Smart Phone APP to Restore Optimal Weight (SPAROW): protocol for a randomised controlled trial for women with recent gestational diabetes

Abstract Background Gestational diabetes (GDM) is a known risk factor for type 2 diabetes mellitus (T2DM), and women with a history of GDM have a 7-fold increased risk of developing the disease. Achieving a healthy weight post-delivery is key in reducing the risk of future diabetes in these women. T...

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Main Authors: Karen Lim, Claudia Chi, Shiao-Yng Chan, Su Lin Lim, Siew Min Ang, Joanne S. Yoong, Cammy Tsai, Su Ren Wong, Tong Wei Yew, E. Shyong Tai, Eu-Leong Yong
Format: Article
Language:English
Published: BMC 2019-10-01
Series:BMC Public Health
Subjects:
Online Access:http://link.springer.com/article/10.1186/s12889-019-7691-3
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author Karen Lim
Claudia Chi
Shiao-Yng Chan
Su Lin Lim
Siew Min Ang
Joanne S. Yoong
Cammy Tsai
Su Ren Wong
Tong Wei Yew
E. Shyong Tai
Eu-Leong Yong
author_facet Karen Lim
Claudia Chi
Shiao-Yng Chan
Su Lin Lim
Siew Min Ang
Joanne S. Yoong
Cammy Tsai
Su Ren Wong
Tong Wei Yew
E. Shyong Tai
Eu-Leong Yong
author_sort Karen Lim
collection DOAJ
description Abstract Background Gestational diabetes (GDM) is a known risk factor for type 2 diabetes mellitus (T2DM), and women with a history of GDM have a 7-fold increased risk of developing the disease. Achieving a healthy weight post-delivery is key in reducing the risk of future diabetes in these women. The aim of this trial is to investigate the use of an interactive smartphone application (APP) to restore women to optimal weight following delivery. Methods This will be an open-label randomized controlled trial. Two hundred women with gestational diabetes will be randomized to receive the intervention or standard care following delivery. Participants will be reviewed at 6 weeks and 4 months post-delivery. The intervention is an APP serving as a platform for weight, diet and physical activity tracking. The APP provides 3–5 min educational videos suggesting suitable lifestyle adjustments relevant to postnatal period such as breast feeding, diet and exercise. Lastly, the APP will allow real-time interaction between users and the team of dietitians, physiotherapists and occupational therapists to encourage restoration of optimal weight. Women in the control arm will be informed about the increased risk of developing T2DM and advised to maintain a healthy weight. Primary outcome measure is the restoration of participants’ booking weight if booking BMI ≤ 23, or weight loss of at least 5% from booking weight if booking BMI > 23 over the 4 month period. Secondary outcome measures will assess serum metabolic and inflammatory markers, quality of life via questionnaires and cost-effectiveness of the intervention at each follow-up visit. Discussion This will be the first randomised controlled trial investigating the use of a smartphone application for postpartum weight loss in women with gestational diabetes. The major ethnic groups in our study population represent the majority of ethnic groups in Asia, amongst which the prevalence of diabetes is high. If shown to be effective, this APP may be used in wider clinical settings to improve postpartum weight loss and reduce the risk of developing T2DM in these women. Trial registration This study was registered on clintrials.gov on the 30th of October 2017, under the trial registration number: NCT03324737.
