Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Tracking Information
First Submitted Date  ICMJE November 15, 2016
First Posted Date  ICMJE December 12, 2016
Last Update Posted Date March 12, 2019
Study Start Date  ICMJE February 2015
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02990039 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2016)
  • 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)
  • 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)
  • physical activity by accelerometry [ Time Frame: Change from Baseline Physical Activity at 12 months ]
    Measures: objective measurement of physical activity by accelerometry
  • 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)
  • sedentary time by accelerometry [ Time Frame: Change from Baseline Sedentary Time at 12 months ]
    Measures: objective measurement of physical activity by accelerometry
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Tailored Feasibility Study to Increase Physical Activity and to Reduce Sedentary Time
Official Title  ICMJE A Tailored Feasibility Study to Increase Physical Activity and to Reduce Sedentary Time
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Condition  ICMJE Cardiovascular Risk Factor
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Counseling letter
  • No Intervention: No counseling letter (control group)
    Participants of the control group did not received the brief counseling letter intervention.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 7, 2016)
176
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2016
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 42 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02990039
Other Study ID Numbers  ICMJE FKZ 81Z5400152
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University Medicine Greifswald
Study Sponsor  ICMJE University Medicine Greifswald
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Sabina Ulbricht, Dr. Institute of Social Medicine and Prevention, University Medicine Greifswald, Greifswald, Germany
PRS Account University Medicine Greifswald
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP