Physical Activity: Feasibility Study

NCT05935111 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-08-06

No results posted yet for this study

Summary

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

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

Interventions

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.).

Sponsors & Collaborators

  • Lehigh University

    collaborator OTHER
  • Ascension Health

    collaborator INDUSTRY
  • Binghamton University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05935111 on ClinicalTrials.gov