Sedentary Lifestyle Clinical Trial
Official title:
Movement-to-music Video Program in Decreasing Sedentary Time in Mothers and Children: a Randomized Controlled Trial
The aims of the study: Main objective of the current study is to decrease sedentary behavior
and increase physical activity among mothers and their offspring by using music-to-movement
video program. Primary outcomes of the study are objectively assessed sedentary behavior and
physical activity time measured both in minutes and as a proportion of measurement time.
Secondary outcomes of the study are quantity and quality of self-reported screen time among
mothers and children and motivational quality of music and music-to-movement video.
Additional secondary outcomes are mother's weight, workability, mental health and mood.
Specific aim is to study effectiveness of intervention with accelerometer use only or with a
combination of accelerometer plus music-to-movement video program for mother-child pairs.
Materials and methods: Participants (mother and child -pairs) of the Movement-to-music video
program (Moving Sound) -study will be recruited from the cohort of the original Lifestyle,
counselling and exercise in maternity care (NELLI) -project from 14 municipalities of
Pirkanmaa area. Participants will be randomized in two groups: accelerometer (ACC) vs.
accelerometer plus movement-to-music video program (ACC+DVD) groups. Objective measurement
of sedentariness and physical activity is based on accelerometer. Information on current
health behavior will be based on intervention questionnaires. In the analysis physical
activity, sedentary time and body weight of the intervention and control group will be
compared. Effects of mother's musical (and PA) background and other mediating factors will
be analyzed separately in subgroup analyses.
The aims of the study Quite many people use music during exercise for example while jogging
or in the gym. Anyhow some mothers might have difficulties to exercise when they have small
children and thereby importance of physical activity at home increases. Consequently, there
is a need to perform an experimental study which combines the understanding of the benefits
of music, objective physical activity measurement in decreasing sedentariness and thereafter
transgenerational obesity.
Main objective of the current study is to decrease sedentary behavior and increase physical
activity among mothers and their offspring by using music-to-movement video program.
Specific aim is to study effectiveness of intervention with accelerometer use only or with a
combination of accelerometer plus music-to-movement video program for mother-child pairs.
Research questions:
I. Are there changes in sedentary time and physical activity while using accelerometer and
movement-to-music video program? Hypothesis: Movement-to-music video program developed for
mother-child pairs decrease sedentary time more than wearing accelerometer only. There are
no changes in moderate-to-vigorous physical activity, although amount of light intensity
physical activity increases.
II. How does motivational effects of music affect to physical activity? Hypothesis:
Movement-to-music video motivates mother-child pairs increase physical activity and decrease
sedentary behavior.
III. Is there any relationship between mothers' musical background and physical
activity/sedentary behavior? Hypothesis: Mothers' musicality motivates them exercise more
with video program than mothers' without musical background.
Research methods Accelerometer measures and pretest. Main aim of the project is to reduce
sedentariness among women and their children. Accelerometer measures continuously tri-axial
acceleration caused by any movement and permits accurate individual assessment of both
physical activity and sedentary behavior. Data on physical activity and sedentary behavior
will be collected with tri-axial accelerometer (Hookie AM 20, Traxmeet Ltd, Espoo, Finland).
The data will be collected in raw mode and analyzed as the mean signal amplitude deviation
(MAD) of acceleration, which permits accurate individual assessment of both physical
activity and sedentariness. The algorithms used in the present study are based on pilot
studies conducted at the UKK Institute.
Accelerometers were pretested with eleven 2-9 years old children. Children did different
kind of free movements, play, and games in test track field during one hour. That was done
to find out how scurry-like movements appear in accelerometers. Another test in running
track tested different speeds from the slow walking to the maximum rate of running. In
addition accelerometers piloted with ten 4-7 years children during one week. On the basis of
these tests acceleration signal acted as expected.
