Body and future health
| ISRCTN | ISRCTN92130721 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN92130721 |
| Secondary identifying numbers | N/A |
- Submission date
- 28/04/2011
- Registration date
- 20/05/2011
- Last edited
- 20/05/2011
- 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 Urho Kujala
Scientific
Scientific
Department of Health Sciences
University of Jyväskylä
Jyväskylä
FI-40014
Finland
| urho.m.kujala@jyu.fi |
Study information
| Study design | Single centre single blind four arm randomised controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Body and future health: a single centre, single blind, four arm, randomised controlled study |
| Study objectives | Body fat percentage and metabolic and mental stress can be reduced using a mini-intervention which includes diet and physical activity guidelines and which the participants can carry out using web-based guidelines and with minimal help from specialists. These effects are stronger when the participants use additional web-based exercise coaching program to increase physical activity and improve fitness, or when the participants use additional whey protein drinks. |
| Ethics approval(s) | The study was approved by the Ethics Committee of the Central Finland Health Care District on 18th February 2011 (Dnro 3U/2011) |
| Health condition(s) or problem(s) studied | Obesity |
| Intervention | The duration of the intervention per participant is 6 months. The participants (goal 160 participants) will be randomised to four groups (40 per group), which are 1. Control group (no lifestyle changes recommended) , 2. Mini-intervention (internet-based recommendations related to changes in diet and increases in physical activity) 3. Mini-intervention plus web-based coaching program to increase physical activity and improve fitness 4. Mini-intervention plus whey protein product taken 6 dL each day |
| Intervention type | Other |
| Primary outcome measure | 1. Fat percentage measured by Dual Energy X-Ray Absorptiometry (DEXA) at baseline, at 3 and at 6 months follow-up 2. Daily stress level measured by heart rate monitor (based on heart rate variability and determined differently for day and night). |
| Secondary outcome measures | 1. Changes in cardio-metabolic risk factors 2. Changes in diet, physical activity and sleep Measured from baseline to 6 months follow up. All questionnaires (including readiness to change, self-efficacy, and acceptance and action questionnaires) and other variables are also analysed to find out which factors predict best adherence and responses to the interventions. |
| Overall study start date | 01/04/2011 |
| Completion date | 31/12/2012 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | The goal for the number of participants to be randomised is 160, 40 per each arm. |
| Key inclusion criteria | 1. The participants are healthy volunteers (young adults, 25-40 years) with a body mass index (BMI) of 25-35 kg/m2 and waist circumference over 94 cm (for men) and over 80 cm (for women) 2. Who do not participate regularly in physical activity 3. Who have access to internet at home 4. Who either regularly use milk or are ready to start using milk products (without lactose) |
| Key exclusion criteria | 1. Chronic disease with regular medication 2. Pregnancy or intention to become pregnant during next 12 months or less than 12 months from latest parturition 3. Milk allergy 4. Eating disorder 5. Regular participation in physical activity (of over 20 min duration more than twice a week) 6. Current smoker or regular smoking during past three months, heavy use of alcohol, use of drugs 7. Over 5 kg weight change during past 6 months 8. Abnormal electrocardiogram |
| Date of first enrolment | 01/04/2011 |
| Date of final enrolment | 31/12/2012 |
Locations
Countries of recruitment
- Finland
Study participating centre
Department of Health Sciences
Jyväskylä
FI-40014
Finland
FI-40014
Finland
Sponsor information
University of Jyvaskyla (Finland)
University/education
University/education
Department of Health Sciences
c/o Urho Kujala
Jyväskylä
FI-40014
Finland
| urho.m.kujala@jyu.fi | |
"ROR" |
https://ror.org/05n3dz165 |
Funders
Funder type
Research council
Finnish Funding Agency for Technology and Innovation (TEKES) (Finland)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
