NCT04131270

Brief Summary

This study would investigate the effects of forming action plans on a reduction of sedentary behaviors. Participants will be randomly assigned to either active control group (education on sedentary behaviors and physical activity) or the intervention group (forming action plans referring to replacing sedentary activities with physical activity. The effects of the intervention will be evaluated at the 2-month follow-up and at the 8-month follow-up.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
900

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

October 15, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 18, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

January 2, 2020

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2024

Completed
Last Updated

March 18, 2024

Status Verified

March 1, 2024

Enrollment Period

4.2 years

First QC Date

October 15, 2019

Last Update Submit

March 15, 2024

Conditions

Keywords

PlanningPhysical Activity

Outcome Measures

Primary Outcomes (1)

  • Sedentary behavior

    minutes of sedentary behavior per day assessed with ActiGraph wGT3X-BT accelerometer

    change from the baseline sedentary behavior at 8 months

Secondary Outcomes (2)

  • The composition of waking time

    change from the baseline composition of waking time at 8 months

  • Physical activity

    change from the baseline physical activity at 8 months

Other Outcomes (9)

  • Sedentary behavior habit

    change from the baseline sedentary behavior habit at 8 months

  • Self-efficacy for reducing sedentary behavior

    change from the baseline self-efficacy at 8 months

  • Risk perception

    change from the baseline risk perception at 8 months

  • +6 more other outcomes

Study Arms (2)

Planning + Education

EXPERIMENTAL

3 education sessions + 1 planning session (integrated into the 3rd education session); delivered face-to-face over 3 weeks (after the baseline measurement), individually. Planning: The planning materials and forms have sections: (a) instructions of what should be included in a good plan (the when, where, and how components), (b) formulating action and coping plans. Action plans (referring to when, when, and how the individual will act) as well as coping plans (referring to how to overcome potential difficulties) will be formed. After forming the plans individually, experimenters will discuss the plans with the participants.

Behavioral: Planning + EducationBehavioral: Education

Education

ACTIVE COMPARATOR

3 education sessions; delivered face-to-face over 3 weeks (after the baseline measurement), individually. The education includes extended physical activity and sedentary behavior education using participant-educator discussions and printed materials.

Behavioral: Education

Interventions

Planning: Participants will fill in the planning forms that efer to replacing sedentary behavior with physical activity. The following behavior change techniques are included in the planning intervention protocol: action planning, barrier identification, prompting self-talk, relapse prevention/coping planning. Applications of all behavior change techniques would include references to planning.

Planning + Education
EducationBEHAVIORAL

The education would include extended sedentary behavior and physical activity education, delivered face-to-face by the experimenters. The education includes: (1) the behavioral guidelines, tailored to age and health status of the participants, (2) the examples of exercises and their metabolic equivalent, and (3) the education about ways to break sedentary behavior with active breaks.

EducationPlanning + Education

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • not meeting physical activity guidelines proposed by the World Health Organization

You may not qualify if:

  • any existing diseases with contraindications for moderate intensity physical activity, confirmed by patient's primary care physician or a specialist in cardiovascular diseases/endocrinology/rehabilitation medicine providing care for the patient during the recruitment and follow-ups

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SWPS University of Social Sciences and Humanities

Wroclaw, Lower Silezia, 53-328, Poland

RECRUITING

Related Publications (7)

  • Gardner B. A review and analysis of the use of 'habit' in understanding, predicting and influencing health-related behaviour. Health Psychol Rev. 2015;9(3):277-95. doi: 10.1080/17437199.2013.876238. Epub 2014 Jan 21.

    PMID: 25207647BACKGROUND
  • Schwarzer R, Luszczynska A. Health action process approach. In: Norman P, Conner M, editors. Predicting and changing health behavior. Maidenead, UK: McGraw-Hill; 2015.

    BACKGROUND
  • Sallis JF, Spoon C, Cavill N, Engelberg JK, Gebel K, Parker M, Thornton CM, Lou D, Wilson AL, Cutter CL, Ding D. Co-benefits of designing communities for active living: an exploration of literature. Int J Behav Nutr Phys Act. 2015 Feb 28;12:30. doi: 10.1186/s12966-015-0188-2.

    PMID: 25886356BACKGROUND
  • Maher JP, Conroy DE. A dual-process model of older adults' sedentary behavior. Health Psychol. 2016 Mar;35(3):262-72. doi: 10.1037/hea0000300. Epub 2015 Dec 21.

    PMID: 26690644BACKGROUND
  • Keller C, Siegrist M. The weight management strategies inventory (WMSI). Development of a new measurement instrument, construct validation, and association with dieting success. Appetite. 2015 Sep;92:322-36. doi: 10.1016/j.appet.2015.05.037. Epub 2015 Jun 3.

    PMID: 26048006BACKGROUND
  • Berli C, Loretini P, Radtke T, Hornung R, Scholz U. Predicting physical activity in adolescents: the role of compensatory health beliefs within the Health Action Process Approach. Psychol Health. 2014;29(4):458-74. doi: 10.1080/08870446.2013.865028. Epub 2013 Dec 20.

    PMID: 24229317BACKGROUND
  • Luszczynska A, Hagger MS, Banik A, Horodyska K, Knoll N, Scholz U. Self-Efficacy, Planning, or a Combination of Both? A Longitudinal Experimental Study Comparing Effects of Three Interventions on Adolescents' Body Fat. PLoS One. 2016 Jul 13;11(7):e0159125. doi: 10.1371/journal.pone.0159125. eCollection 2016.

    PMID: 27410961BACKGROUND

Related Links

MeSH Terms

Conditions

Sedentary BehaviorMotor Activity

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Aleksandra Luszczynska, PhD

    SWPS University of Social Sciences and Humanities

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aleksandra Luszczynska, PhD

CONTACT

Ewa Kulis, MA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to an active control group (education on sedentary behavior and physical activity) or to a planning intervention (education on sedentary behavior and physical activity + education on how to form behavior change plans + forming a plan to change sedentary behavior using a planning sheet)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychology

Study Record Dates

First Submitted

October 15, 2019

First Posted

October 18, 2019

Study Start

January 2, 2020

Primary Completion

March 30, 2024

Study Completion

March 30, 2024

Last Updated

March 18, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will share

De-identified individual participant data for all primary, secondary, and additional outcome measures will be made available.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Respective data will be made available together with the submission of the manuscript reporting the findings for the main outcome (not later that within 2 years after the completion of data collection).
Access Criteria
Data will be uploaded on Open Science Framework, available to researchers who will have a respective link.

Locations