COaching Lifestyle Intervention for FErtility (COLIFE)

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 Overview

• Status: Not yet recruiting
• Conditions: Fertility Disorders; Life Style
• Intervention / Treatment: Behavioral: Life Style

• Study Type: Interventional
• Enrollment (Anticipated): 1560
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maritta Poyhonen-Alho, PhD; Phone Number: +358 50 428 4690; Email: maritta.poyhonen-alho@hus.fi
• Study Contact Backup: Name: Paivi Joki-Korpela, PhD; Phone Number: +358; Email: paivi.joki-korpela@hus.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Conventional treatment
Active Comparator: Intervention; Motivational interview	Behavioral: Life Style; Life Style intervention including physical activity, diet, sleep and stress

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Collaborators: University of Helsinki; University of Eastern Finland
• Investigators: Principal Investigator: Juha Tapanainen, professor, Helsinki University Central Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2021
• Primary Completion (Anticipated): September 1, 2024
• Study Completion (Anticipated): September 1, 2025

Study Registration Dates

• First Submitted: October 9, 2020
• First Submitted That Met QC Criteria: October 9, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): August 12, 2021
• Last Update Submitted That Met QC Criteria: August 6, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Obesity; Infertility; Physical activity; Diet; Intervention; Life Style; Sleep and stress
• Other Study ID Numbers: TYH2020338

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: According to request and after consideration of the study group

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No