Evidence map›Paper›PMID 38926141›Full record

ArticleBMJ open2024

Digital therapeutics-based lifestyle intervention for gestational diabetes mellitus prevention of high-risk pregnant women: a study protocol for a non-randomised controlled trial.

Lihua Lin, Jiayi Dong, Youxin Wang, Libin Song, Xiaoyan Ye, Xingying Chen, Chong Miao, Juan Lin

Abstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Lihua Lin *Fujian Maternity and Child Health Hospital, Fuzhou, Fujian, China.
Jiayi Dong *Fujian Obstetrics and Gynecology Hospital, Fuzhou, Fujian, China.
Youxin WangNorth China University of Science and Technology School of Public Health, Tangshan, Hebei, China.ORCID 0000-0002-6574-6706
Libin SongFuzhou Comvee Network & Technology Co., Ltd, Fuzhou, Fujian, China.
Xiaoyan YeFuzhou Comvee Network & Technology Co., Ltd, Fuzhou, Fujian, China.
Xingying ChenFuzhou Comvee Network & Technology Co., Ltd, Fuzhou, Fujian, China.
Chong MiaoFujian Maternity and Child Health Hospital, Fuzhou, Fujian, China Lin7390@126.com 68484088@qq.com.
Juan LinFujian Maternity and Child Health Hospital, Fuzhou, Fujian, China Lin7390@126.com 68484088@qq.com.ORCID 0000-0002-5277-2825

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionDigital therapeutics have been approved as a treatment aid for various medical conditions and are increasingly prevalent. Despite numerous studies on the potential of digital therapeutic interventions in preventing gestational diabetes mellitus (GDM), there is a critical need for more high-quality, large-scale studies to validate their effectiveness. This need arises from the inconsistencies in results and variations in the quality of previous research. METHODS AND ANALYSIS: We propose a non-randomised controlled trial involving 800 high-risk pregnant women in 6 maternity and child health hospitals in Fujian, China. This study aims to investigate the role and effectiveness of digital therapeutics-based lifestyle intervention in managing the health of pregnant women at high risk for GDM. The study will compare the differences in GDM prevalence, pregnancy weight management and other pregnancy-related health outcomes between pregnant women who received digital therapeutics-based lifestyle intervention and those in the control group. The intervention includes dietary guidance, a personalised physical activity programme and lifestyle improvement strategies delivered through a smartphone app. Primary outcomes include the incidence of GDM at 24-28 weeks gestation and gestational weight gain (GWG). Secondary outcomes comprise improvements in individual lifestyle and risk factors, nutritional issues, implementation outcomes and other pregnancy-related outcomes. ETHICS AND DISSEMINATION SECTION: The trial was approved by the Ethics Committee of Fujian Maternity and Child Health Hospital (approval number: 2023KY046), Jianyang Maternity and Child Health Hospital (approval number: A202401), Fuqing Maternity and Child Health Hospital (approval number: FY2024003), Changting Maternity and Child Health Hospital (approval number: 202401), Datian Maternity and Child Health Hospital (approval number: dtfy202401) and Quanzhou Maternity and Child Health Hospital (approval number: 2024(50)). We will disseminate our findings by publishing articles in leading peer-reviewed journals. TRIAL REGISTRATION NUMBER: ChiCTR2300071496.

Indexed as

Diabetes, GestationalAdultChinaExerciseFemaleGestational Weight GainHumansLife StyleMobile ApplicationsNon-Randomized Controlled Trials as TopicPregnancyPregnancy, High-RiskCell PhoneDiabetes in pregnancyPregnant WomenPublic health

Identifiers

PMID38926141
PMCPMC11216049

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.