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Dietitian-led cluster randomised controlled trial on the effectiveness of mHealth education on health outcomes among pregnant women: a protocol paper

Er YT 1 , Chan YM 2 , Mohd Shariff Z 3 , Abdul Hamid H 4 , Mat Daud Z' 1 , Yong HY 5

Affiliations 

  • 1 Department of Dietetics, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang 43400, Selangor, Malaysia
  • 2 Department of Dietetics, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang 43400, Selangor, Malaysia cym@upm.edu.my
  • 3 Department of Nutrition, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang 43400, Selangor, Malaysia
  • 4 Department of Obstetrics & Gynaecology, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Selangor, Malaysia
  • 5 Division of Nutrition and Dietetics, School of Health Sciences, International Medical University, Bukit Jalil, 57000 Kuala Lumpur, Wilayah Persekutuan, Malaysia
BMJ Open, 2023 Nov 20;13(11):e075937.
PMID: 37989361 DOI: 10.1136/bmjopen-2023-075937

Abstract

INTRODUCTION: Nutrition education is the cornerstone to maintain optimal pregnancy outcomes including gestational weight gain (GWG). Nevertheless, default for appointments is common and often lead to suboptimal achievement of GWG, accompanied with unfavourable maternal and child health outcomes. While mobile health (mHealth) usage is increasing and helps minimising barriers to clinic appointments among pregnant mothers, its effectiveness on health outcomes has been inconclusive. Therefore, this study aimed to address the gap between current knowledge and clinical care, by exploring the effectiveness of mHealth on GWG as the primary outcome, hoping to serve as a fundamental work to achieve optimal health outcomes with the improvement of secondary outcomes such as physical activity, psychosocial well-being, dietary intake, quality of life and sleep quality among pregnant mothers.

METHODS AND ANALYSIS: A total of 294 eligible participants will be recruited and allocated into 3 groups comprising of mHealth intervention alone, mHealth intervention integrated with personal medical nutrition therapy and a control group. Pretested structured questionnaires are used to obtain the respondents' personal information, anthropometry data, prenatal knowledge, physical activity, psychosocial well-being, dietary intake, quality of life, sleep quality and GWG. There will be at least three time points of data collection, with all participants recruited during their first or second trimester will be followed up prospectively (after 3 months or/and after 6 months) until delivery. Generalised linear mixed models will be used to compare the mean changes of outcome measures over the entire study period between the three groups.

ETHICS AND DISSEMINATION: Ethical approvals were obtained from the ethics committee of human subjects research of Universiti Putra Malaysia (JKEUPM-2022-072) and medical research & ethics committee, Ministry of Health Malaysia: NMRR ID-22-00622-EPU(IIR). The results will be disseminated through journals and conferences targeting stakeholders involved in nutrition research.

TRIAL REGISTRATION NUMBER: Clinicaltrial.gov ID: NCT05377151.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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