Evaluation of the efficacy of a family-centered physical activity intervention at the level of sedentary behavior: Study protocol for a population-based intervention

Our study focuses on the 'Family-Centered Physical Activity ' program, designed to encourage lifestyle modifications that reduces sedentary behaviour.

A two-arm, parallel-group, randomized controlled trial with blinded outcome assessment. The study involves 76 participants, with centralized computerized randomization and allocation concealment. It will be conducted as a single-center trial at Tehran University of Medical Sciences.

The trial will be conducted at the Tehran University of Medical Sciences. It employs a single-blind design where participants are blinded to their group assignments. Independent researchers perform assessments to ensure unbiased data collection.

Inclusion Criteria: Women aged 18 to 65 years. Minimum literacy level (reading and writing skills). Access to a mobile phone capable of receiving text messages. Voluntary consent to participate in the study. Exclusion Criteria: Uncontrolled high blood pressure, heart failure, or heart valve disease. Advanced pulmonary disease or history of heart/stroke events in the past 6 months. Severe weight loss (over 10% body weight) in the past 6 months without dietary management. Pregnancy or positive response to any item in the Physical Activity Readiness Questionnaire (PARQ). Orthopedic problems that may limit physical activity.

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.

The primary outcomes are changes in physical activity levels, reductions in sedentary behavior, and improvements in functional fitness. These will be measured using the Global Physical Activity Questionnaire (GPAQ), transtheoretical model questionnaire, and functional tests.

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: 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.

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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

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.