Walking in pregnancy and prevention of insomnia in third trimester using pedometers: study protocol of Walking_Preg project (WPP). A randomized controlled trial

Abstract

Background Previous studies in pregnancy have not focused in evaluating the effect of walking during pregnancy and prevention of insomnia. Our general objective is to determine the effect of a walking program in preventing the appearance of insomnia in the third trimester of pregnancy, increasing sleep quality and improving quality of life throughout pregnancy. Methods Randomized Controlled trial in parallel in healthy sedentary pregnant women (n = 265), Walking_Preg Project (WPP), from university hospital in Granada, Spain. At 12th gestational week (GW), they will be invited to participate and randomly assigned to one of the three arms of study: the intervention group I1 (pedometer, goal of 11,000 steps/day), intervention group I2 (pedometer, no goal) and control (no pedometer). Duration of intervention: 13–32 GW. At 12th, 19th and 31st GW the average steps/day will be measured in groups I1 and I2. At 13th, 20th and 32nd GW, Athens Insomnia Scale (AIS), Pittsburgh Sleep Quality Index (PSQI), Adherence to Mediterranean Diet (AMD), physical activity (short IPAQ), quality of life (PSI), and consumption of toxic substances (caffeine, illegal drugs, alcohol and tobacco) will be collected. Student t test or Mann-Whitney U will be used to compare 19th and 31st GW mean of daily steps between I1 and I2 groups. To compare differences between groups in terms of frequency of insomnia/quality of life for each trimester of pregnancy, Pearson’s Chi-square test or Fisher’s exact test will be used. To determine differences in hours of sleep and quality of sleep throughout each trimester of pregnancy, analysis of variance or Friedman test will be used. McNemar-Bowker test will be used to assess differences in life quality in pre-post analyses in the 3 arms. We will use Stata 15 statistical software. Discussion promoting walking in second half of pregnancy through use of pedometer and health pre-registration of a goal to be achieved –'10,000–11,000 steps a day’– should prevent appearance of insomnia in third trimester, will increase sleep quality and quality of life in pregnant women. Trial registration ClinicalTrials.gov Identifier: NCT03735381. Registered 8th November, 2018.

Criterion validity and reliability of the International Physical Activity Questionnaire – Hungarian short form against the RM42 accelerometer

“…Only the study protocol of the Walking Preg Project (WPP) has been published so far. The authors estimated that the promotion of walking in the second half of pregnancy by using a pedometer and pre-registering a goal to be achieved -'10,000–11,000 steps a day’- can prevent of insomnia in the third trimester and increase the quality of sleep and quality of life for pregnant women [ 20 ].…”

Sleep quality and associated factors among pregnant women attending antenatal care at Jimma Medical Center, Jimma, Southwest Ethiopia, 2020: cross-sectional study

“…The most effective intervention for sleep problems related to pregnancy was basic sleep hygiene practice and progressive muscle relaxation techniques [ 15 ]. The use of medication for sleep problems related to pregnancy is the last option and better not used in the first trimester of pregnancy [ 16 ]. Despite the above prevalence and impact of sleep on the physical and mental well-being of both a mother and a fetus, there is limited study evidence in African countries including Ethiopia.…”

Walking Promotion in Pregnancy and Its Effects on Insomnia: Results of Walking_Preg Project (WPP) Clinical Trial

“…The complete study protocol of this RCT study was previously published [ 14 ]. This paper summarizes the essential information of the methodology and how sample size was determined—for further information, please check the study protocol.…”

“…Inclusion criteria (age between 18 and 39 years, low risk pregnancies, sedentary women, available mobile and e-mail) and exclusion criteria (chronic disease, relative or absolute repose needed, active women, insomnia at the beginning of pregnancy or taking drugs due to sleep problems, intellectual deficits, or difficulty to understand the language) have been published expanded in the protocol [ 14 ].…”

“…All variables were collected by a trained healthcare worker. Baseline variables were collected only in the first interview [ 14 ].…”