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Completed

NCT Number: NCT02686502

Motivation Makes the Move!

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.

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Key information

Conditions

Obesity Behavior Body Weight Cardiovascular Diseases Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Physical Conditioning Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helsinki University Hospital, Helsinki, Finland

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyle

Behavioral

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.

Other names: Exercise, Diet

Primary outcomes

  1. Change from measured baseline maximal O2 uptake (VO2max) at 3 months

    Time frame: 3 months

Secondary outcomes

  1. Change from baseline quality of life at 3 months

    Time frame: 3 months

    Rand-36 questionnaire

  2. Change from baseline total plasma cholesterol at 3 months

    Time frame: 3 months

  3. Change from baseline physical activity at 3 months

    Time frame: 3 months

    The International Physical Activity Questionnaire short version (IPAQ-S)

  4. Change from baseline body weight at 3 months

    Time frame: 3 months

    weight in kilograms

  5. Change from baseline quality of life at 1 year

    Time frame: 1 year

    Rand-36 questionnaire

  6. Change from baseline physical activity at 1 year

    Time frame: 1 year

    The International Physical Activity Questionnaire short version (IPAQ-S)

  7. Change from baseline body weight at 1 year

    Time frame: 1 year

    weight in kilograms

  8. Change from baseline total plasma cholesterol at 1 year

    Time frame: 1 year

  9. Change from baseline plasma HDL cholesterol at 3 months

    Time frame: 3 months

  10. Change from baseline plasma HDL cholesterol at 1 year

    Time frame: 1 year

  11. Change from baseline plasma LDL cholesterol at 3 months

    Time frame: 3 months

  12. Change from baseline plasma LDL cholesterol at 1 year

    Time frame: 1 year

  13. Change from baseline plasma triglycerides at 3 months

    Time frame: 3 months

  14. Change from baseline plasma triglycerides at 1 year

    Time frame: 1 year

  15. Change from baseline blood glucose balance at 3 months

    Time frame: 3 months

    Blood glucose balance assessed by 75-g 2 h oral glucose tolerance test

  16. Change from baseline blood glucose balance at 1 year

    Time frame: 1 year

    Blood glucose balance assessed by 75-g 2 h oral glucose tolerance test

  17. Change from baseline fasting plasma insulin at 3 months

    Time frame: 3 months

  18. Change from baseline fasting plasma insulin at 1 year

    Time frame: 1 year

  19. Change from baseline body composition at 3 months

    Time frame: 3 months

    Body composition assessed by bioimpedance

  20. Change from baseline mood at 3 months

    Time frame: 3 months

    PANAS questionnaire

  21. Change from baseline mood at 1 year

    Time frame: 1 year

    PANAS questionnaire

  22. Change from baseline work productivity at 3 months

    Time frame: 3 months

    Work Productivity and Activity Impairment Questionnaire (WPAI)

  23. Change from baseline work productivity at 1 year

    Time frame: 1 year

    Work Productivity and Activity Impairment Questionnaire (WPAI)

  24. Change from baseline sexual functions at 3 months (females)

    Time frame: 3 months

    The Female Sexual Function Index (FSFI)

  25. Change from baseline sexual functions at 1 year (females)

    Time frame: 1 year

    The Female Sexual Function Index (FSFI)

  26. Change from baseline music consumption at 3 months

    Time frame: 3 months

    Music in Mood Regulation questionnaire (MMR)

  27. Change from baseline music consumption at 1 year

    Time frame: 1 year

    Music in Mood Regulation questionnaire (MMR)

