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

University of Granada (UGR)

Status: Unknown

Conditions: Insomnia

Treatments: Device: Pedometer watch 'Xiomi mi band2'

Study type: Interventional

Funder types: Other

Identifiers

NCT03735381

PI-0350-2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 265 estimated patients

Sex: Female

Ages: 18 to 49 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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265 participants in 3 patient groups

Intervention 1: pedometer

Active Comparator group

Description:

Minimum intervention: 1. Use of pedometer watch from 12 to 32 GW 2. Recommendations of physical activity

Treatment:

Device: Pedometer watch 'Xiomi mi band2'

Intervention 2: pedometer+goal+reminds

Experimental group

Description:

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.

Treatment:

Device: Pedometer watch 'Xiomi mi band2'

Control: without pedometer

No Intervention group

Description:

Women receive some recommendations of physical activity during pregnancy. They do not use the pedometer during pregnancy