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.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
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.
Helsinki University Hospital
Helsinki, Finland
Vantaa Health Care and Social Services
Vantaa, Finland
Change from measured baseline maximal O2 uptake (VO2max) at 3 months
Time frame: 3 months
Change from baseline quality of life at 3 months
Rand-36 questionnaire
Time frame: 3 months
Change from baseline total plasma cholesterol at 3 months
Time frame: 3 months
Change from baseline physical activity at 3 months
The International Physical Activity Questionnaire short version (IPAQ-S)
Time frame: 3 months
Change from baseline body weight at 3 months
weight in kilograms
Time frame: 3 months
Change from baseline quality of life at 1 year
Rand-36 questionnaire
Time frame: 1 year
Change from baseline physical activity at 1 year
The International Physical Activity Questionnaire short version (IPAQ-S)
Time frame: 1 year
Change from baseline body weight at 1 year
weight in kilograms
Time frame: 1 year
Change from baseline total plasma cholesterol at 1 year
Time frame: 1 year
Change from baseline plasma HDL cholesterol at 3 months
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Enrollment
120
Time frame: 3 months
Change from baseline plasma HDL cholesterol at 1 year
Time frame: 1 year
Change from baseline plasma LDL cholesterol at 3 months
Time frame: 3 months
Change from baseline plasma LDL cholesterol at 1 year
Time frame: 1 year
Change from baseline plasma triglycerides at 3 months
Time frame: 3 months
Change from baseline plasma triglycerides at 1 year
Time frame: 1 year
Change from baseline blood glucose balance at 3 months
Blood glucose balance assessed by 75-g 2 h oral glucose tolerance test
Time frame: 3 months
Change from baseline blood glucose balance at 1 year
Blood glucose balance assessed by 75-g 2 h oral glucose tolerance test
Time frame: 1 year
Change from baseline fasting plasma insulin at 3 months
Time frame: 3 months
Change from baseline fasting plasma insulin at 1 year
Time frame: 1 year
Change from baseline body composition at 3 months
Body composition assessed by bioimpedance
Time frame: 3 months
Change from baseline mood at 3 months
PANAS questionnaire
Time frame: 3 months
Change from baseline mood at 1 year
PANAS questionnaire
Time frame: 1 year
Change from baseline work productivity at 3 months
Work Productivity and Activity Impairment Questionnaire (WPAI)
Time frame: 3 months
Change from baseline work productivity at 1 year
Work Productivity and Activity Impairment Questionnaire (WPAI)
Time frame: 1 year
Change from baseline sexual functions at 3 months (females)
The Female Sexual Function Index (FSFI)
Time frame: 3 months
Change from baseline sexual functions at 1 year (females)
The Female Sexual Function Index (FSFI)
Time frame: 1 year
Change from baseline music consumption at 3 months
Music in Mood Regulation questionnaire (MMR)
Time frame: 3 months
Change from baseline music consumption at 1 year
Music in Mood Regulation questionnaire (MMR)
Time frame: 1 year
Change from baseline calorie intake at 3 months
Food diary filled during 3 consecutive days every 2 weeks
Time frame: 3 months
Change from baseline calorie intake at 1 year
Food diary filled during 3 consecutive days every 2 weeks
Time frame: 1 year
Change from baseline heart rate variability at 3 months
3 day electrocardiography monitoring
Time frame: 3 months
Change from baseline heart rate variability at 1 year
3 day electrocardiography monitoring
Time frame: 1 year
Change from baseline protein intake at 3 months
Food diary filled during 3 consecutive days every 2 weeks
Time frame: 3 months
Change from baseline protein intake at 1 year
Food diary filled during 3 consecutive days every 2 weeks
Time frame: 1 year
Change from baseline fat intake at 3 months
Food diary filled during 3 consecutive days every 2 weeks
Time frame: 3 months
Change from baseline fat intake at 1 year
Food diary filled during 3 consecutive days every 2 weeks
Time frame: 1 year
Change from baseline carbohydrate intake at 3 months
Food diary filled during 3 consecutive days every 2 weeks
Time frame: 3 months
Change from baseline carbohydrate intake at 1 year
Food diary filled during 3 consecutive days every 2 weeks
Time frame: 1 year
Height
height measured in centimeters
Time frame: 0 months
Stability of personality
Five Factor Personality test
Time frame: 0 months
Stability of personality
Five Factor Personality test
Time frame: 3 months
Stability of personality
Five Factor Personality test
Time frame: 1 year
Change from baseline depression at 3 months
Beck questionnaire
Time frame: 3 months
Change from baseline depression at 1 year
Beck questionnaire
Time frame: 1 year
Change from baseline waist-hip-ratio at 3 months
Time frame: 3 months
Change from baseline waist-hip-ratio at 1 year
Time frame: 1 year
Change from baseline plasma ferritin (P-Ferrit) level at 3 months
Time frame: 3 months
Change from baseline plasma ferritin (P-Ferrit) level at 1 year
Time frame: 1 year
Change from baseline plasma transferrin receptor (P-TfR) level at 3 months
Time frame: 3 months
Change from baseline plasma transferrin receptor (P-TfR) level at 1 year
Time frame: 1 year
Change from baseline plasma sensitive C-reactive protein (CRP) level at 3 months
Time frame: 3 months
Change from baseline plasma sensitive C-reactive protein (CRP) level at 1 year
Time frame: 1 year
Change from baseline plasma tumor necrosis factor alpha alpha (P-TNF alpha) level at 3 months
Time frame: 3 months
Change from baseline plasma tumor necrosis factor alpha alpha (P-TNF alpha) level at 1 year
Time frame: 1 year
Change from baseline plasma Interleukin-6 (IL6) level at 3 months
Time frame: 3 months
Change from baseline plasma Interleukin-6 (IL-6) level at 1 year
Time frame: 1 year
Change from baseline plasma Interleukin-10 (IL-10) level at 3 months
Time frame: 3 months
Change from baseline plasma IInterleukin-10 (IL-10) level at 1 year
Time frame: 1 year
Change from baseline plasma Interleukin-15 (IL-15) level at 3 months
Time frame: 3 months
Change from baseline plasma Interleukin-15 (IL-15) level at 1 year
Time frame: 1 year
Change from baseline plasma Interleukin-8 (IL-8) level at 3 months
Time frame: 3 months
Change from baseline plasma Interleukin-8 (IL-8) level at 1 year
Time frame: 1 year
Change from baseline plasma Interleukin-1 beta (IL-1 beta) level at 3 months
Time frame: 3 months
Change from baseline plasma Interleukin-1 beta (IL-1 beta) level at 1 year
Time frame: 1 year
Change from baseline body mass index (BMI) at 3 months
BMI in kg/m\^2
Time frame: 3 months
Change from baseline body mass index (BMI) at 1 year
BMI in kg/m\^2
Time frame: 1 year
Change from estimated (non-exercise questionnaire) baseline maximal O2 uptake (VO2max) at 3 months
Time frame: 3 months
Change from estimated (non-exercise questionnaire) baseline maximal O2 uptake (VO2max) at 1 year
Time frame: 1 year
Change from estimated (step test) baseline VO2max at 3 months
Time frame: 3 months
Change from estimated (step test) baseline VO2max at 1 year
Time frame: 1 year
Change from estimated (submaximal cycle ergometer exercise) baseline VO2max at 3 months
Time frame: 3 months
Change from baseline maximal work rate (WR) at 3 months
Time frame: 3 months
Change from baseline maximal and submaximal (work rate specific) pulmonary ventilation (VE) at 3 months
Time frame: 3 months
Change from baseline maximal and submaximal (work rate specific) alveolar ventilation (VA) at 3 months
Time frame: 3 months
Change from baseline maximal and submaximal (work rate specific) breathing frequency (Bf) at 3 months
Time frame: 3 months
Change from baseline maximal and submaximal (work rate specific) tidal volume (VT) at 3 months
Time frame: 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
Change from baseline maximal and submaximal (work rate specific) end tidal O2 (PETO2) at 3 months
Time frame: 3 months
Change from baseline maximal and submaximal (work rate specific) end tidal CO2 (PETCO2) at 3 months
Time frame: 3 months
Change from baseline submaximal (work rate specific) VO2 at 3 months
Time frame: 3 months
