Development and Feasibility of a Theory-guided and Evidence-based Physical Activity Intervention in Pregnant Women with High Risk for Gestational Diabetes Mellitus: a Pilot Clinical Trial

Overview

Journal BMC Pregnancy Childbirth

Publisher Biomed Central

Specialty Gynecology & Obstetrics

Date 2023 Sep 19

PMID 37726710

Authors

Xiao Yang

Zhixuan Xiang

Ji Zhang

Yingli Song

Erfeng Guo

Ruixing Zhang

Xin Chen

Lu Chen

Lingling Gao

Affiliations

Soon will be listed here.

Abstract

Background: Physical activity has been utilized as an effective strategy to prevent gestational diabetes mellitus (GDM). However, most pregnant women with high risk for GDM did not achieve the recommended physical activity level. Furthermore, relevant physical activity protocols have varied without theory-guided and evidence-based tailored to pregnant women with high risk for GDM. This study aimed to develop and pilot test a theory-guided and evidence-based physical activity intervention protocol for pregnant women with high risk for GDM.

Methods: The study design was guided by the Medical Research Council Framework for Developing and Evaluating Complex Intervention (the MRC framework). The preliminary protocol for physical activity intervention was developed based on self-efficacy theory, research evidence identified from systematic reviews and clinic trials, stakeholder engagement, context, and economic considerations. The preliminary intervention protocol was validated through a content validity study by an expert panel of 10 experts. A single-blinded randomized controlled trial (RCT) was designed to test the feasibility and acceptability of the intervention.

Results: The validity of the preliminary intervention protocol was excellent as consensus was achieved. The final 13 sessions of self-efficacy enhancing physical activity intervention protocol were developed, including knowledge education, exercise clinic visits and video, and group discussions with face-to-face and online blended sessions. In the feasibility study, 34 pregnant women with high risk for GDM were randomized for the intervention (n = 17) or the control group (n = 17). The recruitment and retention rates were 82.9% and 58.9%, respectively. Women in the intervention group had a lower incidence of GDM (26.7% vs. 36.5%) than the control group (P >0.05). All participants were satisfied with the intervention and agreed that the intervention was helpful.

Conclusions: The developed self-efficacy-enhancing physical activity intervention is a feasible and acceptable intervention for enhancing physical activity among pregnant women with high risk for GDM and is ready to be tested in a more extensive RCT study.

Trial Registration: The study was registered on 4 February 2022 (ChiCTR2200056355) by the Chinese Clini Trial Registry (CHiCTR).

References

Vounzoulaki E, Khunti K, Abner S, Tan B, Davies M, Gillies C . Progression to type 2 diabetes in women with a known history of gestational diabetes: systematic review and meta-analysis. BMJ. 2020; 369:m1361. PMC: 7218708. DOI: 10.1136/bmj.m1361. View

Gao C, Sun X, Lu L, Liu F, Yuan J . Prevalence of gestational diabetes mellitus in mainland China: A systematic review and meta-analysis. J Diabetes Investig. 2018; 10(1):154-162. PMC: 6319492. DOI: 10.1111/jdi.12854. View

Wang N, Guo H, Jing Y, Song L, Chen H, Wang M . Development and Validation of Risk Prediction Models for Gestational Diabetes Mellitus Using Four Different Methods. Metabolites. 2022; 12(11). PMC: 9697464. DOI: 10.3390/metabo12111040. View

Wei Y, He A, Tang C, Liu H, Li L, Yang X . Risk prediction models of gestational diabetes mellitus before 16 gestational weeks. BMC Pregnancy Childbirth. 2022; 22(1):889. PMC: 9714187. DOI: 10.1186/s12884-022-05219-4. View

Juan J, Yang H . Prevalence, Prevention, and Lifestyle Intervention of Gestational Diabetes Mellitus in China. Int J Environ Res Public Health. 2020; 17(24). PMC: 7766930. DOI: 10.3390/ijerph17249517. View

Guo X, Shu J, Fu X, Chen X, Zhang L, Ji M . Improving the effectiveness of lifestyle interventions for gestational diabetes prevention: a meta-analysis and meta-regression. BJOG. 2018; 126(3):311-320. DOI: 10.1111/1471-0528.15467. View

