Fertility Disorders, Life Style
Conditions
Keywords
Infertility, Life Style, Physical activity, Diet, Sleep and stress, Intervention, Obesity
Brief summary
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.
Interventions
BEHAVIORALLife Style
Life Style intervention including physical activity, diet, sleep and stress
Sponsors
University of Helsinki
University of Eastern Finland
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Behavior change | 6 months | 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 |
| Live birth rate | 3 years | Number of live children born |
| Weight change | 6 months | weight in kg measured without shoes and with light clothing at the beginning, at 3 and 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infertility treatments, mode | 3 years | Mode of infertility treatments needed for a live birth (including ovulation induction, insemination, IVF, ICSI) |
| Miscarriage rate | 3 years | Number of miscarriages |
| Height | 0 months | Measured without shoes (cm) |
| Weight | 0 months | Measured without shoes and with light clothing (kg) |
| Body mass index | 0 months | Weight in kilograms divided by the square of height in meters |
| Body composition | 0 months | Bioimpedance method |
| Waist circumference | 0 months | measured at midpoint between the lower margin of the last palpable rib and the top of the iliac crest (cm) |
| Self-reported physical activity | 0 months | Minutes per week, International Physical Activity Questionnaire - Short Form |
| Physical activity | 0 months | Amount of weekly physical activity, data from Oura ring 3-dimensional accelerometer |
| Maximal oxygen uptake | 0 months | Functional aerobic capacity prediction model (N-Ex BMI) by Johnson et al 1990 |
| Dietary content | 0 months | FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17\_FFQ\_ENG\_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a) |
| Dietary patterns | 0 months | FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17\_FFQ\_ENG\_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a) |
| Folate | 0 months | Plasma folate concentration |
| Vitamin-D | 0 months | Plasma vitamin-D concentration |
| Zinc | 0 months | Plasma zinc concentration |
| Carbohydrates | 0 months | 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 |
| Protein | 0 months | 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 |
| Alcohol | 0 months | Alcohol consumption per week, FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17\_FFQ\_ENG\_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a |
| n-3 fatty acids | 0 months | 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 |
| n-6 fatty acids | 0 months | 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 |
| Saturated fatty acids | 0 months | 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 |
| Monounsaturated fatty acids | 0 months | 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 |
| Polyunsaturated fatty acids | 0 months | 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 |
| Sleep | 0 months | Quality of sleep, Basic Nordic Sleep Questionnaire (BNSQ) |
| Sleep, measured | 0 months | Quality, sleep disruptions, total sleep duration registered by Oura ring application |
| Stress recovery | 0 months | Night-time heart rate variability regisered by Oura ring application |
| Anxiety and depression | 0 months | Hospital Anxiety and Depression Scale (HADS) |
| Fertility quality of life | 0 months | FertiQoL International Questionnaire |
| Depression | 0 months | Edinburgh Postnatal Depression Scale (EPDS) Questionnaire |
| Self-determined motivation for physical activity | 0 months | 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. |
| Intention and action planning for physical activity; Intention to increase physical activity | 0 months | 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) |
| Self-efficacy for physical activity | 0 months | 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) |
| Pregnancy complications | 3 years | Number of pregnancy complications (gestational diabetes, pre-eclampsia, hypertension, fetal growth disorders, preterm birth) |
| Delivery complications | 3 years | Number of delivery complications (cesarean section, assisted vaginal delivery, hemorrhage) |
| Neonatal outcome | 3 years | Birth weight, cord pH, Apgar score |
| Body composition of the newborn | At birth | Bioimpedance method |
| Growth of the child | Up to 16 years of age | From the records of the national child care centers and schools |
| Sperm oxidative stress | 0 months | the Male infertility Oxidative System test (MiOXSYS) |
| A cost-utility of the intervention | 3 years | analysis based on WHOQOL-BREF Questionnaire and FertiQoL, relating the quality-adjusted life years (QALYS) to the costs of the intervention |
| QALY baseline | 0 months | WHOQOL-BREF Questionnaire and FertiQoL International Questionnaire |
| QALY end point | 6 months | WHOQOL-BREF Questionnaire and FertiQoL International Questionnaire |
| Sperm epigenetic profile | 0 months | Determination of heritable phenotype |
| Static postural balance | 0 months | Absolute reach distance measured on balance board, cm (FTC Functional training Company GmbH, AM Haag 10 D-82166 Gräfelfing Germany) |
| Perception of stress | 0 months | Perceived Stress Scale by Sheldon Cohen |
| Personality dimensions | 0 months | The Big Five Personality Test |
| Cost-effectiveness | 3 years | ICER |
| Transcriptome | 0 months | RNA-sequencing |
| Infertility treatments, number | 3 years | Number of infertility treatments needed for a live birth |
Contacts
Primary ContactMaritta Poyhonen-Alho, PhD
Backup ContactPaivi Joki-Korpela, PhD
Outcome results
None listed