Change from baseline maximal and submaximal (work rate specific) CO2 production (VCO2) at 3 months
Time frame: 3 months
Change from baseline maximal and submaximal (work rate specific) respiratory exchange ratio (RER) at 3 months
Time frame: 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
Change from baseline maximal and submaximal (work rate specific) ventilatory equivalent for CO2 production (VE/VCO2) at 3 months
Time frame: 3 months
Change from baseline maximal and submaximal (work rate specific) O2 pulse (VO2/HR) at 3 months
Time frame: 3 months
Change from baseline resting heart rate (HR) at 3 months
Time frame: 3 months
Change from baseline resting heart rate (HR) at 1 year
Time frame: 1 year
Change from baseline resting blood pressure (BP, systolic, diastolic, pulse, mean) at 3 months
Time frame: 3 months
Change from baseline resting blood pressure (BP, systolic, diastolic, pulse, mean) at 1 year
Time frame: 1 year
Change from baseline maximal and submaximal (work rate specific) heart rate (HR) at 3 months
Time frame: 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
Change from baseline maximal and submaximal (work rate specific) cardiac output (Q) at 3 months
Time frame: 3 months
Change from baseline maximal and submaximal (work rate specific) stroke volume (SV) at 3 months
Time frame: 3 months
Change from baseline maximal and submaximal (work rate specific) end-diastolic volume (EDV) at 3 months
Time frame: 3 months
Change from baseline maximal and submaximal (work rate specific) ejection fraction (EF) at 3 months
Time frame: 3 months
Change from baseline maximal and submaximal (work rate specific) cardiac index at 3 months
Time frame: 3 months
Change from baseline maximal and submaximal (work rate specific) contractility index at 3 months
Time frame: 3 months
Change from baseline maximal and submaximal (work rate specific) estimate of left ventricular ejection time at 3 months
Time frame: 3 months
Change from baseline maximal and submaximal (work rate specific) left cardiac work index at 3 months
Time frame: 3 months
Change from baseline maximal and submaximal (work rate specific) early diastolic function ratio at 3 months
Time frame: 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
Change from baseline maximal and submaximal (work rate specific) arterial O2 saturation (SpO2) at 3 months
Time frame: 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
Change from baseline maximal and submaximal (work rate specific) calculated O2 delivery (QaO2) at 3 months
Time frame: 3 months
Change from baseline maximal and submaximal (work rate specific) calculated O2 extraction (O2ext) at 3 months
Time frame: 3 months
Change from baseline maximal and submaximal (work rate specific) calculated systemic vascular resistance (SVR) at 3 months
Time frame: 3 months
Change from baseline maximal and submaximal (work rate specific) metabolic equivalent (MET) at 3 months
Time frame: 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
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
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
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
Change from baseline maximal and submaximal (work rate specific) estimated regional blood flow (BFe) at 3 months
Time frame: 3 months
Change from baseline ankle-brachial blood pressure index (ABI) at 3 months
Time frame: 3 months
Change from baseline cardio-ankle vascular index (CAVI) at 3 months
Time frame: 3 months
Change from baseline blood pressure variability (BPV) at 3 months
Time frame: 3 months
Change from baseline baroreflex sensitivity (BRS) at 3 months
Time frame: 3 months
Change from baseline postural sway during orthostatic test at 3 months
Time frame: 3 months
Change from baseline nocturnal heart rate variability (HRVn) at 3 months
Time frame: 3 months
Change from baseline heart rate on-kinetics and off-kinetics during an exercise test at 3 months
Time frame: 3 months
Change from baseline alveolar gas exchange on-kinetics and off-kinetics during an exercise test at 3 months
Time frame: 3 months
Change from baseline tissue oxygenation on-kinetics and off-kinetics during an exercise test at 3 months
