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Randomized Control Trial (RCT), were healthy but sedentary women are selected in their first trimester of pregnancy. This RCT has two interventions arms (pedometer plus a goal of 11,000 steps / day and pedometer without goal) and a control group arm, without the use of pedometer. The main objective is to promote physical activity in pregnancy decreasing the prevalence of insomina at their third trimester of pregnancy.
General Objective: To determine the effect of a walking program during pregnancy in the prevention of the appearance of insomnia in the third trimester of pregnancy, in the increase of the quality of sleep and in the improvement of the quality of life throughout pregnancy.
Specific Objectives: Comparison of the interventions group versus the control group; at the beginning, middle and end of the program of the following indicators: 1. Average steps/day; 2. Frequency of insomnia; 3. Hours of night sleep and quality of sleep; 4. Quality of life level.
Methodology: Randomized Control trial in parallel in healthy sedentary pregnant women belonging to the Virgen de las Nieves Hospital in Granada, Spain. At 12 weeks of gestation (GW) they will be invited to participate and randomly assigned to the intervention group I2 (pedometer, with goal of 11,000 steps / day), intervention group I1 (pedometer without goal) and control (without pedometer). Duration of the intervention: 13-32 GW. At 12, 19 and 31GW the average steps/day will be measured in groups I2 and I1. In weeks 13, 20 and 32GW, the following variables will be collected: the Athens Insomnia Scale, the Sleep Quality Index (Pittsburgh), adherence to the Mediterranean Diet (Predimed), physical activity (short IPAQ), quality of life (PSI), the consumption of toxic substances (caffeine, illegal drugs, alcohol and tobacco), the anthropometric variables of pregnant woman.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention 1: pedometer | Active Comparator | Minimum intervention:
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| Intervention 2: pedometer+goal+reminds | Experimental | Maximum intervention:
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| Control: without pedometer | No Intervention | Women receive some recommendations of physical activity during pregnancy. They do not use the pedometer during pregnancy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pedometer watch 'Xiomi mi band2' | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of Insomnia in third trimester of pregnancy in the three arms with the Insomnia Athens Scale | Insomnia Athens Scale (IAS): An eight-item scale that assesses the quantity and quality of sleep (first five items) and the diurnal repercussion of insomnia (daytime sleepiness, physical and mental functioning and well-being during the day). Each of the items scores from 0 to 3 (affectation of the item from light to severe). The total score ranges from 0 to 24 points, considering insomnia from a score equal to or greater than 6 points (S = 93% and E = 85%) or equal to or greater than 7 points (S = 84% and E = 90%). | 32 Gestational Week (GW) |
| Change in mean steps/day after intervention in the arms using pedometer | Pedometer register | 19 Gestational Week (GW) and 32 GW |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of sleep of pregnant women through pregnancy in the three arms measure with the Pittsburgh Questionnaire | Pittsburgh Questionnaire (PSQI): it assesses the quality of the individual's sleep during the previous month. It consists of 19 items grouped into seven components: quality, latency, duration, efficiency and sleep disturbances, use of medication for sleep and diurnal dysfunction; each component is scored from 0 to 3, according to a Likert scale in which zero is the absence of the symptom and 3 its maximum presence. This will result in a score that ranges from 0 to 21 points (higher score worse sleep quality): a PSQI score of more than 5 indicates poor sleep quality, with a diagnostic sensitivity of 89.6% and a specificity of 86.5 %. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life of women through pregnancy in the three arms measure with the Pregnancy Synpton Inventory | Pregnancy Sympton Inventory (PSI): Is a 41-item likert scale developed from a group of experts and focus groups. Registers the range of symptoms that appear in the last month (Likert scale from 0 to 4: never, rarely, sometimes, often) and its impact on quality of life, by affecting the activities of daily life (scale Likert from 0 to 3: it does not limit me, it limits me a little, it limits me a lot). The scale has been adapted to Spanish pregnant women and is reliable (Kappa coefficient range = 0.6-0.9). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carmen Amezcua Prieto | Contact | +34 958241000 | 20287 | carmezcua@ugr.es |
| Name | Affiliation | Role |
|---|---|---|
| Carmen Amezcua Prieto | Universidad de Granada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Virgen de las Nieves | Recruiting | Granada | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41697842 | Derived | Benito-Villena R, Cano-Ibanez N, Gallardo-Vera A, Mozas-Moreno J, Khan KS, Puertas-Prieto A, Amezcua-Prieto C. Walking promotion in healthy pregnant women and perinatal outcomes: a multivariate analysis comparing active and sedentary mothers. J Obstet Gynaecol. 2026 Dec;46(1):2628117. doi: 10.1080/01443615.2026.2628117. Epub 2026 Feb 16. | |
| 39432928 |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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Participants know they will be selected for either a pedometer group or a not pedometer group. They wil not know if the intervention is minimum (pedometer only) or maximum (pedometer and a goal of 11000 steps/day)
|
| 12 (GW), 19 GW and 32 GW |
| 12 Gestational Week (GW), 19 GW and 32 GW |
| Women weight gain in kilograms in the three arms measure with a scale | Women weight gain in kilograms measure with a scale | 12 Gestational Week (GW) and 32 GW |
| Weight of the newborn in the three arms collected from the clinical history | Weight of the newborn collected from the clinical history of the women | Delivery |
| Gestational week at delibery in the three arms collected from the clinical history of the women | Gestational week at delibery collected from the clinical history of the women | Delivery |
| Benito-Villena R, Cano-Ibanez N, Roman-Galvez RM, Martin-Pelaez S, Khan KS, Martinez-Galiano JM, Mozas-Moreno J, Amezcua-Prieto C. Gestational weight gain and daily life impact of pregnancy symptoms in healthy women: A multivariable analysis. Eur J Obstet Gynecol Reprod Biol. 2024 Dec;303:85-90. doi: 10.1016/j.ejogrb.2024.10.023. Epub 2024 Oct 16. |
| 32912184 | Derived | Amezcua-Prieto C, Naveiro-Fuentes M, Arco-Jimenez N, Olmedo-Requena R, Barrios-Rodriguez R, Vico-Zuniga I, Manzanares Galan S, Mozas-Moreno J, Jimenez-Moleon JJ, Gallo-Vallejo JL. Walking in pregnancy and prevention of insomnia in third trimester using pedometers: study protocol of Walking_Preg project (WPP). A randomized controlled trial. BMC Pregnancy Childbirth. 2020 Sep 10;20(1):521. doi: 10.1186/s12884-020-03225-y. |
| D001523 |
| Mental Disorders |