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

NCT ID: NCT04735146

Last Updated: 2021-05-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-20
• Study Completion Date: 2022-06-30

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 ).

Conditions

Pregnant Women

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Experimental Group

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.

Group Type: EXPERIMENTAL

Adapted physical activity

Intervention Type: OTHER

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.

Control Group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

First Cycle Degree in Midwifery in collaboration with the Department of Biomedical and Neuromotor Sc

OTHER

Sponsor Role: lead

Responsible Party

Dila Parma

Master's degree in Nursing and Midwifery Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dila Parma

Role: PRINCIPAL_INVESTIGATOR

University of Bologna, Department of Medical and Surgical Sciences

Locations

Corso di Laurea in Ostetricia - Scuola di Medicina e Chirurgia Alma Mater Studiorum - Università di Bologna

Bologna, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Dila Parma

Role: CONTACT

facmed.cdlostetricia@unibo.it

+39 3313571212

Facility Contacts

Dila Parma

Role: primary

facmed.cdlostetricia@unibo.it

+39 3313571212

Other Identifiers

984/2020/Sper/AOUBo

Identifier Type: -

Identifier Source: org_study_id