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IRCT20180129038545N2 IRCT 2024-11-24 Tehran University of Medical Sciences evaluation of the effectiveness of family-centered physical activity intervention in immobility Evaluation of the efficacy of a family-centered physical activity intervention at the level of sedentary behavior: Study protocol for a population-based intervention 2024-08-18 anticipated 76 Complete https://irct.ir/trial/78591 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Single, Purpose: Prevention, Randomization description: Method of Randomization: The study utilized a simple randomization method to allocate participants into either the intervention group or the control group. Simple randomization was chosen to ensure each participant had an equal chance of being assigned to any of the study groups, thereby minimizing selection bias. Unit of Randomization: The unit of randomization was the individual. Each participant was independently randomized into one of the two groups without considering clusters, ensuring that the effects measured are attributable to the individual-level intervention. Randomization Strata: No stratified randomization was applied in this study. Participants were randomized without prior stratification based on any baseline characteristics. This approach was selected due to the homogeneity of the study population, which consisted of women aged 18 to 65 years from Tehran University of Medical Sciences employees. Tools Used in Randomization: Randomization was conducted using computerized software. This method was selected for its efficiency and ability to generate a random sequence without human intervention, thus ensuring the integrity of the randomization process. How the Random Sequence was Built: The random sequence was generated using a computerized algorithm designed to produce a random allocation sequence. Participants meeting the inclusion and exclusion criteria were entered into the software, which then randomly assigned them to either the intervention or control group in a 1:1 ratio. The algorithm used ensured that each assignment was independent of the previous ones. Allocation Concealment: Allocation concealment was strictly maintained throughout the study to prevent selection bias. The randomization sequence was concealed from the investigators and participants until assignments were made. An independent researcher, who was not involved in the recruitment or assessment processes, handled the allocation. The sequence was kept in a secure, password-protected database, accessible only to the independent researcher responsible for allocation. This process ensured that neither the participants nor the investigators could predict or influence group assignments, Blinding description: Blinding: This study implemented single-blind blinding, meaning that the participants were unaware of their group assignments (intervention or control). However, due to the nature of the intervention, complete blinding of the participants was not feasible. Blinded Assessments: To minimize bias, an independent researcher who was blinded to group assignments conducted all baseline and post-intervention assessments. This included administering the Global Physical Activity Questionnaire (GPAQ), the transtheoretical model questionnaire, and performing the functional tests such as the 30-second chair stand test and the single leg stand test for balance. The researcher responsible for data analysis was also blinded to the group assignments to ensure objective and unbiased statistical evaluation. Ensuring Blinding Integrity: Throughout the study, efforts were made to maintain the integrity of the blinding process. The independent researcher handling the randomization and allocation was separate from those conducting the assessments and intervention sessions. Participants were instructed not to disclose their group allocation to the assessors, and the intervention materials provided to participants were neutral in appearance, without any indication of group assignment. N/A Healthy Individuals. Intervention 1: Intervention group: This intervention involves a series of sessions aimed at promoting regular physical activity and reducing sedentary behaviour via simple and available exercises. Also behavior change sessions are included. Behavior change sessions are designed to educate, motivate, and facilitate behavior change in order to establish a routine of physical activity. The approach encompasses several key components, including simple exercises, education, goal setting, regular reminders, and family involvement, all aimed at enhancing participants' commitment to a more active lifestyle. Family-Centered Physical Activity " program consists of fun, easy, accessible, and effective exercises and behavior change education. Intervention 2: Control group: Participants in the control group will receive only general information on physical activity recommended duration of the first session. Unlike the intervention group, participants in the control group will not receive weekly reminder text messages. Yes - There is a plan to make this available What will be shared: all collected deidentified IPD When: starting as soon as the publication To whom: will be available for people working in academic institutions or people working in businesses Conditions: Documents without mentioning the names of the participants can be shared by the researchers after a reasonable request, as well as if there is a need to perform other analyzes after the request and determine the type of analysis and the type of data use with the permission of the authors of the work and the main authors of the final article without is an obstacle Where to obtain: Maryam Selk Ghaffari Tehran University of Medical Sciences Sports medicine specialist Street address No 7, Jalal Al Ahmad Ave, Sports Medicine Research Center Tehran University of Medical Sciences ProvinceTehran Postal code: 1411734141 Phone: +98 21 8863 0228 Mobile: +98 912 135 3654 Email: selk1360@gmail.com How to obtain: After the approval of each of the owners and authors of the work and study, the applicant will be notified by email and will be informed how to access it. It will take approximately 1 to 2 months to submit the documents. Comments:
