire; MEQ, Morningness-Eveningness Questionnaire; PSQI, The Pittsburgh Sleep Quality Index; SHS, Subjective Happiness Scale; HLQ, Health Literacy Questionnaire; PSS-4, Perceived Stress Scale 4; WHO-5, World Health Organization Wellbeing Index; BISQ-R-SF, Brief Infant Sleep Questionnaire-Revised Short Form; CSHQ, Children’s Sleep Habits Questionnaire; StimQ toddler/preschool, Cognitive Home Environment Questionnaire; ASQ-3, Ages & Stages Questionnaires-3; BRIEF-2, Behaviour Rating Inventory of Execute Functions-2; BASC-3-BESS Parent Form, Behavioral and Emotional Screening System; PHQ-4, Patient Health Questionnaire; IPAQ-SF, The International Physical Activity Questionnaire- Short Form; MFFQ, Modified Food Frequency Questionnaire