Actions to reduce sedentary time in parents and their young children

ISRCTN	ISRCTN28668090
DOI	https://doi.org/10.1186/ISRCTN28668090
Protocol serial number	N/A
Sponsor	University of Jyväskylä (Finland)
Funder	Ministry of Education and Culture (Finland) (42/627/2010)

Submission date: 16/09/2011
Registration date: 30/11/2011
Last edited: 20/12/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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 childrens 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

Contact information

Prof Taija Juutinen Finni
Scientific

PO Box 35
Jyväskylä
40014
Finland

Study information

Primary study design	Interventional
Study design	Single-center randomized controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	InPACT
Study objectives	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 childrens physical activity increases
Ethics approval(s)	Ethics committee of Central Finland Health Care District approved on 25 March 2011 (Dnro 6U/2011)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	15/12/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	200
Key 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
Key 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
Date of first enrolment	01/04/2011
Date of final enrolment	15/12/2014

Locations

Countries of recruitment

Finland

Study participating centre

PO Box 35

Jyväskylä
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?
Results article	results	01/01/2014		Yes	No
Results article	results	01/04/2014		Yes	No
Results article	results	01/11/2014		Yes	No
Results article	results	01/06/2015		Yes	No
Results article	results	26/10/2015		Yes	No
Results article	results	01/11/2016		Yes	No
Protocol article	protocol	20/12/2011		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

20/12/2016: Publication reference added.