  28. Change from baseline calorie intake at 3 months

    Time frame: 3 months

    Food diary filled during 3 consecutive days every 2 weeks

  29. Change from baseline calorie intake at 1 year

    Time frame: 1 year

    Food diary filled during 3 consecutive days every 2 weeks

  30. Change from baseline heart rate variability at 3 months

    Time frame: 3 months

    3 day electrocardiography monitoring

  31. Change from baseline heart rate variability at 1 year

    Time frame: 1 year

    3 day electrocardiography monitoring

  32. Change from baseline protein intake at 3 months

    Time frame: 3 months

    Food diary filled during 3 consecutive days every 2 weeks

  33. Change from baseline protein intake at 1 year

    Time frame: 1 year

    Food diary filled during 3 consecutive days every 2 weeks

  34. Change from baseline fat intake at 3 months

    Time frame: 3 months

    Food diary filled during 3 consecutive days every 2 weeks

  35. Change from baseline fat intake at 1 year

    Time frame: 1 year

    Food diary filled during 3 consecutive days every 2 weeks

  36. Change from baseline carbohydrate intake at 3 months

    Time frame: 3 months

    Food diary filled during 3 consecutive days every 2 weeks

  37. Change from baseline carbohydrate intake at 1 year

    Time frame: 1 year

    Food diary filled during 3 consecutive days every 2 weeks

  38. Height

    Time frame: 0 months

    height measured in centimeters

  39. Stability of personality

    Time frame: 0 months

    Five Factor Personality test

  40. Stability of personality

    Time frame: 3 months

    Five Factor Personality test

  41. Stability of personality

    Time frame: 1 year

    Five Factor Personality test

  42. Change from baseline depression at 3 months

    Time frame: 3 months

    Beck questionnaire

  43. Change from baseline depression at 1 year

    Time frame: 1 year

    Beck questionnaire

  44. Change from baseline waist-hip-ratio at 3 months

    Time frame: 3 months

  45. Change from baseline waist-hip-ratio at 1 year

    Time frame: 1 year

  46. Change from baseline plasma ferritin (P-Ferrit) level at 3 months

    Time frame: 3 months

  47. Change from baseline plasma ferritin (P-Ferrit) level at 1 year

    Time frame: 1 year

  48. Change from baseline plasma transferrin receptor (P-TfR) level at 3 months

    Time frame: 3 months

  49. Change from baseline plasma transferrin receptor (P-TfR) level at 1 year

    Time frame: 1 year

  50. Change from baseline plasma sensitive C-reactive protein (CRP) level at 3 months

    Time frame: 3 months

  51. Change from baseline plasma sensitive C-reactive protein (CRP) level at 1 year

    Time frame: 1 year

  52. Change from baseline plasma tumor necrosis factor alpha alpha (P-TNF alpha) level at 3 months

    Time frame: 3 months

  53. Change from baseline plasma tumor necrosis factor alpha alpha (P-TNF alpha) level at 1 year

    Time frame: 1 year

  54. Change from baseline plasma Interleukin-6 (IL6) level at 3 months

    Time frame: 3 months

  55. Change from baseline plasma Interleukin-6 (IL-6) level at 1 year

    Time frame: 1 year

  56. Change from baseline plasma Interleukin-10 (IL-10) level at 3 months

    Time frame: 3 months

  57. Change from baseline plasma IInterleukin-10 (IL-10) level at 1 year

    Time frame: 1 year

  58. Change from baseline plasma Interleukin-15 (IL-15) level at 3 months

    Time frame: 3 months

  59. Change from baseline plasma Interleukin-15 (IL-15) level at 1 year

    Time frame: 1 year

  60. Change from baseline plasma Interleukin-8 (IL-8) level at 3 months

    Time frame: 3 months

  61. Change from baseline plasma Interleukin-8 (IL-8) level at 1 year

    Time frame: 1 year

  62. Change from baseline plasma Interleukin-1 beta (IL-1 beta) level at 3 months

    Time frame: 3 months

  63. Change from baseline plasma Interleukin-1 beta (IL-1 beta) level at 1 year

    Time frame: 1 year

  64. Change from baseline body mass index (BMI) at 3 months

    Time frame: 3 months

    BMI in kg/m^2

  65. Change from baseline body mass index (BMI) at 1 year

    Time frame: 1 year

    BMI in kg/m^2

  66. Change from estimated (non-exercise questionnaire) baseline maximal O2 uptake (VO2max) at 3 months

    Time frame: 3 months

  67. Change from estimated (non-exercise questionnaire) baseline maximal O2 uptake (VO2max) at 1 year

    Time frame: 1 year

  68. Change from estimated (step test) baseline VO2max at 3 months

    Time frame: 3 months

  69. Change from estimated (step test) baseline VO2max at 1 year

    Time frame: 1 year

  70. Change from estimated (submaximal cycle ergometer exercise) baseline VO2max at 3 months

    Time frame: 3 months

  71. Change from baseline maximal work rate (WR) at 3 months

    Time frame: 3 months

  72. Change from baseline maximal and submaximal (work rate specific) pulmonary ventilation (VE) at 3 months

    Time frame: 3 months

  73. Change from baseline maximal and submaximal (work rate specific) alveolar ventilation (VA) at 3 months

    Time frame: 3 months

  74. Change from baseline maximal and submaximal (work rate specific) breathing frequency (Bf) at 3 months

    Time frame: 3 months

  75. Change from baseline maximal and submaximal (work rate specific) tidal volume (VT) at 3 months

    Time frame: 3 months

  76. Change from baseline maximal and submaximal (work rate specific) tidal volume - dead space ratio (VD/VT) at 3 months

    Time frame: 3 months

  77. Change from baseline maximal and submaximal (work rate specific) end tidal O2 (PETO2) at 3 months

    Time frame: 3 months

  78. Change from baseline maximal and submaximal (work rate specific) end tidal CO2 (PETCO2) at 3 months

    Time frame: 3 months

  79. Change from baseline submaximal (work rate specific) VO2 at 3 months

    Time frame: 3 months

  80. Change from baseline maximal and submaximal (work rate specific) CO2 production (VCO2) at 3 months

    Time frame: 3 months

  81. Change from baseline maximal and submaximal (work rate specific) respiratory exchange ratio (RER) at 3 months

    Time frame: 3 months

  82. Change from baseline maximal and submaximal (work rate specific) ventilatory equivalent for O2 uptake (VE/VO2) at 3 months

    Time frame: 3 months

  83. Change from baseline maximal and submaximal (work rate specific) ventilatory equivalent for CO2 production (VE/VCO2) at 3 months

    Time frame: 3 months

  84. Change from baseline maximal and submaximal (work rate specific) O2 pulse (VO2/HR) at 3 months

    Time frame: 3 months

  85. Change from baseline resting heart rate (HR) at 3 months

    Time frame: 3 months

  86. Change from baseline resting heart rate (HR) at 1 year

    Time frame: 1 year

  87. Change from baseline resting blood pressure (BP, systolic, diastolic, pulse, mean) at 3 months

    Time frame: 3 months

  88. Change from baseline resting blood pressure (BP, systolic, diastolic, pulse, mean) at 1 year

    Time frame: 1 year

  89. Change from baseline maximal and submaximal (work rate specific) heart rate (HR) at 3 months

    Time frame: 3 months

  90. Change from baseline maximal and submaximal (work rate specific) arterial blood pressure (BP, systolic, diastolic, pulse, mean) at 3 months

    Time frame: 3 months

  91. Change from baseline maximal and submaximal (work rate specific) cardiac output (Q) at 3 months

    Time frame: 3 months

  92. Change from baseline maximal and submaximal (work rate specific) stroke volume (SV) at 3 months

    Time frame: 3 months

  93. Change from baseline maximal and submaximal (work rate specific) end-diastolic volume (EDV) at 3 months

    Time frame: 3 months

  94. Change from baseline maximal and submaximal (work rate specific) ejection fraction (EF) at 3 months

    Time frame: 3 months

  95. Change from baseline maximal and submaximal (work rate specific) cardiac index at 3 months

    Time frame: 3 months

  96. Change from baseline maximal and submaximal (work rate specific) contractility index at 3 months

    Time frame: 3 months

  97. Change from baseline maximal and submaximal (work rate specific) estimate of left ventricular ejection time at 3 months

    Time frame: 3 months

  98. Change from baseline maximal and submaximal (work rate specific) left cardiac work index at 3 months

    Time frame: 3 months

  99. Change from baseline maximal and submaximal (work rate specific) early diastolic function ratio at 3 months

    Time frame: 3 months

  100. Change from baseline maximal and submaximal (work rate specific) calculated arteriovenous O2 difference ((a-v)O2) at 3 months

