- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02686502
Motivation Makes the Move! (MoMaMo!)
This study evaluates the effect and usability of mobile and cloud technology -based intervention on lifestyle modification in 18-40 year obese and overweight subjects.
The study has a dose-response design with three randomized subjects groups from Mode 1 to Mode 3 with increasing intensity of intervention (guidance, exercise program, diet, support). The special focus of this study is on motivation and use of music and mobile health devices as motivational tools to support individualized exercise training, healthy diet and overall healthy life style.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Obesity negatively impacts health in many ways. It is associated with metabolic diseases and mood disorders and in women pregnancy outcome as well as the health of the offspring.
The modern evolution of societies steers populations towards a profound sedentary lifestyle. Physical activity brings about health benefits, however, the risk reduction for chronic diseases remains significantly greater for fitness than physical activity per se. The recent knowledge suggest Individualized approach rather than general guidelines for exercise in prevention-oriented strategies.
In this study we compare three different intensities of lifestyle intervention: 1) general guidelines for healthy exercise and diet, 2) individual program,and 3) highly individual program. Individual programs will be based on pre-examinations including interview and clinical exercise test. Mobile and cloud technologies will be used to collect data and steer the subjects´ lifestyles and daily activities and together with music to motivate them. The duration of the active intervention is 3 months and it will continue on a self-governing basis up to 1 year. The primary outcome is maximal oxygen consumption (VO2max), and secondary outcomes are physical activity, cardio-respiratory and cardiovascular parameters, blood volume, total hemoglobin mass, metabolic health along with chronic low-grade inflammation and well-being.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Helsinki, Finland
- Helsinki University Hospital
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Vantaa, Finland
- Vantaa Health Care and Social Services
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- BMI ≥ 27,5 kg/m2
- estimated by health care personnel to benefit from lifestyle modification
Exclusion Criteria:
- inability to perform exercise testing and intervention (physical, mental or other reason)
- not able to operate in Finnish (some applications only in Finnish for the time being)
- severe anemia (Hb<108 g/l for women and < 124 g/l for men)
- smoking (disturbs autonomic nervous system measurements)
- regular medication affecting glucose metabolism (excluding insulin) or autonomic nervous system (e.g. beta blockers, SSRI)
- ongoing pregnancy or breast feeding
- prisoner
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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No Intervention: Mode 1
Current guidelines.
Subjects attending the examinations and the tests but not participating the individualized intervention.
The subjects will receive general guidance on healthy exercise and diet.
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Active Comparator: Mode 2
Individualized lifestyle intervention.
Exercise intervention will be based on submaximal ergometer test (estimated VO2max), clinical status, personal goals and preferences.
Intervention also includes diet counseling, multiprofessional team support, peer support and use of mobile health applications.
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As part of the intervention Mode 2 and 3 subjects will use various mobile health applications including heart rate monitor, global positioning system, diet diary, and weight, sleep and mood monitors.
They will also be offered music streaming service for e.g.
motivation and relaxation.
Other Names:
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Active Comparator: Mode 3
Highly individual lifestyle intervention.
In addition to Mode 2 arm intervention optimal intensity zones and volumes for individual exercise training will be determined based on advanced cardiopulmonary exercise test.
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As part of the intervention Mode 2 and 3 subjects will use various mobile health applications including heart rate monitor, global positioning system, diet diary, and weight, sleep and mood monitors.
They will also be offered music streaming service for e.g.
motivation and relaxation.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from measured baseline maximal O2 uptake (VO2max) at 3 months
Time Frame: 3 months
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3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline quality of life at 3 months
Time Frame: 3 months
|
Rand-36 questionnaire
|
3 months
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Change from baseline total plasma cholesterol at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline physical activity at 3 months
Time Frame: 3 months
|
The International Physical Activity Questionnaire short version (IPAQ-S)
|
3 months
|
Change from baseline body weight at 3 months
Time Frame: 3 months
|
weight in kilograms
|
3 months
|
Change from baseline quality of life at 1 year
Time Frame: 1 year
|
Rand-36 questionnaire
|
1 year
|
Change from baseline physical activity at 1 year
Time Frame: 1 year
|
The International Physical Activity Questionnaire short version (IPAQ-S)
|
1 year
|
Change from baseline body weight at 1 year
Time Frame: 1 year
|
weight in kilograms
|
1 year
|
Change from baseline total plasma cholesterol at 1 year
Time Frame: 1 year
|
1 year
|
|
Change from baseline plasma HDL cholesterol at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline plasma HDL cholesterol at 1 year
Time Frame: 1 year
|
1 year
|
|
Change from baseline plasma LDL cholesterol at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline plasma LDL cholesterol at 1 year
Time Frame: 1 year
|
1 year
|
|
Change from baseline plasma triglycerides at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline plasma triglycerides at 1 year
Time Frame: 1 year
|
1 year
|
|
Change from baseline blood glucose balance at 3 months
Time Frame: 3 months
|
Blood glucose balance assessed by 75-g 2 h oral glucose tolerance test
|
3 months
|
Change from baseline blood glucose balance at 1 year
Time Frame: 1 year
|
Blood glucose balance assessed by 75-g 2 h oral glucose tolerance test
|
1 year
|
Change from baseline fasting plasma insulin at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline fasting plasma insulin at 1 year
Time Frame: 1 year
|
1 year
|
|
Change from baseline body composition at 3 months
Time Frame: 3 months
|
Body composition assessed by bioimpedance
|
3 months
|
Change from baseline mood at 3 months
Time Frame: 3 months
|
PANAS questionnaire
|
3 months
|
Change from baseline mood at 1 year
Time Frame: 1 year
|
PANAS questionnaire
|
1 year
|
Change from baseline work productivity at 3 months
Time Frame: 3 months
|
Work Productivity and Activity Impairment Questionnaire (WPAI)
|
3 months
|
Change from baseline work productivity at 1 year
Time Frame: 1 year
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Work Productivity and Activity Impairment Questionnaire (WPAI)
|
1 year
|
Change from baseline sexual functions at 3 months (females)
Time Frame: 3 months
|
The Female Sexual Function Index (FSFI)
|
3 months
|
Change from baseline sexual functions at 1 year (females)
Time Frame: 1 year
|
The Female Sexual Function Index (FSFI)
|
1 year
|
Change from baseline music consumption at 3 months
Time Frame: 3 months
|
Music in Mood Regulation questionnaire (MMR)
|
3 months
|
Change from baseline music consumption at 1 year
Time Frame: 1 year
|
Music in Mood Regulation questionnaire (MMR)
|
1 year
|
Change from baseline calorie intake at 3 months
Time Frame: 3 months
|
Food diary filled during 3 consecutive days every 2 weeks
|
3 months
|
Change from baseline calorie intake at 1 year
Time Frame: 1 year
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Food diary filled during 3 consecutive days every 2 weeks
|
1 year
|
Change from baseline heart rate variability at 3 months
Time Frame: 3 months
|
3 day electrocardiography monitoring
|
3 months
|
Change from baseline heart rate variability at 1 year
Time Frame: 1 year
|
3 day electrocardiography monitoring
|
1 year
|
Change from baseline protein intake at 3 months
Time Frame: 3 months
|
Food diary filled during 3 consecutive days every 2 weeks
|
3 months
|
Change from baseline protein intake at 1 year
Time Frame: 1 year
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Food diary filled during 3 consecutive days every 2 weeks
|
1 year
|
Change from baseline fat intake at 3 months
Time Frame: 3 months
|
Food diary filled during 3 consecutive days every 2 weeks
|
3 months
|
Change from baseline fat intake at 1 year
Time Frame: 1 year
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Food diary filled during 3 consecutive days every 2 weeks
|
1 year
|
Change from baseline carbohydrate intake at 3 months
Time Frame: 3 months
|
Food diary filled during 3 consecutive days every 2 weeks
|
3 months
|
Change from baseline carbohydrate intake at 1 year
Time Frame: 1 year
|
Food diary filled during 3 consecutive days every 2 weeks
|
1 year
|
Height
Time Frame: 0 months
|
height measured in centimeters
|
0 months
|
Stability of personality
Time Frame: 0 months
|
Five Factor Personality test
|
0 months
|
Stability of personality
Time Frame: 3 months
|
Five Factor Personality test
|
3 months
|
Stability of personality
Time Frame: 1 year
|
Five Factor Personality test
|
1 year
|
Change from baseline depression at 3 months
Time Frame: 3 months
|
Beck questionnaire
|
3 months
|
Change from baseline depression at 1 year
Time Frame: 1 year
|
Beck questionnaire
|
1 year
|
Change from baseline waist-hip-ratio at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline waist-hip-ratio at 1 year
Time Frame: 1 year
|
1 year
|
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Change from baseline plasma ferritin (P-Ferrit) level at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline plasma ferritin (P-Ferrit) level at 1 year
Time Frame: 1 year
|
1 year
|
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Change from baseline plasma transferrin receptor (P-TfR) level at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline plasma transferrin receptor (P-TfR) level at 1 year
Time Frame: 1 year
|
1 year
|
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Change from baseline plasma sensitive C-reactive protein (CRP) level at 3 months
Time Frame: 3 months
|
3 months
|
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Change from baseline plasma sensitive C-reactive protein (CRP) level at 1 year
Time Frame: 1 year
|
1 year
|
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Change from baseline plasma tumor necrosis factor alpha alpha (P-TNF alpha) level at 3 months
Time Frame: 3 months
|
3 months
|
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Change from baseline plasma tumor necrosis factor alpha alpha (P-TNF alpha) level at 1 year
Time Frame: 1 year
|
1 year
|
|
Change from baseline plasma Interleukin-6 (IL6) level at 3 months
Time Frame: 3 months
|
3 months
|
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Change from baseline plasma Interleukin-6 (IL-6) level at 1 year
Time Frame: 1 year
|
1 year
|
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Change from baseline plasma Interleukin-10 (IL-10) level at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline plasma IInterleukin-10 (IL-10) level at 1 year
Time Frame: 1 year
|
1 year
|
|
Change from baseline plasma Interleukin-15 (IL-15) level at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline plasma Interleukin-15 (IL-15) level at 1 year
Time Frame: 1 year
|
1 year
|
|
Change from baseline plasma Interleukin-8 (IL-8) level at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline plasma Interleukin-8 (IL-8) level at 1 year
Time Frame: 1 year
|
1 year
|
|
Change from baseline plasma Interleukin-1 beta (IL-1 beta) level at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline plasma Interleukin-1 beta (IL-1 beta) level at 1 year
Time Frame: 1 year
|
1 year
|
|
Change from baseline body mass index (BMI) at 3 months
Time Frame: 3 months
|
BMI in kg/m^2
|
3 months
|
Change from baseline body mass index (BMI) at 1 year
Time Frame: 1 year
|
BMI in kg/m^2
|
1 year
|
Change from estimated (non-exercise questionnaire) baseline maximal O2 uptake (VO2max) at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from estimated (non-exercise questionnaire) baseline maximal O2 uptake (VO2max) at 1 year
Time Frame: 1 year
|
1 year
|
|
Change from estimated (step test) baseline VO2max at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from estimated (step test) baseline VO2max at 1 year
Time Frame: 1 year
|
1 year
|
|
Change from estimated (submaximal cycle ergometer exercise) baseline VO2max at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline maximal work rate (WR) at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline maximal and submaximal (work rate specific) pulmonary ventilation (VE) at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline maximal and submaximal (work rate specific) alveolar ventilation (VA) at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline maximal and submaximal (work rate specific) breathing frequency (Bf) at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline maximal and submaximal (work rate specific) tidal volume (VT) at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline maximal and submaximal (work rate specific) tidal volume - dead space ratio (VD/VT) at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline maximal and submaximal (work rate specific) end tidal O2 (PETO2) at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline maximal and submaximal (work rate specific) end tidal CO2 (PETCO2) at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline submaximal (work rate specific) VO2 at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline maximal and submaximal (work rate specific) CO2 production (VCO2) at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline maximal and submaximal (work rate specific) respiratory exchange ratio (RER) at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline maximal and submaximal (work rate specific) ventilatory equivalent for O2 uptake (VE/VO2) at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline maximal and submaximal (work rate specific) ventilatory equivalent for CO2 production (VE/VCO2) at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline maximal and submaximal (work rate specific) O2 pulse (VO2/HR) at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline resting heart rate (HR) at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline resting heart rate (HR) at 1 year
Time Frame: 1 year
|
1 year
|
|
Change from baseline resting blood pressure (BP, systolic, diastolic, pulse, mean) at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline resting blood pressure (BP, systolic, diastolic, pulse, mean) at 1 year
Time Frame: 1 year
|
1 year
|
|
Change from baseline maximal and submaximal (work rate specific) heart rate (HR) at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline maximal and submaximal (work rate specific) arterial blood pressure (BP, systolic, diastolic, pulse, mean) at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline maximal and submaximal (work rate specific) cardiac output (Q) at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline maximal and submaximal (work rate specific) stroke volume (SV) at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline maximal and submaximal (work rate specific) end-diastolic volume (EDV) at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline maximal and submaximal (work rate specific) ejection fraction (EF) at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline maximal and submaximal (work rate specific) cardiac index at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline maximal and submaximal (work rate specific) contractility index at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline maximal and submaximal (work rate specific) estimate of left ventricular ejection time at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline maximal and