Skip to main content
Top
Published in: Trials 1/2022

Open Access 01-12-2022 | Gestational Diabetes | Study protocol

Effect of smartphone app-based health care intervention for health management of high-risk mothers: a study protocol for a randomized controlled trial

Authors: Bora Kim, Jong Youn Moon, Jae Yong Shin, Hae Rin Jeon, So Yeon Oh, Suk Young Kim

Published in: Trials | Issue 1/2022

Login to get access

Abstract

Background

The 4th Industrial Revolution with the advent of the smart era, in which artificial intelligence, such as big data analysis and machine learning, is expected, and the provision of healthcare services using smartphones has become a reality. In particular, high-risk mothers who experience gestational diabetes, gestational hypertension, and prenatal and postpartum depression are highly likely to have adverse effects on the mother and newborn due to the disease. Therefore, continuous observation and intervention in health management are needed to prevent diseases and promote healthy behavior for a healthy life.

Methods

This randomized controlled trial will provide mothers 18 years of age or older with health care information collected based on evidence-based literature data using a smartphone app for 6 weeks. About 500 mothers will be selected in consideration of the dropout rate due to the characteristics of mothers. The study group and control group will be computer-generated in a 1:1 ratio through random assignment. The research group will receive health management items through the app, and health management information suitable for the pregnancy cycle is pushed to an alarm. The control group will receive the health management information of the paper. We also followed the procedure for developing mobile apps using the IDEAS framework.

Discussion

These results show the effectiveness of smart medical healthcare services and promote changes in health behaviors throughout pregnancy in high-risk mothers.

Trial registration

Clinical trial registration information for this study has been registered with WHO ICTRP and CRIS (Korea Clinical Research Information Service, CRIS). Clinical trial registration information is as follows:
Study of development of integrated smart health management service for the whole life cycle of high-risk mothers and newborns based on community, KCT0007193. Registered on April 14, 2022, prospectively registered. This protocol version is Version 1.0. April 14, 2022.
Literature
1.
go back to reference Shin HC. High-risk maternal pregnancy. Analysis of medical trends related to childbirth. HIRA Policy Trends. 2012;6:51–60. Shin HC. High-risk maternal pregnancy. Analysis of medical trends related to childbirth. HIRA Policy Trends. 2012;6:51–60.
8.
go back to reference Kendall, Philip C., and Steven D. Hollon, eds. Cognitive-behavioral interventions: Theory, research, and procedures. Vol. 21. Academic Press; 2013. Kendall, Philip C., and Steven D. Hollon, eds. Cognitive-behavioral interventions: Theory, research, and procedures. Vol. 21. Academic Press; 2013.
12.
go back to reference Mateo GF, et al. Mobile phone apps to promote weight loss and increase physical activity: a systematic review and meta-analysis. J Med Internet Res. 2015;17(11):e4836. Mateo GF, et al. Mobile phone apps to promote weight loss and increase physical activity: a systematic review and meta-analysis. J Med Internet Res. 2015;17(11):e4836.
19.
go back to reference GUIDELINE NG133. N. I. C. E. diagnosis and management. 2019. GUIDELINE NG133. N. I. C. E. diagnosis and management. 2019.
20.
go back to reference Mechanick JI, et al. Clinical practice guidelines for the perioperative nutrition, metabolic, and nonsurgical support of patients undergoing bariatric procedures-2019 update: cosponsored by American Association of Clinical Endocrinologists/American College of Endocrinology, The Obesity Society, American Society for Metabolic & Bariatric Surgery, Obesity Medicine Association, and American Society of Anesthesiologists. Surg Obes Relat Dis. 2020;16:175–247. https://doi.org/10.1016/j.soard.2019.10.025.CrossRefPubMed Mechanick JI, et al. Clinical practice guidelines for the perioperative nutrition, metabolic, and nonsurgical support of patients undergoing bariatric procedures-2019 update: cosponsored by American Association of Clinical Endocrinologists/American College of Endocrinology, The Obesity Society, American Society for Metabolic & Bariatric Surgery, Obesity Medicine Association, and American Society of Anesthesiologists. Surg Obes Relat Dis. 2020;16:175–247. https://​doi.​org/​10.​1016/​j.​soard.​2019.​10.​025.CrossRefPubMed
23.
go back to reference N.H.a.M.R. Council. Clinical practice guidelines: pregnancy care. Canberra: Australian Government Department of Health; 2020. N.H.a.M.R. Council. Clinical practice guidelines: pregnancy care. Canberra: Australian Government Department of Health; 2020.
24.
go back to reference O.C.f.W.s. Oshu. Dibets and pregnancy program DAPP guideline. 2013. O.C.f.W.s. Oshu. Dibets and pregnancy program DAPP guideline. 2013.
28.
go back to reference Chan A-W, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin J, Dickersin K, Hróbjartsson A, Schulz KF, Parulekar WR, Krleža-Jerić K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586.CrossRef Chan A-W, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin J, Dickersin K, Hróbjartsson A, Schulz KF, Parulekar WR, Krleža-Jerić K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586.CrossRef
Metadata
Title
Effect of smartphone app-based health care intervention for health management of high-risk mothers: a study protocol for a randomized controlled trial
Authors
Bora Kim
Jong Youn Moon
Jae Yong Shin
Hae Rin Jeon
So Yeon Oh
Suk Young Kim
Publication date
01-12-2022
Publisher
BioMed Central
Published in
Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-022-06425-3

Other articles of this Issue 1/2022

Trials 1/2022 Go to the issue