A Tailored Feasibility Study to Increase Physical Activity and to Reduce Sedentary Time
March 8, 2019 updated by: University Medicine Greifswald
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
176
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
42 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Counseling letter (intervention group)
Participants of the intervention group received a brief counseling letter intervention aiming to reduce sedentary time and to increase physical activity.
The intervention comprised up to three tailored letters based on separate questionnaires.
|
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.
Other Names:
|
|
No Intervention: No counseling letter (control group)
Participants of the control group did not received the brief counseling letter intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adherence: Drop-out rates in control and intervention group
Time Frame: up to 12 month
|
Measures: Analyses of drop-out rates (%) in control and intervention group
|
up to 12 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility: Comprehensibility on intervention material via paper-pencil-assessment
Time Frame: 12 month
|
Measures: questions regarding the comprehensibility on intervention material (via paper-pencil-assessment)
|
12 month
|
|
physical activity by self-report
Time Frame: Change from Baseline Physical Activity at 12 months
|
Measures: paper-pencil-assessment (International Physical Activity Questionnaire-Long version, IPAQ-L)
|
Change from Baseline Physical Activity at 12 months
|
|
physical activity by accelerometry
Time Frame: Change from Baseline Physical Activity at 12 months
|
Measures: objective measurement of physical activity by accelerometry
|
Change from Baseline Physical Activity at 12 months
|
|
sedentary time by self-report
Time Frame: Change from Baseline Sedentary Time at 12 months
|
Measures: paper-pencil-assessment (last 7-d sedentary behavior questionnaire, SIT-Q-7d)
|
Change from Baseline Sedentary Time at 12 months
|
|
sedentary time by accelerometry
Time Frame: Change from Baseline Sedentary Time at 12 months
|
Measures: objective measurement of physical activity by accelerometry
|
Change from Baseline Sedentary Time at 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Sabina Ulbricht, Dr., Institute of Social Medicine and Prevention, University Medicine Greifswald, Greifswald, Germany
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2015
Primary Completion (Actual)
September 1, 2016
Study Completion (Actual)
September 1, 2016
Study Registration Dates
First Submitted
November 15, 2016
First Submitted That Met QC Criteria
December 7, 2016
First Posted (Estimate)
December 12, 2016
Study Record Updates
Last Update Posted (Actual)
March 12, 2019
Last Update Submitted That Met QC Criteria
March 8, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- FKZ 81Z5400152
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.