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

NCT ID: NCT02990039

Last Updated: 2019-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-09-30

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.

Conditions

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Cardiovascular Risk Factor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Counseling letter

Intervention Type 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.

No counseling letter (control group)

Participants of the control group did not received the brief counseling letter intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Feasibility of brief counseling letter intervention

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
Minimum Eligible Age

42 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Medicine Greifswald

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sabina Ulbricht, Dr.

Role: STUDY_CHAIR

Institute of Social Medicine and Prevention, University Medicine Greifswald, Greifswald, Germany

References

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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.

Reference Type RESULT
PMID: 29410786 (View on PubMed)

Ullrich 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.

Reference Type RESULT
PMID: 29510707 (View on PubMed)

Baumann 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.

Reference Type RESULT
PMID: 28921747 (View on PubMed)

Voigt 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.

Reference Type DERIVED
PMID: 36899317 (View on PubMed)

Voigt 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.

Reference Type DERIVED
PMID: 32503441 (View on PubMed)

Other Identifiers

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FKZ 81Z5400152

Identifier Type: -

Identifier Source: org_study_id

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