Physical Activity: Feasibility Study

Binghamton University

Status: Enrolling

Conditions: Physical Activity; Accelerometers; Obesity; Online Intervention; Self-efficacy

Treatments: Behavioral: Physical Activity Self-efficacy (PAS) intervention

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05935111

RNY20230009

Details and patient eligibility

About

The Physical Activity Self-efficacy (PAS) intervention is a web-based behavioral intervention newly developed to promote physical activity in adults with obesity. The conceptual framework for the PAS intervention is based on self-efficacy theory. The objective of this study is to investigate the feasibility and acceptability of implementing the PAS online intervention for adults with obesity recruited from a local weight management center in the United States of America (USA). The study design is a prospective, double-blind, parallel group randomized pilot trial. Thirty participants will be randomly assigned to the PAS group or usual care group to achieve a 1:1 group assignment. Recruitment of participants is scheduled to begin in January 2024 or earlier at a local weight management center within a private healthcare system in the USA. There are five eligibility criteria for participation in this study (e.g., a body mass index ≥ 25.00 kg/m2). Eligibility verification and data collection will be conducted online. Three waves of data collection will take up to 14 weeks depending on participants' progress in the study. Instruments designed to measure demographic information, anthropometric characteristics, self-efficacy, and acceptability will be included in the survey battery. A research-grade accelerometer will be used to measure free-living physical activity objectively. Data will be analyzed using descriptive statistics and inferential statistical models under an intention-to-treat approach. This study will be sponsored by the Transdisciplinary Areas of Excellence Seed Grant Program from Binghamton University.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

There are five eligibility criteria for participation in this study. Values for each of the eligibility criteria will be based on self-report by the potential participant. Potential participants who do not meet one or more of the eligibility criteria will be informed that they are ineligible for the study and then will be taken to the exit page from the PAS website (http://pasintervention.com/login).

• The first criterion is being between 18 and 64 years old, consistent with evidence-based age groupings for global recommendations on physical activity for health.
• The second criterion is a body mass index (BMI) ≥ 25.00 kg/m2, consistent with many physical activity interventions in adults with obesity. A justification for this criterion is the need to promote physical activity in a BMI-based population in which few individuals may meet public health guidelines for physical activity.
• The third criterion is the ability to access the online intervention. This criterion will be assessed by asking them to confirm that they will have access to a technological device (e.g., computer, smart phone) that can access the online intervention via a web browser.
• The fourth criterion is a willingness to comply with instructions for physical activity monitoring. This criterion will be assessed by asking them if they are willing to wear a physical activity monitor on their waist for two 7-day intervals and complete a daily log sheet regarding wear time during each of the two 7-day intervals in the study. A justification for this criterion is based on previous studies where a similar question was asked to potential participants at screening. Those who indicate a willingness to comply with instructions for physical activity monitoring will be asked to provide information about their non-dominant hand.
• The final criterion is a willingness to respond to study-related contacts (e.g., email, text message, phone call). A justification for this criterion is that participants will be asked to complete some tasks in a specifically structured schedule.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups

Physical Activity Self-efficacy (PAS) group

Active Comparator group

Description:

Participants assigned to the PAS group will proceed through the weight management program provided by the center and will be given 4 weeks of 24-hour access to the PAS intervention during data collection for this study. The login credential for PAS participants will provide access to both the PAS intervention and to a secure website to complete data collection at W1, W2, and W3.

Treatment:

Behavioral: Physical Activity Self-efficacy (PAS) intervention

Usual Care (UC) group

No Intervention group

Description:

Participants assigned to the UC group will proceed through the weight management program provided by the center. The login credential for UC participants will provide access to a secure website to complete data collection (i.e., a survey battery, physical activity monitoring) at W1, W2, and W3.