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

NCT03249896 | Unknown

• 1 other identifier: DSRB 2017/00088
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes; Pregnancy Complications; Weight Gain

Keywords

Gestational Diabetes; RCT; Lifestyle coaching program; Smartphone app; Gestational weight gain

Outcome Measures

Primary Outcomes (1)

• Percentage of patients who have excessive gestational weight gain (EGWG)

  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.

  during the pregnancy until delivery

Secondary Outcomes (19)

• Absolute GWG stratified by whether or not the subject has EGWG for the gestational weeks at recruitment

  during the pregnancy until delivery

• Absolute gestational weight gain

  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 EGWG for the gestational weeks at recruitment

  during the pregnancy until delivery

• Adherence to SMBG

  From recruitment until delivery

• Average readings of self-monitored blood glucose

  From recruitment until delivery

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Habits-GDM mobile app BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to provide informed consent.
• Women aged 21 years and older.
• Singleton pregnancy.
• 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).
• Possesses a smartphone and ability to navigate a smartphone app.
• Proficient in English language.
• Plan to deliver the baby in National University Hospital.

You may not qualify if:

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

Sponsors & Collaborators

• National University Hospital, Singapore: lead
• Jana Care: collaborator

Study Sites (1)

National University Hospital

Singapore, 119228, Singapore

Location

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Related Links

• Consumer Barometer with Google.
• World Health Organization. Diagnostic criteria and classification of hyperglycaemia first detected in pregnancy.

MeSH Terms

Conditions

Diabetes, Gestational; Pregnancy Complications; Weight Gain; Gestational Weight Gain

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 1, 2017
• First Posted: August 15, 2017
• Study Start: September 5, 2017
• Primary Completion: April 26, 2019
• Study Completion: May 1, 2019
• Last Updated: May 29, 2019

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)