Clinical trial NCT02686502: Motivation Makes the Move!
Official title: Motivation Makes the Move!
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Cardiovascular Diseases
Physical Conditioning
Lead sponsor: University of Helsinki
Sponsor class: OTHER
Collaborators: name: VTT Technical Research Centre of Finland
name: Finnish Institute of Occupational Health
name: University of Western Ontario, Canada
name: Helsinki University Central Hospital
First posted: 2016-02-19
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change from measured baseline maximal O2 uptake (VO2max) at 3 months
timeFrame: 3 months
Secondary outcomes:
measure: Change from baseline quality of life at 3 months
timeFrame: 3 months
measure: Change from baseline total plasma cholesterol at 3 months
timeFrame: 3 months
measure: Change from baseline physical activity at 3 months
timeFrame: 3 months
measure: Change from baseline body weight at 3 months
timeFrame: 3 months
measure: Change from baseline quality of life at 1 year
timeFrame: 1 year
measure: Change from baseline physical activity at 1 year
timeFrame: 1 year
measure: Change from baseline body weight at 1 year
timeFrame: 1 year
measure: Change from baseline total plasma cholesterol at 1 year
timeFrame: 1 year
measure: Change from baseline plasma HDL cholesterol at 3 months
timeFrame: 3 months
measure: Change from baseline plasma HDL cholesterol at 1 year
timeFrame: 1 year
measure: Change from baseline plasma LDL cholesterol at 3 months
timeFrame: 3 months
measure: Change from baseline plasma LDL cholesterol at 1 year
timeFrame: 1 year
measure: Change from baseline plasma triglycerides at 3 months
timeFrame: 3 months
measure: Change from baseline plasma triglycerides at 1 year
timeFrame: 1 year
measure: Change from baseline blood glucose balance at 3 months
timeFrame: 3 months
measure: Change from baseline blood glucose balance at 1 year
timeFrame: 1 year
measure: Change from baseline fasting plasma insulin at 3 months
timeFrame: 3 months
measure: Change from baseline fasting plasma insulin at 1 year
timeFrame: 1 year
measure: Change from baseline body composition at 3 months
timeFrame: 3 months
measure: Change from baseline mood at 3 months
timeFrame: 3 months
measure: Change from baseline mood at 1 year
timeFrame: 1 year
measure: Change from baseline work productivity at 3 months
timeFrame: 3 months
measure: Change from baseline work productivity at 1 year
timeFrame: 1 year
measure: Change from baseline sexual functions at 3 months (females)
timeFrame: 3 months
measure: Change from baseline sexual functions at 1 year (females)
timeFrame: 1 year
measure: Change from baseline music consumption at 3 months
timeFrame: 3 months
measure: Change from baseline music consumption at 1 year
timeFrame: 1 year
measure: Change from baseline calorie intake at 3 months
timeFrame: 3 months
measure: Change from baseline calorie intake at 1 year
timeFrame: 1 year
measure: Change from baseline heart rate variability at 3 months
timeFrame: 3 months
measure: Change from baseline heart rate variability at 1 year
timeFrame: 1 year
measure: Change from baseline protein intake at 3 months
timeFrame: 3 months
measure: Change from baseline protein intake at 1 year
timeFrame: 1 year
measure: Change from baseline fat intake at 3 months
timeFrame: 3 months
measure: Change from baseline fat intake at 1 year
timeFrame: 1 year
measure: Change from baseline carbohydrate intake at 3 months
timeFrame: 3 months
measure: Change from baseline carbohydrate intake at 1 year
timeFrame: 1 year
measure: Height
timeFrame: 0 months
measure: Stability of personality
timeFrame: 0 months
measure: Stability of personality
timeFrame: 3 months
measure: Stability of personality
timeFrame: 1 year
measure: Change from baseline depression at 3 months
timeFrame: 3 months
measure: Change from baseline depression at 1 year
timeFrame: 1 year
measure: Change from baseline waist-hip-ratio at 3 months
timeFrame: 3 months
measure: Change from baseline waist-hip-ratio at 1 year
timeFrame: 1 year
measure: Change from baseline plasma ferritin (P-Ferrit) level at 3 months
timeFrame: 3 months
measure: Change from baseline plasma ferritin (P-Ferrit) level at 1 year
timeFrame: 1 year
measure: Change from baseline plasma transferrin receptor (P-TfR) level at 3 months
timeFrame: 3 months
measure: Change from baseline plasma transferrin receptor (P-TfR) level at 1 year
timeFrame: 1 year
measure: Change from baseline plasma sensitive C-reactive protein (CRP) level at 3 months
