Guided exercise intervention for improving physical fitness and weight control in overweight and obese males and females

ISRCTN ISRCTN87529813
DOI https://doi.org/10.1186/ISRCTN87529813
Secondary identifying numbers EWI-study; K-S shp:n Dnro 4U/2009
Submission date
29/09/2009
Registration date
09/11/2009
Last edited
09/11/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Sulin Cheng
Scientific

Deparment of Health Sciences
PO Box 35
Jyväskylä
401001
Finland

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleExercise and weight control intervention for improving physical fitness - fitness line algorithm validation: a randomised controlled trial
Study acronymEWI-study
Study objectives1. 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(s)Ethics Committee of Central Finland Health Care District, Jyväskylä, Finland, approved on the 17th June 2009 (ref: K-S shp:n Dnro 4U/2009)
Health condition(s) or problem(s) studiedOverweight/obesity
InterventionPhase 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 typeOther
Primary outcome measureEfficacy 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 measuresMaintenance 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 study start date20/06/2009
Completion date31/12/2012

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants100 women and 100 men
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment20/06/2009
Date of final enrolment31/12/2012

Locations

Countries of recruitment

  • Finland

Study participating centre

Deparment of Health Sciences
Jyväskylä
401001
Finland

Sponsor information

Suunto Oy (Finland)
Industry

c/o Veikko Koivumaa
Valimotie 7
Vantaa
01510
Finland

Website http://www.suunto.com/suunto/main/index.jsp
ROR logo "ROR" https://ror.org/04n2d2p10

Funders

Funder type

Industry

Suunto Oy (Finland)

No information available

University of Jyväskylä (Finland) - Wellness Program

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan