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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04131270
Other study ID # USSHWarsaw
Secondary ID 2017/27/B/HS6/00
Status Recruiting
Phase N/A
First received
Last updated
Start date January 2, 2020
Est. completion date March 30, 2024

Study information

Verified date March 2024
Source University of Social Sciences and Humanities, Warsaw
Contact Aleksandra Luszczynska, PhD
Phone +48694441765
Email aluszczynska@swps.edu.pl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

The effects of three sessions (3 education sessions versus 3 education sessions+ forming plans to replace sedentary behavior with physical activity) will be investigated among participants from three age groups: adolescents (12-17 years old), adults (18-60 years old), and older adults (>60 years old). Compared to education only, forming plans about how to replace time spent on sedentary activities with physical activity is expected to result in a significantly larger change (a reduction) of sedentary time at the follow-up. Accelerometers will be used to evaluate short-term and mid-term changes in total sedentary time and the relative proportion of time spent on sedentary behavior vs light-intensity and moderate-to-vigorous- intensity physical activity. Additionally, the study will observe changes in if the cognitions included in the Health Action Process Approach model (HAPA), such risk perception, self-efficacy, outcome expectancies, intention, action control, as well as changes in behavioral habit, presence of sedentary behavior cues in physical environment, and physical activity behavior. The observations will be conducted three times, at the baseline (before the intervention), the 2-month follow up, and at the 8-month follow-up.


Recruitment information / eligibility

Status Recruiting
Enrollment 900
Est. completion date March 30, 2024
Est. primary completion date March 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years and older
Eligibility Inclusion Criteria: - not meeting physical activity guidelines proposed by the World Health Organization Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Planning + Education
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.
Education
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.

Locations

Country Name City State
Poland SWPS University of Social Sciences and Humanities Wroclaw Lower Silezia

Sponsors (2)

Lead Sponsor Collaborator
University of Social Sciences and Humanities, Warsaw National Science Centre, Poland

Country where clinical trial is conducted

Poland, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

Outcome

Type Measure Description Time frame Safety issue
Other Sedentary behavior habit Self-Reported Habit Scale; mean item score ranging from 1 to 4, higher scores indicate stronger sedentary behavior habit change from the baseline sedentary behavior habit at 8 months
Other Self-efficacy for reducing sedentary behavior 9 self-efficacy questionnaire items; mean item score ranging from 1 to 4, higher scores indicate stronger self-efficacy change from the baseline self-efficacy at 8 months
Other Risk perception 3 questionnaire items to assess risk perception; mean item score ranging from 1 to 4, higher scores indicate higher risk perception change from the baseline risk perception at 8 months
Other Outcome expectancies 18 items assessing positive (9 items) and negative (9 items) outcome expectancies; item score ranging from 1 to 4, higher scores indicate more positive outcome expectancies change from the baseline outcome expectancies at 8 months
Other Action control 10 questionnaire items assessing action control; mean item score ranging from 1 to 4, higher scores indicate stronger action control change from the baseline outcome expectancies at 8 months
Other Intention 3 questionnaire items assessing intention to reduce sedentary behavior; mean item score ranging from 1 to 4, higher scores indicate stronger intention to reduce sedentary behavior change from the baseline intention at 8 months
Other Self-reported planning 4 questionnaire items assessing action planning; mean item score ranging from 1 to 4, higher scores indicate a higher level of self-reported planning change from the baseline planning at 8 months
Other Environmental cues for sedentary behavior 10 questionnaire items assessing physical environment cues for sedentary behavior and its reduction; the total sum score ranging from 0 to 10; higher scores indicate more environmental cues for sedentary behavior change from the baseline planning at 8 months
Other Body mass index (BMI) Certified and standardized body weight scales (Beurer; European Union safety certificate; measurement error < 5%) and measuring rods will be used. Body mass index will be calculated using the following formula: body weight [in kg] divided by a square of body height (in meters). Body weight will be recorded in kilograms and body height will be recorded in meters. change from the baseline planning at 8 months
Primary Sedentary behavior minutes of sedentary behavior per day assessed with ActiGraph wGT3X-BT accelerometer change from the baseline sedentary behavior at 8 months
Secondary The composition of waking time the proportion of time spent on sedentary behavior (minutes per day) to time spent on light-intensity physical activity (minutes per day) and moderate-to-vigorous physical activity (minutes per day) assessed with ActiGraph wGT3X-BT accelerometer change from the baseline composition of waking time at 8 months
Secondary Physical activity minutes of light, moderate and vigorous intensity physical activity per day measured with ActiGraph wGT3X-BT accelerometer change from the baseline physical activity at 8 months
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