timeFrame: 3 months
measure: Change from baseline plasma sensitive C-reactive protein (CRP) level at 1 year
timeFrame: 1 year
measure: Change from baseline plasma tumor necrosis factor alpha alpha (P-TNF alpha) level at 3 months
timeFrame: 3 months
measure: Change from baseline plasma tumor necrosis factor alpha alpha (P-TNF alpha) level at 1 year
timeFrame: 1 year
measure: Change from baseline plasma Interleukin-6 (IL6) level at 3 months
timeFrame: 3 months
measure: Change from baseline plasma Interleukin-6 (IL-6) level at 1 year
timeFrame: 1 year
measure: Change from baseline plasma Interleukin-10 (IL-10) level at 3 months
timeFrame: 3 months
measure: Change from baseline plasma IInterleukin-10 (IL-10) level at 1 year
timeFrame: 1 year
measure: Change from baseline plasma Interleukin-15 (IL-15) level at 3 months
timeFrame: 3 months
measure: Change from baseline plasma Interleukin-15 (IL-15) level at 1 year
timeFrame: 1 year
measure: Change from baseline plasma Interleukin-8 (IL-8) level at 3 months
timeFrame: 3 months
measure: Change from baseline plasma Interleukin-8 (IL-8) level at 1 year
timeFrame: 1 year
measure: Change from baseline plasma Interleukin-1 beta (IL-1 beta) level at 3 months
timeFrame: 3 months
measure: Change from baseline plasma Interleukin-1 beta (IL-1 beta) level at 1 year
timeFrame: 1 year
measure: Change from baseline body mass index (BMI) at 3 months
timeFrame: 3 months
measure: Change from baseline body mass index (BMI) at 1 year
timeFrame: 1 year
measure: Change from estimated (non-exercise questionnaire) baseline maximal O2 uptake (VO2max) at 3 months
timeFrame: 3 months
measure: Change from estimated (non-exercise questionnaire) baseline maximal O2 uptake (VO2max) at 1 year
timeFrame: 1 year
measure: Change from estimated (step test) baseline VO2max at 3 months
timeFrame: 3 months
measure: Change from estimated (step test) baseline VO2max at 1 year
timeFrame: 1 year
measure: Change from estimated (submaximal cycle ergometer exercise) baseline VO2max at 3 months
timeFrame: 3 months
measure: Change from baseline maximal work rate (WR) at 3 months
timeFrame: 3 months
measure: Change from baseline maximal and submaximal (work rate specific) pulmonary ventilation (VE) at 3 months
timeFrame: 3 months
measure: Change from baseline maximal and submaximal (work rate specific) alveolar ventilation (VA) at 3 months
timeFrame: 3 months
measure: Change from baseline maximal and submaximal (work rate specific) breathing frequency (Bf) at 3 months
timeFrame: 3 months
measure: Change from baseline maximal and submaximal (work rate specific) tidal volume (VT) at 3 months
timeFrame: 3 months
measure: Change from baseline maximal and submaximal (work rate specific) tidal volume - dead space ratio (VD/VT) at 3 months
timeFrame: 3 months
measure: Change from baseline maximal and submaximal (work rate specific) end tidal O2 (PETO2) at 3 months
timeFrame: 3 months
measure: Change from baseline maximal and submaximal (work rate specific) end tidal CO2 (PETCO2) at 3 months
timeFrame: 3 months
measure: Change from baseline submaximal (work rate specific) VO2 at 3 months
timeFrame: 3 months
measure: Change from baseline maximal and submaximal (work rate specific) CO2 production (VCO2) at 3 months
timeFrame: 3 months
measure: Change from baseline maximal and submaximal (work rate specific) respiratory exchange ratio (RER) at 3 months
timeFrame: 3 months
measure: Change from baseline maximal and submaximal (work rate specific) ventilatory equivalent for O2 uptake (VE/VO2) at 3 months
timeFrame: 3 months
measure: Change from baseline maximal and submaximal (work rate specific) ventilatory equivalent for CO2 production (VE/VCO2) at 3 months
timeFrame: 3 months
measure: Change from baseline maximal and submaximal (work rate specific) O2 pulse (VO2/HR) at 3 months
timeFrame: 3 months
measure: Change from baseline resting heart rate (HR) at 3 months
timeFrame: 3 months
measure: Change from baseline resting heart rate (HR) at 1 year
timeFrame: 1 year
measure: Change from baseline resting blood pressure (BP, systolic, diastolic, pulse, mean) at 3 months
timeFrame: 3 months
measure: Change from baseline resting blood pressure (BP, systolic, diastolic, pulse, mean) at 1 year
timeFrame: 1 year
measure: Change from baseline maximal and submaximal (work rate specific) heart rate (HR) at 3 months
timeFrame: 3 months
measure: Change from baseline maximal and submaximal (work rate specific) arterial blood pressure (BP, systolic, diastolic, pulse, mean) at 3 months
timeFrame: 3 months
measure: Change from baseline maximal and submaximal (work rate specific) cardiac output (Q) at 3 months
timeFrame: 3 months
measure: Change from baseline maximal and submaximal (work rate specific) stroke volume (SV) at 3 months
timeFrame: 3 months
measure: Change from baseline maximal and submaximal (work rate specific) end-diastolic volume (EDV) at 3 months
timeFrame: 3 months
measure: Change from baseline maximal and submaximal (work rate specific) ejection fraction (EF) at 3 months
timeFrame: 3 months
measure: Change from baseline maximal and submaximal (work rate specific) cardiac index at 3 months
timeFrame: 3 months
measure: Change from baseline maximal and submaximal (work rate specific) contractility index at 3 months
timeFrame: 3 months
measure: Change from baseline maximal and submaximal (work rate specific) estimate of left ventricular ejection time at 3 months
timeFrame: 3 months
measure: Change from baseline maximal and submaximal (work rate specific) left cardiac work index at 3 months
timeFrame: 3 months
measure: Change from baseline maximal and submaximal (work rate specific) early diastolic function ratio at 3 months
timeFrame: 3 months
measure: Change from baseline maximal and submaximal (work rate specific) calculated arteriovenous O2 difference ((a-v)O2) at 3 months
timeFrame: 3 months
measure: Change from baseline maximal and submaximal (work rate specific) arterial O2 saturation (SpO2) at 3 months
timeFrame: 3 months
measure: Change from baseline maximal and submaximal (work rate specific) calculated arterial O2 content (CaO2) heart rate (HR) at 3 months
timeFrame: 3 months
measure: Change from baseline maximal and submaximal (work rate specific) calculated O2 delivery (QaO2) at 3 months
timeFrame: 3 months
measure: Change from baseline maximal and submaximal (work rate specific) calculated O2 extraction (O2ext) at 3 months
timeFrame: 3 months
measure: Change from baseline maximal and submaximal (work rate specific) calculated systemic vascular resistance (SVR) at 3 months
timeFrame: 3 months
measure: Change from baseline maximal and submaximal (work rate specific) metabolic equivalent (MET) at 3 months
timeFrame: 3 months
measure: Change from baseline maximal and submaximal (work rate specific) tissue saturation index (TSI) in skeletal muscle and cerebral tissue at 3 months
timeFrame: 3 months
measure: Change from baseline maximal and submaximal (work rate specific) oxyhemoglobin concentration (O2Hb) in skeletal muscle and cerebral tissue at 3 months
timeFrame: 3 months
measure: Change from baseline maximal and submaximal (work rate specific) deoxyhemoglobin concentration (HHb) in skeletal muscle and cerebral tissue at 3 months
timeFrame: 3 months
measure: Change from baseline maximal and submaximal (work rate specific) total hemoglobin concentration (Hbtot) in skeletal muscle and cerebral tissue at 3 months
timeFrame: 3 months
measure: Change from baseline maximal and submaximal (work rate specific) estimated regional blood flow (BFe) at 3 months
timeFrame: 3 months
measure: Change from baseline ankle-brachial blood pressure index (ABI) at 3 months
timeFrame: 3 months
measure: Change from baseline cardio-ankle vascular index (CAVI) at 3 months
timeFrame: 3 months
measure: Change from baseline blood pressure variability (BPV) at 3 months
timeFrame: 3 months
measure: Change from baseline baroreflex sensitivity (BRS) at 3 months
timeFrame: 3 months
measure: Change from baseline postural sway during orthostatic test at 3 months
timeFrame: 3 months
measure: Change from baseline nocturnal heart rate variability (HRVn) at 3 months
timeFrame: 3 months
measure: Change from baseline heart rate on-kinetics and off-kinetics during an exercise test at 3 months
timeFrame: 3 months
measure: Change from baseline alveolar gas exchange on-kinetics and off-kinetics during an exercise test at 3 months
timeFrame: 3 months
measure: Change from baseline tissue oxygenation on-kinetics and off-kinetics during an exercise test at 3 months
timeFrame: 3 months
measure: Change from baseline hemoglobin concentration ([Hb]) at 3 months
timeFrame: 3 months
measure: Change from baseline hemoglobin concentration ([Hb]) at 1 year
timeFrame: 1 year
measure: Change from baseline hematocrit (Hct) at 3 months
timeFrame: 3 months
measure: Change from baseline hematocrit (Hct) at 1 year
timeFrame: 1 year
