NCT04735146

Adapted Physical Activity to Promote Quality of Life, Well-being and Physical Activity Levels in Pregnant Women (WELL-DONE!Study)

Co-design and Evaluation of the Feasibility and the Efficacy of a Multiple-targeted Adapted Physical Activity Intervention to Promote Quality of Life, Well-being and Physical Activity Levels in Pregnant Women: the WELL-DONE! Study.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: First Cycle Degree in Midwifery in collaboration with the Department of Biomedical and Neuromotor Sc · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

Summary

The aim of the WELL-DONE! Study is to co-design, using different professional figures (midwives, psychologists, master's degree in motor science) but also taking into consideration the pregnant women's point of view, an intervention of adapted physical activity for pregnant women, included in the birth accompaniment courses and conducted by midwives, and to evaluate its effectiveness in terms of quality of life, well-being, levels of physical activity and satisfaction with respect to the proposed intervention.

Detailed description

The primary objective is the evaluation of an integrated, co-designed intervention of adapted physical activity, included in the birth accompaniment courses, in order to improve the quality of life of pregnant women. * The secondary objective is the evaluation of the feasibility, efficacy and safety of the intervention in terms of general satisfaction with the proposed intervention, levels of physical activity practiced, physical performance, self-efficacy, sleep quality, anxiety and depression. * The tertiary objective is to translate, adapt and validate in Italian a specific questionnaire to measure physical activity levels in pregnant women, Pregnancy Physical Activity Questionnaire (PPAQ), through the use of Actigraph accelerometers (ActiLife6 wGT3X-BT ).

Conditions

• Pregnant Women

Interventions

Type	Name	Description
OTHER	Adapted physical activity	Participants in the experimental group will undergo the adapted physical activity program that will be co-designed during phase I of the study. The 6-week program is aimed at improving the quality of life; increase the physical activity levels according to recommended guidelines; improving body awareness through an educational component; maintain and ameliorate the previous functions (for women previously active) and build the exercise background for sedentary women; increase physical fitness and functional capacity.

Timeline

• Start date: 2021-02-20
• Primary completion: 2022-06-30
• Completion: 2022-06-30
• First posted: 2021-02-03
• Last updated: 2021-05-10

Locations

1 site across 1 country: Italy