Motivation Makes the Move!
Not Applicable
Completed
- Conditions
- ObesityCardiovascular DiseasesPhysical Conditioning
- Interventions
- Behavioral: Lifestyle
- Registration Number
- NCT02686502
- Lead Sponsor
- University of Helsinki
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mode 2 Lifestyle 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. Mode 3 Lifestyle 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.
- Primary Outcome Measures
Name Time Method Change from measured baseline maximal O2 uptake (VO2max) at 3 months 3 months
- Secondary Outcome Measures
Name Time Method Change from baseline depression at 3 months 3 months Beck questionnaire
Change from baseline waist-hip-ratio at 1 year 1 year Change from baseline quality of life at 3 months 3 months Rand-36 questionnaire
Change from baseline plasma HDL cholesterol at 1 year 1 year Change from baseline fasting plasma insulin at 1 year 1 year Change from baseline mood at 3 months 3 months PANAS questionnaire
Change from baseline music consumption at 3 months 3 months Music in Mood Regulation questionnaire (MMR)
Change from baseline protein intake at 3 months 3 months Food diary filled during 3 consecutive days every 2 weeks
Change from baseline total plasma 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 body composition at 3 months 3 months Body composition assessed by bioimpedance
Change from baseline work productivity at 1 year 1 year Work Productivity and Activity Impairment Questionnaire (WPAI)
Change from baseline calorie intake at 1 year 1 year Food diary filled during 3 consecutive days every 2 weeks
Change from baseline waist-hip-ratio at 3 months 3 months Change from baseline total plasma cholesterol at 3 months 3 months Change from baseline body weight at 3 months 3 months weight in kilograms
Change from baseline plasma LDL cholesterol at 1 year 1 year Change from baseline mood at 1 year 1 year PANAS questionnaire
Change from baseline work productivity at 3 months 3 months Work Productivity and Activity Impairment Questionnaire (WPAI)
Change from baseline protein intake at 1 year 1 year Food diary filled during 3 consecutive days every 2 weeks
Change from baseline plasma HDL cholesterol at 3 months 3 months Change from baseline fat intake at 3 months 3 months Food diary filled during 3 consecutive days every 2 weeks
Change from baseline depression at 1 year 1 year Beck questionnaire
Change from baseline physical activity at 3 months 3 months The International Physical Activity Questionnaire short version (IPAQ-S)
Change from baseline quality of life at 1 year 1 year Rand-36 questionnaire
Change from baseline physical activity at 1 year 1 year The International Physical Activity Questionnaire short version (IPAQ-S)
Change from baseline body weight at 1 year 1 year weight in kilograms
Change from baseline plasma LDL cholesterol at 3 months 3 months Change from baseline blood glucose balance at 3 months 3 months Blood glucose balance assessed by 75-g 2 h oral glucose tolerance test
Change from baseline blood glucose balance at 1 year 1 year Blood glucose balance assessed by 75-g 2 h oral glucose tolerance test
Change from baseline fasting plasma insulin at 3 months 3 months Change from baseline calorie intake at 3 months 3 months Food diary filled during 3 consecutive days every 2 weeks
Change from baseline heart rate variability at 3 months 3 months 3 day electrocardiography monitoring
Change from baseline carbohydrate intake at 3 months 3 months Food diary filled during 3 consecutive days every 2 weeks
Change from baseline carbohydrate intake at 1 year 1 year Food diary filled during 3 consecutive days every 2 weeks
Stability of personality 1 year Five Factor Personality test
Change from baseline sexual functions at 3 months (females) 3 months The Female Sexual Function Index (FSFI)
Change from baseline sexual functions at 1 year (females) 1 year The Female Sexual Function Index (FSFI)
Change from baseline music consumption at 1 year 1 year Music in Mood Regulation questionnaire (MMR)
Change from baseline heart rate variability at 1 year 1 year 3 day electrocardiography monitoring
Change from baseline fat intake at 1 year 1 year Food diary filled during 3 consecutive days every 2 weeks
Height 0 months height measured in centimeters
Change from baseline plasma Interleukin-6 (IL6) level at 3 months 3 months 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-1 beta (IL-1 beta) level at 1 year 1 year 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 baseline maximal and submaximal (work rate specific) O2 pulse (VO2/HR) at 3 months 3 months Change from baseline resting blood pressure (BP, systolic, diastolic, pulse, mean) at 3 months 3 months Change from baseline maximal and submaximal (work rate specific) heart rate (HR) at 3 months 3 months Change from baseline plasma ferritin (P-Ferrit) level at 1 year 1 year 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 Interleukin-8 (IL-8) level at 1 year 1 year Change from baseline body mass index (BMI) at 1 year 1 year BMI in kg/m\^2
