Condition category
Nutritional, Metabolic, Endocrine
Date applied
28/04/2011
Date assigned
20/05/2011
Last edited
20/05/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Publication citations

Additional files

Editorial Notes