Smartphone App to Restore Optimal Weight in Women With Recent Gestational Diabetes (SPAROW)

August 6, 2019 updated by: National University Hospital, Singapore

Primary Prevention of Type 2 Diabetes: A Randomized Control Trial With Interactive Smartphone App to Restore Optimal Weight in Women With Recent Gestational Diabetes

Gestational diabetes (GDM) complicates about 20% of pregnancies in Singapore. These women are at high risk of developing type 2 diabetes years after pregnancy; seven times more likely than normal. Achieving a healthy weight post-delivery is key to reduce the risk of future diabetes. This study, from a multidisciplinary team, intends to create a unique seamless care model to restore optimal weight post-delivery in women with recent GDM. The innovation examined in this randomized control trial is an INTERACTIVE SMARTPHONE APP. The APP monitors weight, dietary habits, and exercise activity patterns, gives feedback, and provides practical personalized lifestyle coaching that is culturally appropriate and customized to the Singapore context. If efficacy is confirmed in this RCT, the APP can be easily scaled up as a cost-effective way to potentially prevent or delay the onset of type 2 diabetes in Singaporean women. Additionally, measurement of markers of cardiometabolic risk will give indications on future cardiovascular health, utilizing an underused opportunity to improve women's health.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

About 20% of pregnant Singaporean women are diagnosed with gestational diabetes (GDM), defined as the onset of glucose intolerance that is first recognized in pregnancy. These women are at seven times higher risk of developing type 2 diabetes in the future. About 20 - 50% of women who were diagnosed with GDM during their pregnancies eventually develop type 2 diabetes, with resultant huge health care costs for Singapore and other countries globally. The Diabetes Prevention Program Study has shown that lifestyle changes resulting in modest weight loss are effective in preventing type 2 diabetes in women with a history of GDM. The investigators estimate that about 50% of all type 2 diabetes in women in Singapore occurs when they have a history of GDM and represent a sizeable subpopulation where primary prevention could have a highly significant national impact. Preliminary data indicates that after birth, women with GDM are overwhelmed with care for the newborn and tend to neglect their own health needs. They welcome reminders and coaching but are time-challenged and cannot attend regular on-site lifestyle coaching sessions.

Hypothesis:

  1. Use of an INTERACTIVE SMARTPHONE APP that can track weight, diet and activity linked to an interactive lifestyle coaching intervention can restore optimal weight in women with recent GDM. The team hypothesizes that at 4 months post-delivery, participants in the intervention arm will have significantly higher probability of returning to weight at the start of pregnancy, a significantly improved cardiometabolic status and overall lower risk profile for type 2 diabetes development compared with those receiving standard care (control).
  2. The use of this INTERACTIVE SMARTPHONE APP is cost-effective from the perspective of the Singapore healthcare system.

Aims:

  1. To conduct a randomized control trial to examine the efficacy of an INTERACTIVE SMARTPHONE APP, customized for Singaporean women with recent GDM, in optimizing post-delivery weight and metabolic profiles compared with standard care.

    Primary outcome:

    • Restoration of booking weight if previous booking BMI ≤ 23
    • Weight loss of 5% with respect to booking weight if BMI > 23

    Secondary outcomes:

    - Improved cardiometabolic and inflammatory markers: fasting and 2h post-glucose load plasma glucose in an oral glucose tolerance test, HbA1C, advanced glycation end-products, C-peptide, HOMA-IR, lipid profile, liver function, hsCRP, IL-6.

  2. Evaluate the relative cost-effectiveness of this INTERACTIVE SMARTPHONE APP compared to standard care within the Singapore healthcare system in terms of improvements in quality of life, feasibility, acceptability, scalability and sustainability.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 119074
        • National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female aged 21 years and above
  • Plans to deliver in NUH
  • Diagnosed with GDM antenatally (between 24-34 weeks gestation) defined using the 2013 World Health Organization criteria (fasting plasma glucose = 5.1 mmol/L, plasma glucose at 1H <10 or plasma glucose at 2H post 75gm glucose load of =8.5 mmol/L)
  • Has a smartphone and able to independently use a smartphone app
  • Willing to provide a blood sample
  • Able to give written informed consent
  • Able to speak and read English

Exclusion Criteria:

  • Subjects with type 1 and/or type 2 diabetes (including suspected cases diagnosed by an abnormal oral glucose tolerance test in the 1st and early 2nd trimesters of pregnancy)
  • drugs that affect glucose or lipid metabolism (e.g. systemic steroids, metformin, insulin, statins, orlistat)
  • terminal or life threatening condition
  • physical or mental condition that would prevent completion of a majority of study instruments.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Standard Care Arm
Subjects in the standard care arm will be informed of their increased risk of developing type 2 diabetes in the future, and given general lifestyle verbal advice to maintain a healthy weight, eat a well-balanced diet and do regular exercise during their 6 week postnatal visit. Women found to have impaired fasting glucose (6.1-6.9 mmol/L) or impaired glucose tolerance (2H post glucose of 7.8-11.0 mmol/L) will be issued a letter reinforcing lifestyle changes namely weight loss (if raised BMI), diet, exercise, and encouragement to consult a family physician to discuss the appropriateness of starting medications that can prevent the progression to type 2 diabetes, or restore the blood glucose to normal levels. Those with a normal OGTT result will just be informed that it is normal.
Active Comparator: Interactive Smartphone App Arm

Participants will download the INTERACTIVE SMARTPHONE APP and will be briefed on its use by our team of nutritionists/dieticians, exercise physiologists and life style coaches. Weight: Participants will be reminded that the goal is satisfactory weight loss.

NUH occupational therapist-trained lifestyle coaches, exercise physiotherapists, and clinical nutritionist/ dietician will interact with participants through real-time chats channels via the APP; all culturally appropriate and customized to the Singapore context.
Device: Interactive Smartphone App

There are six main components to the APP.

  • Goal Setting: personalizes diet, activity, and weight loss goals for patients based on their starting point.
  • Food choices and recommendations: App has an automated and immediate recommendation of foods if the choice selected from food database is not optimal. It has a calorie and nutrients tracker to enable patients to track their food intake.
  • Activity and steps tracker: App has a pedometer to count physical activity and steps to enable patients to track their progress towards goals.
  • Interactive video lessons: App has video lessons pushed weekly to the patient according to her needs. The videos encompass aspects of diet, lifestyle and behavior management.
  • Healthcare Professionals Support: App has a chat channel to enable interaction between participants and healthcare professionals.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Weight at 4 months post-delivery
Time Frame: 4 months
Satisfactory weight is defined as return to weight at first booking visit (during 1st trimester) if booking BMI ≤23. If the booking weight is high (BMI>23), the goal would be return to weight that is 5% lower than booking weight.
4 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Markers predictive of future type 2 diabetes and cardiometabolic risk
Time Frame: 4 months
Fasting and 2h post-glucose load plasma glucose in an oral glucose tolerance test, HbA1C, advanced glycation end-products, C-peptide, HOMA IR, lipid profile, liver function; and inflammatory risk: hsCRP, IL-6
4 months
Dietary assessment
Time Frame: 4 months
Food Diary over 3 days to monitor the calorie intake and eating habits of the subject.
4 months
Subject's Self Efficacy to Regulate Exercise
Time Frame: 4 months
The scale is devised by Bandura, and participants have to rate their degree of confidence in performing the described situations with a number from 0 to 100. The higher the value, the greater confidence the subject has in doing the activity.
4 months
Subject's Self Efficacy to Regulate Eating Habits
Time Frame: 4 months
The scale is devised by Bandura, and participants have to rate their degree of confidence in performing the described situations with a number from 0 to 100. The higher the value, the greater confidence the subject has in doing the activity.
4 months
Subject's response to the research study using the Health Education Impact Questionnaire
Time Frame: 4 months
A comparison between subjects' responses in the control and intervention arm, through a series of questions with 4 options - strongly disagree, disagree, agree, or strongly agree.
4 months
Subject's medical outcomes assessed through RAND-12 Item Health Survey
Time Frame: 4 months
A comparison between subjects' responses in the control and intervention arm, through a series of questions about how she feels regarding aspects of her health and life. Questions are all multiple choice questions.
4 months
Subjects' health expenditure
Time Frame: 4 months
A comparison between subjects' expenditure in the control and intervention arm, to find out the cost effectiveness of the study. Bill sizes and monetary expenditure (in dollars) will be calculated for every individual to find the amount she has spent on healthcare postnatally, due to GDM in her pregnancy.
4 months
DNA
Time Frame: 4 months
DNA will be extracted and stored for future gene association studies with respect to type 2 diabetes susceptibility loci.
4 months
Breastfeeding Status
Time Frame: 4 months
Patients will be categorised into fully, partial or no breastfeeding
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National University Hospital, Singapore

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Eu Leong Yong, National University Hospital, Singapore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 16, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 7, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 7, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 16, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 30, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 8, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NMRC/HSRG/0071/2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Weight Loss

Clinical Trials on Interactive Smartphone App

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings