Clinical trial NCT03164239: Aktiv i Sør: a Randomized Controlled Trial
Official title: The Effect of a Tailored Telephone and Email Based Physical Activity Intervention on Physical Fitness and Body Composition: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Lead sponsor: University of Agder
Sponsor class: OTHER
Collaborators: name: Norwegian School of Sport Sciences
First posted: 2017-05-23
Enrollment: 111
Sex: ALL
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this regional parallel-group RCT was to assess the effect of a six-month tailored telephone and email based physical activity intervention on various measures of physical fitness and body composition in a sample of physically inactive adults. A total of 111 physically inactive adults (40-55yr) from Agder, Norway were randomly allocated to either an intervention group (IG;n=56) or a no-intervention control group (CG;n=55). The IG received tailored exercise recommendations, every two months by email or mail (print) in addition to motivational follow-ups every second week, alternatively by email and telephone. Primary outcome measures were various objective measures of musculoskeletal and cardiorespiratory fitness in addition to various measures of body composition, including waist circumference, body mass index and fat percentage, which were assessed pre- and post-intervention.


Eligibility criteria: Inclusion Criteria:

Participants were included in the study if they were

* healthy
* between the ages of 40-55
* residents of the Agder counties in Norway
* classified as physically inactive (not fulfill the recommendations for physical activity given by the Norwegian Directorate of Health
* within stage one to three of the five stages of change in the transtheoretical model stages of change

Exclusion Criteria:

Participants were excluded if they were

* Unhealthy/ill
* younger than 40 years or older than 55 years
* living outside the Agder counties in Norway
* allready fulfilling the national recommendations given by the Norwegian Directorate of Health
* within stage four or five of the five stages of change in the transtheoretical model stages of change

Primary outcomes:
measure: Change from Baseline Cardiorespiratory fitness at 6 months
timeFrame: Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
measure: Change from Baseline Muscular endurance of the back extensors at 6 months
timeFrame: Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
measure: Change from Baseline Hand grip strength at 6 months
timeFrame: Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
measure: Change from Baseline Neuromotor fitness at 6 months
timeFrame: Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
measure: Change from Baseline Muscular dynamic endurance of and the ability to stabilize the upper body at 6 months
timeFrame: Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
measure: Change from Baseline Flexibility of the hamstring musculature at 6 months
timeFrame: Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
measure: Change from Baseline Flexibility in the shoulder joint at 6 months
timeFrame: Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
measure: Change from Baseline Explosive power in the lower extremities at 6 months
timeFrame: Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
measure: Change from Baseline Body mass index at 6 months
timeFrame: Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
measure: Change from Baseline Waist circumference at 6 months
timeFrame: Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
measure: Change from Baseline Fat percentage at 6 months
timeFrame: Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
measure: Change from Baseline Cardiorespiratory fitness at 6 months
timeFrame: Data collected prior to (pre) and after (post) a 6 month intervention period. Pretest was conducted in March-April, 2011 and post test was conducted in October-November, 2011.
Secondary outcomes:
measure: Age
timeFrame: This is one of the descriptive statistics which was collected at one time point only. Data were collected on day one, in april 2011.
measure: Gender
timeFrame: This is one of the descriptive statistics which was collected at one time point only. Data were collected on day one, in april 2011
measure: Educational level
timeFrame: This is one of the descriptive statistics which was collected at one time point only. Data were collected on day one, in april 2011
Other outcomes:
measure: Physical activity level
timeFrame: This is one of the variables determining inclusion to the study and was collected at one time point only. Data were collected on day one, in april 2011
measure: Stage of change
timeFrame: This is one of the variables determining inclusion to the study and was collected at one time point only. Data were collected on day one, in april 2011
Locations:
Study officials:
affiliation: University of Agder
name: Monica K Torstveit, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kjaer IGH, Anderssen SA, Torstveit MK. A tailored telephone and email based exercise intervention induced reductions in various measures of body composition in physically inactive adults: A randomized controlled trial. Prev Med Rep. 2018 Jun 27;11:160-168. doi: 10.1016/j.pmedr.2018.06.011. eCollection 2018 Sep.