ObesityMoMaMo!NCT02686502
Motivation Makes the Move!
A study testing Lifestyle in people with Obesity and Cardiovascular Diseases, run by University of Helsinki at 2 sites in Finland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Cardiovascular Diseases, Physical Conditioning
- What is being tested?
- Lifestyle
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesFinland
- Study dates
- Apr 2016to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI ≥ 27,5 kg/m2
- estimated by health care personnel to benefit from lifestyle modification
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Finland2 sites
Helsinki University Hospital
Helsinki
Vantaa Health Care and Social Services
Vantaa
About this study
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.
Read the 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.
- Conditions
- Obesity, Cardiovascular Diseases, Physical Conditioning
- Being tested
- Lifestyle
- Medical subject headings
- Obesity, Cardiovascular Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LifestyleBehavioural
Also called Exercise, Diet
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.
| Study group | Role | What they receive |
|---|---|---|
| Mode 1 | No intervention | 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. |
| Mode 2 | Active comparator | 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. Receives: Behavioral: Lifestyle |
| Mode 3 | Active comparator | 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. Receives: Behavioral: Lifestyle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from measured baseline maximal O2 uptake (VO2max) at 3 months
Measured: 3 months
Secondary outcomes (169)
Change from baseline quality of life at 3 months
Rand-36 questionnaire
Measured: 3 months
Change from baseline total plasma cholesterol at 3 months
Measured: 3 months
Change from baseline physical activity at 3 months
The International Physical Activity Questionnaire short version (IPAQ-S)
Measured: 3 months
Change from baseline body weight at 3 months
weight in kilograms
Measured: 3 months
Change from baseline quality of life at 1 year
Rand-36 questionnaire
Measured: 1 year
Change from baseline physical activity at 1 year
The International Physical Activity Questionnaire short version (IPAQ-S)
Measured: 1 year
Change from baseline body weight at 1 year
weight in kilograms
Measured: 1 year
Change from baseline total plasma cholesterol at 1 year
Measured: 1 year
Change from baseline plasma HDL cholesterol at 3 months
Measured: 3 months
Change from baseline plasma HDL cholesterol at 1 year
Measured: 1 year
Change from baseline plasma LDL cholesterol at 3 months
Measured: 3 months
Change from baseline plasma LDL cholesterol at 1 year
Measured: 1 year
Change from baseline plasma triglycerides at 3 months
Measured: 3 months
Change from baseline plasma triglycerides at 1 year
Measured: 1 year
Change from baseline blood glucose balance at 3 months
Blood glucose balance assessed by 75-g 2 h oral glucose tolerance test
Measured: 3 months
Change from baseline blood glucose balance at 1 year
Blood glucose balance assessed by 75-g 2 h oral glucose tolerance test
Measured: 1 year
Change from baseline fasting plasma insulin at 3 months
Measured: 3 months
Change from baseline fasting plasma insulin at 1 year
Measured: 1 year
Change from baseline body composition at 3 months
Body composition assessed by bioimpedance
Measured: 3 months
Change from baseline mood at 3 months
PANAS questionnaire
Measured: 3 months
Change from baseline mood at 1 year
PANAS questionnaire
Measured: 1 year
Change from baseline work productivity at 3 months
Work Productivity and Activity Impairment Questionnaire (WPAI)
Measured: 3 months
Change from baseline work productivity at 1 year
Work Productivity and Activity Impairment Questionnaire (WPAI)
Measured: 1 year
Change from baseline sexual functions at 3 months (females)
The Female Sexual Function Index (FSFI)
Measured: 3 months
Change from baseline sexual functions at 1 year (females)
The Female Sexual Function Index (FSFI)
Measured: 1 year
Change from baseline music consumption at 3 months
Music in Mood Regulation questionnaire (MMR)
Measured: 3 months
Change from baseline music consumption at 1 year
Music in Mood Regulation questionnaire (MMR)
Measured: 1 year
Change from baseline calorie intake at 3 months
Food diary filled during 3 consecutive days every 2 weeks
Measured: 3 months
Change from baseline calorie intake at 1 year
Food diary filled during 3 consecutive days every 2 weeks
Measured: 1 year
Change from baseline heart rate variability at 3 months
3 day electrocardiography monitoring
Measured: 3 months
Change from baseline heart rate variability at 1 year
3 day electrocardiography monitoring
Measured: 1 year
Change from baseline protein intake at 3 months
Food diary filled during 3 consecutive days every 2 weeks
Measured: 3 months
Change from baseline protein intake at 1 year
Food diary filled during 3 consecutive days every 2 weeks
Measured: 1 year
Change from baseline fat intake at 3 months
Food diary filled during 3 consecutive days every 2 weeks
Measured: 3 months
Change from baseline fat intake at 1 year
Food diary filled during 3 consecutive days every 2 weeks
Measured: 1 year
Change from baseline carbohydrate intake at 3 months
Food diary filled during 3 consecutive days every 2 weeks
Measured: 3 months
Change from baseline carbohydrate intake at 1 year
Food diary filled during 3 consecutive days every 2 weeks
Measured: 1 year
Height
height measured in centimeters
Measured: 0 months
Stability of personality
Five Factor Personality test
Measured: 0 months
Stability of personality
Five Factor Personality test
Measured: 3 months
Stability of personality
Five Factor Personality test
Measured: 1 year
Change from baseline depression at 3 months
Beck questionnaire
Measured: 3 months
Change from baseline depression at 1 year
Beck questionnaire
Measured: 1 year
Change from baseline waist-hip-ratio at 3 months
Measured: 3 months
Change from baseline waist-hip-ratio at 1 year
Measured: 1 year
Change from baseline plasma ferritin (P-Ferrit) level at 3 months
Measured: 3 months
Change from baseline plasma ferritin (P-Ferrit) level at 1 year
Measured: 1 year
Change from baseline plasma transferrin receptor (P-TfR) level at 3 months
Measured: 3 months
Change from baseline plasma transferrin receptor (P-TfR) level at 1 year
Measured: 1 year
Change from baseline plasma sensitive C-reactive protein (CRP) level at 3 months
Measured: 3 months
Change from baseline plasma sensitive C-reactive protein (CRP) level at 1 year
Measured: 1 year
Change from baseline plasma tumor necrosis factor alpha alpha (P-TNF alpha) level at 3 months
Measured: 3 months
Change from baseline plasma tumor necrosis factor alpha alpha (P-TNF alpha) level at 1 year
Measured: 1 year
Change from baseline plasma Interleukin-6 (IL6) level at 3 months
Measured: 3 months
Change from baseline plasma Interleukin-6 (IL-6) level at 1 year
Measured: 1 year
Change from baseline plasma Interleukin-10 (IL-10) level at 3 months
Measured: 3 months
Change from baseline plasma IInterleukin-10 (IL-10) level at 1 year
Measured: 1 year
Change from baseline plasma Interleukin-15 (IL-15) level at 3 months
Measured: 3 months
Change from baseline plasma Interleukin-15 (IL-15) level at 1 year
Measured: 1 year
Change from baseline plasma Interleukin-8 (IL-8) level at 3 months
Measured: 3 months
Change from baseline plasma Interleukin-8 (IL-8) level at 1 year
Measured: 1 year
Change from baseline plasma Interleukin-1 beta (IL-1 beta) level at 3 months
Measured: 3 months
Change from baseline plasma Interleukin-1 beta (IL-1 beta) level at 1 year
Measured: 1 year
Change from baseline body mass index (BMI) at 3 months
BMI in kg/m^2
Measured: 3 months
Change from baseline body mass index (BMI) at 1 year
BMI in kg/m^2
Measured: 1 year
Change from estimated (non-exercise questionnaire) baseline maximal O2 uptake (VO2max) at 3 months
Measured: 3 months
Change from estimated (non-exercise questionnaire) baseline maximal O2 uptake (VO2max) at 1 year
Measured: 1 year
Change from estimated (step test) baseline VO2max at 3 months
Measured: 3 months
Change from estimated (step test) baseline VO2max at 1 year
Measured: 1 year
Change from estimated (submaximal cycle ergometer exercise) baseline VO2max at 3 months
Measured: 3 months
Change from baseline maximal work rate (WR) at 3 months
Measured: 3 months
Change from baseline maximal and submaximal (work rate specific) pulmonary ventilation (VE) at 3 months
Measured: 3 months
Change from baseline maximal and submaximal (work rate specific) alveolar ventilation (VA) at 3 months
Measured: 3 months
Change from baseline maximal and submaximal (work rate specific) breathing frequency (Bf) at 3 months
Measured: 3 months
Change from baseline maximal and submaximal (work rate specific) tidal volume (VT) at 3 months
Measured: 3 months
Change from baseline maximal and submaximal (work rate specific) tidal volume - dead space ratio (VD/VT) at 3 months
Measured: 3 months
Change from baseline maximal and submaximal (work rate specific) end tidal O2 (PETO2) at 3 months
Measured: 3 months
Change from baseline maximal and submaximal (work rate specific) end tidal CO2 (PETCO2) at 3 months
Measured: 3 months
Change from baseline submaximal (work rate specific) VO2 at 3 months
Measured: 3 months
Change from baseline maximal and submaximal (work rate specific) CO2 production (VCO2) at 3 months
Measured: 3 months
Change from baseline maximal and submaximal (work rate specific) respiratory exchange ratio (RER) at 3 months
Measured: 3 months
Change from baseline maximal and submaximal (work rate specific) ventilatory equivalent for O2 uptake (VE/VO2) at 3 months
Measured: 3 months
Change from baseline maximal and submaximal (work rate specific) ventilatory equivalent for CO2 production (VE/VCO2) at 3 months
Measured: 3 months
Change from baseline maximal and submaximal (work rate specific) O2 pulse (VO2/HR) at 3 months
Measured: 3 months
Change from baseline resting heart rate (HR) at 3 months
Measured: 3 months
Change from baseline resting heart rate (HR) at 1 year
Measured: 1 year
Change from baseline resting blood pressure (BP, systolic, diastolic, pulse, mean) at 3 months
Measured: 3 months
Change from baseline resting blood pressure (BP, systolic, diastolic, pulse, mean) at 1 year
Measured: 1 year
Change from baseline maximal and submaximal (work rate specific) heart rate (HR) at 3 months
Measured: 3 months
Change from baseline maximal and submaximal (work rate specific) arterial blood pressure (BP, systolic, diastolic, pulse, mean) at 3 months
Measured: 3 months
Change from baseline maximal and submaximal (work rate specific) cardiac output (Q) at 3 months
Measured: 3 months
Change from baseline maximal and submaximal (work rate specific) stroke volume (SV) at 3 months
Measured: 3 months
Change from baseline maximal and submaximal (work rate specific) end-diastolic volume (EDV) at 3 months
Measured: 3 months
Change from baseline maximal and submaximal (work rate specific) ejection fraction (EF) at 3 months
Measured: 3 months
Change from baseline maximal and submaximal (work rate specific) cardiac index at 3 months
Measured: 3 months
Change from baseline maximal and submaximal (work rate specific) contractility index at 3 months
Measured: 3 months
Change from baseline maximal and submaximal (work rate specific) estimate of left ventricular ejection time at 3 months
Measured: 3 months
Change from baseline maximal and submaximal (work rate specific) left cardiac work index at 3 months
Measured: 3 months
Change from baseline maximal and submaximal (work rate specific) early diastolic function ratio at 3 months
Measured: 3 months
Change from baseline maximal and submaximal (work rate specific) calculated arteriovenous O2 difference ((a-v)O2) at 3 months
Measured: 3 months
Change from baseline maximal and submaximal (work rate specific) arterial O2 saturation (SpO2) at 3 months
Measured: 3 months
Change from baseline maximal and submaximal (work rate specific) calculated arterial O2 content (CaO2) heart rate (HR) at 3 months
Measured: 3 months
Change from baseline maximal and submaximal (work rate specific) calculated O2 delivery (QaO2) at 3 months
Measured: 3 months
Change from baseline maximal and submaximal (work rate specific) calculated O2 extraction (O2ext) at 3 months
Measured: 3 months
Change from baseline maximal and submaximal (work rate specific) calculated systemic vascular resistance (SVR) at 3 months
Measured: 3 months
Change from baseline maximal and submaximal (work rate specific) metabolic equivalent (MET) at 3 months
Measured: 3 months
Change from baseline maximal and submaximal (work rate specific) tissue saturation index (TSI) in skeletal muscle and cerebral tissue at 3 months
Measured: 3 months
Change from baseline maximal and submaximal (work rate specific) oxyhemoglobin concentration (O2Hb) in skeletal muscle and cerebral tissue at 3 months
Measured: 3 months
Change from baseline maximal and submaximal (work rate specific) deoxyhemoglobin concentration (HHb) in skeletal muscle and cerebral tissue at 3 months
Measured: 3 months
Change from baseline maximal and submaximal (work rate specific) total hemoglobin concentration (Hbtot) in skeletal muscle and cerebral tissue at 3 months
Measured: 3 months
Change from baseline maximal and submaximal (work rate specific) estimated regional blood flow (BFe) at 3 months
Measured: 3 months
Change from baseline ankle-brachial blood pressure index (ABI) at 3 months
Measured: 3 months
Change from baseline cardio-ankle vascular index (CAVI) at 3 months
Measured: 3 months
Change from baseline blood pressure variability (BPV) at 3 months
Measured: 3 months
Change from baseline baroreflex sensitivity (BRS) at 3 months
Measured: 3 months
Change from baseline postural sway during orthostatic test at 3 months
Measured: 3 months
Change from baseline nocturnal heart rate variability (HRVn) at 3 months
Measured: 3 months
Change from baseline heart rate on-kinetics and off-kinetics during an exercise test at 3 months
Measured: 3 months
Change from baseline alveolar gas exchange on-kinetics and off-kinetics during an exercise test at 3 months
Measured: 3 months
Change from baseline tissue oxygenation on-kinetics and off-kinetics during an exercise test at 3 months
Measured: 3 months
Change from baseline hemoglobin concentration ([Hb]) at 3 months
Measured: 3 months
Change from baseline hemoglobin concentration ([Hb]) at 1 year
Measured: 1 year
Change from baseline hematocrit (Hct) at 3 months
Measured: 3 months
Change from baseline hematocrit (Hct) at 1 year
Measured: 1 year
Change from baseline blood count at 3 months
Measured: 3 months
Change from baseline blood count at 1 year
Measured: 1 year
Change from baseline blood volume (BV) at 3 months
Measured: 3 months
Change from baseline total hemoglobin mass (tHb-mass]) at 3 months
Measured: 3 months
Change from baseline erythrocyte volume (EV) at 3 months
Measured: 3 months
Change from baseline erythrocyte volume (EV) at 1 year
Measured: 1 year
Change from baseline plasma volume (PV) at 3 months
Measured: 3 months
