Condition category
Mental and Behavioural Disorders
Date applied
16/09/2011
Date assigned
30/11/2011
Last edited
27/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
There is enough evidence showing that we should be more active. This study examines how personalised counselling (including a half an hour lecture followed by face-to-face discussions with the researchers) can reduce sedentary time, and what impact this will have on health.

Who can participate?
The study participants are recruited via daycare centres and primary schools in the Jyväskylä region in Finland. Eligible participants are parents of 3-8 year old children having an occupation where they sit more than 50% of their work time. The adults are to be healthy without chronic metabolic or musculoskeletal diseases. The children should be in all-day daycare and should not have developmental or other disorders delaying motor development.

What does the study involve?
The participants are randomly allocated to one of two groups: one receiving personalised counselling at the beginning of the study and the other receiving the counselling at the end of the study. During counselling the parents commit themselves to spending less time in a sitting position and to increasing physical activity during work and leisure time for one year. During leisure time the parents are guided to ensure that children are more active. The participants undergo various tests 5 times a year including physical activity measurements and blood sampling. Physical activity level and motor skills will be measured in children.

What are the possible benefits and risks of participating?
Adult participants will receive information on their health, daily physical activity, body composition, muscle strength and diet. Feedback of children’s physical activity and motor skills will be given. All the subjects will receive tips for increasing physical activity in everyday life.
The tests include venous blood samples that sometimes can cause bruising inside of the elbow. Dual energy x-ray absorptiometry is used three times during the study to measure body composition. This procedure results in a radiation dose that corresponds to the amount people typically are exposed to during 2.4 hours in Finland. Heart rate will be measured by placing two electrodes on the chest. Electrodes are also used to measure thigh muscle electrical activity. The electrodes contain a gel that may cause skin irritation or allergic reaction (this is rare). Physical activity measurements include maximal contractions that are done after a warm-up. These tests may cause muscle or tendon strains but the risk is no greater than in normal exercise at the gym.

Where is the study run from?
The study is conducted at the Department of Biology of Physical Activity, University of Jyväskylä, Finland

When is the study starting and how long is it expected to run for?
From April 2011 to December 2014

Who is funding the study?
Finnish Ministry of Education and Culture

Who is the main contact?
Prof. Taija Juutinen Finni
taija.finni@jyu.fi

Trial website

https://staff.jyu.fi/Members/finni/InPact

Contact information

Type

Scientific

Primary contact

Prof Taija Juutinen Finni

ORCID ID

Contact details

PO Box 35
Jyväskylä
40014
Finland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Tailored Counseling to Increase non-exercise Physical Activity in adults with a sedentary job and in their young children: A year-long randomized controlled trial

Acronym

InPACT

Study hypothesis

1. Counseling increases physical activity and decreases muscle inactivity time during workday and leisure time in adults
2. Counseling induces behavioral changes that last over 6 months maintenance period
3. There is transfer effect of parental counseling so that also the children’s physical activity increases

Ethics approval

Ethics committee of Central Finland Health Care District approved on 25 March 2011 (Dnro 6U/2011)

Study design

Single-center randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Physical inactivity and sedentary work

Intervention

Intervention group receives tailored counseling with a half-an-hour common lecture followed by face-to-face discussion with the researcher that results in signing the agreement of the behavioral changes. The intervention is reinforced in the first six months by phone calls and e-mails and the following six months are maintenance period.

Control group undergoes the same assessments but receives no tailored counseling.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. From children, physical activity level is assessed five times a year using triaxial accelerometers that are worn on the waist for one week during waking hours
2. From adults accelerometer data is also assessed 5*1 week during the year
2.1. From adults also heart rate and thigh muscle electrical activity are measured for shorter periods of time

Secondary outcome measures

1. From adults:
1.1. Venous blood samples
1.2. Body composition
1.3. 12-month physical activity questionnaire
1.4. RAND-36
1.5. Work Ability Index and Occupational Stress Questionnaire (Finnish Institute of Occupational Health)
2. Children's fundamental motor skills are evaluated three times during the year

Overall trial start date

01/04/2011

Overall trial end date

15/12/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Healthy men and women with children 3-8 years old
2. Having work where they sit more than 50% of their work time
3. Children in all-day daycare and at least 10 days per month

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200 men and women and their children aged 3-8 years

Participant exclusion criteria

1. Self-reported chronic, long-term musculoskeletal disease or progressive neurological disease, diagnosed cardiovascular or metabolic disease with regular medication
2. Families with pregnant mother at baseline and body mass index (BMI) > 35
3. Children with a developmental disorder or other disorders delaying motor development

Recruitment start date

01/04/2011

Recruitment end date

15/12/2014

Locations

Countries of recruitment

Finland

Trial participating centre

PO Box 35
Jyväskylä
40014
Finland

Sponsor information

Organisation

University of Jyväskylä (Finland)

Sponsor details

Neuromuscular Reserach Center
Department of Biology of Physical Activity
PO Box 35
Jyväskylä
40014
Finland

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Ministry of Education and Culture (Finland) (42/627/2010)

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

1. 2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/22185647
2. 2015 results in http://www.ncbi.nlm.nih.gov/pubmed/25251049
3. 2015 results in http://www.ncbi.nlm.nih.gov/pubmed/24674974
4. 2015 results in http://www.ncbi.nlm.nih.gov/pubmed/24118456
5. 2015 results in http://www.ncbi.nlm.nih.gov/pubmed/23894111
6. 2015 results in http://www.ncbi.nlm.nih.gov/pubmed/26502183

Publication citations

  1. Protocol

    Finni T, Sääkslahti A, Laukkanen A, Pesola A, Sipilä S, A family based tailored counselling to increase non-exercise physical activity in adults with a sedentary job and physical activity in their young children: design and methods of a year-long randomized controlled trial., BMC Public Health, 2011, 11, 944, doi: 10.1186/1471-2458-11-944.

Additional files

Editorial Notes