Aktiv i Sør: a Randomized Controlled Trial

NCT ID: NCT03164239

Last Updated: 2017-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-01

Study Completion Date

2012-02-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Physical Activity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention group - telephone and print exercise intervention

The intervention group (IG) received a total of three intervention packages, one every second month, during the intervention period. The first intervention package was distributed at intervention start. The intervention package consisted of a tailored exercise program, national recommendations for physical activity, prompts and reminders. Additionally the IG received fortnightly supportive motivational contact every two weeks, alternately by telephone og email

Group Type EXPERIMENTAL

Intervention group - telephone and print exercise intervention

Intervention Type BEHAVIORAL

Intervention has previously been described.

Control group

The control group (CG) were encouraged to continue previous lifestyle.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intervention group - telephone and print exercise intervention

Intervention has previously been described.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Norwegian School of Sport Sciences

OTHER

Sponsor Role collaborator

University of Agder

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Monica Klungland Torstveit

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Monica K Torstveit, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Agder

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 29988751 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Aktiv i Sør

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.