Change from baseline glycosylated hemoglobin (HbA1c) at 3 months
Measured: 3 months
Change from baseline glycosylated hemoglobin (HbA1c) at 1 year
Measured: 1 year
Change from baseline homeostasis model assessment of insulin resistance (HOMA-IR) at 3 months
Measured: 3 months
Change from baseline homeostasis model assessment of insulin resistance (HOMA-IR) at 1 year
Measured: 1 year
Change from baseline blood interleukin 2 (IL-2) at 3 months
Measured: 3 months
Change from baseline blood interleukin 2 (IL-2) at 1 year
Measured: 1 year
Change from baseline blood interleukin (IL-4) at 3 months
Measured: 3 months
Change from baseline blood interleukin (IL-4) at 1 year
Measured: 1 year
Change from baseline blood interleukin 5 (IL-5) at 3 months
Measured: 3 months
Change from baseline blood interleukin 5 (IL-5) at 1 year
Measured: 1 year
Change from baseline blood granulocyte-macrophage colony-stimulating factor (GM-CSF) at 3 months
Measured: 3 months
Change from baseline blood granulocyte-macrophage colony-stimulating factor (GM-CSF) at 1 year
Measured: 1 year
Change from baseline blood interferon gamma (IFNγ) at 3 months
Measured: 3 months
Change from baseline blood interferon gamma (IFNγ) at 1 year
Measured: 1 year
Change from baseline blood resistin at 3 months
Measured: 3 months
Change from baseline blood resistin at 1 year
Measured: 1 year
Change from baseline blood leptin at 3 months
Measured: 3 months
Change from baseline blood leptin at 1 year
Measured: 1 year
Change from baseline blood adiponectin at 3 months
Measured: 3 months
Change from baseline blood adiponectin at 1 year
Measured: 1 year
Change from baseline Forced Vital Capacity (FVC) at 3 months
Measured: 3 months
Change from baseline Forced Expiratory Volume in the 1st second (FEV1) at 3 months
Measured: 3 months
Change from baseline The percentage of total expired volume that was expired in the first second (FEV1%) at 3 months
Measured: 3 months
Change from baseline Forced Inspiratory Vital Capacity (FIV) at 3 months
Measured: 3 months
Change from baseline Peak Expiratory Flow (PEF) at 3 months
Measured: 3 months
Change from baseline Peak Inspiratory Flow (PIF) at 3 months
Measured: 3 months
Change from baseline Forced Expiratory Flow between 25% and 75% of FVC (FEF2575) at 3 months
Measured: 3 months
Change from baseline Forced Expiratory Flow at 25% of expired volume during FVC test (FEF25) at 3 months
Measured: 3 months
Change from baseline Forced Expiratory Flow at 50% of expired volume during FVC test (FEF50) at 3 months
Measured: 3 months
Change from baseline Forced Expiratory Flow at 75% of expired volume during FVC test (FEF75) at 3 months
Measured: 3 months
Change from baseline Forced Expiratory Time (FET) at 3 months
Measured: 3 months
Change from baseline sleep time cumulatively to 3 months
Measured: 3 months
Change from baseline sleep time cumulatively to 1 year
Measured: 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
Measured: 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
Measured: 1 year
Change from baseline possible obstructive sleep apnea (OSA) to 3 months
Measured: 3 months
Change from baseline calculated Wellness Index (WI) at 3 months
Measured: 3 months
Change from baseline calculated Wellness Index (WI) at 1 year
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Collaborators
- VTT Technical Research Centre of Finland, Finnish Institute of Occupational Health, University of Western Ontario, Canada, Helsinki University Central Hospital
- Responsible party
- Principal investigator, Maritta Pöyhönen-Alho, Helsinki University Central Hospital
- Investigators
- Seppo Heinonen, Professor, Study director, HUCH, Dept. of Obstetrics and Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02686502
- Sponsor's protocol ID
- TYH2016215
- Other IDs
- 575/31/2015
- Acronym
- MoMaMo!
- Status last verified
- May 2022
- First submitted
- 22 Jan 2016
- Last updated
- 2 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kaseva K, Tervaniemi M, Heikura E, Kostilainen K, Poyhonen-Alho M, Shoemaker JK, Petrella RJ, Peltonen JE. Identifying Personality Characteristics and Indicators of Psychological Well-Being Associated With Attrition in the Motivation Makes the Move! Physical Activity Intervention: Randomized Technology-Supported Trial. JMIR Form Res. 2022 Nov 25;6(11):e30285. doi: 10.2196/30285.
PubMed 36427239
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivation Makes the Move!
- ClinicalTrials.gov ID
- NCT02686502
- Acronym / sponsor ID
- MoMaMo! / TYH2016215
- Conditions
- Obesity, Cardiovascular Diseases, Physical Conditioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Collaborators
- VTT Technical Research Centre of Finland, Finnish Institute of Occupational Health, University of Western Ontario, Canada, Helsinki University Central Hospital
- Study start
- Apr 2016
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 19 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mode 1 | No intervention | –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. |
| Mode 2 | Active comparator | Behavioral: LifestyleIndividualized 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 | Active comparator | Behavioral: LifestyleHighly 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI ≥ 27,5 kg/m2
- estimated by health care personnel to benefit from lifestyle modification
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LifestyleAlso: Exercise, DietAs 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. | Behavioural | Mode 2, Mode 3 |
Primary outcome
Change from measured baseline maximal O2 uptake (VO2max) at 3 months
Time frame: 3 months
169 secondary outcomes
Change from baseline quality of life at 3 months
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
Time frame: 3 months
Change from baseline body weight at 3 months
Time frame: 3 months
Change from baseline quality of life at 1 year
Time frame: 1 year
Change from baseline physical activity at 1 year
Time frame: 1 year
Change from baseline body weight at 1 year
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
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
Time frame: 3 months
Change from baseline blood glucose balance at 1 year
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
Time frame: 3 months
Change from baseline mood at 3 months
Time frame: 3 months
Change from baseline mood at 1 year
Time frame: 1 year
Change from baseline work productivity at 3 months
Time frame: 3 months
Change from baseline work productivity at 1 year
Time frame: 1 year
Change from baseline sexual functions at 3 months (females)
Time frame: 3 months
Change from baseline sexual functions at 1 year (females)
Time frame: 1 year
Change from baseline music consumption at 3 months
Time frame: 3 months
Change from baseline music consumption at 1 year
Time frame: 1 year
Change from baseline calorie intake at 3 months
Time frame: 3 months
Change from baseline calorie intake at 1 year
Time frame: 1 year
Change from baseline heart rate variability at 3 months
Time frame: 3 months
Change from baseline heart rate variability at 1 year
Time frame: 1 year
Change from baseline protein intake at 3 months
Time frame: 3 months
Change from baseline protein intake at 1 year
Time frame: 1 year
Change from baseline fat intake at 3 months
Time frame: 3 months
Change from baseline fat intake at 1 year
Time frame: 1 year
Change from baseline carbohydrate intake at 3 months
Time frame: 3 months
Change from baseline carbohydrate intake at 1 year
Time frame: 1 year
Height
Time frame: 0 months
Stability of personality
Time frame: 0 months
Stability of personality
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
- Derived from this study: PubMed 36427239Kaseva K, Tervaniemi M, Heikura E, Kostilainen K, Poyhonen-Alho M, Shoemaker JK, Petrella RJ, Peltonen JE. Identifying Personality Characteristics and Indicators of Psychological Well-Being Associated With Attrition in the Motivation Makes the Move! Physical Activity Intervention: Randomized Technology-Supported Trial. JMIR Form Res. 2022 Nov 25;6(11):e30285. doi: 10.2196/30285.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seppo Heinonen, Professor study director
HUCH, Dept. of Obstetrics and Gynecology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle in people with Obesity and Cardiovascular Diseases, run by University of Helsinki at 2 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from measured baseline maximal O2 uptake (VO2max) at 3 months (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02686502, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2022.