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

Cardiovascular Risk Factor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02990039
• Other study ID #: FKZ 81Z5400152
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: September 2016

Study information

• Verified date: March 2019
• Source: University Medicine Greifswald
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 42 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Risk Factor

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Medicine Greifswald

References & Publications (3)

Baumann S, Groß S, Voigt L, Ullrich A, Weymar F, Schwaneberg T, Dörr 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 — View Citation

Ullrich A, Voigt L, Baumann S, Weymar F, John U, Dörr 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/s12889-0 — View 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: 10.118 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Feasibility: Comprehensibility on intervention material via paper-pencil-assessment	Measures: questions regarding the comprehensibility on intervention material (via paper-pencil-assessment)	12 month
Secondary	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
Secondary	physical activity by accelerometry	Measures: objective measurement of physical activity by accelerometry	Change from Baseline Physical Activity at 12 months
Secondary	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
Secondary	sedentary time by accelerometry	Measures: objective measurement of physical activity by accelerometry	Change from Baseline Sedentary Time at 12 months