In Finland, every third woman is overweight (BMI\>25) and 11,5% obese (BMI\>30). Cohort and national studies reveal that 46% of fertile-aged men have BMI≥25 and 20% BMI≥30. Overweight has negative impact on both female and male fertility and weakens markedly the results of infertility treatments. In this study, 780 infertile couples will be randomized to control group (conventional infertility treatment) and lifestyle intervention arm undergoing 4 sessions of video-mediated motivational interview, anthropometric measurements, laboratory tests and epigenetic samples. Economic evaluation of the intervention will also be performed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,560
Life Style intervention including physical activity, diet, sleep and stress
Behavior change
score from 1 to 4: (smoking + daily vegetable, fruit and berry use \>500g + BMI 19-27 + 150 min of moderate exercise/week) No=0, Yes=1 measured at the beginning, at 3 and 6 months
Time frame: 6 months
Live birth rate
Number of live children born
Time frame: 3 years
Weight change
weight in kg measured without shoes and with light clothing at the beginning, at 3 and 6 months
Time frame: 6 months
Infertility treatments, number
Number of infertility treatments needed for a live birth
Time frame: 3 years
Infertility treatments, mode
Mode of infertility treatments needed for a live birth (including ovulation induction, insemination, IVF, ICSI)
Time frame: 3 years
Miscarriage rate
Number of miscarriages
Time frame: 3 years
Height
Measured without shoes (cm)
Time frame: 0 months
Weight
Measured without shoes and with light clothing (kg)
Time frame: 0 months
Weight
Measured without shoes and with light clothing (kg)
Time frame: 3 months
Weight
Measured without shoes and with light clothing (kg)
Time frame: 6 months
Body mass index
Weight in kilograms divided by the square of height in meters
Time frame: 0 months
Body mass index
Weight in kilograms divided by the square of height in meters
Time frame: 3 months
Body mass index
Weight in kilograms divided by the square of height in meters
Time frame: 6 months
Body composition
Bioimpedance method
Time frame: 0 months
Body composition
Bioimpedance method
Time frame: 3 months
Body composition
Bioimpedance method
Time frame: 6 months
Waist circumference
measured at midpoint between the lower margin of the last palpable rib and the top of the iliac crest (cm)
Time frame: 0 months
Waist circumference
measured at midpoint between the lower margin of the last palpable rib and the top of the iliac crest (cm)
Time frame: 3 months
Waist circumference
measured at midpoint between the lower margin of the last palpable rib and the top of the iliac crest (cm)
Time frame: 6 months
Self-reported physical activity
Minutes per week, International Physical Activity Questionnaire - Short Form
Time frame: 0 months
Self-reported physical activity
Minutes per week, International Physical Activity Questionnaire - Short Form
Time frame: 6 months
Physical activity
Amount of weekly physical activity, data from Oura ring 3-dimensional accelerometer
Time frame: 0 months
Physical activity
Amount of weekly physical activity, data from Oura ring 3-dimensional accelerometer
Time frame: 3 months
Physical activity
Amount of weekly physical activity, data from Oura ring 3-dimensional accelerometer
Time frame: 6 months
Maximal oxygen uptake
Functional aerobic capacity prediction model (N-Ex BMI) by Johnson et al 1990
Time frame: 0 months
Maximal oxygen uptake
Functional aerobic capacity prediction model (N-Ex BMI) by Johnson et al 1990
Time frame: 3 months
Maximal oxygen uptake
Functional aerobic capacity prediction model (N-Ex BMI) by Johnson et al 1990
Time frame: 6 months
Dietary content
FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17\_FFQ\_ENG\_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a)
Time frame: 0 months
Dietary content
FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17\_FFQ\_ENG\_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a)
Time frame: 6 months
Dietary patterns
FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17\_FFQ\_ENG\_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a)
Time frame: 0 months
Dietary patterns
FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17\_FFQ\_ENG\_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a)
Time frame: 6 months
Folate
Plasma folate concentration
Time frame: 0 months
Folate
Plasma folate concentration
Time frame: 6 months
Vitamin-D
Plasma vitamin-D concentration
Time frame: 0 months
Vitamin-D
Plasma vitamin-D concentration
Time frame: 6 months
Zinc
Plasma zinc concentration
Time frame: 0 months
Zinc
Plasma zinc concentration
Time frame: 6 months
Carbohydrates
Amount of daily carbohydrates in diet , FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17\_FFQ\_ENG\_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a
Time frame: 0 months
Carbohydrates
Amount of daily carbohydrates in diet, FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17\_FFQ\_ENG\_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a
Time frame: 6 months
Protein
Amount of daily proteins in diet, FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17\_FFQ\_ENG\_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a
Time frame: 0 months
Protein
Amount of daily proteins in diet, FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17\_FFQ\_ENG\_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a
Time frame: 6 months
Alcohol
Alcohol consumption per week, FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17\_FFQ\_ENG\_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a
Time frame: 0 months
Alcohol
Alcohol consumption per week, FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17\_FFQ\_ENG\_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a
Time frame: 6 months
n-3 fatty acids
Amount of daily n-3 fatty acids, FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17\_FFQ\_ENG\_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a
Time frame: 0 months
n-3 fatty acids
Amount of daily n-3 fatty acids, FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17\_FFQ\_ENG\_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a
Time frame: 6 months
n-6 fatty acids
Amount of daily n-6 fatty acids, FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17\_FFQ\_ENG\_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a
Time frame: 0 months
n-6 fatty acids
Amount of daily n-6 fatty acids, FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17\_FFQ\_ENG\_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a
Time frame: 6 months
Saturated fatty acids
Amount of daily saturated fatty acids, FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17\_FFQ\_ENG\_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a
Time frame: 0 months
Saturated fatty acids
Amount of daily saturated fatty acids, FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17\_FFQ\_ENG\_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a
Time frame: 6 months
Monounsaturated fatty acids
Amount of daily monounsaturated fatty acids, FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17\_FFQ\_ENG\_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a
Time frame: 0 months
Monounsaturated fatty acids
Amount of daily monounsaturated fatty acids, FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17\_FFQ\_ENG\_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a
Time frame: 6 months
Polyunsaturated fatty acids
Amount of daily polyunsaturated fatty acids, FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17\_FFQ\_ENG\_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a
Time frame: 0 months
Polyunsaturated fatty acids
Amount of daily polyunsaturated fatty acids, FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17\_FFQ\_ENG\_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a
Time frame: 6 months
Sleep
Quality of sleep, Basic Nordic Sleep Questionnaire (BNSQ)
Time frame: 0 months
Sleep
Quality of sleep, Basic Nordic Sleep Questionnaire (BNSQ)
Time frame: 6 months
Sleep, measured
Quality, sleep disruptions, total sleep duration registered by Oura ring application
Time frame: 0 months
Sleep, measured
Quality, sleep disruptions, total sleep duration registered by Oura ring application
Time frame: 3 months
Sleep, measured
Quality, sleep disruptions, total sleep duration registered by Oura ring application
Time frame: 6 months
Stress recovery
Night-time heart rate variability regisered by Oura ring application
Time frame: 0 months
Stress recovery
Night-time heart rate variability registered by Oura ring application
Time frame: 3 months
Stress recovery
Night-time heart rate variability registered by Oura ring application
Time frame: 6 months
Anxiety and depression
Hospital Anxiety and Depression Scale (HADS)
Time frame: 0 months
Anxiety and depression
Hospital Anxiety and Depression Scale (HADS)
Time frame: 3 months
Anxiety and depression
Hospital Anxiety and Depression Scale (HADS)
Time frame: 6 months
Fertility quality of life
FertiQoL International Questionnaire
Time frame: 0 months
Fertility quality of life
FertiQoL International Questionnaire
Time frame: 6 months
Depression
Edinburgh Postnatal Depression Scale (EPDS) Questionnaire
Time frame: 0 months
Depression
Edinburgh Postnatal Depression Scale (EPDS) Questionnaire
Time frame: 6 months
Self-determined motivation for physical activity
Behavioral Regulations for Exercise Questionnaire (BREQ-3, Markland, D. \& Tobin, 2004). Includes the subscales: Amotivation, External regulation, Introjected regulation, Identified regulation, Integrated regulation, Intrinsic regulation.
