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

Study Overview
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Brief Summary
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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
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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 ).

Official Title
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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.

Conditions
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Pregnant Women

Intervention / Treatment
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* Other: Adapted physical activity


Participation Criteria
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Eligibility Criteria
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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. Uncontrolled hypertension. Uncontrolled thyroid disease. Other severe cardiovascular, respiratory or systemic disorders. Any other condition the operator deems may contraindicate participation in a moderate intensity exercise program.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>The Experimental Group will be involved in 1 weekly session of adapted physical activity lasting 1 hour for 6 weeks within the normal cycle of accompanying birth meetings provided by the University Hospital of Bologna. | Other: Adapted physical activity<br>* 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.<br>|
| No Intervention: Control Group<br>The control group is expected to participate in 6 birth accompaniment meetings held online, 1 hour of which will be dedicated to the topic of exercise and physical activity recommendations in pregnancy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Women's Quality of Life | 12-Item Short-Form Health Survey (SF-12 Questionnaire) | Baseline (T1); after 6 weeks of intervention (T2); 3 months after childbirth (T3) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Physical activity levels | Pregnancy Physical Activity Questionnaire (PPAQ) | Baseline (T1); follow-up after 6 weeks (T2); 3 months after childbirth (T3) | 
| Change in Physical Performance | Six minutes walking distance; Sit to stand test | Baseline (T1); after 6 weeks of intervention (T2); 3 months after childbirth (T3) |