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

Insomnia Clinical Trial

— Walking_preg  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03735381
• Other study ID #: PI-0350-2018
• Status: Recruiting
• Phase: N/A
• Start date: June 2, 2019
• Est. completion date: September 30, 2020

Study information

• Verified date: September 2019
• Source: Universidad de Granada
• Contact: Carmen Amezcua Prieto
• Phone: +34 958241000
• Email: carmezcua[@]ugr.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 265
• Est. completion date: September 30, 2020
• Est. primary completion date: December 15, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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.

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Device:
• Pedometer watch 'Xiomi mi band2'
They receive information on the use of the pedometer. Carry the pedometer (Xiaomi Mi Band 2 ™) from 12 to 32GW. 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. 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).

Locations

Country	Name	City	State
Spain	Hospital Virgen de las Nieves	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of life of women through pregnancy in the three arms measure with the Pregnancy Synpton Inventory	Pregnancy Sympton Inventory (PSI): Is a 41-item likert scale developed from a group of experts and focus groups. Registers the range of symptoms that appear in the last month (Likert scale from 0 to 4: never, rarely, sometimes, often) and its impact on quality of life, by affecting the activities of daily life (scale Likert from 0 to 3: it does not limit me, it limits me a little, it limits me a lot). The scale has been adapted to Spanish pregnant women and is reliable (Kappa coefficient range = 0.6-0.9).	12 Gestational Week (GW), 19 GW and 32 GW
Other	Women weight gain in kilograms in the three arms measure with a scale	Women weight gain in kilograms measure with a scale	12 Gestational Week (GW) and 32 GW
Other	Weight of the newborn in the three arms collected from the clinical history	Weight of the newborn collected from the clinical history of the women	Delivery
Other	Gestational week at delibery in the three arms collected from the clinical history of the women	Gestational week at delibery collected from the clinical history of the women	Delivery
Primary	Prevalence of Insomnia in third trimester of pregnancy in the three arms with the Insomnia Athens Scale	Insomnia Athens Scale (IAS): An eight-item scale that assesses the quantity and quality of sleep (first five items) and the diurnal repercussion of insomnia (daytime sleepiness, physical and mental functioning and well-being during the day). Each of the items scores from 0 to 3 (affectation of the item from light to severe). The total score ranges from 0 to 24 points, considering insomnia from a score equal to or greater than 6 points (S = 93% and E = 85%) or equal to or greater than 7 points (S = 84% and E = 90%).	32 Gestational Week (GW)
Primary	Change in mean steps/day after intervention in the arms using pedometer	Pedometer register	19 Gestational Week (GW) and 32 GW
Secondary	Quality of sleep of pregnant women through pregnancy in the three arms measure with the Pittsburgh Questionnaire	Pittsburgh Questionnaire (PSQI): it assesses the quality of the individual's sleep during the previous month. It consists of 19 items grouped into seven components: quality, latency, duration, efficiency and sleep disturbances, use of medication for sleep and diurnal dysfunction; each component is scored from 0 to 3, according to a Likert scale in which zero is the absence of the symptom and 3 its maximum presence. This will result in a score that ranges from 0 to 21 points (higher score worse sleep quality): a PSQI score of more than 5 indicates poor sleep quality, with a diagnostic sensitivity of 89.6% and a specificity of 86.5 %.	12 (GW), 19 GW and 32 GW