submaximal (work rate specific) left cardiac work index at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline maximal and submaximal (work rate specific) early diastolic function ratio at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline maximal and submaximal (work rate specific) calculated arteriovenous O2 difference ((a-v)O2) at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline maximal and submaximal (work rate specific) arterial O2 saturation (SpO2) at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline maximal and submaximal (work rate specific) calculated arterial O2 content (CaO2) heart rate (HR) at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline maximal and submaximal (work rate specific) calculated O2 delivery (QaO2) at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline maximal and submaximal (work rate specific) calculated O2 extraction (O2ext) at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline maximal and submaximal (work rate specific) calculated systemic vascular resistance (SVR) at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline maximal and submaximal (work rate specific) metabolic equivalent (MET) at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline maximal and submaximal (work rate specific) tissue saturation index (TSI) in skeletal muscle and cerebral tissue at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline maximal and submaximal (work rate specific) oxyhemoglobin concentration (O2Hb) in skeletal muscle and cerebral tissue at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline maximal and submaximal (work rate specific) deoxyhemoglobin concentration (HHb) in skeletal muscle and cerebral tissue at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline maximal and submaximal (work rate specific) total hemoglobin concentration (Hbtot) in skeletal muscle and cerebral tissue at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline maximal and submaximal (work rate specific) estimated regional blood flow (BFe) at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline ankle-brachial blood pressure index (ABI) at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline cardio-ankle vascular index (CAVI) at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline blood pressure variability (BPV) at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline baroreflex sensitivity (BRS) at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline postural sway during orthostatic test at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline nocturnal heart rate variability (HRVn) at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline heart rate on-kinetics and off-kinetics during an exercise test at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline alveolar gas exchange on-kinetics and off-kinetics during an exercise test at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline tissue oxygenation on-kinetics and off-kinetics during an exercise test at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline hemoglobin concentration ([Hb]) at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline hemoglobin concentration ([Hb]) at 1 year
Time Frame: 1 year
|
1 year
|
|
Change from baseline hematocrit (Hct) at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline hematocrit (Hct) at 1 year
Time Frame: 1 year
|
1 year
|
|
Change from baseline blood count at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline blood count at 1 year
Time Frame: 1 year
|
1 year
|
|
Change from baseline blood volume (BV) at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline total hemoglobin mass (tHb-mass]) at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline erythrocyte volume (EV) at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline erythrocyte volume (EV) at 1 year
Time Frame: 1 year
|
1 year
|
|
Change from baseline plasma volume (PV) at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline glycosylated hemoglobin (HbA1c) at 3 months
Time Frame: 3 months
|
3 months
|
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Change from baseline glycosylated hemoglobin (HbA1c) at 1 year
Time Frame: 1 year
|
1 year
|
|
Change from baseline homeostasis model assessment of insulin resistance (HOMA-IR) at 3 months
Time Frame: 3 months
|
3 months
|
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Change from baseline homeostasis model assessment of insulin resistance (HOMA-IR) at 1 year
Time Frame: 1 year
|
1 year
|
|
Change from baseline blood interleukin 2 (IL-2) at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline blood interleukin 2 (IL-2) at 1 year
Time Frame: 1 year
|
1 year
|
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Change from baseline blood interleukin (IL-4) at 3 months
Time Frame: 3 months
|
3 months
|
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Change from baseline blood interleukin (IL-4) at 1 year
Time Frame: 1 year
|
1 year
|
|
Change from baseline blood interleukin 5 (IL-5) at 3 months
Time Frame: 3 months
|
3 months
|
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Change from baseline blood interleukin 5 (IL-5) at 1 year
Time Frame: 1 year
|
1 year
|
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Change from baseline blood granulocyte-macrophage colony-stimulating factor (GM-CSF) at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline blood granulocyte-macrophage colony-stimulating factor (GM-CSF) at 1 year
Time Frame: 1 year
|
1 year
|
|
Change from baseline blood interferon gamma (IFNγ) at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline blood interferon gamma (IFNγ) at 1 year
Time Frame: 1 year
|
1 year
|
|
Change from baseline blood resistin at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline blood resistin at 1 year
Time Frame: 1 year
|
1 year
|
|
Change from baseline blood leptin at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline blood leptin at 1 year
Time Frame: 1 year
|
1 year
|
|
