Clinical trial NCT04735146: Adapted Physical Activity to Promote Quality of Life, Well-being and Physical Activity Levels in Pregnant Women (WELL-DONE!Study)
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnant Women
Lead sponsor: First Cycle Degree in Midwifery in collaboration with the Department of Biomedical and Neuromotor Sc
Sponsor class: OTHER
First posted: 2021-02-03
Enrollment: 150
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 ).

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.
  * 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.

Primary outcomes:
measure: Change in Women's Quality of Life
timeFrame: Baseline (T1); after 6 weeks of intervention (T2); 3 months after childbirth (T3)
Secondary outcomes:
measure: Change in Physical activity levels
timeFrame: Baseline (T1); follow-up after 6 weeks (T2); 3 months after childbirth (T3)
measure: Change in Physical Performance
timeFrame: Baseline (T1); after 6 weeks of intervention (T2); 3 months after childbirth (T3)
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Corso di Laurea in Ostetricia - Scuola di Medicina e Chirurgia Alma Mater Studiorum - Università di Bologna
Study officials:
affiliation: University of Bologna, Department of Medical and Surgical Sciences
name: Dila Parma
role: PRINCIPAL_INVESTIGATOR
References: