Actively Recruiting

Phase Not Applicable
Age: 18Years - 64Years
All Genders
Healthy Volunteers
ID05935111

Obesity and Physical Activity: Feasibility Study of the Physical Activity Self-efficacy (PAS) Online Intervention

Led by Binghamton University · Updated on 2024-08-06

30

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

B

Binghamton University

Lead Sponsor

L

Lehigh University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the Physical Activity Self-efficacy (PAS) intervention, a new web-based behavioral program designed to promote physical activity in adults with obesity. This study aims to test the feasibility and acceptability of delivering the PAS intervention online to adults recruited from a local weight management center in the USA. The trial is a prospective, double-blind, parallel group randomized pilot study sponsored by Binghamton University. Participants will be randomly assigned to either the PAS group or a usual care group in a 1:1 ratio. Those in the PAS group will continue their weight management program and receive 24-hour access to the PAS online intervention for 4 weeks during data collection. The usual care group will also follow the weight management program but will not have access to the PAS intervention. Both groups will complete surveys and physical activity monitoring at three time points during the study. Participants will provide demographic and health information through online surveys and wear a research-grade accelerometer to measure their physical activity. Data collection will occur over up to 14 weeks across three waves. The study will assess feasibility outcomes like recruitment and eligibility rates, acceptability through engagement and physical activity measurements, and preliminary effect sizes on self-efficacy related to physical activity. Participants will be contacted via email, text, or phone to support study tasks and compliance.

CONDITIONS

Brief Title

Physical Activity: Feasibility Study

Who Can Participate

Age: 18Years - 64Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 64 years
  • Body mass index (BMI) of 25.00 kg/m2 or higher
  • Ability to access the online intervention using a device such as a computer or smartphone
  • Willingness to wear a physical activity monitor on the waist for two 7-day intervals and complete daily logs
  • Willingness to respond to study-related contacts such as email, text message, or phone call
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 4 weeks

Participants assigned to the PAS group receive 4 weeks of access to a web-based Physical Activity Self-efficacy (PAS) intervention to support physical activity behavior change. Participants assigned to the Usual Care group continue their weight management program without the PAS intervention.

Access to the online intervention and data collection at Week 1, Week 2, and Week 3

Follow-up

Duration - Up to Week 14 from start

Participants complete further assessments to evaluate the preliminary effect size and longer term self-efficacy outcomes after the intervention period.

Data collection visits up to Week 7 and Week 14

Trial Site Locations

Total: 1 location

1

Guthrie

Binghamton, New York, United States, 13903

Actively Recruiting

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Research Team

S

Seungmin Lee, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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Published Research Related To This Trial

Initial outcomes from the Confident Moves online intervention to promote physical activity in adults with obesity: a longitudinal feasibility and acceptability pilot trial.

Seungmin Lee, Kevin Lahoda, Nicholas Myers...

https://pubmed.ncbi.nlm.nih.gov/41083971