Physical Activity Program for Obesity

Overseen By Seungmin Lee, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Binghamton University

Disqualifiers: Age, BMI, Access, Compliance, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

Adults aged 18-64 with obesity (BMI ≥ 25 kg/m2) who can access the internet for a web-based intervention, are willing to wear an activity monitor on their wrist, and agree to respond to study-related contacts. Exclusion criteria were not provided.

Inclusion Criteria

My BMI is 25 or higher, indicating I am overweight or obese.

I am willing to respond to study-related contacts like emails, texts, and calls.

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).

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Online eligibility verification

Treatment

Participants receive the PAS intervention or usual care for 4 weeks

4 weeks

Online data collection at W1, W2, and W3

Data Collection

Three waves of data collection to measure physical activity and self-efficacy

14 weeks

Online data collection at W1, W2, and W3

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Physical Activity Self-efficacy (PAS) intervention

Trial Overview The trial is testing a new online program called Physical Activity Self-efficacy (PAS) designed to encourage physical activity in adults with obesity. Participants will be randomly assigned either PAS or usual care in equal numbers and progress will be tracked over up to 14 weeks.

Participant Groups

Group I: Physical Activity Self-efficacy (PAS) group Active Control 1 Intervention

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.

Group II: Usual Care (UC) group Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Binghamton University

Lead Sponsor

Trials

15

Recruited

2,900+

Lehigh University

Collaborator

Trials

24

Recruited

6,800+

Ascension Health

Industry Sponsor

Trials

28

Recruited

543,000+