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.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pregnant Women
- Sponsor
- First Cycle Degree in Midwifery in collaboration with the Department of Biomedical and Neuromotor Sc
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Change in Women's Quality of Life
- Last Updated
- 4 years ago
Overview
Brief 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 ).
Investigators
Dila Parma
Master's degree in Nursing and Midwifery Sciences
University of Bologna
Eligibility Criteria
Inclusion Criteria
- •Pregnant women between the 24th and 32th week.
- •Pregnant women belonging to the birth accompaniment meetings organized by University Hospital of Bologna
Exclusion Criteria
- •Alterations in communication skills and / or sensory functions so severe as to make it impossible to understand and / or execute the instructions given by the trainer (dementia, aphasia, blindness, deafness);
- •Premature Rupture of Membranes (PROM).
- •Premature labor.
- •Vaginal bleeding.
- •Placenta previa after 28 weeks gestation.
- •Pre-eclampsia
- •Cervical incontinence
- •Intrauterine fetal growth delay or arrest.
- •Plurigemellarità
- •Uncontrolled type I diabetes.
Outcomes
Primary Outcomes
Change in Women's Quality of Life
Time Frame: Baseline (T1); after 6 weeks of intervention (T2); 3 months after childbirth (T3)
12-Item Short-Form Health Survey (SF-12 Questionnaire)
Secondary Outcomes
- Change in Physical activity levels(Baseline (T1); follow-up after 6 weeks (T2); 3 months after childbirth (T3))
- Change in Physical Performance(Baseline (T1); after 6 weeks of intervention (T2); 3 months after childbirth (T3))