Clinical trial NCT04589793: COaching Lifestyle Intervention for FErtility
Official title: COaching Lifestyle Intervention for FErtility
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Life Style
Fertility Disorders
Keywords: Infertility
Life Style
Physical activity
Diet
Sleep and stress
Intervention
Obesity
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: University of Helsinki
name: University of Eastern Finland
First posted: 2020-10-19
Enrollment: 1560
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Behavior change
timeFrame: 6 months
measure: Live birth rate
timeFrame: 3 years
measure: Weight change
timeFrame: 6 months
Secondary outcomes:
measure: Infertility treatments, number
timeFrame: 3 years
measure: Infertility treatments, mode
timeFrame: 3 years
measure: Miscarriage rate
timeFrame: 3 years
measure: Height
timeFrame: 0 months
measure: Weight
timeFrame: 0 months
measure: Weight
timeFrame: 3 months
measure: Weight
timeFrame: 6 months
measure: Body mass index
timeFrame: 0 months
measure: Body mass index
timeFrame: 3 months
measure: Body mass index
timeFrame: 6 months
measure: Body composition
timeFrame: 0 months
measure: Body composition
timeFrame: 3 months
measure: Body composition
timeFrame: 6 months
measure: Waist circumference
timeFrame: 0 months
measure: Waist circumference
timeFrame: 3 months
measure: Waist circumference
timeFrame: 6 months
measure: Self-reported physical activity
timeFrame: 0 months
measure: Self-reported physical activity
timeFrame: 6 months
measure: Physical activity
timeFrame: 0 months
measure: Physical activity
timeFrame: 3 months
measure: Physical activity
timeFrame: 6 months
measure: Maximal oxygen uptake
timeFrame: 0 months
measure: Maximal oxygen uptake
timeFrame: 3 months
measure: Maximal oxygen uptake
timeFrame: 6 months
measure: Dietary content
timeFrame: 0 months
measure: Dietary content
timeFrame: 6 months
measure: Dietary patterns
timeFrame: 0 months
measure: Dietary patterns
timeFrame: 6 months
measure: Folate
timeFrame: 0 months
measure: Folate
timeFrame: 6 months
measure: Vitamin-D
timeFrame: 0 months
measure: Vitamin-D
timeFrame: 6 months
measure: Zinc
timeFrame: 0 months
measure: Zinc
timeFrame: 6 months
measure: Carbohydrates
timeFrame: 0 months
measure: Carbohydrates
timeFrame: 6 months
measure: Protein
timeFrame: 0 months
measure: Protein
timeFrame: 6 months
measure: Alcohol
timeFrame: 0 months
measure: Alcohol
timeFrame: 6 months
measure: n-3 fatty acids
timeFrame: 0 months
measure: n-3 fatty acids
timeFrame: 6 months
measure: n-6 fatty acids
timeFrame: 0 months
measure: n-6 fatty acids
timeFrame: 6 months
measure: Saturated fatty acids
timeFrame: 0 months
measure: Saturated fatty acids
timeFrame: 6 months
measure: Monounsaturated fatty acids
timeFrame: 0 months
measure: Monounsaturated fatty acids
timeFrame: 6 months
measure: Polyunsaturated fatty acids
timeFrame: 0 months
measure: Polyunsaturated fatty acids
timeFrame: 6 months
measure: Sleep
timeFrame: 0 months
measure: Sleep
timeFrame: 6 months
measure: Sleep, measured
timeFrame: 0 months
measure: Sleep, measured
timeFrame: 3 months
measure: Sleep, measured
timeFrame: 6 months
measure: Stress recovery
timeFrame: 0 months
measure: Stress recovery
timeFrame: 3 months
measure: Stress recovery
timeFrame: 6 months
measure: Anxiety and depression
timeFrame: 0 months
measure: Anxiety and depression
timeFrame: 3 months
measure: Anxiety and depression
timeFrame: 6 months
measure: Fertility quality of life
timeFrame: 0 months
measure: Fertility quality of life
timeFrame: 6 months
measure: Depression
timeFrame: 0 months
measure: Depression
timeFrame: 6 months
measure: Self-determined motivation for physical activity
timeFrame: 0 months
measure: Self-determined motivation for physical activity
timeFrame: 6 months
measure: Intention and action planning for physical activity; Intention to increase physical activity
timeFrame: 0 months
measure: Intention and action planning for physical activity; Intention to increase physical activity
timeFrame: 6 months
measure: Self-efficacy for physical activity
timeFrame: 0 months
measure: Self-efficacy for physical activity
timeFrame: 6 months
measure: Pregnancy complications
timeFrame: 3 years
measure: Delivery complications
timeFrame: 3 years
measure: Neonatal outcome
timeFrame: 3 years
measure: Body composition of the newborn
timeFrame: At birth
measure: Growth of the child
timeFrame: Up to 16 years of age
measure: Sperm epigenetic profile
timeFrame: 0 months
measure: Sperm epigenetic profile
timeFrame: 6 months
measure: Transcriptome
timeFrame: 0 months
measure: Transcriptome
timeFrame: 6 months
measure: Sperm oxidative stress
timeFrame: 0 months
measure: Sperm oxidative stress
timeFrame: 6 months
measure: A cost-utility of the intervention
timeFrame: 3 years
measure: QALY baseline
timeFrame: 0 months
measure: QALY end point
timeFrame: 6 months
measure: Cost-effectiveness
timeFrame: 3 years
measure: Static postural balance
timeFrame: 0 months
measure: Static postural balance
timeFrame: 1st trimester of pregnancy
measure: Static postural balance
timeFrame: 2nd trimester of pregnancy
measure: Static postural balance
timeFrame: 3rd trimester of pregnancy
measure: Static postural balance
timeFrame: 3 months postpartum
measure: Perception of stress
timeFrame: 0 months
measure: Perception of stress
timeFrame: 3 months
measure: Perception of stress
timeFrame: 6 months
measure: Personality dimensions
timeFrame: 0 months
measure: Personality dimensions
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Helsinki University Central Hospital
name: Juha Tapanainen, professor
role: PRINCIPAL_INVESTIGATOR
References: