Motivation Makes the Move!

Study Overview
=================
Brief Summary
-----------------
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.

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.

Official Title
-----------------
Motivation Makes the Move!

Conditions
-----------------
Obesity, Cardiovascular Diseases, Physical Conditioning

Intervention / Treatment
-----------------
* Behavioral: Lifestyle


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Mode 1<br>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. | |
| Active Comparator: Mode 2<br>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. | Behavioral: Lifestyle<br>* 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.<br>* Other names: Diet;|
| Active Comparator: Mode 3<br>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. | Behavioral: Lifestyle<br>* 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.<br>* Other names: Diet;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from measured baseline maximal O2 uptake (VO2max) at 3 months |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline quality of life at 3 months | Rand-36 questionnaire | 3 months | 
| Change from baseline total plasma cholesterol at 3 months |  | 3 months | 
| Change from baseline physical activity at 3 months | The International Physical Activity Questionnaire short version (IPAQ-S) | 3 months | 
| Change from baseline body weight at 3 months | weight in kilograms | 3 months | 
| Change from baseline quality of life at 1 year | Rand-36 questionnaire | 1 year | 
| Change from baseline physical activity at 1 year | The International Physical Activity Questionnaire short version (IPAQ-S) | 1 year | 
| Change from baseline body weight at 1 year | weight in kilograms | 1 year | 
| Change from baseline total plasma cholesterol at 1 year |  | 1 year | 
| Change from baseline plasma HDL cholesterol at 3 months |  | 3 months | 
| Change from baseline plasma HDL cholesterol at 1 year |  | 1 year | 
| Change from baseline plasma LDL cholesterol at 3 months |  | 3 months | 
| Change from baseline plasma LDL cholesterol at 1 year |  | 1 year | 
| Change from baseline plasma triglycerides at 3 months |  | 3 months | 
| Change from baseline plasma triglycerides at 1 year |  | 1 year | 
| Change from baseline blood glucose balance at 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 | Blood glucose balance assessed by 75-g 2 h oral glucose tolerance test | 1 year | 
| Change from baseline fasting plasma insulin at 3 months |  | 3 months | 
| Change from baseline fasting plasma insulin at 1 year |  | 1 year | 
| Change from baseline body composition at 3 months | Body composition assessed by bioimpedance | 3 months | 
| Change from baseline mood at 3 months | PANAS questionnaire | 3 months | 
| Change from baseline mood at 1 year | PANAS questionnaire | 1 year | 
| Change from baseline work productivity at 3 months | Work Productivity and Activity Impairment Questionnaire (WPAI) | 3 months | 
| Change from baseline work productivity at 1 year | Work Productivity and Activity Impairment Questionnaire (WPAI) | 1 year | 
| Change from baseline sexual functions at 3 months (females) | The Female Sexual Function Index (FSFI) | 3 months | 
| Change from baseline sexual functions at 1 year (females) | The Female Sexual Function Index (FSFI) | 1 year | 
| Change from baseline music consumption at 3 months | Music in Mood Regulation questionnaire (MMR) | 3 months | 
| Change from baseline music consumption at 1 year | Music in Mood Regulation questionnaire (MMR) | 1 year | 
| Change from baseline calorie intake at 3 months | Food diary filled during 3 consecutive days every 2 weeks | 3 months | 
| Change from baseline calorie intake at 1 year | Food diary filled during 3 consecutive days every 2 weeks | 1 year | 
| Change from baseline heart rate variability at 3 months | 3 day electrocardiography monitoring | 3 months | 
| Change from baseline heart rate variability at 1 year | 3 day electrocardiography monitoring | 1 year | 
| Change from baseline protein intake at 3 months | Food diary filled during 3 consecutive days every 2 weeks | 3 months | 
| Change from baseline protein intake at 1 year | Food diary filled during 3 consecutive days every 2 weeks | 1 year | 
| Change from baseline fat intake at 3 months | Food diary filled during 3 consecutive days every 2 weeks | 3 months | 
| Change from baseline fat intake at 1 year | Food diary filled during 3 consecutive days every 2 weeks | 1 year | 
| Change from baseline carbohydrate intake at 3 months | Food diary filled during 3 consecutive days every 2 weeks | 3 months | 
| Change from baseline carbohydrate intake at 1 year | Food diary filled during 3 consecutive days every 2 weeks | 1 year | 
| Height | height measured in centimeters | 0 months | 
| Stability of personality | Five Factor Personality test | 0 months | 
| Stability of personality | Five Factor Personality test | 3 months | 
| Stability of personality | Five Factor Personality test | 1 year | 
| Change from baseline depression at 3 months | Beck questionnaire | 3 months | 
| Change from baseline depression at 1 year | Beck questionnaire | 1 year | 
| Change from baseline waist-hip-ratio at 3 months |  | 3 months | 
| Change from baseline waist-hip-ratio at 1 year |  | 1 year | 
| Change from baseline plasma ferritin (P-Ferrit) level at 3 months |  | 3 months | 
| Change from baseline plasma ferritin (P-Ferrit) level at 1 year |  | 1 year | 
| Change from baseline plasma transferrin receptor (P-TfR) level at 3 months |  | 3 months | 
| Change from baseline plasma transferrin receptor (P-TfR) level at 1 year |  | 1 year | 
| Change from baseline plasma sensitive C-reactive protein (CRP) level at 3 months |  | 3 months | 
| Change from baseline plasma sensitive C-reactive protein (CRP) level at 1 year |  | 1 year | 
| Change from baseline plasma tumor necrosis factor alpha alpha (P-TNF alpha) level at 3 months |  | 3 months | 
| Change from baseline plasma tumor necrosis factor alpha alpha (P-TNF alpha) level at 1 year |  | 1 year | 
| Change from baseline plasma Interleukin-6 (IL6) level at 3 months |  | 3 months | 
| Change from baseline plasma Interleukin-6 (IL-6) level at 1 year |  | 1 year | 
| Change from baseline plasma Interleukin-10 (IL-10) level at 3 months |  | 3 months | 
| Change from baseline plasma IInterleukin-10 (IL-10) level at 1 year |  | 1 year | 
| Change from baseline plasma Interleukin-15 (IL-15) level at 3 months |  | 3 months | 
| Change from baseline plasma Interleukin-15 (IL-15) level at 1 year |  | 1 year | 
| Change from baseline plasma Interleukin-8 (IL-8) level at 3 months |  | 3 months | 
| Change from baseline plasma Interleukin-8 (IL-8) level at 1 year |  | 1 year | 
| Change from baseline plasma Interleukin-1 beta (IL-1 beta) level at 3 months |  | 3 months | 
| Change from baseline plasma Interleukin-1 beta (IL-1 beta) level at 1 year |  | 1 year | 
| Change from baseline body mass index (BMI) at 3 months | BMI in kg/m^2 | 3 months | 
| Change from baseline body mass index (BMI) at 1 year | BMI in kg/m^2 | 1 year | 
| Change from estimated (non-exercise questionnaire) baseline maximal O2 uptake (VO2max) at 3 months |  | 3 months | 
| Change from estimated (non-exercise questionnaire) baseline maximal O2 uptake (VO2max) at 1 year |  | 1 year | 
| Change from estimated (step test) baseline VO2max at 3 months |  | 3 months | 
| Change from estimated (step test) baseline VO2max at 1 year |  | 1 year | 
| Change from estimated (submaximal cycle ergometer exercise) baseline VO2max at 3 months |  | 3 months | 
| Change from baseline maximal work rate (WR) at 3 months |  | 3 months | 
| Change from baseline maximal and submaximal (work rate specific) pulmonary ventilation (VE) at 3 months |  | 3 months | 
| Change from baseline maximal and submaximal (work rate specific) alveolar ventilation (VA) at 3 months |  | 3 months | 
| Change from baseline maximal and submaximal (work rate specific) breathing frequency (Bf) at 3 months |  | 3 months | 
| Change from baseline maximal and submaximal (work rate specific) tidal volume (VT) at 3 months |  | 3 months | 
| Change from baseline maximal and submaximal (work rate specific) tidal volume - dead space ratio (VD/VT) at 3 months |  | 3 months | 
| Change from baseline maximal and submaximal (work rate specific) end tidal O2 (PETO2) at 3 months |  | 3 months | 
| Change from baseline maximal and submaximal (work rate specific) end tidal CO2 (PETCO2) at 3 months |  | 3 months | 
| Change from baseline submaximal (work rate specific) VO2 at 3 months |  | 3 months | 
| Change from baseline maximal and submaximal (work rate specific) CO2 production (VCO2) at 3 months |  | 3 months | 
| Change from baseline maximal and submaximal (work rate specific) respiratory exchange ratio (RER) at 3 months |  | 3 months | 
| Change from baseline maximal and submaximal (work rate specific) ventilatory equivalent for O2 uptake (VE/VO2) at 3 months |  | 3 months | 
| Change from baseline maximal and submaximal (work rate specific) ventilatory equivalent for CO2 production (VE/VCO2) at 3 months |  | 3 months | 
| Change from baseline maximal and submaximal (work rate specific) O2 pulse (VO2/HR) at 3 months |  | 3 months | 
| Change from baseline resting heart rate (HR) at 3 months |  | 3 months | 
| Change from baseline resting heart rate (HR) at 1 year |  | 1 year | 
| Change from baseline resting blood pressure (BP, systolic, diastolic, pulse, mean) at 3 months |  | 3 months | 
| Change from baseline resting blood pressure (BP, systolic, diastolic, pulse, mean) at 1 year |  | 1 year | 
| Change from baseline maximal and submaximal (work rate specific) heart rate (HR) at 3 months |  | 3 months | 
| Change from baseline maximal and submaximal (work rate specific) arterial blood pressure (BP, systolic, diastolic, pulse, mean) at 3 months |  | 3 months | 
| Change from baseline maximal and submaximal (work rate specific) cardiac output (Q) at 3 months |  | 3 months | 
| Change from baseline maximal and submaximal (work rate specific) stroke volume (SV) at 3 months |  | 3 months | 
| Change from baseline maximal and submaximal (work rate specific) end-diastolic volume (EDV) at 3 months |  | 3 months | 
| Change from baseline maximal and submaximal (work rate specific) ejection fraction (EF) at 3 months |  | 3 months | 
| Change from baseline maximal and submaximal (work rate specific) cardiac index at 3 months |  | 3 months | 
| Change from baseline maximal and submaximal (work rate specific) contractility index at 3 months |  | 3 months | 
| Change from baseline maximal and submaximal (work rate specific) estimate of left ventricular ejection time at 3 months |  | 3 months | 
| Change from baseline maximal and submaximal (work rate specific) left cardiac work index at 3 months |  | 3 months | 
| Change from baseline maximal and submaximal (work rate specific) early diastolic function ratio at 3 months |  | 3 months | 
| Change from baseline maximal and submaximal (work rate specific) calculated arteriovenous O2 difference ((a-v)O2) at 3 months |  | 3 months | 
| Change from baseline maximal and submaximal (work rate specific) arterial O2 saturation (SpO2) at 3 months |  | 3 months | 
| Change from baseline maximal and submaximal (work rate specific) calculated arterial O2 content (CaO2) heart rate (HR) at 3 months |  | 3 months | 
| Change from baseline maximal and submaximal (work rate specific) calculated O2 delivery (QaO2) at 3 months |  | 3 months | 
| Change from baseline maximal and submaximal (work rate specific) calculated O2 extraction (O2ext) at 3 months |  | 3 months | 
| Change from baseline maximal and submaximal (work rate specific) calculated systemic vascular resistance (SVR) at 3 months |  | 3 months | 
| Change from baseline maximal and submaximal (work rate specific) metabolic equivalent (MET) at 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 |  | 3 months | 
| Change from baseline maximal and submaximal (work rate specific) oxyhemoglobin concentration (O2Hb) in skeletal muscle and cerebral tissue at 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 |  | 3 months | 
| Change from baseline maximal and submaximal (work rate specific) total hemoglobin concentration (Hbtot) in skeletal muscle and cerebral tissue at 3 months |  | 3 months | 
| Change from baseline maximal and submaximal (work rate specific) estimated regional blood flow (BFe) at 3 months |  | 3 months | 
| Change from baseline ankle-brachial blood pressure index (ABI) at 3 months |  | 3 months | 
| Change from baseline cardio-ankle vascular index (CAVI) at 3 months |  | 3 months | 
| Change from baseline blood pressure variability (BPV) at 3 months |  | 3 months | 
| Change from baseline baroreflex sensitivity (BRS) at 3 months |  | 3 months | 
| Change from baseline postural sway during orthostatic test at 3 months |  | 3 months | 
| Change from baseline nocturnal heart rate variability (HRVn) at 3 months |  | 3 months | 
