Cardiovascular Risk FactorNCT02990039
A Tailored Feasibility Study to Increase Physical Activity and to Reduce Sedentary Time
A study testing Counseling letter in people with Cardiovascular Risk Factor, run by University Medicine Greifswald.
Trial 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. Read more about this study
- Who is it for?
- Ages 42 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factor
- What is being tested?
- Counseling letter
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 42 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age between 42 and 65 years
- resident in a pre-defined zip-code area
Who cannot join
- cardiovascular event (myocardial infarction, stroke) or vascular intervention
- self-reported body-mass-index over 35 kg/m²
About this study
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.
Read the 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.
- Conditions
- Cardiovascular Risk Factor
- Being tested
- Counseling letter
- Keywords
- physical activity, sedentary time, feasibility study, accelerometer
- Medical subject headings
- Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Counseling letterBehavioural
Also called Feasibility of brief counseling letter intervention
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.
| Study group | Role | What they receive |
|---|---|---|
| Counseling letter (intervention group) | Experimental | 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. Receives: Behavioral: Counseling letter |
| No counseling letter (control group) | No intervention | Participants of the control group did not received the brief counseling letter intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence: Drop-out rates in control and intervention group
Measures: Analyses of drop-out rates (%) in control and intervention group
Measured: up to 12 month
Secondary outcomes (5)
Feasibility: Comprehensibility on intervention material via paper-pencil-assessment
Measures: questions regarding the comprehensibility on intervention material (via paper-pencil-assessment)
Measured: 12 month
physical activity by self-report
Measures: paper-pencil-assessment (International Physical Activity Questionnaire-Long version, IPAQ-L)
Measured: Change from Baseline Physical Activity at 12 months
physical activity by accelerometry
Measures: objective measurement of physical activity by accelerometry
Measured: Change from Baseline Physical Activity at 12 months
sedentary time by self-report
Measures: paper-pencil-assessment (last 7-d sedentary behavior questionnaire, SIT-Q-7d)
Measured: Change from Baseline Sedentary Time at 12 months
sedentary time by accelerometry
Measures: objective measurement of physical activity by accelerometry
Measured: Change from Baseline Sedentary Time at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2016 (estimated)
- Study startFeb 2015
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Risk FactorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sabina Ulbricht, Dr., Study chair, Institute of Social Medicine and Prevention, University Medicine Greifswald, Greifswald, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02990039
- Sponsor's protocol ID
- FKZ 81Z5400152
- Status last verified
- Mar 2019
- First submitted
- 15 Nov 2016
- Last updated
- 12 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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.
PubMed 29410786Ullrich 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.
PubMed 29510707Baumann 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.
PubMed 28921747Voigt L, Ullrich A, Gross S, Guertler D, Jaeschke L, Dorr M, van den Berg N, John U, Ulbricht S. Associations of accelerometer-based sedentary bouts with adiposity markers among German adults - results from a cross-sectional study. BMC Public Health. 2023 Mar 10;23(1):469. doi: 10.1186/s12889-023-15304-8.
PubMed 36899317Voigt 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.
PubMed 32503441
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Tailored Feasibility Study to Increase Physical Activity and to Reduce Sedentary Time
- ClinicalTrials.gov ID
- NCT02990039
- Acronym / sponsor ID
- FKZ 81Z5400152
- Conditions
- Cardiovascular Risk Factor
- Keywords
- physical activity, sedentary time, feasibility study, accelerometer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 12 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Counseling letter (intervention group) | Experimental | Behavioral: Counseling letterParticipants 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. |
| No counseling letter (control group) | No intervention | –Participants of the control group did not received the brief counseling letter intervention. |
Who may qualify
- Ages
- 42 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age between 42 and 65 years
- resident in a pre-defined zip-code area
Key exclusion criteria (2 listed)
- cardiovascular event (myocardial infarction, stroke) or vascular intervention
- self-reported body-mass-index over 35 kg/m²
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Counseling letterAlso: Feasibility of brief counseling letter interventionThe 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. | Behavioural | Counseling letter (intervention group) |
Primary outcome
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
5 secondary outcomes
Feasibility: Comprehensibility on intervention material via paper-pencil-assessment
Time frame: 12 month
physical activity by self-report
Time frame: Change from Baseline Physical Activity at 12 months
physical activity by accelerometry
Time frame: Change from Baseline Physical Activity at 12 months
sedentary time by self-report
Time frame: Change from Baseline Sedentary Time at 12 months
sedentary time by accelerometry
Time frame: Change from Baseline Sedentary Time at 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2019.
- Results publication: PubMed 29410786Voigt 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.
- Results publication: PubMed 29510707Ullrich 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.
- Results publication: PubMed 28921747Baumann 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.
- Derived from this study: PubMed 36899317Voigt L, Ullrich A, Gross S, Guertler D, Jaeschke L, Dorr M, van den Berg N, John U, Ulbricht S. Associations of accelerometer-based sedentary bouts with adiposity markers among German adults - results from a cross-sectional study. BMC Public Health. 2023 Mar 10;23(1):469. doi: 10.1186/s12889-023-15304-8.
- Derived from this study: PubMed 32503441Voigt 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sabina Ulbricht, Dr. study chair
Institute of Social Medicine and Prevention, University Medicine Greifswald, Greifswald, Germany
Questions about this trial
What is this clinical trial studying?
A study testing Counseling letter in people with Cardiovascular Risk Factor, run by University Medicine Greifswald.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence: Drop-out rates in control and intervention group (time frame: up to 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02990039, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2019.