Clinical trial NCT02990039: A Tailored Feasibility Study to Increase Physical Activity and to Reduce Sedentary Time
Official title: A Tailored Feasibility Study to Increase Physical Activity and to Reduce Sedentary Time
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Risk Factor
Keywords: physical activity
sedentary time
feasibility study
accelerometer
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
First posted: 2016-12-12
Enrollment: 176
Sex: ALL
Minimum age (years): 42
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Adherence: Drop-out rates in control and intervention group
timeFrame: up to 12 month
Secondary outcomes:
measure: Feasibility: Comprehensibility on intervention material via paper-pencil-assessment
timeFrame: 12 month
measure: physical activity by self-report
timeFrame: Change from Baseline Physical Activity at 12 months
measure: physical activity by accelerometry
timeFrame: Change from Baseline Physical Activity at 12 months
measure: sedentary time by self-report
timeFrame: Change from Baseline Sedentary Time at 12 months
measure: sedentary time by accelerometry
timeFrame: Change from Baseline Sedentary Time at 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Institute of Social Medicine and Prevention, University Medicine Greifswald, Greifswald, Germany
name: Sabina Ulbricht, Dr.
role: STUDY_CHAIR
References:
citation: Voigt L, Baumann S, Ullrich A, Weymar F, John U, Ulbricht S. The effect of mere measurement from a cardiovascular examination program on physical activity and sedentary time in an adult population. BMC Sports Sci Med Rehabil. 2018 Jan 23;10:1. doi: 10.1186/s13102-018-0090-8. eCollection 2018.
citation: Ullrich A, Voigt L, Baumann S, Weymar F, John U, Dorr M, Ulbricht S. A cross-sectional analysis of the associations between leisure-time sedentary behaviors and clustered cardiometabolic risk. BMC Public Health. 2018 Mar 6;18(1):327. doi: 10.1186/s12889-018-5213-3.
citation: Baumann S, Gross S, Voigt L, Ullrich A, Weymar F, Schwaneberg T, Dorr M, Meyer C, John U, Ulbricht S. Pitfalls in accelerometer-based measurement of physical activity: The presence of reactivity in an adult population. Scand J Med Sci Sports. 2018 Mar;28(3):1056-1063. doi: 10.1111/sms.12977. Epub 2017 Oct 12.
citation: Voigt L, Ullrich A, Baumann S, Dorr M, John U, Ulbricht S. Do sociodemographic variables and cardiometabolic risk factors moderate the mere-measurement effect on physical activity and sedentary time? BMC Cardiovasc Disord. 2020 Jun 5;20(1):272. doi: 10.1186/s12872-020-01551-9.