Time frame: 3 months
Change from baseline hemoglobin concentration ([Hb]) at 3 months
Time frame: 3 months
Change from baseline hemoglobin concentration ([Hb]) at 1 year
Time frame: 1 year
Change from baseline hematocrit (Hct) at 3 months
Time frame: 3 months
Change from baseline hematocrit (Hct) at 1 year
Time frame: 1 year
Change from baseline blood count at 3 months
Time frame: 3 months
Change from baseline blood count at 1 year
Time frame: 1 year
Change from baseline blood volume (BV) at 3 months
Time frame: 3 months
Change from baseline total hemoglobin mass (tHb-mass]) at 3 months
Time frame: 3 months
Change from baseline erythrocyte volume (EV) at 3 months
Time frame: 3 months
Change from baseline erythrocyte volume (EV) at 1 year
Time frame: 1 year
Change from baseline plasma volume (PV) at 3 months
Time frame: 3 months
Change from baseline glycosylated hemoglobin (HbA1c) at 3 months
Time frame: 3 months
Change from baseline glycosylated hemoglobin (HbA1c) at 1 year
Time frame: 1 year
Change from baseline homeostasis model assessment of insulin resistance (HOMA-IR) at 3 months
Time frame: 3 months
Change from baseline homeostasis model assessment of insulin resistance (HOMA-IR) at 1 year
Time frame: 1 year
Change from baseline blood interleukin 2 (IL-2) at 3 months
Time frame: 3 months
Change from baseline blood interleukin 2 (IL-2) at 1 year
Time frame: 1 year
Change from baseline blood interleukin (IL-4) at 3 months
Time frame: 3 months
Change from baseline blood interleukin (IL-4) at 1 year
Time frame: 1 year
Change from baseline blood interleukin 5 (IL-5) at 3 months
Time frame: 3 months
Change from baseline blood interleukin 5 (IL-5) at 1 year
Time frame: 1 year
Change from baseline blood granulocyte-macrophage colony-stimulating factor (GM-CSF) at 3 months
Time frame: 3 months
Change from baseline blood granulocyte-macrophage colony-stimulating factor (GM-CSF) at 1 year
Time frame: 1 year
Change from baseline blood interferon gamma (IFNγ) at 3 months
Time frame: 3 months
Change from baseline blood interferon gamma (IFNγ) at 1 year
Time frame: 1 year
Change from baseline blood resistin at 3 months
Time frame: 3 months
Change from baseline blood resistin at 1 year
Time frame: 1 year
Change from baseline blood leptin at 3 months
Time frame: 3 months
Change from baseline blood leptin at 1 year
Time frame: 1 year
Change from baseline blood adiponectin at 3 months
Time frame: 3 months
Change from baseline blood adiponectin at 1 year
Time frame: 1 year
Change from baseline Forced Vital Capacity (FVC) at 3 months
Time frame: 3 months
Change from baseline Forced Expiratory Volume in the 1st second (FEV1) at 3 months
Time frame: 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
Change from baseline Forced Inspiratory Vital Capacity (FIV) at 3 months
Time frame: 3 months
Change from baseline Peak Expiratory Flow (PEF) at 3 months
Time frame: 3 months
Change from baseline Peak Inspiratory Flow (PIF) at 3 months
Time frame: 3 months
Change from baseline Forced Expiratory Flow between 25% and 75% of FVC (FEF2575) at 3 months
Time frame: 3 months
Change from baseline Forced Expiratory Flow at 25% of expired volume during FVC test (FEF25) at 3 months
Time frame: 3 months
Change from baseline Forced Expiratory Flow at 50% of expired volume during FVC test (FEF50) at 3 months
Time frame: 3 months
Change from baseline Forced Expiratory Flow at 75% of expired volume during FVC test (FEF75) at 3 months
Time frame: 3 months
Change from baseline Forced Expiratory Time (FET) at 3 months
Time frame: 3 months
Change from baseline sleep time cumulatively to 3 months
Time frame: 3 months
Change from baseline sleep time cumulatively to 1 year
Time frame: 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
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
Change from baseline possible obstructive sleep apnea (OSA) to 3 months
Time frame: 3 months
Change from baseline calculated Wellness Index (WI) at 3 months
Time frame: 3 months
Change from baseline calculated Wellness Index (WI) at 1 year
Time frame: 1 year