NCT03735381

Walking in Pregnancy and Prevention of Insomnia in Third Trimester Using Pedometers

Efecto de Caminar en La prevención de aparición de Insomnio en el Tercer Trimestre de la gestación. Ensayo de Campo Controlado y Aleatorizado

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 265 (estimated)
• Sponsor: Universidad de Granada · Academic / Other
• Sex: Female
• Age: 18 Years – 49 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Insomnia

Interventions

Type	Name	Description
DEVICE	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).

Timeline

• Start date: 2019-06-02
• Primary completion: 2019-12-15
• Completion: 2020-09-30
• First posted: 2018-11-08
• Last updated: 2019-09-26

Locations

1 site across 1 country: Spain