Movement-to-music DVD production and pretest. There will be three separate movement-to-music
video programs prepared by the Sibelius-Academy music education students in the specific
course for children's music programs during spring 2014. Directors, Soili Perkiö and
Eeva-Leena Pokela are children's music professionals. The student group is called
Mutaveijarit (The Mud Mates). Video programs were produced for this study. First and second
videos last about 10 minutes including two songs and their movement preparation. There are
three songs altogether, because the title song Mutaveijarit is in both tracks. The third
video includes all songs together without their movement preparation.
To rate the motivational qualities of these three songs, a panel of 8 physiotherapists (all
female) assessed each song by using Brunel Music Rating Inventory-2 (BMRI-2; BMRI-3).
Another reason for pretest was to find out the influence of visual stimuli on the responses
to the music. BMRI-2 was translated in Finnish by investigators of this study.
Each song was rated by indicating one number between 1 (strongly disagree) and 7 (strongly
agree) for six statements about how much the song would motivate a person during exercise.
The possible range of scores is 6-42, wherein scores below 24 mean low/oudeterous, middle
range 24-35 moderately and scores over 36 mean highly motivating ratings.
Video group (n=4, mean age 41 years, SD 16,2 years) was first watching DVD and assessed all
three songs separately using BMRI-2. Then they listened music only (without illustration)
and rated the motivational qualities of each song. Music group (n=4, mean age 42,8 years, SD
15,8 years) assessed first only the motivational qualities of the songs. After that music
group was watching DVD and appraised the music and illustration together. In addition both
groups moved to DVD and rated the motivational qualities of music during movement. All songs
were rated moderately motivating (ratings between 31,4 and 34,6).
The rhythm, style, melody, tempo and beat motivated movement more in video group than in
music group. Music group assessed sound motivated them more than sound did in video group.
During movement rhythm, style, and beat motivated video group more while melody, tempo, and
sound motivated music group. As expected in both groups music and picture together motivated
movement more than music alone.
Data collection. Objective measurements of sedentary behavior and physical activity of the
mothers and their children will be collected at first, second and eighth weeks of the
intervention by using accelerometer. Body weight of the mothers will be measured at
baseline. Information on current physical activity, screen time, diet, and self-reported
weight, as well as information on quality of life will be collected at the baseline by using
same questionnaires as in the NELLI 5-years follow-up study (based on one-year follow-up
questionnaires of the NELLI cohort). At 2 and 8 weeks after baseline information on physical
activity, screen time, self-reported weight and motivation to exercise by using
movement-to-music video program will be collected by questionnaires. Information of the
children's physical activity and screen time will be collected at baseline, 2nd and 8th
weeks after baseline by questionnaires.
Statistical methods. Effect of the intervention will be analyzed following the
intention-to-treat principle by comparing the changes in the main outcomes between
intervention and control group participants. Multivariate methods corresponding to analysis
of covariance and logistic regression will be used. Non-paramet¬ric methods will also be
utilized if needed. In the analysis physical activity, sedentary time and body weight of the
intervention and control group will be compared. Subgroup analysis in intervention group
will be conducted for mother's motivation to exercise with movement-to-music video program
and effects of musical background.
Research materials Participants of the Moving Sound -study will be recruited from the cohort
of the original NELLI-RTC. Mother and child -pairs (n=837) will be invited to NELLI 5-years
follow-up study and to Moving Sound -study from 14 municipalities of Pirkanmaa area. We
expect to get involved 30-40 % of the original cohort, which will be 251-335 mother and
child -pairs, altogether.
Randomization will be done for 2:2 ratios, which means two mother-child pairs to
intervention group per two pairs of control participants. For allocation of the participants
an appointment order list for NELLI 5-years follow-up study will be used. Mothers will be
randomized to intervention or control group by using sealed envelopes in contact of sampling
for NELLI-study.
Power calculations for the study show that approximately 91 mother and child -pairs are
needed, if there are 80 % sedentary women at baseline and the anticipated difference in
sedentariness is 25 % between the ACC (accelerometer) and ACC + DVD (accelerometer plus
movement-to-music video program) groups after intervention. If the anticipated difference
between groups is smaller (than 25 %), the number of pairs needed is 135 per group. In this
study sedentary women are defined as being sitting or in reclining posture more than 76 % of
waking hours.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention
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