COaching Lifestyle Intervention for FErtility (COLIFE)
2021年8月6日 更新者：Maritta Poyhonen-Alho、Helsinki University Central Hospital
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.
研究概览
研究类型
介入性
注册 (预期的)
1560
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Maritta Poyhonen-Alho, PhD
- 电话号码：+358 50 428 4690
- 邮箱：maritta.poyhonen-alho@hus.fi
研究联系人备份
- 姓名：Paivi Joki-Korpela, PhD
- 电话号码：+358
- 邮箱：paivi.joki-korpela@hus.fi
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 40年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
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)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预：控制
常规治疗
|
|
|
有源比较器：Intervention
Motivational interview
|
Life Style intervention including physical activity, diet, sleep and stress
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Behavior change
大体时间：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
|
6 months
|
|
Live birth rate
大体时间：3 years
|
Number of live children born
|
3 years
|
|
Weight change
大体时间：6 months
|
weight in kg measured without shoes and with light clothing at the beginning, at 3 and 6 months
|
6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Infertility treatments, number
大体时间：3 years
|
Number of infertility treatments needed for a live birth
|
3 years
|
|
Infertility treatments, mode
大体时间：3 years
|
Mode of infertility treatments needed for a live birth (including ovulation induction, insemination, IVF, ICSI)
|
3 years
|
|
Miscarriage rate
大体时间：3 years
|
Number of miscarriages
|
3 years
|
|
Height
大体时间：0 months
|
Measured without shoes (cm)
|
0 months
|
|
Weight
大体时间：0 months
|
Measured without shoes and with light clothing (kg)
|
0 months
|
|
Weight
大体时间：3 months
|
Measured without shoes and with light clothing (kg)
|
3 months
|
|
Weight
大体时间：6 months
|
Measured without shoes and with light clothing (kg)
|
6 months
|
|
Body mass index
大体时间：0 months
|
Weight in kilograms divided by the square of height in meters
|
0 months
|
|
Body mass index
大体时间：3 months
|
Weight in kilograms divided by the square of height in meters
|
3 months
|
|
Body mass index
大体时间：6 months
|
Weight in kilograms divided by the square of height in meters
|
6 months
|
|
Body composition
大体时间：0 months
|
Bioimpedance method
|
0 months
|
|
Body composition
大体时间：3 months
|
Bioimpedance method
|
3 months
|
|
Body composition
大体时间：6 months
|
Bioimpedance method
|
6 months
|
|
Waist circumference
大体时间：0 months
|
measured at midpoint between the lower margin of the last palpable rib and the top of the iliac crest (cm)
|
0 months
|
|
Waist circumference
大体时间：3 months
|
measured at midpoint between the lower margin of the last palpable rib and the top of the iliac crest (cm)
|
3 months
|
|
Waist circumference
大体时间：6 months
|
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
大体时间：0 months
|
Minutes per week, International Physical Activity Questionnaire - Short Form
|
0 months
|
|
Self-reported physical activity
大体时间：6 months
|
Minutes per week, International Physical Activity Questionnaire - Short Form
|
6 months
|
|
Physical activity
大体时间：0 months
|
Amount of weekly physical activity, data from Oura ring 3-dimensional accelerometer
|
0 months
|
|
Physical activity
大体时间：3 months
|
Amount of weekly physical activity, data from Oura ring 3-dimensional accelerometer
|
3 months
|
|
Physical activity
大体时间：6 months
|
Amount of weekly physical activity, data from Oura ring 3-dimensional accelerometer
|
6 months
|
|
Maximal oxygen uptake
大体时间：0 months
|
Functional aerobic capacity prediction model (N-Ex BMI) by Johnson et al 1990
|
0 months
|
|
Maximal oxygen uptake
大体时间：3 months
|
Functional aerobic capacity prediction model (N-Ex BMI) by Johnson et al 1990
|
3 months
|
|
Maximal oxygen uptake
大体时间：6 months
|
Functional aerobic capacity prediction model (N-Ex BMI) by Johnson et al 1990
|
6 months
|
|
Dietary content
大体时间：0 months
|
FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17_FFQ_ENG_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a)
|
0 months
|
|
Dietary content
大体时间：6 months
|
FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17_FFQ_ENG_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a)
|
6 months
|
|
Dietary patterns
大体时间：0 months
|
FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17_FFQ_ENG_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a)
|
0 months
|
|
Dietary patterns
大体时间：6 months
|
FinTerveys dietary questionnaire (https://thl.fi/documents/189940/4779595/FT17_FFQ_ENG_paino.pdf/4a2ef46b-272e-4bb4-827c-e1cb1314f09a)
|
6 months
|
|
Folate
大体时间：0 months
|
Plasma folate concentration
|
0 months
|
|
Folate
大体时间：6 months
|
Plasma folate concentration
|
6 months
|
|
Vitamin-D
大体时间：0 months
|
Plasma vitamin-D concentration
|
0 months
|
|
Vitamin-D
大体时间：6 months
|
Plasma vitamin-D concentration
|
6 months
|
|
Zinc
大体时间：0 months
|
Plasma zinc concentration
|
0 months
|
|
Zinc
大体时间：6 months
|
Plasma zinc concentration
|
6 months
|
|
Carbohydrates
大体时间：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
|
0 months
|
|
Carbohydrates
大体时间：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
|
6 months
|
|
Protein
大体时间：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
|
0 months
|
|
Protein
大体时间：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
|
6 months
|
|
Alcohol
大体时间：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
|
0 months
|
|
Alcohol
大体时间：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
|
6 months
|
|
n-3 fatty acids
大体时间：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
|
0 months
|
|
n-3 fatty acids
大体时间：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
|
6 months
|
|
n-6 fatty acids
大体时间：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
|
0 months
|
|
n-6 fatty acids
大体时间：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
|
6 months
|
|
Saturated fatty acids
大体时间：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
|
0 months
|
|
Saturated fatty acids
大体时间：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
|
6 months
|
|
Monounsaturated fatty acids
大体时间：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
|
0 months
|
|
Monounsaturated fatty acids
大体时间：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
|
6 months
|
|
Polyunsaturated fatty acids
大体时间：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
|
0 months
|
|
Polyunsaturated fatty acids
大体时间：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
|
6 months
|
|
Sleep
大体时间：0 months
|
Quality of sleep, Basic Nordic Sleep Questionnaire (BNSQ)
|
0 months
|
|
Sleep
大体时间：6 months
|
Quality of sleep, Basic Nordic Sleep Questionnaire (BNSQ)
|
6 months
|
|
Sleep, measured
大体时间：0 months
|
Quality, sleep disruptions, total sleep duration registered by Oura ring application
|
0 months
|
|
Sleep, measured
大体时间：3 months
|
Quality, sleep disruptions, total sleep duration registered by Oura ring application
|
3 months
|
|
Sleep, measured
大体时间：6 months
|
Quality, sleep disruptions, total sleep duration registered by Oura ring application
|
6 months
|
|
Stress recovery
大体时间：0 months
|
Night-time heart rate variability regisered by Oura ring application
|
0 months
|
|
Stress recovery
大体时间：3 months
|
Night-time heart rate variability registered by Oura ring application
|
3 months
|
|
Stress recovery
大体时间：6 months
|
Night-time heart rate variability registered by Oura ring application
|
6 months
|
|
Anxiety and depression
大体时间：0 months
|
Hospital Anxiety and Depression Scale (HADS)
|
0 months
|
|
Anxiety and depression
大体时间：3 months
|
Hospital Anxiety and Depression Scale (HADS)
|
3 months
|
|
焦虑和抑郁
大体时间：6个月
|
医院焦虑抑郁量表 (HADS)
|
6个月
|
|
Fertility quality of life
大体时间：0 months
|
FertiQoL International Questionnaire
|
0 months
|
|
Fertility quality of life
大体时间：6 months
|
FertiQoL International Questionnaire
|
6 months
|
|
Depression
大体时间：0 months
|
Edinburgh Postnatal Depression Scale (EPDS) Questionnaire
|
0 months
|
|
Depression
大体时间：6 months
|
Edinburgh Postnatal Depression Scale (EPDS) Questionnaire
|
6 months
|
|
Self-determined motivation for physical activity
大体时间：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.
