A Mobile Health-enabled Lifestyle Intervention Among Women With History of Gestational Diabetes(GDM)
Condition: Healthy; Gestational Diabetes Mellitus in Pregnancy; Diabetes, Gestational
MeSH terms: Diabetes, Gestational; Pregnancy in Diabetics; Diabetes Mellitus
Study type: Interventional

Summary: 
      This study aims to explore: (1) the relationship between lifestyle factors (eating, movement
      behaviour, sleep and stress) and glycaemic profile, and (2) the feasibility of delivering
      lifestyle intervention through the proposed mHealth strategy.
    

Detailed description: 
      A 2-week observational period, followed by a 8-week parallel 2-arm, single-centre, randomized
      controlled trial (RCT) study involving 60-80 multi-ethnic healthy women (Chinese, Malay,
      Indian, others) subjects aged between 21 and 45 years who had a previous diagnosis of
      Gestational diabetes mellitus (GDM).

      Type 2 diabetes is the most common type of diabetes and if left untreated or is ill-managed,
      can lead to detrimental long-term health problems such as heart disease, kidney disease and
      stroke. Type 2 diabetes is often related to lifestyle and develops over time; with proper
      interventions, it could be avoided in some cases. GDM stands for Gestational Diabetes
      Mellitus and can occur in some pregnant women, usually from week 24 of pregnancy. Women with
      a history of GDM have also been connected to a lifetime risk of developing type 2 diabetes
      and cardiovascular disease. In Singapore, it is estimated that 4 in 10 women with GDM could
      develop pre-diabetes or diabetes within five years of their pregnancy. Therefore, postpartum
      follow-up is essential in early detection of, preventing or delaying the development of Type
      2 diabetes in this group.

      The study hypothesize that there is an association between glycaemic profile and daily
      lifestyle (i.e. eating behavior, physical activity sleep and stress) among women with a
      history of GDM. The study also hypothesize that it is feasible to adopt a holistic approach
      and introduce a personalized mHealth intervention to promote metabolic and mental health
      among women with a history of GDM. The study is a parallel 2-arm, single-centre randomized
      controlled trial based on 1:1 allocation ratio.

      The study arms are; Group 1 (Intervention group) and Group 2 (Control group). The study will
      begin with baseline data collection (anthropometric measures, body composition, biochemistry
      tests, questionnaires) and 14-day observation of interstitial glucose and lifestyle (diet,
      physical activity, sleep and stress). Every subject, irrespective of their group allocation,
      will use Oura ring and Oura App throughout the study duration. Every subject randomized to
      Group 1( Intervention group) will additionally receive HealthifySG App which provides
      personalized lifestyle interventions that last for 4 weeks. Lifestyle recommendations
      (targeting diet, physical activity, sleep and stress) will be delivered by study team member
      through the HealthifySG App on a weekly basis. On the contrary, subjects randomized to Group
      2 (Control group) will not receive the HealthifySGApp and lifestyle interventions during this
      period. Subsequently, both groups will be followed-up for 4 weeks.

      The overall aim of the REVERSE DIABETES programme is three pronged: (1) to be more proactive
      in screening to identify women with a history of GDM in polyclinics and the community, (2) to
      explore the potential of mobile health (mHealth) strategies to engage these women and deliver
      holistic and personalized interventions for promoting metabolic health and mental wellbeing,
      and (3) to engage primary care physicians to use mHealth if proven acceptable and useful in
      the long term follow up of these GDM women in the polyclinics and communities. We hope to
      optimize the preventive measures within the community in the long term.

      Based on the above considerations, conducting a pilot randomized controlled trial would allow
      the study team to: (1) better understand the women's lifestyle behaviours and preferences,
      (2) validate the devices used for measuring lifestyle behaviours, (3) examine the feasibility
      of the proposed mHealth intervention and personalized lifestyle recommendation, (4) evaluate
      the initial effects and cost-effectiveness of the intervention, and (5) identify other
      benefits and potential risk of the proposed idea.
    

Intervention name(s): Personalized mHealth intervention to promote short-term metabolic and mental health among women with a history of Gestational Diabetes Mellitus (GDM)
Intervention type(s): Behavioral
Intervention description(s): The study aim to conduct lifestyle intervention trials to examine the feasibility, efficacy, and cost-effectiveness of the mHealth approach in preventing them from developing Type 2 Diabetes in the future. This pilot study will primarily aim to determine the feasibility of our intervention approaches as well as enhance health literacy and promote healthy lifestyle in the study participants. In the longer term, we hope that the proposed mHealth intervention can be translated to include women from the community setting and involve wider healthcare setting to come together and reduce the burden of Type 2 Diabetes in Singapore.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study is a parallel 2-arm, single-centre randomized controlled trial based on 1:1 allocation ratio:
Group1 (Intervention group) - Oura ring with Oura App + HealthifySG App (receive lifestyle interventions via HealthifySG App) Group 2 (Control group) - Oura ring with Oura App alone (without lifestyle interventions)
Masking: None (Open Label)
Primary purpose: Other
Keywords: Healthy women, Gestational Diabetes Mellitus history, GDM history, mobile health apps