Walking in Pregnancy and Prevention of Insomnia in Third Trimester Using Pedometers (Walking_preg)
Primary Purpose
Insomnia
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Pedometer watch 'Xiomi mi band2'
Sponsored by
About this trial
This is an interventional prevention trial for Insomnia focused on measuring Pedometer watch, walking, pregnancy, insomnia
Eligibility Criteria
Inclusion Criteria:
- Low risk pregnancies that are attending in the Unit of Obstetrics and Gynecology of the Hospital Materno-Infantil de Granada.
- Sedentary women (<5 days/week of moderate-vigorous physical activity at least >30 min.; equivalent to <7.000 steps/day).
- With mobile phone and e-mail
- Without intellectual deficits or difficulty to understand the language.
Exclusion Criteria:
- Chronic disease: diabetes, high pressure, cardiac or respiratory disease, liver or kidney disease or mobility problems.
- Women with relative or absolute repose.
- Active women (>5 days/week of moderate-vigorous physical activity at least >30 min.; equivalent to >7.000 steps/day).
- Insomnia at beginning of pregnancy or having drugs for sleep problems.
Sites / Locations
- Hospital Virgen de las NievesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
No Intervention
Arm Label
Intervention 1: pedometer
Intervention 2: pedometer+goal+reminds
Control: without pedometer
Arm Description
Minimum intervention: Use of pedometer watch from 12 to 32 GW Recommendations of physical activity
Maximum intervention: Use of pedometer from 12 to 32 GW Recommendations of physical activity Information about get a goal of 11000 steps/day Reminds the goal every two weeks.
Women receive some recommendations of physical activity during pregnancy. They do not use the pedometer during pregnancy
Outcomes
Primary Outcome Measures
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%).
Change in mean steps/day after intervention in the arms using pedometer
Pedometer register
Secondary Outcome Measures
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 %.
Full Information
NCT ID
NCT03735381
First Posted
November 3, 2018
Last Updated
September 25, 2019
Sponsor
Universidad de Granada
1. Study Identification
Unique Protocol Identification Number
NCT03735381
Brief Title
Walking in Pregnancy and Prevention of Insomnia in Third Trimester Using Pedometers
Acronym
Walking_preg
Official Title
Efecto de Caminar en La prevención de aparición de Insomnio en el Tercer Trimestre de la gestación. Ensayo de Campo Controlado y Aleatorizado
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 2, 2019 (Actual)
Primary Completion Date
December 15, 2019 (Anticipated)
Study Completion Date
September 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
Keywords
Pedometer watch, walking, pregnancy, insomnia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
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)
Allocation
Randomized
Enrollment
265 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention 1: pedometer
Arm Type
Active Comparator
Arm Description
Minimum intervention:
Use of pedometer watch from 12 to 32 GW
Recommendations of physical activity
Arm Title
Intervention 2: pedometer+goal+reminds
Arm Type
Experimental
Arm Description
Maximum intervention:
Use of pedometer from 12 to 32 GW
Recommendations of physical activity
Information about get a goal of 11000 steps/day
Reminds the goal every two weeks.
Arm Title
Control: without pedometer
Arm Type
No Intervention
Arm Description
Women receive some recommendations of physical activity during pregnancy. They do not use the pedometer during pregnancy
Intervention Type
Device
Intervention Name(s)
Pedometer watch 'Xiomi mi band2'
Intervention Description
They receive information on the use of the pedometer.
Carry the pedometer (Xiaomi Mi Band 2 ™) from 12 to 32GW.
Prescription of benefits of walking in pregnancy:
Receive information about the goal of steps / day to be reached: 10,000-11,000 steps / day (Only the intervention 2 group).
Receive information on the adequacy of walking with moderate intensity.
They will receive messages on the mobile phone remembering the goal to achieve and a notification that the researching staff will proceed to collect the average count of steps / day of the week prior to 20 and 32 gestation weeks (only for the intervention 2 group).
Primary Outcome Measure Information:
Title
Prevalence of Insomnia in third trimester of pregnancy in the three arms with the Insomnia Athens Scale
Description
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%).
Time Frame
32 Gestational Week (GW)
Title
Change in mean steps/day after intervention in the arms using pedometer
Description
Pedometer register
Time Frame
19 Gestational Week (GW) and 32 GW
Secondary Outcome Measure Information:
Title
Quality of sleep of pregnant women through pregnancy in the three arms measure with the Pittsburgh Questionnaire
Description
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 %.
Time Frame
12 (GW), 19 GW and 32 GW
Other Pre-specified Outcome Measures:
Title
Quality of life of women through pregnancy in the three arms measure with the Pregnancy Synpton Inventory
Description
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).
Time Frame
12 Gestational Week (GW), 19 GW and 32 GW
Title
Women weight gain in kilograms in the three arms measure with a scale
Description
Women weight gain in kilograms measure with a scale
Time Frame
12 Gestational Week (GW) and 32 GW
Title
Weight of the newborn in the three arms collected from the clinical history
Description
Weight of the newborn collected from the clinical history of the women
Time Frame
Delivery
Title
Gestational week at delibery in the three arms collected from the clinical history of the women
Description
Gestational week at delibery collected from the clinical history of the women
Time Frame
Delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Low risk pregnancies that are attending in the Unit of Obstetrics and Gynecology of the Hospital Materno-Infantil de Granada.
Sedentary women (<5 days/week of moderate-vigorous physical activity at least >30 min.; equivalent to <7.000 steps/day).
With mobile phone and e-mail
Without intellectual deficits or difficulty to understand the language.
Exclusion Criteria:
Chronic disease: diabetes, high pressure, cardiac or respiratory disease, liver or kidney disease or mobility problems.
Women with relative or absolute repose.
Active women (>5 days/week of moderate-vigorous physical activity at least >30 min.; equivalent to >7.000 steps/day).
Insomnia at beginning of pregnancy or having drugs for sleep problems.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carmen Amezcua Prieto
Phone
+34 958241000
Ext
20287
Email
carmezcua@ugr.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmen Amezcua Prieto
Organizational Affiliation
Universidad de Granada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Virgen de las Nieves
City
Granada
Country
Spain
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32912184
Citation
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.
Results Reference
derived
Learn more about this trial
Walking in Pregnancy and Prevention of Insomnia in Third Trimester Using Pedometers
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