|
0 months
|
|
Self-determined motivation for physical activity
大体时间：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
|
6 months
|
|
Intention and action planning for physical activity; Intention to increase physical activity
大体时间：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)
|
0 months
|
|
Intention and action planning for physical activity; Intention to increase physical activity
大体时间：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)
|
6 months
|
|
Self-efficacy for physical activity
大体时间：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)
|
0 months
|
|
Self-efficacy for physical activity
大体时间：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)
|
6 months
|
|
Pregnancy complications
大体时间：3 years
|
Number of pregnancy complications (gestational diabetes, pre-eclampsia, hypertension, fetal growth disorders, preterm birth)
|
3 years
|
|
Delivery complications
大体时间：3 years
|
Number of delivery complications (cesarean section, assisted vaginal delivery, hemorrhage)
|
3 years
|
|
Neonatal outcome
大体时间：3 years
|
Birth weight, cord pH, Apgar score
|
3 years
|
|
Body composition of the newborn
大体时间：At birth
|
Bioimpedance method
|
At birth
|
|
Growth of the child
大体时间：Up to 16 years of age
|
From the records of the national child care centers and schools
|
Up to 16 years of age
|
|
Sperm epigenetic profile
大体时间：0 months
|
Determination of heritable phenotype
|
0 months
|
|
Sperm epigenetic profile
大体时间：6 months
|
Determination of heritable phenotype
|
6 months
|
|
Transcriptome
大体时间：0 months
|
RNA-sequencing
|
0 months
|
|
Transcriptome
大体时间：6 months
|
RNA-sequencing
|
6 months
|
|
Sperm oxidative stress
大体时间：0 months
|
the Male infertility Oxidative System test (MiOXSYS)
|
0 months
|
|
Sperm oxidative stress
大体时间：6 months
|
the Male infertility Oxidative System test (MiOXSYS)
|
6 months
|
|
A cost-utility of the intervention
大体时间：3 years
|
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
大体时间：0 months
|
WHOQOL-BREF Questionnaire and FertiQoL International Questionnaire
|
0 months
|
|
QALY end point
大体时间：6 months
|
WHOQOL-BREF Questionnaire and FertiQoL International Questionnaire
|
6 months
|
|
Cost-effectiveness
大体时间：3 years
|
ICER
|
3 years
|
|
Static postural balance
大体时间：0 months
|
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
大体时间：1st trimester of pregnancy
|
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
大体时间：2nd trimester of pregnancy
|
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
大体时间：3rd trimester of pregnancy
|
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
大体时间：3 months postpartum
|
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
大体时间：0 months
|
Perceived Stress Scale by Sheldon Cohen
|
0 months
|
|
Perception of stress
大体时间：3 months
|
Perceived Stress Scale by Sheldon Cohen
|
3 months
|
|
Perception of stress
大体时间：6 months
|
Perceived Stress Scale by Sheldon Cohen
|
6 months
|
|
Personality dimensions
大体时间：0 months
|
The Big Five Personality Test
|
0 months
|
|
Personality dimensions
大体时间：6 months
|
The Big Five Personality Test
|
6 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Juha Tapanainen, professor、Helsinki University Central Hospital
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (预期的)
2021年10月1日
初级完成 (预期的)
2024年9月1日
研究完成 (预期的)
2025年9月1日
研究注册日期
首次提交
2020年10月9日
首先提交符合 QC 标准的
2020年10月9日
首次发布 (实际的)
2020年10月19日
研究记录更新
最后更新发布 (实际的)
2021年8月12日
上次提交的符合 QC 标准的更新
2021年8月6日
最后验证
2021年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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