Physical Inactivity Clinical Trial
Official title:
The Effect After 12 Weeks of Having Received a Pedometer and a Pedometer Program on Physical Activity, Health Measurements, Self-rated Health, Stress, and Sleep Quality: a Randomized Controlled Trial
Physical activity is associated with a reduced risk of several chronic diseases in addition
to all-cause mortality. Hence for public health purposes, knowledge of effective
interventions to increase the physical activity level in the population is important.
The objective of this randomized controlled trial was to examine the effect 12 weeks after
having received a pedometer and a pedometer program on physical activity, health
measurements, self-rated health, stress, and sleep quality.
A total of 223 men and 445 women were randomly assigned to either a pedometer group (n =
333) in which participants received a pedometer and pedometer program or a control group (n
= 335). Of the participants included in the study 198 and 178 completed the health
examination, and 192 and 187 completed the questionnaire at follow up in the pedometer group
and in the control group, respectively.
The results from the KRAM Study are used as baseline for this intervention. In the KRAM
study all adult citizens (18+ years) in 13 Danish municipalities were invited by letter to
take part in an internet based questionnaire concerning socio-demography, life style, and
other health aspects. Furthermore, a random sample of the citizens was invited to
participate in a health examination. A total of 76.484 of the invited 538.497 citizens
filled in the entire or partially the questionnaire and 18.065 of the invited 180.103
citizens completed the health examination. The examination included the following
measurements: Blood pressure, height, weight, fat percentage, blood samples, pulmonary
function, bone mineral density, muscle strength, balance test, and aerobic fitness.
Intervention The intervention was carried out in three of the 13 municipalities (Silkeborg,
Frederiksberg, and Varde). Participants with a low aerobic fitness (defined for men and
women in different age groups) or those who reported being sedentary or light physically
active in leisure time were - after they had accomplished the health examination - invited
to participate in the intervention. Participants were not included if they participated in
other interventions initiated in relation with the KRAM Study or if they were pregnant. All
participants gave informed consent. The protocol was approved by the Scientific Ethical
Committee B for the Capital Region of Denmark (H-B-2008-097).
The participants were randomly assigned to either a pedometer group or a control group by
drawing a sealed envelope with a unique randomizing number. The participants in the
pedometer group received a pedometer (Yamax Digi-Walker SW-200), a book with a pedometer
program, a handout with a summary of the pedometer program, and a calendar for registration
of daily steps. The aim of the program is to guide people to use a pedometer and increase
their steps with 20 % each week until they reach their goal. During the trial period, they
were asked to reset the pedometer every morning and to wear it during the entire day. In the
evening, they should take the pedometer off and register the total number of steps in the
calendar. After three, six, and nine weeks, the participants in the pedometer group got a
mail to encourage them to keep using the pedometer and follow the program. Participants
assigned to the control group received a leaflet from the National Board of Health in
Denmark recommending all adults to be physical active for 30 minutes each day of moderate
intensity.
Follow up After 12 weeks, participants were invited by letter to answer a short
questionnaire. Furthermore, they were invited to participate in a health examination
including the measurements of blood pressure, weight, fat percentage, and aerobic fitness.
The researchers who performed the examinations were blinded to group assignment.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
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