Change from baseline blood adiponectin at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline blood adiponectin at 1 year
Time Frame: 1 year
|
1 year
|
|
Change from baseline Forced Vital Capacity (FVC) at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline Forced Expiratory Volume in the 1st second (FEV1) at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline The percentage of total expired volume that was expired in the first second (FEV1%) at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline Forced Inspiratory Vital Capacity (FIV) at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline Peak Expiratory Flow (PEF) at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline Peak Inspiratory Flow (PIF) at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline Forced Expiratory Flow between 25% and 75% of FVC (FEF2575) at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline Forced Expiratory Flow at 25% of expired volume during FVC test (FEF25) at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline Forced Expiratory Flow at 50% of expired volume during FVC test (FEF50) at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline Forced Expiratory Flow at 75% of expired volume during FVC test (FEF75) at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline Forced Expiratory Time (FET) at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline sleep time cumulatively to 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline sleep time cumulatively to 1 year
Time Frame: 1 year
|
1 year
|
|
Change from baseline self-reported feelings on him-/herself, health, outlook, intimate relationship/marriage, family, friends, sex, work, studies, hobbies, money, pets, technology and traffic cumulatively to 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline self-reported feelings on him-/herself, health, outlook, intimate relationship/marriage, family, friends, sex, work, studies, hobbies, money, pets, technology and traffic cumulatively to 1 year
Time Frame: 1 year
|
1 year
|
|
Change from baseline possible obstructive sleep apnea (OSA) to 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline calculated Wellness Index (WI) at 3 months
Time Frame: 3 months
|
3 months
|
|
Change from baseline calculated Wellness Index (WI) at 1 year
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Seppo Heinonen, Professor, HUCH, Dept. of Obstetrics and Gynecology
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TYH2016215
- 575/31/2015 (Other Grant/Funding Number: Tekes - the Finnish Funding Agency for Innovation)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cardiovascular Diseases
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Medical College of WisconsinRecruitingCardiovascular Diseases | Cardiovascular Risk Factor | Cardiovascular HealthUnited States
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Hospital Mutua de TerrassaCompleted
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Oregon Health and Science UniversityCompletedCardiovascular Disease | Cardiovascular Risk FactorsUnited States
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Women's College HospitalUniversity Health Network, Toronto; Sunnybrook Health Sciences Centre; Brigham... and other collaboratorsUnknownCARDIOVASCULAR DISEASESCanada, United States
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Groupe Hospitalier Paris Saint JosephTerminatedCARDIOVASCULAR DISEASESFrance
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University of FloridaUniversity of Alabama at Birmingham; Brown UniversityCompletedCardiovascular Disease | Psychosocial Influence on Cardiovascular DiseaseUnited States
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VA Office of Research and DevelopmentNot yet recruitingCardiovascular DiseaseUnited States
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Baptist Health South FloridaUniversity of California, Los Angeles; Quest Diagnostics-Nichols InsituteActive, not recruitingCardiovascular DiseaseUnited States
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Laval UniversityActive, not recruitingCardiovascular DiseaseCanada
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Penn State UniversityCalifornia Healthcare InstituteCompleted
Clinical Trials on Lifestyle
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Northwestern UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedHyperglycemia | Glucose Metabolism Disorders | Metabolic Diseases | Obesity | Diabetes Mellitus | Endocrine System Diseases | Overnutrition | Nutrition Disorders | Overweight | Body Weight | Signs and SymptomsUnited States
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Umeå UniversityActive, not recruitingHypertension,Essential | Lifestyle-related ConditionSweden
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Sheba Medical CenterD-Cure, Israel; Chief Scientist, The Israel Ministry of ScienceCompleted
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University of ChicagoNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Northwestern...Not yet recruitingWeight Loss
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MS Ramaiah Medical College & HospitalsIndian Council of Medical ResearchCompleted
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Baylor College of MedicineNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Michael... and other collaboratorsActive, not recruiting
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Massachusetts General HospitalNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed
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University of OuluOulu University Hospital; Oulu Deaconess Institute Foundation srCompletedObesity | Physical Activity | Weight Loss | Healthy Obesity, MetabolicallyFinland
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Ankara Yildirim Beyazıt UniversityNot yet recruiting
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Ankara Yildirim Beyazıt UniversityCompletedOveractive BladderTurkey