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.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Change in Women's Quality of Life
研究概览
简要总结
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.
详细描述
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 ).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women between the 24th and 32th week.
- •Pregnant women belonging to the birth accompaniment meetings organized by University Hospital of Bologna
排除标准
- •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.
结局指标
主要结局
Change in Women's Quality of Life
时间窗: Baseline (T1); after 6 weeks of intervention (T2); 3 months after childbirth (T3)
12-Item Short-Form Health Survey (SF-12 Questionnaire)
次要结局
- 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))
研究者
Dila Parma
Master's degree in Nursing and Midwifery Sciences
University of Bologna