Patients in the intervention arm will receive standard medical care and in addition to that, be given the Aina or Aina Mini device for self-monitoring of blood glucose (SMBG), the Habits-GDM mobile app, and a weighing scale.

Patients in the control arm will receive standard medical care and only be given the Aina or Aina Mini device for SMBG.
Standard medical care involves one session of face-to-face education by a diabetes nurse educator and a dietician. Patients are initiated on capillary glucose monitoring. Subsequently, standard clinical care is provided by their obstetrician. Participation in this study will not increase the frequency of clinic visits. The frequency of SMBG will be as clinically indicated and not increased as a result of participation in this study. Should the obstetrician feels that insulin is required, it will be initiated and if necessary the patient will be referred to the endocrinology service for management of insulin therapy. In some patients, the clinician may decide to prescribe metformin.

Gestational Diabetes

Pregnancy Complications

Weight Gain

The intervention is a self-administered mobile app designed for GDM. It targets behavioural change by providing personalised GDM management program which consists of three main elements: lessons, tracking and coaching/feedback. Lessons contains 12 interactive modules which provide patient education on GDM. Each lesson will take approximately 10-20 minutes. Information on SMBG (linked to the Aina or Aina Mini device), weight (linked to the Bluetooth weighing scale), physical activity (physical activity tracking function in the app), and food (equipped with common local food using the Singapore food database) can be tracked and displayed visually. An interactive messaging platform is used for coaching. Generic and customised automated messages are sent from a virtual lifestyle coach to encourage and motivate patients towards healthy behaviour beneficial for GDM.

Habits-GDM mobile app

World Health Organization. Diagnostic criteria and classification of hyperglycaemia first detected in pregnancy.

National University Hospital

Web/Smartphone-based Lifestyle Coaching Program in Pregnant Women With Gestational Diabetes

Effects of a Web/Smartphone-based Lifestyle Coaching Program on Gestational Weight Gain in Pregnant Women With Gestational Diabetes

Percentage of patients who have EGWG is the proportion of subjects whose gestational weight gain (GWG) exceed the upper range of recommended weight gain for corresponding pre-pregnancy BMI (in this study, this is calculated using the first recorded weight and height in pregnancy at or before 12 weeks gestation) according to the 2009 IOM guidelines.
GWG is calculated by subtracting the first recorded weight (in kilograms) in pregnancy at or before 12 weeks gestation from the most recent weight measurement taken in the hospital (either in the clinic or in the ward) prior to delivery.
Pre-pregnancy BMI is calculated using the first recorded weight (in kilograms) and height (in meters) in pregnancy at or before 12 weeks gestation.

Absolute GWG stratified by whether or not the subject has exceeded the optimal GWG for the gestational weeks at recruitment (based on the 2009 IOM guidelines).

Absolute gestational weight gain is calculated by subtracting the first recorded weight (in kilograms) in pregnancy at or before 12 weeks gestation from the most recent weight measurement taken in the hospital (either in the clinic or in the ward) prior to delivery.

Percentage of patients who have EGWG according to the 2009 US IOM guidelines stratified by whether or not the subject has exceeded the optimal GWG for the gestational weeks at recruitment

Average readings of self-monitored blood glucose

Glycemic targets are </=5.5 mmol/L premeals, </= 6.6 mmol/L at 2 hours post meals

Needing metformin and/or insulin therapy in addition to diet modification

Vaginal delivery, assisted delivery, cesarean section

Pregnancy induced hypertension, preeclampsia, eclampsia

Apgar score at 1 and 5 minutes after birth

Capillary blood glucose level of <2.6mmol/L

National University Hospital, Singapore

Jana Care

This is a prospective, randomised, controlled, parallel-group, single centre study. Study subjects will be randomised into either the intervention or the control arm in a 1:1 ratio. The randomisation will be stratified by ethnicity (Chinese or non-Chinese) and pre-pregnancy BMI (BMI of <25kg/m2 or ≥25kg/m2), and will be performed using computer-generated randomisation.

Lifestyle coaches will provide personalized instruction on physical activity, dietary data, and behavioral strategies.

The usual care/control groups will be followed by their primary Obstetrical provider. All overweight/obese women will be offered nutrition counseling early in pregnancy by a registered dietician to support GWG within the IOM guidelines.

Obesity

Lifestyle-related Condition

Macrosomia, Fetal

We will recruit a total of 200 overweight/obese subjects (defined as pregravid BMI 25-35 kg/m2) at the time of their first pregnancy, hereafter defined as obese for the purposes of the proposal) determined by review of the electronic medical record (EMR) after delivery of their first child.

The lifestyle intervention is healthy eating (Medeterranian diet) and exercise to decrease weight by 5-7% compared to prepregnancy weight.

Lifestyle Intervention

Pennington Biomedical Research Center

Tufts Medical Center

Massachusetts General Hospital

MetroHealth Medical Center

Cleveland Clinic

Lifestyle Intervention in Preparation for Pregnancy (LIPP)

Neonatal anthropometry and air densitometry (pea pod)

body composition, insulin sensitivity and insulin response

The results of the study will be available in a de-identified manner by contacting the Principal Investigator, after the results have been published.

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

The Cleveland Clinic

The intervention will last 8-10 months depending on when during pregnancy the participant is randomized. The intervention will consist of three components (i.e., telephone, print materials, and exercise log/goal setting) designed to increase exercise. Social Cognitive Theory (SCT) and Self-Determination Theory will guide the exercise intervention. The counseling sessions will be a collaboration between the counselor and participants on how to best integrate exercise into the participant's daily routine. Participants will receive 15 intervention phone calls lasting approximately 15-20 minutes each. There will be a one-month intensive phase (weekly contacts), followed by bi-weekly contacts for two months, and then monthly until delivery. Beginning at 6 weeks postpartum, bi-weekly contacts will resume through 3 months postpartum.

Participants in the usual care condition will follow their usual standard of care as suggested by their healthcare provider. Participants will complete the same assessments and incentives as the active interventions but will not receive the exercise counseling sessions. Following completion of the nine-month follow-up, the usual care arm can choose to receive a six-month version of the exercise intervention.

gestational weight gain/cansancio

Web/Smartphone-based Lifestyle Coaching Program in Pregnant Women With Gestational Diabetes

Lifestyle Intervention in Preparation for Pregnancy (LIPP)

Effect of Exercise on Perinatal Depression

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