InsomniaWalking_pregNCT03735381
Walking in Pregnancy and Prevention of Insomnia in Third Trimester Using Pedometers
A study testing Pedometer watch 'Xiomi mi band2' in people with Insomnia, run by Universidad de Granada at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Insomnia
- What is being tested?
- Pedometer watch 'Xiomi mi band2'
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 265 participants
- Where
- 1 siteSpain
- Study dates
- 2 Jun 2019to 30 Sep 2020
- 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 18 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Insomnia
- Being tested
- Pedometer watch 'Xiomi mi band2'
- Keywords
- Pedometer watch, walking, pregnancy, insomnia
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pedometer watch 'Xiomi mi band2'Device
- 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).
| Study group | Role | What they receive |
|---|---|---|
| Intervention 1: pedometer | Active comparator | Minimum intervention:
1. Use of pedometer watch from 12 to 32 GW
2. Recommendations of physical activity Receives: Device: Pedometer watch 'Xiomi mi band2' |
| Intervention 2: pedometer+goal+reminds | Experimental | Maximum intervention:
1. Use of pedometer from 12 to 32 GW
2. Recommendations of physical activity
3. Information about get a goal of 11000 steps/day
4. Reminds the goal every two weeks. Receives: Device: Pedometer watch 'Xiomi mi band2' |
| Control: without pedometer | No intervention | Women receive some recommendations of physical activity during pregnancy. They do not use the pedometer during pregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%).
Measured: 32 Gestational Week (GW)
Change in mean steps/day after intervention in the arms using pedometer
Pedometer register
Measured: 19 Gestational Week (GW) and 32 GW
Secondary outcomes (1)
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 %.
Measured: 12 (GW), 19 GW and 32 GW
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start2 Jun 2019
- Primary completion15 Dec 2019 (estimated)
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 265 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carmen Amezcua Prieto, Universidad de Granada
- Investigators
- Carmen Amezcua Prieto, Principal investigator, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03735381
- Sponsor's protocol ID
- PI-0350-2018
- Acronym
- Walking_preg
- Status last verified
- Sep 2019
- First submitted
- 3 Nov 2018
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 41697842Benito-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.
PubMed 39432928Amezcua-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.
PubMed 32912184
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03735381
- Acronym / sponsor ID
- Walking_preg / PI-0350-2018
- Conditions
- Insomnia
- Keywords
- Pedometer watch, walking, pregnancy, insomnia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 265 participants (estimated)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 2 Jun 2019 (actual)
- Primary completion
- 15 Dec 2019 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 8 Nov 2018 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention 1: pedometer | Active comparator | Device: Pedometer watch 'Xiomi mi band2'Minimum intervention: 1. Use of pedometer watch from 12 to 32 GW 2. Recommendations of physical activity |
| Intervention 2: pedometer+goal+reminds | Experimental | Device: Pedometer watch 'Xiomi mi band2'Maximum intervention: 1. Use of pedometer from 12 to 32 GW 2. Recommendations of physical activity 3. Information about get a goal of 11000 steps/day 4. Reminds the goal every two weeks. |
| Control: without pedometer | No intervention | –Women receive some recommendations of physical activity during pregnancy. They do not use the pedometer during pregnancy |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Pedometer watch 'Xiomi mi band2'1. They receive information on the use of the pedometer. 2. Carry the pedometer (Xiaomi Mi Band 2 ™) from 12 to 32GW. 3. 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. 4. 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). | Device | Intervention 1: pedometer, Intervention 2: pedometer+goal+reminds |
Primary outcome
Prevalence of Insomnia in third trimester of pregnancy in the three arms with the Insomnia Athens Scale
Time frame: 32 Gestational Week (GW)
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
Time frame: 19 Gestational Week (GW) and 32 GW
Pedometer register
1 secondary outcome
Quality of sleep of pregnant women through pregnancy in the three arms measure with the Pittsburgh Questionnaire
Time frame: 12 (GW), 19 GW and 32 GW
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
- Derived from this study: PubMed 41697842Benito-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.
- Derived from this study: PubMed 39432928Benito-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.
- Derived from this study: PubMed 32912184Amezcua-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.
- Individual participant dataSharing planned: Undecided
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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.
Carmen Amezcua Prieto principal investigator
Universidad de Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pedometer watch 'Xiomi mi band2' in people with Insomnia, run by Universidad de Granada at 1 site in Spain.
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 4 inclusion and 4 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 26 Sep 2019. 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 Spain. 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 Carmen Amezcua Prieto (+34 958241000 ext. 20287, carmezcua@ugr.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Insomnia in third trimester of pregnancy in the three arms with the Insomnia Athens Scale (time frame: 32 Gestational Week (GW)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03735381, which also lists 3 linked publications.
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 26 Sep 2019.