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 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) end tidal CO2 (PETCO2) 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 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 tumor necrosis factor alpha alpha (P-TNF alpha) level at 3 months 3 months Change from baseline plasma Interleukin-8 (IL-8) level at 3 months 3 months Change from baseline body mass index (BMI) at 3 months 3 months BMI in kg/m\^2
Change from baseline maximal work rate (WR) at 3 months 3 months Change from baseline resting heart rate (HR) 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) calculated arterial O2 content (CaO2) heart rate (HR) 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) 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 plasma ferritin (P-Ferrit) level at 3 months 3 months Change from baseline plasma transferrin receptor (P-TfR) 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 1 year 1 year Change from baseline plasma IInterleukin-10 (IL-10) level at 1 year 1 year Change from baseline plasma Interleukin-1 beta (IL-1 beta) level at 3 months 3 months Change from estimated (non-exercise questionnaire) baseline maximal O2 uptake (VO2max) 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) 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 submaximal (work rate specific) VO2 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) left cardiac work index 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 blood interleukin 2 (IL-2) at 1 year 1 year 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) ventilatory equivalent for CO2 production (VE/VCO2) 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) estimate of left ventricular ejection time 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 blood pressure variability (BPV) at 3 months 3 months Change from baseline baroreflex sensitivity (BRS) 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 1 year 1 year 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) end-diastolic volume (EDV) 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) 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 O2 delivery (QaO2) 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 nocturnal heart rate variability (HRVn) 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 total hemoglobin mass (tHb-mass]) 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) total hemoglobin concentration (Hbtot) in skeletal muscle and cerebral tissue at 3 months 3 months Change from baseline ankle-brachial blood pressure index (ABI) at 3 months 3 months Change from baseline postural sway during orthostatic test 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 hemoglobin concentration ([Hb]) 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 glycosylated hemoglobin (HbA1c) 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 cardio-ankle vascular index (CAVI) at 3 months 3 months Change from baseline hemoglobin concentration ([Hb]) at 3 months 3 months Change from baseline hematocrit (Hct) at 1 year 1 year Change from baseline blood interleukin 5 (IL-5) at 3 months 3 months Change from baseline blood granulocyte-macrophage colony-stimulating factor (GM-CSF) at 3 months 3 months Change from baseline Forced Vital Capacity (FVC) at 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 hematocrit (Hct) 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 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 adiponectin 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 Expiratory Flow between 25% and 75% of FVC (FEF2575) at 3 months 3 months 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 blood interleukin 5 (IL-5) at 1 year 1 year Change from baseline blood granulocyte-macrophage colony-stimulating factor (GM-CSF) at 1 year 1 year Change from baseline blood interferon gamma (IFNγ) at 1 year 1 year Change from baseline blood leptin at 3 months 3 months Change from baseline blood adiponectin at 1 year 1 year Change from baseline Peak Inspiratory Flow (PIF) 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 blood resistin at 3 months 3 months Change from baseline blood resistin at 1 year 1 year Change from baseline blood interferon gamma (IFNγ) at 3 months 3 months Change from baseline Peak Expiratory Flow (PEF) at 3 months 3 months Change from baseline blood leptin at 1 year 1 year Change from baseline Forced Expiratory Volume in the 1st second (FEV1) at 3 months 3 months Change from baseline Forced Inspiratory Vital Capacity (FIV) 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 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 sleep time cumulatively to 3 months 3 months Change from baseline sleep time cumulatively to 1 year 1 year Change from baseline calculated Wellness Index (WI) at 3 months 3 months Change from baseline possible obstructive sleep apnea (OSA) to 3 months 3 months Change from baseline calculated Wellness Index (WI) at 1 year 1 year
Trial Locations
- Locations (2)
Vantaa Health Care and Social Services
🇫🇮Vantaa, Finland
Helsinki University Hospital
🇫🇮Helsinki, Finland