    Time frame: 3 months

  101. Change from baseline maximal and submaximal (work rate specific) arterial O2 saturation (SpO2) at 3 months

    Time frame: 3 months

  102. Change from baseline maximal and submaximal (work rate specific) calculated arterial O2 content (CaO2) heart rate (HR) at 3 months

    Time frame: 3 months

  103. Change from baseline maximal and submaximal (work rate specific) calculated O2 delivery (QaO2) at 3 months

    Time frame: 3 months

  104. Change from baseline maximal and submaximal (work rate specific) calculated O2 extraction (O2ext) at 3 months

    Time frame: 3 months

  105. Change from baseline maximal and submaximal (work rate specific) calculated systemic vascular resistance (SVR) at 3 months

    Time frame: 3 months

  106. Change from baseline maximal and submaximal (work rate specific) metabolic equivalent (MET) at 3 months

    Time frame: 3 months

  107. Change from baseline maximal and submaximal (work rate specific) tissue saturation index (TSI) in skeletal muscle and cerebral tissue at 3 months

    Time frame: 3 months

  108. Change from baseline maximal and submaximal (work rate specific) oxyhemoglobin concentration (O2Hb) in skeletal muscle and cerebral tissue at 3 months

    Time frame: 3 months

  109. Change from baseline maximal and submaximal (work rate specific) deoxyhemoglobin concentration (HHb) in skeletal muscle and cerebral tissue at 3 months

    Time frame: 3 months

  110. Change from baseline maximal and submaximal (work rate specific) total hemoglobin concentration (Hbtot) in skeletal muscle and cerebral tissue at 3 months