Kanaley J, Colberg S, Corcoran M, Malin S, Rodriguez N, Crespo C . Exercise/Physical Activity in Individuals with Type 2 Diabetes: A Consensus Statement from the American College of Sports Medicine. Med Sci Sports Exerc. 2022; 54(2):353-368. PMC: 8802999. DOI: 10.1249/MSS.0000000000002800. View

Martinez-Vizcaino V, Sanabria-Martinez G, Fernandez-Rodriguez R, Cavero-Redondo I, Pascual-Morena C, Alvarez-Bueno C . Exercise during pregnancy for preventing gestational diabetes mellitus and hypertensive disorders: An umbrella review of randomised controlled trials and an updated meta-analysis. BJOG. 2022; 130(3):264-275. PMC: 10092296. DOI: 10.1111/1471-0528.17304. View

Bennett G, King N, Redfern K, Breese B . Supervised physical activity and the incidence of gestational diabetes mellitus: a systematic review and meta-analysis. J Matern Fetal Neonatal Med. 2022; 36(1):2155043. DOI: 10.1080/14767058.2022.2155043. View

10.

Yang X, Li H, Zhao Q, Han R, Xiang Z, Gao L . Clinical Practice Guidelines That Address Physical Activity and Exercise During Pregnancy: A Systematic Review. J Midwifery Womens Health. 2021; 67(1):53-68. DOI: 10.1111/jmwh.13286. View

11.

Srugo S, da Silva D, Menard L, Shukla N, Lang J . Recent Patterns of Physical Activity and Sedentary Behaviour Among Pregnant Adults in Canada. J Obstet Gynaecol Can. 2022; 45(2):141-149. DOI: 10.1016/j.jogc.2022.11.011. View

12.

Zhou T, Lin Y, Xu F, Ma X, Wang N, Ding Y . Factors influencing physical inactivity status among chinese pregnant women: a cross-sectional study. BMC Public Health. 2022; 22(1):2310. PMC: 9733201. DOI: 10.1186/s12889-022-14757-7. View

13.

Bianchi C, De Gennaro G, Romano M, Baronti W, Aragona M, Battini L . Exercise during pregnancy: how much active are pregnant women at risk of gestational diabetes despite few contraindications?. Gynecol Endocrinol. 2020; 37(2):101-104. DOI: 10.1080/09513590.2020.1775196. View

14.

Kazemi M, Kim J, Wan C, Xiong J, Michalak J, Xavier I . Comparison of dietary and physical activity behaviors in women with and without polycystic ovary syndrome: a systematic review and meta-analysis of 39 471 women. Hum Reprod Update. 2022; 28(6):910-955. PMC: 9629501. DOI: 10.1093/humupd/dmac023. View

15.

Garland M, Wilbur J, Fogg L, Halloway S, Braun L, Miller A . Self-Efficacy, Outcome Expectations, Group Social Support, and Adherence to Physical Activity in African American Women. Nurs Res. 2021; 70(4):239-247. PMC: 8222161. DOI: 10.1097/NNR.0000000000000516. View

16.

Gothe N . Correlates of Physical Activity in Urban African American Adults and Older Adults: Testing the Social Cognitive Theory. Ann Behav Med. 2018; 52(9):743-751. PMC: 6128373. DOI: 10.1093/abm/kax038. View

17.

Steca P, Pancani L, Cesana F, Fattirolli F, Giannattasio C, Greco A . Changes in physical activity among coronary and hypertensive patients: A longitudinal study using the Health Action Process Approach. Psychol Health. 2017; 32(3):361-380. DOI: 10.1080/08870446.2016.1273353. View

18.

Luszczynska A, Schwarzer R, Lippke S, Mazurkiewicz M . Self-efficacy as a moderator of the planning-behaviour relationship in interventions designed to promote physical activity. Psychol Health. 2011; 26(2):151-66. DOI: 10.1080/08870446.2011.531571. View

19.

Bandura A . Health promotion by social cognitive means. Health Educ Behav. 2004; 31(2):143-64. DOI: 10.1177/1090198104263660. View

20.

Young M, Plotnikoff R, Collins C, Callister R, Morgan P . Social cognitive theory and physical activity: a systematic review and meta-analysis. Obes Rev. 2014; 15(12):983-95. DOI: 10.1111/obr.12225. View