Walking in Pregnancy and Prevention of Insomnia in Third Trimester Using Pedometers (Walking_preg)

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.

Study Overview

• Status: Unknown
• Conditions: Insomnia
• Intervention / Treatment: Device: Pedometer watch 'Xiomi mi band2'

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 Type: Interventional
• Enrollment (Anticipated): 265
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Granada, Spain
    • Recruiting
    • Hospital Virgen de las Nieves

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention 1: pedometer; Minimum intervention: Use of pedometer watch from 12 to 32 GW; Recommendations of physical activity	Device: Pedometer watch 'Xiomi mi band2'; 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).
Experimental: Intervention 2: pedometer+goal+reminds; 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.	Device: Pedometer watch 'Xiomi mi band2'; 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).
No Intervention: Control: without pedometer; Women receive some recommendations of physical activity during pregnancy. They do not use the pedometer during pregnancy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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 %.	12 (GW), 19 GW and 32 GW

Other Outcome Measures

Outcome Measure	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).	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

Collaborators and Investigators

• Sponsor: Universidad de Granada
• Investigators: Principal Investigator: Carmen Amezcua Prieto, Universidad de Granada

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2019
• Primary Completion (Anticipated): December 15, 2019
• Study Completion (Anticipated): September 30, 2020

Study Registration Dates

• First Submitted: November 3, 2018
• First Submitted That Met QC Criteria: November 7, 2018
• First Posted (Actual): November 8, 2018

Study Record Updates

• Last Update Posted (Actual): September 26, 2019
• Last Update Submitted That Met QC Criteria: September 25, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Pedometer watch, walking, pregnancy, insomnia
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: PI-0350-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No