COaching Lifestyle Intervention for FErtility NCT04589793

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number	NCT04589793
Other study ID #	TYH2020338
Secondary ID
Status	Not yet recruiting
Phase	N/A
First received
Last updated
Start date	October 2021
Est. completion date	September 2025

Study information
Verified date	August 2021
Source	Helsinki University Central Hospital
Contact	Maritta Poyhonen-Alho, PhD
Phone	+358 50 428 4690
Email	maritta.poyhonen-alho[@]hus.fi
Is FDA regulated	No
Health authority
Study type	Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status	Not yet recruiting
Enrollment	1560
Est. completion date	September 2025
Est. primary completion date	September 2024
Accepts healthy volunteers	Accepts Healthy Volunteers
Gender	All
Age group	18 Years to 40 Years
Eligibility	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)

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Life Style
Life Style intervention including physical activity, diet, sleep and stress

Locations
Country	Name	City	State
n/a

Sponsors *(3)*
Lead Sponsor	Collaborator
Helsinki University Central Hospital	University of Eastern Finland, University of Helsinki

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

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COaching Lifestyle Intervention for FErtility

Clinical Trial Details — Status: Not yet recruiting

Administrative data

Study information

Clinical Trial Summary

Recruitment information / eligibility

Study Design

Related Conditions & MeSH terms

Intervention

Locations

Sponsors (3)

Outcome