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

Sponsor

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

Overall Status

Recruiting

CT.gov ID

NCT04735146

Collaborator

(none)

150

Enrollment

Location

Arms

16.3

Anticipated Duration (Months)

9.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pregnant Women	Other: Adapted physical activity	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Other

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.

Actual Study Start Date :

Feb 20, 2021

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Jun 30, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change in Women's Quality of Life [Baseline (T1); after 6 weeks of intervention (T2); 3 months after childbirth (T3)]
12-Item Short-Form Health Survey (SF-12 Questionnaire)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Corso di Laurea in Ostetricia - Scuola di Medicina e Chirurgia Alma Mater Studiorum - Università di Bologna	Bologna		Italy	40138

Sponsors and Collaborators

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dila Parma, Master's degree in Nursing and Midwifery Sciences, University of Bologna

ClinicalTrials.gov Identifier:

NCT04735146

Other Study ID Numbers:

984/2020/Sper/AOUBo

First Posted:

Feb 3, 2021

Last Update Posted:

May 10, 2021

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of May 10, 2021