Motivation Makes the Move!

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2019-12-31

Brief Summary

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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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Detailed Description

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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

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Obesity Cardiovascular Diseases Physical Conditioning

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Mode 1

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Mode 2

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.

Group Type ACTIVE_COMPARATOR

Lifestyle

Intervention Type 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.

Mode 3

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.

Group Type ACTIVE_COMPARATOR

Lifestyle

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Exercise Diet

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes