NCT02990039

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
176

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2016

Completed
27 days until next milestone

First Posted

Study publicly available on registry

December 12, 2016

Completed
Last Updated

March 12, 2019

Status Verified

March 1, 2019

Enrollment Period

1.6 years

First QC Date

November 15, 2016

Last Update Submit

March 8, 2019

Conditions

Keywords

physical activitysedentary timefeasibility studyaccelerometer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Feasibility: Comprehensibility on intervention material via paper-pencil-assessment

    12 month

  • physical activity by self-report

    Change from Baseline Physical Activity at 12 months

  • physical activity by accelerometry

    Change from Baseline Physical Activity at 12 months

  • sedentary time by self-report

    Change from Baseline Sedentary Time at 12 months

  • sedentary time by accelerometry

    Change from Baseline Sedentary Time at 12 months

Study Arms (2)

Counseling letter (intervention group)

EXPERIMENTAL

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

No counseling letter (control group)

NO INTERVENTION

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

Interventions

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.

Also known as: Feasibility of brief counseling letter intervention
Counseling letter (intervention group)

Eligibility Criteria

Age42 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age between 42 and 65 years
  • resident in a pre-defined zip-code area

You may not qualify if:

  • cardiovascular event (myocardial infarction, stroke) or vascular intervention
  • self-reported body-mass-index over 35 kg/m²

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Motor ActivitySedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Sabina Ulbricht, Dr.

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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2016

First Posted

December 12, 2016

Study Start

February 1, 2015

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

March 12, 2019

Record last verified: 2019-03