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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

265 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-02

Study Completion Date

2020-09-30

Brief Summary

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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.

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Detailed Description

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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

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Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Participants know they will be selected for either a pedometer group or a not pedometer group. They wil not know if the intervention is minimum (pedometer only) or maximum (pedometer and a goal of 11000 steps/day)

Study Groups

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Intervention 1: pedometer

Minimum intervention:

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

Group Type ACTIVE_COMPARATOR

Pedometer watch 'Xiomi mi band2'

Intervention Type DEVICE

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).

Intervention 2: pedometer+goal+reminds

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.

Group Type EXPERIMENTAL

Pedometer watch 'Xiomi mi band2'

Intervention Type DEVICE

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).

Control: without pedometer

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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).

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No