Pregnant WomenWELL-DONE!NCT04735146
Adapted Physical Activity to Promote Quality of Life, Well-being and Physical Activity Levels in Pregnant Women (WELL-DONE!Study)
A study testing Adapted physical activity in people with Pregnant Women, run by First Cycle Degree in Midwifery in collaboration with the Department of Biomedical and Neuromotor Sc at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnant Women
- What is being tested?
- Adapted physical activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 20 Feb 2021to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Pregnant women between the 24th and 32th week.
- Pregnant women belonging to the birth accompaniment meetings organized by University Hospital of Bologna
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Corso di Laurea in Ostetricia - Scuola di Medicina e Chirurgia Alma Mater Studiorum - Università di Bologna
Bologna, 40138
Dila Parma, +39 3313571212, facmed.cdlostetricia@unibo.it
About this 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.
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.
Read the 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
- Being tested
- Adapted physical activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted physical activityOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Women's Quality of Life
12-Item Short-Form Health Survey (SF-12 Questionnaire)
Measured: Baseline (T1); after 6 weeks of intervention (T2); 3 months after childbirth (T3)
Secondary outcomes (2)
Change in Physical activity levels
Pregnancy Physical Activity Questionnaire (PPAQ)
Measured: 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
Measured: Baseline (T1); after 6 weeks of intervention (T2); 3 months after childbirth (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start20 Feb 2021
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnant WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Cycle Degree in Midwifery in collaboration with the Department of Biomedical and Neuromotor Sc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dila Parma, University of Bologna
- Investigators
- Dila Parma, Principal investigator, University of Bologna, Department of Medical and Surgical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04735146
- Sponsor's protocol ID
- 984/2020/Sper/AOUBo
- Acronym
- WELL-DONE!
- Status last verified
- May 2021
- First submitted
- 27 Jan 2021
- Last updated
- 10 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04735146
- Acronym / sponsor ID
- WELL-DONE! / 984/2020/Sper/AOUBo
- Conditions
- Pregnant Women
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- First Cycle Degree in Midwifery in collaboration with the Department of Biomedical and Neuromotor ScUniversity, hospital or other
- Study start
- 20 Feb 2021 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 3 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 ).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Adapted physical activityThe 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. |
| 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Pregnant women between the 24th and 32th week.
- Pregnant women belonging to the birth accompaniment meetings organized by University Hospital of Bologna
Key exclusion criteria (14 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adapted physical activityParticipants 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. | Other | Experimental Group |
Primary outcome
Change in Women's Quality of Life
Time frame: Baseline (T1); after 6 weeks of intervention (T2); 3 months after childbirth (T3)
12-Item Short-Form Health Survey (SF-12 Questionnaire)
2 secondary outcomes
Change in Physical activity levels
Time frame: Baseline (T1); follow-up after 6 weeks (T2); 3 months after childbirth (T3)
Change in Physical Performance
Time frame: Baseline (T1); after 6 weeks of intervention (T2); 3 months after childbirth (T3)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dila Parma principal investigator
University of Bologna, Department of Medical and Surgical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted physical activity in people with Pregnant Women, run by First Cycle Degree in Midwifery in collaboration with the Department of Biomedical and Neuromotor Sc at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dila Parma (+39 3313571212, facmed.cdlostetricia@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Women's Quality of Life (time frame: Baseline (T1); after 6 weeks of intervention (T2); 3 months after childbirth (T3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2021.