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

NCT04735146 | Unknown

• 1 other identifier: 984/2020/Sper/AOUBo
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnant Women

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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)

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

Interventions

Adapted physical activity 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.

Experimental Group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women between the 24th and 32th week.
• Pregnant women belonging to the birth accompaniment meetings organized by University Hospital of Bologna

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

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

Bologna, 40138, Italy

RECRUITING

Study Officials

• Dila Parma

  University of Bologna, Department of Medical and Surgical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dila Parma

CONTACT

+39 3313571212; facmed.cdlostetricia@unibo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's degree in Nursing and Midwifery Sciences

Study Record Dates

• First Submitted: January 27, 2021
• First Posted: February 3, 2021
• Study Start: February 20, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: May 10, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)