Healthy Clinical Trial
Official title:
A Mobile Health (mHealth)-Enabled Lifestyle Intervention Among Women With History of Gestational Diabetes (GDM): a Pilot Randomized Controlled Trial
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.
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06052553 -
A Study of TopSpin360 Training Device
|
N/A | |
Completed |
NCT05511077 -
Biomarkers of Oat Product Intake: The BiOAT Marker Study
|
N/A | |
Recruiting |
NCT04632485 -
Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
|
||
Completed |
NCT05931237 -
Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults
|
N/A | |
Terminated |
NCT04556032 -
Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women
|
N/A | |
Completed |
NCT04527718 -
Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers
|
Phase 1 | |
Completed |
NCT04998695 -
Health Effects of Consuming Olive Pomace Oil
|
N/A | |
Completed |
NCT04107441 -
AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects
|
Phase 1 | |
Completed |
NCT04065295 -
A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225
|
Phase 1 | |
Completed |
NCT01442831 -
Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects
|
Phase 1 | |
Terminated |
NCT05934942 -
A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood
|
Phase 1 | |
Recruiting |
NCT05525845 -
Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI
|
N/A | |
Completed |
NCT05515328 -
A Study in Healthy Men to Test How BI 685509 is Processed in the Body
|
Phase 1 | |
Completed |
NCT05030857 -
Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects
|
Phase 1 | |
Completed |
NCT04967157 -
Cognitive Effects of Citicoline on Attention in Healthy Men and Women
|
N/A | |
Recruiting |
NCT04714294 -
Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers
|
Phase 1 | |
Recruiting |
NCT04494269 -
A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls
|
Phase 1 | |
Completed |
NCT04539756 -
Writing Activities and Emotions
|
N/A | |
Recruiting |
NCT04098510 -
Concentration of MitoQ in Human Skeletal Muscle
|
N/A | |
Completed |
NCT03308110 -
Bioavailability and Food Effect Study of Two Formulations of PF-06650833
|
Phase 1 |