    Time frame: 3 months

  111. Change from baseline maximal and submaximal (work rate specific) estimated regional blood flow (BFe) at 3 months

    Time frame: 3 months

  112. Change from baseline ankle-brachial blood pressure index (ABI) at 3 months

    Time frame: 3 months

  113. Change from baseline cardio-ankle vascular index (CAVI) at 3 months

    Time frame: 3 months

  114. Change from baseline blood pressure variability (BPV) at 3 months

    Time frame: 3 months

  115. Change from baseline baroreflex sensitivity (BRS) at 3 months

    Time frame: 3 months

  116. Change from baseline postural sway during orthostatic test at 3 months

    Time frame: 3 months

  117. Change from baseline nocturnal heart rate variability (HRVn) at 3 months

    Time frame: 3 months

  118. Change from baseline heart rate on-kinetics and off-kinetics during an exercise test at 3 months

    Time frame: 3 months

  119. Change from baseline alveolar gas exchange on-kinetics and off-kinetics during an exercise test at 3 months

    Time frame: 3 months

  120. Change from baseline tissue oxygenation on-kinetics and off-kinetics during an exercise test at 3 months

    Time frame: 3 months

  121. Change from baseline hemoglobin concentration ([Hb]) at 3 months

    Time frame: 3 months

  122. Change from baseline hemoglobin concentration ([Hb]) at 1 year

    Time frame: 1 year

  123. Change from baseline hematocrit (Hct) at 3 months

    Time frame: 3 months

  124. Change from baseline hematocrit (Hct) at 1 year

    Time frame: 1 year

  125. Change from baseline blood count at 3 months

    Time frame: 3 months

  126. Change from baseline blood count at 1 year

    Time frame: 1 year

  127. Change from baseline blood volume (BV) at 3 months

    Time frame: 3 months

  128. Change from baseline total hemoglobin mass (tHb-mass]) at 3 months

    Time frame: 3 months

  129. Change from baseline erythrocyte volume (EV) at 3 months

    Time frame: 3 months

  130. Change from baseline erythrocyte volume (EV) at 1 year

    Time frame: 1 year

  131. Change from baseline plasma volume (PV) at 3 months

    Time frame: 3 months

  132. Change from baseline glycosylated hemoglobin (HbA1c) at 3 months

    Time frame: 3 months

  133. Change from baseline glycosylated hemoglobin (HbA1c) at 1 year

    Time frame: 1 year

  134. Change from baseline homeostasis model assessment of insulin resistance (HOMA-IR) at 3 months

    Time frame: 3 months

  135. Change from baseline homeostasis model assessment of insulin resistance (HOMA-IR) at 1 year

    Time frame: 1 year

  136. Change from baseline blood interleukin 2 (IL-2) at 3 months

    Time frame: 3 months

  137. Change from baseline blood interleukin 2 (IL-2) at 1 year

    Time frame: 1 year

  138. Change from baseline blood interleukin (IL-4) at 3 months

    Time frame: 3 months

  139. Change from baseline blood interleukin (IL-4) at 1 year

    Time frame: 1 year

  140. Change from baseline blood interleukin 5 (IL-5) at 3 months

    Time frame: 3 months

  141. Change from baseline blood interleukin 5 (IL-5) at 1 year

    Time frame: 1 year

  142. Change from baseline blood granulocyte-macrophage colony-stimulating factor (GM-CSF) at 3 months

    Time frame: 3 months

  143. Change from baseline blood granulocyte-macrophage colony-stimulating factor (GM-CSF) at 1 year

    Time frame: 1 year

  144. Change from baseline blood interferon gamma (IFNγ) at 3 months

    Time frame: 3 months

  145. Change from baseline blood interferon gamma (IFNγ) at 1 year

    Time frame: 1 year

  146. Change from baseline blood resistin at 3 months

    Time frame: 3 months

  147. Change from baseline blood resistin at 1 year

    Time frame: 1 year

  148. Change from baseline blood leptin at 3 months

    Time frame: 3 months

  149. Change from baseline blood leptin at 1 year

    Time frame: 1 year

  150. Change from baseline blood adiponectin at 3 months

    Time frame: 3 months

  151. Change from baseline blood adiponectin at 1 year

    Time frame: 1 year

  152. Change from baseline Forced Vital Capacity (FVC) at 3 months

    Time frame: 3 months

  153. Change from baseline Forced Expiratory Volume in the 1st second (FEV1) at 3 months

    Time frame: 3 months

  154. Change from baseline The percentage of total expired volume that was expired in the first second (FEV1%) at 3 months

    Time frame: 3 months

  155. Change from baseline Forced Inspiratory Vital Capacity (FIV) at 3 months

    Time frame: 3 months

  156. Change from baseline Peak Expiratory Flow (PEF) at 3 months

    Time frame: 3 months

  157. Change from baseline Peak Inspiratory Flow (PIF) at 3 months

    Time frame: 3 months

  158. Change from baseline Forced Expiratory Flow between 25% and 75% of FVC (FEF2575) at 3 months

    Time frame: 3 months

  159. Change from baseline Forced Expiratory Flow at 25% of expired volume during FVC test (FEF25) at 3 months

    Time frame: 3 months

  160. Change from baseline Forced Expiratory Flow at 50% of expired volume during FVC test (FEF50) at 3 months

    Time frame: 3 months

  161. Change from baseline Forced Expiratory Flow at 75% of expired volume during FVC test (FEF75) at 3 months

    Time frame: 3 months

  162. Change from baseline Forced Expiratory Time (FET) at 3 months

    Time frame: 3 months

  163. Change from baseline sleep time cumulatively to 3 months

    Time frame: 3 months

  164. Change from baseline sleep time cumulatively to 1 year

    Time frame: 1 year

  165. 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

    Time frame: 3 months

  166. 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

    Time frame: 1 year

  167. Change from baseline possible obstructive sleep apnea (OSA) to 3 months

    Time frame: 3 months

  168. Change from baseline calculated Wellness Index (WI) at 3 months

    Time frame: 3 months

  169. Change from baseline calculated Wellness Index (WI) at 1 year

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University of Helsinki

Other

Collaborators

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

Registry information

Acronym: MoMaMo!

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Feb 19, 2016
Registry last updated
Jun 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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