COaching Lifestyle Intervention for FErtility

Study Overview
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Brief Summary
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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.

Official Title
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COaching Lifestyle Intervention for FErtility

Conditions
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Life Style, Fertility Disorders

Intervention / Treatment
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* Behavioral: Life Style


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: infertility BMI 27-34.9 kg/m2 Exclusion Criteria: no mobile device available evident sperm defect or ovarian tube block hinder for fluent treatment schedule due to the subjec´s obstacle (inadequate language skills, major time table problems)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Conventional treatment | |
| Active Comparator: Intervention<br>Motivational interview | Behavioral: Life Style<br>* Life Style intervention including physical activity, diet, sleep and stress<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 months | 
| Live birth rate | Number of live children born | 3 years | 
| Weight change | weight in kg measured without shoes and with light clothing at the beginning, at 3 and 6 months | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infertility treatments, number | Number of infertility treatments needed for a live birth | 3 years | 
| Infertility treatments, mode | Mode of infertility treatments needed for a live birth (including ovulation induction, insemination, IVF, ICSI) | 3 years | 
| Miscarriage rate | Number of miscarriages | 3 years | 
| Height | Measured without shoes (cm) | 0 months | 
| Weight | Measured without shoes and with light clothing (kg) | 0 months | 
| Weight | Measured without shoes and with light clothing (kg) | 3 months | 
| Weight | Measured without shoes and with light clothing (kg) | 6 months | 
| Body mass index | Weight in kilograms divided by the square of height in meters | 0 months | 
| Body mass index | Weight in kilograms divided by the square of height in meters | 3 months | 
| Body mass index | Weight in kilograms divided by the square of height in meters | 6 months | 
| Body composition | Bioimpedance method | 0 months | 
| Body composition | Bioimpedance method | 3 months | 
| Body composition | Bioimpedance method | 6 months | 
| Waist circumference | measured at midpoint between the lower margin of the last palpable rib and the top of the iliac crest (cm) | 0 months | 
| Waist circumference | measured at midpoint between the lower margin of the last palpable rib and the top of the iliac crest (cm) | 3 months | 
| Waist circumference | measured at midpoint between the lower margin of the last palpable rib and the top of the iliac crest (cm) | 6 months | 
| Self-reported physical activity | Minutes per week, International Physical Activity Questionnaire - Short Form | 0 months | 
| Self-reported physical activity | Minutes per week, International Physical Activity Questionnaire - Short Form | 6 months | 
| Physical activity | Amount of weekly physical activity, data from Oura ring 3-dimensional accelerometer | 0 months | 
| Physical activity | Amount of weekly physical activity, data from Oura ring 3-dimensional accelerometer | 3 months | 
| Physical activity | Amount of weekly physical activity, data from Oura ring 3-dimensional accelerometer | 6 months | 
| Maximal oxygen uptake | Functional aerobic capacity prediction model (N-Ex BMI) by Johnson et al 1990 | 0 months | 
| Maximal oxygen uptake | Functional aerobic capacity prediction model (N-Ex BMI) by Johnson et al 1990 | 3 months | 
| Maximal oxygen uptake | Functional aerobic capacity prediction model (N-Ex BMI) by Johnson et al 1990 | 6 months | 
| Dietary content | FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17_FFQ_ENG_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a) | 0 months | 
| Dietary content | FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17_FFQ_ENG_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a) | 6 months | 
| Dietary patterns | FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17_FFQ_ENG_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a) | 0 months | 
| Dietary patterns | FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17_FFQ_ENG_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a) | 6 months | 
| Folate | Plasma folate concentration | 0 months | 
| Folate | Plasma folate concentration | 6 months | 
| Vitamin-D | Plasma vitamin-D concentration | 0 months | 
| Vitamin-D | Plasma vitamin-D concentration | 6 months | 
| Zinc | Plasma zinc concentration | 0 months | 
| Zinc | Plasma zinc concentration | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 6 months | 
| Sleep | Quality of sleep, Basic Nordic Sleep Questionnaire (BNSQ) | 0 months | 
| Sleep | Quality of sleep, Basic Nordic Sleep Questionnaire (BNSQ) | 6 months | 
| Sleep, measured | Quality, sleep disruptions, total sleep duration registered by Oura ring application | 0 months | 
| Sleep, measured | Quality, sleep disruptions, total sleep duration registered by Oura ring application | 3 months | 
| Sleep, measured | Quality, sleep disruptions, total sleep duration registered by Oura ring application | 6 months | 
| Stress recovery | Night-time heart rate variability regisered by Oura ring application | 0 months | 
| Stress recovery | Night-time heart rate variability registered by Oura ring application | 3 months | 
| Stress recovery | Night-time heart rate variability registered by Oura ring application | 6 months | 
| Anxiety and depression | Hospital Anxiety and Depression Scale (HADS) | 0 months | 
| Anxiety and depression | Hospital Anxiety and Depression Scale (HADS) | 3 months | 
| Anxiety and depression | Hospital Anxiety and Depression Scale (HADS) | 6 months | 
| Fertility quality of life | FertiQoL International Questionnaire | 0 months | 
| Fertility quality of life | FertiQoL International Questionnaire | 6 months | 
| Depression | Edinburgh Postnatal Depression Scale (EPDS) Questionnaire | 0 months | 
| Depression | Edinburgh Postnatal Depression Scale (EPDS) Questionnaire | 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. | 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 | 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) | 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) | 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) | 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) | 6 months | 
| Pregnancy complications | Number of pregnancy complications (gestational diabetes, pre-eclampsia, hypertension, fetal growth disorders, preterm birth) | 3 years | 
| Delivery complications | Number of delivery complications (cesarean section, assisted vaginal delivery, hemorrhage) | 3 years | 
| Neonatal outcome | Birth weight, cord pH, Apgar score | 3 years | 
| Body composition of the newborn | Bioimpedance method | At birth | 
| Growth of the child | From the records of the national child care centers and schools | Up to 16 years of age | 
| Sperm epigenetic profile | Determination of heritable phenotype | 0 months | 
| Sperm epigenetic profile | Determination of heritable phenotype | 6 months | 
| Transcriptome | RNA-sequencing | 0 months | 
| Transcriptome | RNA-sequencing | 6 months | 
| Sperm oxidative stress | the Male infertility Oxidative System test (MiOXSYS) | 0 months | 
| Sperm oxidative stress | the Male infertility Oxidative System test (MiOXSYS) | 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 | 3 years | 
| QALY baseline | WHOQOL-BREF Questionnaire and FertiQoL International Questionnaire | 0 months | 
| QALY end point | WHOQOL-BREF Questionnaire and FertiQoL International Questionnaire | 6 months | 
| Cost-effectiveness | ICER | 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) | 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) | 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) | 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) | 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) | 3 months postpartum | 
| Perception of stress | Perceived Stress Scale by Sheldon Cohen | 0 months | 
| Perception of stress | Perceived Stress Scale by Sheldon Cohen | 3 months | 
| Perception of stress | Perceived Stress Scale by Sheldon Cohen | 6 months | 
| Personality dimensions | The Big Five Personality Test | 0 months | 
| Personality dimensions | The Big Five Personality Test | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infertility, Life Style, Physical activity, Diet, Sleep and stress, Intervention, Obesity