public Maryam Selk Ghaffari
No 7, Jalal Al Ahmad Ave, Sports medicine research center Tehran University of Medical Sciences
Tehran Iran (Islamic Republic of) 1411734141 +98 21 8863 0228 selk1360@gmail.com Tehran University of Medical Sciences scientific Maryam Selk Ghaffari
No 7, Jalal Al Ahmad Ave, Sports medicine research center Tehran University of Medical Sciences
Tehran Iran (Islamic Republic of) 1411734141 +98 21 8863 0228 selk1360@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Women aged 18 to 65 years A minimum level of literacy(reading and writing skills) Access to a mobile phone capable of receiving text messages Voluntary consent to participate in the study 18 years 65 years Female Uncontrolled high blood pressure Heart failure Heart valve disease Advanced pulmonary disease History of heart or Stroke events in the past 6 months Severe weight loss (more than 10% of body weight) in the past 6 months without dietary management Pregnancy positive response to one or more items inthe Physical Activity Readiness Questionnaire (PARQ) orthopedic problems that may limit physical activity Z00.0 Encounter for general adult medical examination Prevention Prevention Intervention group: This intervention involves a series of sessions aimed at promoting regular physical activity and reducing sedentary behaviour via simple and available exercises. Also behavior change sessions are included. Behavior change sessions are designed to educate, motivate, and facilitate behavior change in order to establish a routine of physical activity. The approach encompasses several key components, including simple exercises, education, goal setting, regular reminders, and family involvement, all aimed at enhancing participants' commitment to a more active lifestyle. Family-Centered Physical Activity " program consists of fun, easy, accessible, and effective exercises and behavior change education. Control group: Participants in the control group will receive only general information on physical activity recommended duration of the first session. Unlike the intervention group, participants in the control group will not receive weekly reminder text messages. Physical Activity Level: Changes in physical activity levels will be measured using the Global Physical Activity Questionnaire (GPAQ). This questionnaire assesses the intensity, duration, and domain of physical activity. Timepoint: Primary outcomes will be measured at the following time intervals:Before Intervention:Baseline measurements. Two Months After Intervention. Six Months After Intervention:Follow-up measurements. Method of measurement: Physical Activity Level:The primary outcome of physical activity level will be measured using the Global Physical Activity Questionnaire. This tool evaluates the intensity, duration, and domain of physical activity through a structured questionnaire. Reduction in Sedentary Behavior: Reduction in sedentary behaviors will be measured through participants' self-reports. This variable includes a decrease in the time spent sitting, reclining, and other sedentary activities throughout the day. Timepoint: Primary outcomes will be measured at the following time intervals:Before Intervention:Baseline measurements. Two Months After Intervention. Six Months After Intervention:Follow-up measurements. Method of measurement: Reduction in Sedentary Behavior: Sedentary behavior will be measured through self-reported data using a detailed questionnaire. Participants will log their daily activities, specifying the duration of sitting, reclining, and other sedentary behaviors. Improvement in Functional Fitness: Improvement in functional fitness will be measured using functional tests such as the 30-second chair stand test and the single-leg stand test for balance. These tests provide quantitative insights into participants' muscular strength and balance. Timepoint: Primary outcomes will be measured at the following time intervals:Before Intervention:Baseline measurements. Two Months After Intervention. Six Months After Intervention:Follow-up measurements. Method of measurement: Improvement in Functional Fitness:Functional fitness will be measured using the 30-second chair stand test and the single-leg stand test for balance. The 30-second chair stand test assesses lower body strength by counting the number of times a participant can stand from a seated position in 30 seconds. The single-leg stand test evaluates balance by timing how long a participant can stand on one leg without support. Tehran University of Medical Sciences Approved 2021-06-01 Ethics committee of Tehran University of Medical Sciences 16th Azar St., Enghelab Sq., Tehran, Iran Tehran Tehran Iran (Islamic Republic of)