| Change from baseline heart rate on-kinetics and off-kinetics during an exercise test at 3 months |  | 3 months | 
| Change from baseline alveolar gas exchange on-kinetics and off-kinetics during an exercise test at 3 months |  | 3 months | 
| Change from baseline tissue oxygenation on-kinetics and off-kinetics during an exercise test at 3 months |  | 3 months | 
| Change from baseline hemoglobin concentration ([Hb]) at 3 months |  | 3 months | 
| Change from baseline hemoglobin concentration ([Hb]) at 1 year |  | 1 year | 
| Change from baseline hematocrit (Hct) at 3 months |  | 3 months | 
| Change from baseline hematocrit (Hct) at 1 year |  | 1 year | 
| Change from baseline blood count at 3 months |  | 3 months | 
| Change from baseline blood count at 1 year |  | 1 year | 
| Change from baseline blood volume (BV) at 3 months |  | 3 months | 
| Change from baseline total hemoglobin mass (tHb-mass]) at 3 months |  | 3 months | 
| Change from baseline erythrocyte volume (EV) at 3 months |  | 3 months | 
| Change from baseline erythrocyte volume (EV) at 1 year |  | 1 year | 
| Change from baseline plasma volume (PV) at 3 months |  | 3 months | 
| Change from baseline glycosylated hemoglobin (HbA1c) at 3 months |  | 3 months | 
| Change from baseline glycosylated hemoglobin (HbA1c) at 1 year |  | 1 year | 
| Change from baseline homeostasis model assessment of insulin resistance (HOMA-IR) at 3 months |  | 3 months | 
| Change from baseline homeostasis model assessment of insulin resistance (HOMA-IR) at 1 year |  | 1 year | 
| Change from baseline blood interleukin 2 (IL-2) at 3 months |  | 3 months | 
| Change from baseline blood interleukin 2 (IL-2) at 1 year |  | 1 year | 
| Change from baseline blood interleukin (IL-4) at 3 months |  | 3 months | 
| Change from baseline blood interleukin (IL-4) at 1 year |  | 1 year | 
| Change from baseline blood interleukin 5 (IL-5) at 3 months |  | 3 months | 
| Change from baseline blood interleukin 5 (IL-5) at 1 year |  | 1 year | 
| Change from baseline blood granulocyte-macrophage colony-stimulating factor (GM-CSF) at 3 months |  | 3 months | 
| Change from baseline blood granulocyte-macrophage colony-stimulating factor (GM-CSF) at 1 year |  | 1 year | 
| Change from baseline blood interferon gamma (IFNγ) at 3 months |  | 3 months | 
| Change from baseline blood interferon gamma (IFNγ) at 1 year |  | 1 year | 
| Change from baseline blood resistin at 3 months |  | 3 months | 
| Change from baseline blood resistin at 1 year |  | 1 year | 
| Change from baseline blood leptin at 3 months |  | 3 months | 
| Change from baseline blood leptin at 1 year |  | 1 year | 
| Change from baseline blood adiponectin at 3 months |  | 3 months | 
| Change from baseline blood adiponectin at 1 year |  | 1 year | 
| Change from baseline Forced Vital Capacity (FVC) at 3 months |  | 3 months | 
| Change from baseline Forced Expiratory Volume in the 1st second (FEV1) at 3 months |  | 3 months | 
| Change from baseline The percentage of total expired volume that was expired in the first second (FEV1%) at 3 months |  | 3 months | 
| Change from baseline Forced Inspiratory Vital Capacity (FIV) at 3 months |  | 3 months | 
| Change from baseline Peak Expiratory Flow (PEF) at 3 months |  | 3 months | 
| Change from baseline Peak Inspiratory Flow (PIF) at 3 months |  | 3 months | 
| Change from baseline Forced Expiratory Flow between 25% and 75% of FVC (FEF2575) at 3 months |  | 3 months | 
| Change from baseline Forced Expiratory Flow at 25% of expired volume during FVC test (FEF25) at 3 months |  | 3 months | 
| Change from baseline Forced Expiratory Flow at 50% of expired volume during FVC test (FEF50) at 3 months |  | 3 months | 
| Change from baseline Forced Expiratory Flow at 75% of expired volume during FVC test (FEF75) at 3 months |  | 3 months | 
| Change from baseline Forced Expiratory Time (FET) at 3 months |  | 3 months | 
| Change from baseline sleep time cumulatively to 3 months |  | 3 months | 
| Change from baseline sleep time cumulatively to 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 |  | 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 |  | 1 year | 
| Change from baseline possible obstructive sleep apnea (OSA) to 3 months |  | 3 months | 
| Change from baseline calculated Wellness Index (WI) at 3 months |  | 3 months | 
| Change from baseline calculated Wellness Index (WI) at 1 year |  | 1 year |