measure: Change from baseline blood count at 3 months
timeFrame: 3 months
measure: Change from baseline blood count at 1 year
timeFrame: 1 year
measure: Change from baseline blood volume (BV) at 3 months
timeFrame: 3 months
measure: Change from baseline total hemoglobin mass (tHb-mass]) at 3 months
timeFrame: 3 months
measure: Change from baseline erythrocyte volume (EV) at 3 months
timeFrame: 3 months
measure: Change from baseline erythrocyte volume (EV) at 1 year
timeFrame: 1 year
measure: Change from baseline plasma volume (PV) at 3 months
timeFrame: 3 months
measure: Change from baseline glycosylated hemoglobin (HbA1c) at 3 months
timeFrame: 3 months
measure: Change from baseline glycosylated hemoglobin (HbA1c) at 1 year
timeFrame: 1 year
measure: Change from baseline homeostasis model assessment of insulin resistance (HOMA-IR) at 3 months
timeFrame: 3 months
measure: Change from baseline homeostasis model assessment of insulin resistance (HOMA-IR) at 1 year
timeFrame: 1 year
measure: Change from baseline blood interleukin 2 (IL-2) at 3 months
timeFrame: 3 months
measure: Change from baseline blood interleukin 2 (IL-2) at 1 year
timeFrame: 1 year
measure: Change from baseline blood interleukin (IL-4) at 3 months
timeFrame: 3 months
measure: Change from baseline blood interleukin (IL-4) at 1 year
timeFrame: 1 year
measure: Change from baseline blood interleukin 5 (IL-5) at 3 months
timeFrame: 3 months
measure: Change from baseline blood interleukin 5 (IL-5) at 1 year
timeFrame: 1 year
measure: Change from baseline blood granulocyte-macrophage colony-stimulating factor (GM-CSF) at 3 months
timeFrame: 3 months
measure: Change from baseline blood granulocyte-macrophage colony-stimulating factor (GM-CSF) at 1 year
timeFrame: 1 year
measure: Change from baseline blood interferon gamma (IFNγ) at 3 months
timeFrame: 3 months
measure: Change from baseline blood interferon gamma (IFNγ) at 1 year
timeFrame: 1 year
measure: Change from baseline blood resistin at 3 months
timeFrame: 3 months
measure: Change from baseline blood resistin at 1 year
timeFrame: 1 year
measure: Change from baseline blood leptin at 3 months
timeFrame: 3 months
measure: Change from baseline blood leptin at 1 year
timeFrame: 1 year
measure: Change from baseline blood adiponectin at 3 months
timeFrame: 3 months
measure: Change from baseline blood adiponectin at 1 year
timeFrame: 1 year
measure: Change from baseline Forced Vital Capacity (FVC) at 3 months
timeFrame: 3 months
measure: Change from baseline Forced Expiratory Volume in the 1st second (FEV1) at 3 months
timeFrame: 3 months
measure: Change from baseline The percentage of total expired volume that was expired in the first second (FEV1%) at 3 months
timeFrame: 3 months
measure: Change from baseline Forced Inspiratory Vital Capacity (FIV) at 3 months
timeFrame: 3 months
measure: Change from baseline Peak Expiratory Flow (PEF) at 3 months
timeFrame: 3 months
measure: Change from baseline Peak Inspiratory Flow (PIF) at 3 months
timeFrame: 3 months
measure: Change from baseline Forced Expiratory Flow between 25% and 75% of FVC (FEF2575) at 3 months
timeFrame: 3 months
measure: Change from baseline Forced Expiratory Flow at 25% of expired volume during FVC test (FEF25) at 3 months
timeFrame: 3 months
measure: Change from baseline Forced Expiratory Flow at 50% of expired volume during FVC test (FEF50) at 3 months
timeFrame: 3 months
measure: Change from baseline Forced Expiratory Flow at 75% of expired volume during FVC test (FEF75) at 3 months
timeFrame: 3 months
measure: Change from baseline Forced Expiratory Time (FET) at 3 months
timeFrame: 3 months
measure: Change from baseline sleep time cumulatively to 3 months
timeFrame: 3 months
measure: Change from baseline sleep time cumulatively to 1 year
timeFrame: 1 year
measure: 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
timeFrame: 3 months
measure: 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
timeFrame: 1 year
measure: Change from baseline possible obstructive sleep apnea (OSA) to 3 months
timeFrame: 3 months
measure: Change from baseline calculated Wellness Index (WI) at 3 months
timeFrame: 3 months
measure: Change from baseline calculated Wellness Index (WI) at 1 year
timeFrame: 1 year
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Vantaa
country: Finland
facility: Vantaa Health Care and Social Services
Study officials:
affiliation: HUCH, Dept. of Obstetrics and Gynecology
name: Seppo Heinonen, Professor
role: STUDY_DIRECTOR
References: