Effects of Structured Supervised Exercise Training or Motivational Counseling on Pregnant Women's Physical Activity Level: FitMum - Randomized Controlled Trial

Signe de Place Knudsen, Saud Abdulaziz Alomairah, Caroline Borup Roland, Anne Dsane Jessen, Ida-Marie Hergel, Tine D Clausen, Jakob Eg Larsen, Gerrit van Hall, Andreas Kryger Jensen, Stig Molsted, Jane M Bendix, Ellen Løkkegaard, Bente Stallknecht, Signe de Place Knudsen, Saud Abdulaziz Alomairah, Caroline Borup Roland, Anne Dsane Jessen, Ida-Marie Hergel, Tine D Clausen, Jakob Eg Larsen, Gerrit van Hall, Andreas Kryger Jensen, Stig Molsted, Jane M Bendix, Ellen Løkkegaard, Bente Stallknecht

Abstract

Background: Physical activity (PA) during pregnancy is an effective and safe way to improve maternal health in uncomplicated pregnancies. However, compliance with PA recommendations remains low among pregnant women.

Objective: The purpose of this study was to evaluate the effects of offering structured supervised exercise training (EXE) or motivational counseling on PA (MOT) during pregnancy on moderate-to-vigorous intensity physical activity (MVPA) level. Additionally, complementary measures of PA using the Pregnancy Physical Activity Questionnaire (PPAQ) and gold standard doubly labeled water (DLW) technique were investigated. The hypotheses were that both EXE and MOT would increase MVPA in pregnancy compared with standard care (CON) and that EXE would be more effective than MOT. In addition, the association between MVPA and the number of sessions attended was explored.

Methods: A randomized controlled trial included 220 healthy, inactive pregnant women with a median gestational age of 12.9 (IQR 9.4-13.9) weeks. A total of 219 women were randomized to CON (45/219), EXE (87/219), or MOT (87/219). The primary outcome was MVPA (minutes per week) from randomization to the 29th gestational week obtained by a wrist-worn commercial activity tracker (Vivosport, Garmin International). PA was measured by the activity tracker throughout pregnancy, PPAQ, and DLW. The primary outcome analysis was performed as an analysis of covariance model adjusting for baseline PA.

Results: The average MVPA (minutes per week) from randomization to the 29th gestational week was 33 (95% CI 18 to 47) in CON, 50 (95% CI 39 to 60) in EXE, and 40 (95% CI 30 to 51) in MOT. When adjusted for baseline MVPA, participants in EXE performed 20 (95% CI 4 to 36) minutes per week more MVPA than participants in CON (P=.02). MOT was not more effective than CON; EXE and MOT also did not differ. MVPA was positively associated with the number of exercise sessions attended in EXE from randomization to delivery (P=.04). Attendance was higher for online (due to COVID-19 restrictions) compared with physical exercise training (P=.03). Adverse events and serious adverse events did not differ between groups.

Conclusions: Offering EXE was more effective than CON to increase MVPA among pregnant women, whereas offering MOT was not. MVPA in the intervention groups did not reach the recommended level in pregnancy. Changing the intervention to online due to COVID-19 restrictions did not affect MVPA level but increased exercise participation.

Trial registration: ClinicalTrials.gov NCT03679130; https://ichgcp.net/clinical-trials-registry/NCT03679130.

International registered report identifier (irrid): RR2-10.1136/bmjopen-2020-043671.

Keywords: COVID-19; RCT; commercial activity tracker; digital health; doubly labeled water; exercise; fitness; health outcome; intervention; maternal; maternal health; maternity; motivation; physical activity; physical activity questionnaire; pregnancy; pregnant; randomized controlled trial; tracker; women's health.

Conflict of interest statement

Conflicts of Interest: None declared.

©Signe de Place Knudsen, Saud Abdulaziz Alomairah, Caroline Borup Roland, Anne Dsane Jessen, Ida-Marie Hergel, Tine D Clausen, Jakob Eg Larsen, Gerrit van Hall, Andreas Kryger Jensen, Stig Molsted, Jane M Bendix, Ellen Løkkegaard, Bente Stallknecht. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 20.07.2022.

Figures

Figure 1
Figure 1
Flowchart of the FitMum randomized controlled trial including enrollment, study group allocation, follow-up, and data analysis. GA: gestational age; CON: standard care; EXE: structured supervised exercise training; MOT: motivational counseling on physical activity.
Figure 2
Figure 2
Schedule of visits. GA: gestational age; CON: standard care; EXE: structured supervised exercise training; MOT: motivational counseling on physical activity; DLW: doubly labeled water technique; PP: postpartum; DXA: dual-energy x-ray absorptiometry.
Figure 3
Figure 3
Moderate-to-vigorous intensity physical activity (primary outcome) and additional activity tracker outcomes (mean and 95% CI) from randomization to visit 2 (29th week of gestation; solid line) and from randomization to delivery (dotted line). MVPA: moderate-to-vigorous intensity physical activity; CON: standard care; EXE: structured supervised exercise training; MOT: motivational counseling on physical activity.
Figure 4
Figure 4
Cumulative moderate-to-vigorous intensity physical activity from randomization to delivery: (A) group averages, (B) EXE vs CON, (C) MOT vs CON, and (D) EXE vs MOT. MVPA: moderate-to-vigorous intensity physical activity; CON: standard care; EXE: structured supervised exercise training; MOT: motivational counseling on physical activity.
Figure 5
Figure 5
Individual cumulative moderate-to-vigorous intensity physical activity from randomization to delivery in (A) standard care, (B) structured supervised exercise training, and (C) motivational counseling on physical activity. MVPA: moderate-to-vigorous intensity physical activity.
Figure 6
Figure 6
Baseline-constrained comparison between groups based on the means of physical activity level from the Danish version of the Pregnancy Physical Activity Questionnaire. MET: metabolic equivalent of task; CON: standard care; EXE: structured supervised exercise training; MOT: motivational counseling on physical activity.

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