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spelling doaj.art-55517b19ecf1403097f8095885b251912022-12-22T02:24:07ZengBMCBMC Public Health1471-24582019-10-011911910.1186/s12889-019-7691-3Smart Phone APP to Restore Optimal Weight (SPAROW): protocol for a randomised controlled trial for women with recent gestational diabetesKaren Lim0Claudia Chi1Shiao-Yng Chan2Su Lin Lim3Siew Min Ang4Joanne S. Yoong5Cammy Tsai6Su Ren Wong7Tong Wei Yew8E. Shyong Tai9Eu-Leong Yong10Department of Obstetrics and Gynecology, National University HospitalDepartment of Obstetrics and Gynecology, National University HospitalDepartment of Obstetrics and Gynecology, National University HospitalDepartment of Dietetics, National University HospitalDepartment of Dietetics, National University HospitalSaw Swee Hock School of Public HealthDepartment of Rehabilitation, National University HospitalDepartment of Rehabilitation, National University HospitalDepartment of Medicine, National University HospitalDepartment of Medicine, National University HospitalDepartment of Obstetrics and Gynecology, National University HospitalAbstract Background Gestational diabetes (GDM) is a known risk factor for type 2 diabetes mellitus (T2DM), and women with a history of GDM have a 7-fold increased risk of developing the disease. Achieving a healthy weight post-delivery is key in reducing the risk of future diabetes in these women. The aim of this trial is to investigate the use of an interactive smartphone application (APP) to restore women to optimal weight following delivery. Methods This will be an open-label randomized controlled trial. Two hundred women with gestational diabetes will be randomized to receive the intervention or standard care following delivery. Participants will be reviewed at 6 weeks and 4 months post-delivery. The intervention is an APP serving as a platform for weight, diet and physical activity tracking. The APP provides 3–5 min educational videos suggesting suitable lifestyle adjustments relevant to postnatal period such as breast feeding, diet and exercise. Lastly, the APP will allow real-time interaction between users and the team of dietitians, physiotherapists and occupational therapists to encourage restoration of optimal weight. Women in the control arm will be informed about the increased risk of developing T2DM and advised to maintain a healthy weight. Primary outcome measure is the restoration of participants’ booking weight if booking BMI ≤ 23, or weight loss of at least 5% from booking weight if booking BMI > 23 over the 4 month period. Secondary outcome measures will assess serum metabolic and inflammatory markers, quality of life via questionnaires and cost-effectiveness of the intervention at each follow-up visit. Discussion This will be the first randomised controlled trial investigating the use of a smartphone application for postpartum weight loss in women with gestational diabetes. The major ethnic groups in our study population represent the majority of ethnic groups in Asia, amongst which the prevalence of diabetes is high. If shown to be effective, this APP may be used in wider clinical settings to improve postpartum weight loss and reduce the risk of developing T2DM in these women. Trial registration This study was registered on clintrials.gov on the 30th of October 2017, under the trial registration number: NCT03324737.http://link.springer.com/article/10.1186/s12889-019-7691-3Randomized controlled trialGestational diabetesPreventionSmartphone applicationWeight loss
spellingShingle Karen Lim
Claudia Chi
Shiao-Yng Chan
Su Lin Lim
Siew Min Ang
Joanne S. Yoong
Cammy Tsai
Su Ren Wong
Tong Wei Yew
E. Shyong Tai
Eu-Leong Yong
Smart Phone APP to Restore Optimal Weight (SPAROW): protocol for a randomised controlled trial for women with recent gestational diabetes
BMC Public Health
Randomized controlled trial
Gestational diabetes
Prevention
Smartphone application
Weight loss
title Smart Phone APP to Restore Optimal Weight (SPAROW): protocol for a randomised controlled trial for women with recent gestational diabetes
title_full Smart Phone APP to Restore Optimal Weight (SPAROW): protocol for a randomised controlled trial for women with recent gestational diabetes
title_fullStr Smart Phone APP to Restore Optimal Weight (SPAROW): protocol for a randomised controlled trial for women with recent gestational diabetes
title_full_unstemmed Smart Phone APP to Restore Optimal Weight (SPAROW): protocol for a randomised controlled trial for women with recent gestational diabetes
title_short Smart Phone APP to Restore Optimal Weight (SPAROW): protocol for a randomised controlled trial for women with recent gestational diabetes
title_sort smart phone app to restore optimal weight sparow protocol for a randomised controlled trial for women with recent gestational diabetes
topic Randomized controlled trial
Gestational diabetes
Prevention
Smartphone application
Weight loss
url http://link.springer.com/article/10.1186/s12889-019-7691-3
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