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
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...
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| Format: | Article |
| Language: | English |
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BMC
2023-09-01
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| Series: | BMC Pregnancy and Childbirth |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12884-023-05995-7 |
| _version_ | 1797451109430722560 |
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| author | Xiao Yang Zhixuan Xiang Ji Zhang Yingli Song Erfeng Guo Ruixing Zhang Xin Chen Lu Chen Lingling Gao |
| author_facet | Xiao Yang Zhixuan Xiang Ji Zhang Yingli Song Erfeng Guo Ruixing Zhang Xin Chen Lu Chen Lingling Gao |
| author_sort | Xiao Yang |
| collection | DOAJ |
| description | 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). |
| first_indexed | 2024-03-09T14:50:09Z |
| format | Article |
| id | doaj.art-3653201e65a64497ab54175c616c6a0f |
| institution | Directory Open Access Journal |
| issn | 1471-2393 |
| language | English |
| last_indexed | 2024-03-09T14:50:09Z |
| publishDate | 2023-09-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Pregnancy and Childbirth |
| spelling | doaj.art-3653201e65a64497ab54175c616c6a0f2023-11-26T14:31:11ZengBMCBMC Pregnancy and Childbirth1471-23932023-09-0123111710.1186/s12884-023-05995-7Development 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 trialXiao Yang0Zhixuan Xiang1Ji Zhang2Yingli Song3Erfeng Guo4Ruixing Zhang5Xin Chen6Lu Chen7Lingling Gao8School of Nursing, Sun Yat-Sen UniversitySchool of Nursing, Xiangtan Medicine & Health Vocational CollegeZhengzhou Maternal and Child Health Care HospitalZhengzhou Maternal and Child Health Care HospitalSchool of Nursing, Zhengzhou UniversitySchool of Nursing, Zhengzhou UniversitySchool of Nursing, Sun Yat-Sen UniversitySchool of Nursing, Sun Yat-Sen UniversitySchool of Nursing, Sun Yat-Sen UniversityAbstract 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).https://doi.org/10.1186/s12884-023-05995-7Physical activitySelf-efficacyGestational diabetesPreventionContent validityFeasibility |
| spellingShingle | Xiao Yang Zhixuan Xiang Ji Zhang Yingli Song Erfeng Guo Ruixing Zhang Xin Chen Lu Chen Lingling Gao 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 BMC Pregnancy and Childbirth Physical activity Self-efficacy Gestational diabetes Prevention Content validity Feasibility |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Physical activity Self-efficacy Gestational diabetes Prevention Content validity Feasibility |
| url | https://doi.org/10.1186/s12884-023-05995-7 |
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