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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cardiovascular Risk Factor

Intervention / Treatment
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* Behavioral: Counseling letter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 42 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Counseling letter (intervention group)<br>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. | Behavioral: Counseling letter<br>* 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.<br>* Other names: Feasibility of brief counseling letter intervention;|
| No Intervention: No counseling letter (control group)<br>Participants of the control group did not received the brief counseling letter intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence: Drop-out rates in control and intervention group | 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 | Measures: questions regarding the comprehensibility on intervention material (via paper-pencil-assessment) | 12 month | 
| physical activity by self-report | Measures: paper-pencil-assessment (International Physical Activity Questionnaire-Long version, IPAQ-L) | Change from Baseline Physical Activity at 12 months | 
| physical activity by accelerometry | Measures: objective measurement of physical activity by accelerometry | 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) | Change from Baseline Sedentary Time at 12 months | 
| sedentary time by accelerometry | Measures: objective measurement of physical activity by accelerometry | Change from Baseline Sedentary Time at 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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physical activity, sedentary time, feasibility study, accelerometer