Time frame: 0 months
Self-determined motivation for physical activity
Behavioral Regulations for Exercise Questionnaire (BREQ-3, Markland, D. \& Tobin, 2004). Includes the subscales: Amotivation, External regulation, Introjected regulation, Identified regulation, Integrated regulation, Intrinsic regulation
Time frame: 6 months
Intention and action planning for physical activity; Intention to increase physical activity
Three (adapted) items from the Health Action Process Approach Questionnaire, (Schwarzer R. Modeling health behaviour change: how to predict and modify the adoption and maintenance of health behaviors. Appl Psychol, 2008; 57:1-29)
Time frame: 0 months
Intention and action planning for physical activity; Intention to increase physical activity
Three (adapted) items from the Health Action Process Approach Questionnaire (Schwarzer R. Modeling health behaviour change: how to predict and modify the adoption and maintenance of health behaviors. Appl Psychol, 2008; 57:1-29)
Time frame: 6 months
Self-efficacy for physical activity
18-item scale developed by Albert Bandura (Bandura A. 2006). Guide for constructing self-efficacy scales. In: Pajares F, Urdan T (eds)Self-efficacy beliefs of adolescents. Information Age, Charlotte, pp 307-337)
Time frame: 0 months
Self-efficacy for physical activity
18-item scale developed by Albert Bandura (Bandura A. 2006). Guide for constructing self-efficacy scales. In: Pajares F, Urdan T (eds)Self-efficacy beliefs of adolescents. Information Age, Charlotte, pp 307-337)
Time frame: 6 months
Pregnancy complications
Number of pregnancy complications (gestational diabetes, pre-eclampsia, hypertension, fetal growth disorders, preterm birth)
Time frame: 3 years
Delivery complications
Number of delivery complications (cesarean section, assisted vaginal delivery, hemorrhage)
Time frame: 3 years
Neonatal outcome
Birth weight, cord pH, Apgar score
Time frame: 3 years
Body composition of the newborn
Bioimpedance method
Time frame: At birth
Growth of the child
From the records of the national child care centers and schools
Time frame: Up to 16 years of age
Sperm epigenetic profile
Determination of heritable phenotype
Time frame: 0 months
Sperm epigenetic profile
Determination of heritable phenotype
Time frame: 6 months
Transcriptome
RNA-sequencing
Time frame: 0 months
Transcriptome
RNA-sequencing
Time frame: 6 months
Sperm oxidative stress
the Male infertility Oxidative System test (MiOXSYS)
Time frame: 0 months
Sperm oxidative stress
the Male infertility Oxidative System test (MiOXSYS)
Time frame: 6 months
A cost-utility of the intervention
analysis based on WHOQOL-BREF Questionnaire and FertiQoL, relating the quality-adjusted life years (QALYS) to the costs of the intervention
Time frame: 3 years
QALY baseline
WHOQOL-BREF Questionnaire and FertiQoL International Questionnaire
Time frame: 0 months
QALY end point
WHOQOL-BREF Questionnaire and FertiQoL International Questionnaire
Time frame: 6 months
Cost-effectiveness
ICER
Time frame: 3 years
Static postural balance
Absolute reach distance measured on balance board, cm (FTC Functional training Company GmbH, AM Haag 10 D-82166 Gräfelfing Germany)
Time frame: 0 months
Static postural balance
Absolute reach distance measured on balance board, cm (FTC Functional training Company GmbH, AM Haag 10 D-82166 Gräfelfing Germany)
Time frame: 1st trimester of pregnancy
Static postural balance
Absolute reach distance measured on balance board, cm (FTC Functional training Company GmbH, AM Haag 10 D-82166 Gräfelfing Germany)
Time frame: 2nd trimester of pregnancy
Static postural balance
Absolute reach distance measured on balance board, cm (FTC Functional training Company GmbH, AM Haag 10 D-82166 Gräfelfing Germany)
Time frame: 3rd trimester of pregnancy
Static postural balance
Absolute reach distance measured on balance board, cm (FTC Functional training Company GmbH, AM Haag 10 D-82166 Gräfelfing Germany)
Time frame: 3 months postpartum
Perception of stress
Perceived Stress Scale by Sheldon Cohen
Time frame: 0 months
Perception of stress
Perceived Stress Scale by Sheldon Cohen
Time frame: 3 months
Perception of stress
Perceived Stress Scale by Sheldon Cohen
Time frame: 6 months
Personality dimensions
The Big Five Personality Test
Time frame: 0 months
Personality dimensions
The Big Five Personality Test
Time frame: 6 months
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