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Completed

NCT Number: NCT02990039

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

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.

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Key information

Conditions

Cardiovascular Risk Factor Behavior Motor Activity Sedentary Behavior

Age range

42 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Counseling letter

Behavioral

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: Feasibility of brief counseling letter intervention

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Medicine Greifswald

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 12, 2016
Registry last updated
Mar 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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