Body and future health

ISRCTN	ISRCTN92130721
DOI	https://doi.org/10.1186/ISRCTN92130721
Protocol serial number	N/A
Sponsor	University of Jyvaskyla (Finland)
Funder	Finnish Funding Agency for Technology and Innovation (TEKES) (Finland)

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

Department of Health Sciences
University of Jyväskylä
Jyväskylä
FI-40014
Finland

Email	urho.m.kujala@jyu.fi

Study information

Primary study design	Interventional
Study design	Single centre single blind four arm randomised controlled study
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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).
Key secondary outcome measure(s)	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.
Completion date	31/12/2012

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Sex	All
Target sample size at registration	160
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

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