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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnant Women
• Intervention / Treatment: Other: Adapted physical activity

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 ).

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dila Parma; Phone Number: +39 3313571212; Email: facmed.cdlostetricia@unibo.it

Study Locations

• Italy
  • Bologna, Italy, 40138
    • Recruiting
    • Corso di Laurea in Ostetricia - Scuola di Medicina e Chirurgia Alma Mater Studiorum - Università di Bologna
    • Contact: Dila Parma; Phone Number: +39 3313571212; Email: facmed.cdlostetricia@unibo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
No Intervention: 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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: First Cycle Degree in Midwifery in collaboration with the Department of Biomedical and Neuromotor Sc
• Investigators: Principal Investigator: Dila Parma, University of Bologna, Department of Medical and Surgical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2021
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: January 27, 2021
• First Submitted That Met QC Criteria: January 30, 2021
• First Posted (Actual): February 3, 2021

Study Record Updates

• Last Update Posted (Actual): May 10, 2021
• Last Update Submitted That Met QC Criteria: May 6, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 984/2020/Sper/AOUBo

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No