Condition category
Nutritional, Metabolic, Endocrine
Date applied
29/09/2009
Date assigned
09/11/2009
Last edited
09/11/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Sulin Cheng

ORCID ID

Contact details

Deparment of Health Sciences
PO Box 35
Jyväskylä
401001
Finland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

EWI-study; K-S shp:n Dnro 4U/2009

Study information

Scientific title

Exercise and weight control intervention for improving physical fitness - fitness line algorithm validation: a randomised controlled trial

Acronym

EWI-study

Study hypothesis

1. Guided exercise is more effective for improving physical fitness and weight control than unguided exercise. The most sensitive changes will be seen in maximal oxygen uptake (max VO2) and gut microbiota after a short-term exercise program while the differences will be more pronounced in heart rate variability (HRV) and body composition after long-term exercise program.
2. There will be high dropout after a short-term intervention. Overweight and obese people need guidance and monitoring of their physical condition to motivate them towards continuing exercise and weight control. To establish "habitual exercise" requires long term guidance and commitment.

Ethics approval

Ethics Committee of Central Finland Health Care District, Jyväskylä, Finland, approved on the 17th June 2009 (ref: K-S shp:n Dnro 4U/2009)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Overweight/obesity

Intervention

Phase I (6-week intervention):
Group 1 - exercise follows guidance from a wrist computer: subjects will follow the daily guidance of the device to exercise (Nordic break walking) 30 minutes to 1 hour each time and gradually increase the intensity and duration. The intensity of exercise will be checked every 2nd week and the guidance will be modified accordingly.
Group 2 - general training advice but no device: subjects will follow the instruction by a researcher to exercise (Nordic break walking) 30 minutes to 1 hour a time and gradually increase the intensity and duration.
Group 3 - weight control follows guidance from a wrist computer: subjects follow the weight guidance from device to change their weight either by eating or exercise. The weight (body composition) will be checked every 2nd week and the guidance will be modified accordingly.
Group 4 - weight control gets general advice but no device: subjects follow the instruction by a nutritionist to change their weight either by eating or exercise.

After the first phase of the study, subjects will not be informed that they will be followed-up for phase II of the study. Thus it can be ensured that the maintenance rate is not interfered with by the participants knowing that they will be followed later.

In study phase II (1-year intervention), all of the subjects will be invited back 6 months after the onset of the phase I study. A wrist computer will be provided to them and subjects will follow the instruction to set the exercise intensity/duration and target weight on the basis of their fitness level and weight to exercise. Those people who are not maintaining their leisure time physical activity (LTPA) will be randomly assigned to two groups. One group will have and one will not have 6 months measurements. Phone call tracking interview will be contacted every 3 months interval to evaluate the maintenance rate.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Efficacy of guided exercise on fitness and weight control: physical fitness and body composition (HRV, gut microbiota, Max VO2, fat mass, lean mass) -
1. Daily physical activity and a diet diary will be assessed at baseline, every week during the intervention, at follow-up point 2, and every week during the long term intervention until follow-up point 3
2. Anthropometry and blood pressure will be measured at baseline, half-way through the long-term intervention and at follow-up points 1, 2 and 3. Blood samples will also be taken at this point.
3. Body composition, and the 10-metre walking test will be measured at baseline and every two weeks through the short term intervention until follow-up point 1, and at follow-up point 2, halfway-way through the long term intervention and at follow-up point 3. The treadmill test will also be taken at all of these points apart from follow-up point 3.
4. Faecal samples, basal metabolic rate and max VO2 will be measured at baseline and follow-up points 1, 2 and 3

Secondary outcome measures

Maintenance of exercise and weight control intervention:
1. How many people will maintain their physical activity and weight control after a short intervention?
2. What are the reasons for people stopping exercise and weight control after a short intervention?
3. Does long-term guided exercise and weight control intervention help to maintain peoples LTPA and weight control after intervention?

Overall trial start date

20/06/2009

Overall trial end date

31/12/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women and men aged 20 - 50 years
2. Physically inactive (regular exercise less than or equal to two times per week and less than or equal to 45 minutes per session)
3. Body mass index (BMI) greater than 25 kg/m^2 – 38 kg/m^2

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100 women and 100 men

Participant exclusion criteria

1. BMI greater than 38 kg/m^2
2. Serious cardiovascular or musculoskeletal problems
3. Diagnosed type I diabetes
4. Change in weight more than 5 kg during last 6 months

Recruitment start date

20/06/2009

Recruitment end date

31/12/2012

Locations

Countries of recruitment

Finland

Trial participating centre

Deparment of Health Sciences
Jyväskylä
401001
Finland

Sponsor information

Organisation

Suunto Oy (Finland)

Sponsor details

c/o Veikko Koivumaa
Valimotie 7
Vantaa
01510
Finland

Sponsor type

Industry

Website

http://www.suunto.com/suunto/main/index.jsp

Funders

Funder type

Industry

Funder name

Suunto Oy (Finland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

University of Jyväskylä (Finland) - Wellness Program

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes