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

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ClinicalTrials.gov Identifier: NCT02990039
Recruitment Status : Completed
First Posted : December 12, 2016
Last Update Posted : March 12, 2019
Sponsor:
Information provided by (Responsible Party):
University Medicine Greifswald

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Risk Factor Behavioral: Counseling letter Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: A Tailored Feasibility Study to Increase Physical Activity and to Reduce Sedentary Time
Study Start Date : February 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


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.
Behavioral: Counseling letter
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 Name: Feasibility of brief counseling letter intervention

No Intervention: No counseling letter (control group)
Participants of the control group did not received the brief counseling letter intervention.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. physical activity by accelerometry [ Time Frame: Change from Baseline Physical Activity at 12 months ]
    Measures: objective measurement of physical activity by accelerometry

  4. 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)

  5. sedentary time by accelerometry [ Time Frame: Change from Baseline Sedentary Time at 12 months ]
    Measures: objective measurement of physical activity by accelerometry



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Ages Eligible for Study:   42 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02990039


Sponsors and Collaborators
University Medicine Greifswald
Investigators
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Study Chair: Sabina Ulbricht, Dr. Institute of Social Medicine and Prevention, University Medicine Greifswald, Greifswald, Germany