COaching Lifestyle Intervention for FErtility
- Conditions
- Life StyleFertility Disorders
- Interventions
- Behavioral: Life Style
- Registration Number
- NCT04589793
- Lead Sponsor
- Helsinki University Central Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 1560
- infertility
- BMI 27-34.9 kg/m2
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Life Style Motivational interview
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method n-6 fatty acids 6 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
Growth of the child Up to 16 years of age From the records of the national child care centers and schools
Transcriptome 6 months RNA-sequencing
Sperm oxidative stress 6 months the Male infertility Oxidative System test (MiOXSYS)
Folate 6 months Plasma folate concentration
Infertility treatments, number 3 years Number of infertility treatments needed for a live birth
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 6 months Measured without shoes and with light clothing (kg)
Body mass index 6 months Weight in kilograms divided by the square of height in meters
Waist circumference 6 months measured at midpoint between the lower margin of the last palpable rib and the top of the iliac crest (cm)
Protein 6 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
Body composition 6 months Bioimpedance method
Self-reported physical activity 6 months Minutes per week, International Physical Activity Questionnaire - Short Form
Physical activity 6 months Amount of weekly physical activity, data from Oura ring 3-dimensional accelerometer
Maximal oxygen uptake 6 months Functional aerobic capacity prediction model (N-Ex BMI) by Johnson et al 1990
Dietary content 6 months FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17_FFQ_ENG_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a)
Alcohol 6 months Alcohol consumption per week, FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17_FFQ_ENG_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a
Saturated fatty acids 6 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 6 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
Dietary patterns 6 months FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17_FFQ_ENG_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a)
Vitamin-D 6 months Plasma vitamin-D concentration
Zinc 6 months Plasma zinc concentration
Carbohydrates 6 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
Delivery complications 3 years Number of delivery complications (cesarean section, assisted vaginal delivery, hemorrhage)
n-3 fatty acids 6 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
Neonatal outcome 3 years Birth weight, cord pH, Apgar score
Body composition of the newborn At birth Bioimpedance method
Sleep, measured 6 months Quality, sleep disruptions, total sleep duration registered by Oura ring application
Polyunsaturated fatty acids 6 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 6 months Quality of sleep, Basic Nordic Sleep Questionnaire (BNSQ)
Intention and action planning for physical activity; Intention to increase physical activity 6 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)
Sperm epigenetic profile 6 months Determination of heritable phenotype
Stress recovery 6 months Night-time heart rate variability registered by Oura ring application
Anxiety and depression 6 months Hospital Anxiety and Depression Scale (HADS)
Fertility quality of life 6 months FertiQoL International Questionnaire
Depression 6 months Edinburgh Postnatal Depression Scale (EPDS) Questionnaire
Self-efficacy for physical activity 6 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)
Self-determined motivation for physical activity 6 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
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
Cost-effectiveness 3 years ICER
Perception of stress 6 months Perceived Stress Scale by Sheldon Cohen
Personality dimensions 6 months The Big Five Personality Test
Static postural balance 3 months postpartum Absolute reach distance measured on balance board, cm (FTC Functional training Company GmbH, AM Haag 10 D-82166 Gräfelfing Germany)