Physical Activity: Feasibility Study

Part of paid clinical trials in Binghamton, New York.

Sponsor
Binghamton University
Study ID
NCT05935111
Status
Recruiting
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Conditions

  • Accelerometers
  • Obesity
  • Online Intervention
  • Physical Activity
  • Self-efficacy

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Accepted

Interventions

  • Physical Activity Self-efficacy (PAS) intervention — BEHAVIORAL
    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.).

Study Details

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.

Key Dates

Start date
Jan 1, 2024
Status verified
Aug 2024
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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.
  • 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.

Primary Outcome Measure

the feasibility of implementing the PAS intervention (e.g., recruitment rate, eligibility rate) for adults with obesity recruited from a local weight management center in the USA. [ Time Frame: By Week 7 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
GuthrieBinghamtonNew York13903
Seungmin Lee
[email protected]
517-898-0020
Seungmin Lee (PRINCIPAL_INVESTIGATOR)

Find similar trials in Binghamton, NY

By condition
Obesity / overweight
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By research site
Guthrie· Binghamton, NY

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