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Web/Smartphone-based Lifestyle Coaching Program in Pregnant Women With Gestational Diabetes (SMART-GDM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03249896
Recruitment Status : Active, not recruiting
First Posted : August 15, 2017
Last Update Posted : May 29, 2019
Sponsor:
Collaborator:
Jana Care
Information provided by (Responsible Party):
National University Hospital, Singapore

Brief Summary:
Gestational diabetes mellitus (GDM) affects one fifth of Singaporean pregnancies and can result in short and long term complications for mother and child. Mobile applications are effective in improving diabetes care and weight related behaviors through improved self-management. A multidisciplinary healthcare team from National University Hospital, Singapore has worked with Jana Care to develop the Habits-GDM smartphone app, a lifestyle coaching program specific for gestational diabetes. It consists of interactive lessons to provide patient education, diet, activity and weight tracking tools, messaging platform for coaching and motivating patients towards healthy behavior beneficial for gestational diabetes. It interfaces with the Aina device, a novel hardware sensor that plugs into any smartphone and can be used for glucose monitoring. This study aims to test the effectiveness of this app in preventing excessive weight gain in pregnancy among patients with gestational diabetes.

Condition or disease Intervention/treatment Phase
Gestational Diabetes Pregnancy Complications Weight Gain Behavioral: Habits-GDM mobile app Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 340 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effects of a Web/Smartphone-based Lifestyle Coaching Program on Gestational Weight Gain in Pregnant Women With Gestational Diabetes
Actual Study Start Date : September 5, 2017
Actual Primary Completion Date : April 26, 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Experimental: Intervention
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.
Behavioral: Habits-GDM mobile app
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.

No Intervention: Control

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.




Primary Outcome Measures :
  1. Percentage of patients who have excessive gestational weight gain (EGWG) [ Time Frame: during the pregnancy until delivery ]

    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.


Secondary Outcome Measures :
  1. Absolute GWG stratified by whether or not the subject has EGWG for the gestational weeks at recruitment [ Time Frame: during the pregnancy until delivery ]
    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).

  2. Absolute gestational weight gain [ Time Frame: during the pregnancy until delivery ]
    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.

  3. Percentage of patients who have EGWG according to the 2009 US IOM guidelines stratified by whether or not the subject has EGWG for the gestational weeks at recruitment [ Time Frame: during the pregnancy until 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

  4. Adherence to SMBG [ Time Frame: From recruitment until delivery ]
    Numbers of SMBG performed

  5. Average readings of self-monitored blood glucose [ Time Frame: From recruitment until delivery ]
    Average readings of self-monitored blood glucose

  6. Proportion of glucose readings above glycemic targets [ Time Frame: From recruitment until delivery ]
    Glycemic targets are </=5.5 mmol/L premeals, </= 6.6 mmol/L at 2 hours post meals

  7. Proportion of subjects who progress to needing metformin and/or insulin therapy [ Time Frame: From recruitment until delivery ]
    Needing metformin and/or insulin therapy in addition to diet modification

  8. Mode of delivery [ Time Frame: At delivery ]
    Vaginal delivery, assisted delivery, cesarean section

  9. Hypertensive disorders in pregnancy [ Time Frame: During the pregnancy until delivery ]
    Pregnancy induced hypertension, preeclampsia, eclampsia

  10. Depression score [ Time Frame: Between 35-37 weeks of gestation ]
    Edinburgh Postnatal Depression Scale

  11. Anxiety score [ Time Frame: Between 35-37 weeks of gestation ]
    State-Trait Anxiety Inventory

  12. Premature delivery [ Time Frame: At delivery ]
    Delivery before 37 weeks of gestation

  13. Apgar score [ Time Frame: At birth ]
    Apgar score at 1 and 5 minutes after birth

  14. Birth weight [ Time Frame: At birth ]
    Weight of the baby at birth

  15. Shoulder dystocia [ Time Frame: At birth ]
    Shoulder dystocia at birth

  16. Birth trauma [ Time Frame: At birth ]
    Birth trauma at birth

  17. Neonatal hypoglycemia [ Time Frame: First 24 hours from birth ]
    Capillary blood glucose level of <2.6mmol/L

  18. Respiratory distress needing intubation [ Time Frame: At birth ]
    Respiratory distress needing intubation

  19. Neonatal intensive care unit admission [ Time Frame: First 24 hours from birth ]
    Neonatal intensive care unit admission



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Ability to provide informed consent.
  2. Women aged 21 years and older.
  3. Singleton pregnancy.
  4. GDM diagnosed between 12 to 30 weeks of gestation, based on the 2013 World Health Organization (WHO) criteria, i.e. either of the following: fasting plasma glucose ≥5.1 mmol/L, 60-minute plasma glucose ≥10.0 mmol/L, 120-minute plasma glucose ≥8.5 mmol/L, during a 75g oral glucose tolerance test (OGTT).
  5. Possesses a smartphone and ability to navigate a smartphone app.
  6. Proficient in English language.
  7. Plan to deliver the baby in National University Hospital.

Exclusion Criteria:

  1. Multiple pregnancy.
  2. Pre-existing diabetes (type 1 diabetes, type 2 diabetes, or other specific types of diabetes) diagnosed prior to current pregnancy.
  3. GDM diagnosed before 12 weeks of gestation.
  4. No weight available in first trimester (at or before 12 weeks gestation) of the pregnancy.
  5. Need for insulin therapy from the start of diagnosis of GDM, as determined by the primary clinician.
  6. Heart failure.
  7. Chronic kidney disease
  8. Feeding and eating disorders.
  9. History of bariatric surgery.
  10. Long-term systemic corticosteroids use.
  11. Impaired mobility.
  12. Concomitant participation in another clinical study (i.e. Phase I-III clinical studies) with investigational medicinal product(s).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03249896


Locations
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Singapore
National University Hospital
Singapore, Singapore, 119228
Sponsors and Collaborators
National University Hospital, Singapore
Jana Care
Additional Information:
Publications:

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Responsible Party: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT03249896    
Other Study ID Numbers: DSRB 2017/00088
First Posted: August 15, 2017    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National University Hospital, Singapore:
Gestational Diabetes
RCT
Lifestyle coaching program
Smartphone app
Gestational weight gain
Additional relevant MeSH terms:
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Diabetes, Gestational
Pregnancy Complications
Diabetes Mellitus
Weight Gain
Gestational Weight Gain
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Body Weight
Signs and Symptoms
Body Weight Changes