Motivation Makes the Move!

Obesity Clinical Trial

— MoMaMo!  

Official title:

Motivation Makes the Move!

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02686502
• Other study ID #: TYH2016215
• Secondary ID: 575/31/2015
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: December 2019

Study information

• Verified date: May 2022
• Source: University of Helsinki
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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, 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.

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 information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Obesity
• Physical Conditioning

Intervention

Behavioral:
• Lifestyle
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.

Locations

Country	Name	City	State
Finland	Helsinki University Hospital	Helsinki
Finland	Vantaa Health Care and Social Services	Vantaa

Sponsors (5)

Lead Sponsor	Collaborator
University of Helsinki	Finnish Institute of Occupational Health, Helsinki University Central Hospital, University of Western Ontario, Canada, VTT Technical Research Centre of Finland

Country where clinical trial is conducted

Finland, 

Outcome

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