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
Protocol serial number	EWI-study; K-S shp:n Dnro 4U/2009
Sponsor	Suunto Oy (Finland)
Funders	Suunto Oy (Finland), University of Jyväskylä (Finland) - Wellness Program

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Exercise and weight control intervention for improving physical fitness - fitness line algorithm validation: a randomised controlled trial
Study acronym	EWI-study
Study objectives	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(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) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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?
Completion date	31/12/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	200
Key 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
Key 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
Date of first enrolment	20/06/2009
Date of final enrolment	31/12/2012

Locations

Countries of recruitment

Finland

Study participating centre

Deparment of Health Sciences

Jyväskylä
401001
Finland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes