Explaining Sedentary Behavior With Planning (the Revised HAPA Model)

Study Overview
=================
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.

Detailed 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.

Official Title
-----------------
Explaining Sedentary Behavior With the Revised Reflective + Impulsive Health Action Process Approach (HAPA) Model

Conditions
-----------------
Sedentary Behavior

Intervention / Treatment
-----------------
* Behavioral: Planning + Education
* Behavioral: Education


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Planning + Education<br>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 + Education<br>* 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.<br>Behavioral: Education<br>* 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.<br>|
| Active Comparator: Education<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sedentary behavior | minutes of sedentary behavior per day assessed with ActiGraph wGT3X-BT accelerometer | change from the baseline sedentary behavior at 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Planning, Physical Activity