A physical activity counseling intervention to promote health among pregnant women: a study protocol of randomized clinical trial.

BACKGROUND

Pregnancy may result in gestational diabetes mellitus (GDM), discomfort, pregnancy-related musculoskeletal pain, sleep disturbances, and decreased quality of life in pregnant women. Physical activity during pregnancy can lower the odds ratio of developing GDM and offer numerous health benefits for mothers and infants. However, the prevalence of physical inactivity among pregnant women worldwide is high. The Behavior Change Wheel (BCW) can be used to develop interventions to enhance physical activity. However, no research has been conducted to evaluate the effectiveness of physical activity interventions among Chinese pregnant women using the BCW framework.

METHODS/DESIGN: We will conduct a single-center, parallel, randomized controlled trial at a maternal-child health care center. A total of 244 pregnant women at high risk for GDM will be randomly allocated to either a study group receiving a physical activity counseling intervention or a control group receiving standard care. The intervention will comprise one face-to-face individual counseling session combined with three weekly online group counseling sessions based on Motivational Interviewing, supplemented by four biweekly counseling before 24 gestation weeks, and WeChat group support (Tencent, Shenzhen, China). Educational materials will also be available on the WeChat Official Account. The program will begin before 12 gestational weeks, the counseling sessions will end before 24 gestation weeks and WeChat group support will end before delivery. The primary outcomes will include physical activity, the incidence of GDM and glucose level. The secondary outcomes will include gestational weight gain, sleep quality, quality of life, low back pain, pelvic girdle pain, physical activity-related variables, and maternal and newborns health outcomes.

DISCUSSION

This research will contribute to understanding the effects of a physical activity counseling intervention, including physical activity, incidence of GDM, glucose levels, gestational weight gain, sleep quality, quality of life, low back and pelvic girdle pain, and maternal and newborn health outcomes.

TRIAL REGISTRATION

Chinese Clinical Trial Registry (CHiCTR) ChiCTR2400081364, on February 29, 2024.