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A Tailored Feasibility Study to Increase Physical Activity and to Reduce Sedentary Time

A Tailored Feasibility Study to Increase Physical Activity and to Reduce Sedentary Time

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02990039
Enrollment
176
Registered
2016-12-12
Start date
2015-02-28
Completion date
2016-09-30
Last updated
2019-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Risk Factor

Keywords

physical activity, sedentary time, feasibility study, accelerometer

Brief summary

The purpose of this study was (i) to develop a brief counseling letter intervention aiming to reduce sedentary time and to increase physical activity during leisure time among adults aged 42 to 64 years and (ii) to provide information on the feasibility.

Detailed description

The study aimed to assess the feasibility of a brief counseling letter intervention to increase physical activity and to reduce sedentary time in leisure time. Following the Intervention Mapping Protocol we developed the counseling letter intervention. The intervention is based on the Health Action Process Approach, comprising 3 tailored letters based on separate assessments, delivered over 6 month. All participants consented (i) to participate in an examination at the university hospital including standardized measurements of blood pressure, waist and hip circumference, body height and weight as well as blood sample taking, (ii) to fill in a paper-pencil questionnaire, and (iii) to wear an accelerometer for 7 days at baseline and at 12-month follow-up. A general population sample of cardiovascular healthy adults was randomly allocated to a control and an intervention group. At 5 time points (baseline, 3-month, 6-month, 7-month, and 12-month follow-up) participants of both study groups completed standardized questionnaires.

Interventions

The intervention is based on the Health Action Process Approach. The first letter provides information on knowledge regarding sedentary time and physical activity as well as intervenes on self-efficacy depending on the mindset of participants (non-intender, intender, actor). The second letter focuses on benefits and barriers of physical activity as well as the role of social support for physical activity. In case of actional stage, the third letter intervenes on self-efficacy again and suggests action and coping planning. Otherwise, the letter includes ipsative feedback according to the second letter.

Sponsors

University Medicine Greifswald
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
42 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* age between 42 and 65 years * resident in a pre-defined zip-code area

Exclusion criteria

* cardiovascular event (myocardial infarction, stroke) or vascular intervention * self-reported body-mass-index over 35 kg/m²

Design outcomes

Primary

MeasureTime frameDescription
Adherence: Drop-out rates in control and intervention groupup to 12 monthMeasures: Analyses of drop-out rates (%) in control and intervention group

Secondary

MeasureTime frameDescription
Feasibility: Comprehensibility on intervention material via paper-pencil-assessment12 monthMeasures: questions regarding the comprehensibility on intervention material (via paper-pencil-assessment)
physical activity by self-reportChange from Baseline Physical Activity at 12 monthsMeasures: paper-pencil-assessment (International Physical Activity Questionnaire-Long version, IPAQ-L)
physical activity by accelerometryChange from Baseline Physical Activity at 12 monthsMeasures: objective measurement of physical activity by accelerometry
sedentary time by self-reportChange from Baseline Sedentary Time at 12 monthsMeasures: paper-pencil-assessment (last 7-d sedentary behavior questionnaire, SIT-Q-7d)
sedentary time by accelerometryChange from Baseline Sedentary Time at 12 monthsMeasures: objective measurement of physical activity by accelerometry

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026