Clinical trial NCT03735381: Walking in Pregnancy and Prevention of Insomnia in Third Trimester Using Pedometers
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
Overall status: UNKNOWN
Phase: NA
Conditions: Insomnia
Keywords: Pedometer watch, walking, pregnancy, insomnia
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2018-11-08
Enrollment: 265
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Prevalence of Insomnia in third trimester of pregnancy in the three arms with the Insomnia Athens Scale
timeFrame: 32 Gestational Week (GW)
measure: Change in mean steps/day after intervention in the arms using pedometer
timeFrame: 19 Gestational Week (GW) and 32 GW
Secondary outcomes:
measure: Quality of sleep of pregnant women through pregnancy in the three arms measure with the Pittsburgh Questionnaire
timeFrame: 12 (GW), 19 GW and 32 GW
Other outcomes:
measure: Quality of life of women through pregnancy in the three arms measure with the Pregnancy Synpton Inventory
timeFrame: 12 Gestational Week (GW), 19 GW and 32 GW
measure: Women weight gain in kilograms in the three arms measure with a scale
timeFrame: 12 Gestational Week (GW) and 32 GW
measure: Weight of the newborn in the three arms collected from the clinical history
timeFrame: Delivery
measure: Gestational week at delibery in the three arms collected from the clinical history of the women
timeFrame: Delivery
Locations:
city: Granada
country: Spain
facility: Hospital Virgen de las Nieves
Study officials:
affiliation: Universidad de Granada
name: Carmen Amezcua Prieto
role: PRINCIPAL_INVESTIGATOR
References:
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.