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Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 64 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Physical Activity Self-efficacy (PAS) group 		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.
  • Behavioral: Physical Activity Self-efficacy (PAS) intervention
    The PAS intervention will be a web-based intervention to address the unique barriers to physical activity in adults with obesity, based on self-efficacy theory and effective behavioral change techniques. Self-efficacy is specified as a mediating psychological variable in the conceptual model for the promotion of physical activity. Self-efficacy refers to domain-specific beliefs (e.g., job-, transport-, domestic-, leisure-related physical activity) about their ability to execute differing levels of performance given situational demands. There is a rich literature on the importance of targeting self-efficacy as a modifiable mediating variable in PA-promoting interventions. Also, the PAS intervention will consist of effective behavioral change techniques (e.g., action planning, teach to use prompts/cues, goal setting, etc.).
    Other names:
    • PAS intervention
No Intervention
Usual Care (UC) group 		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.

Recruiting Locations

Guthrie
Binghamton, New York 13903
Contact:
Seungmin Lee
517-898-0020
leeseung@binghamton.edu

More Details

Status
Recruiting
Sponsor
Binghamton University

Study Contact

Seungmin Lee, PhD
517-898-0020
leeseung@binghamton.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.