Contact information
Type
Scientific
Primary contact
Prof Urho Kujala
ORCID ID
Contact details
Department of Health Sciences
University of Jyväskylä
Jyväskylä
FI-40014
Finland
urho.m.kujala@jyu.fi
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Body and future health: a single centre, single blind, four arm, randomised controlled study
Acronym
Study hypothesis
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
The study was approved by the Ethics Committee of the Central Finland Health Care District on 18th February 2011 (Dnro 3U/2011)
Study design
Single centre single blind four arm randomised controlled study
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
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
01/04/2011
Overall trial end date
31/12/2012
Reason abandoned
Eligibility
Participant 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)
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
The goal for the number of participants to be randomised is 160, 40 per each arm.
Participant 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
Recruitment start date
01/04/2011
Recruitment end date
31/12/2012
Locations
Countries of recruitment
Finland
Trial participating centre
Department of Health Sciences
Jyväskylä
FI-40014
Finland
Sponsor information
Organisation
University of Jyvaskyla (Finland)
Sponsor details
Department of Health Sciences
c/o Urho Kujala
Jyväskylä
FI-40014
Finland
urho.m.kujala@jyu.fi
Sponsor type
University/education
Website
Funders
Funder type
Research council
Funder name
Finnish Funding Agency for Technology and Innovation (TEKES) (Finland)
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