Physical Activity: Feasibility Study

Official title

Obesity and Physical Activity: Feasibility Study

Overview

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.

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

Primary outcome measures

• 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]
• the acceptability of implementing the PAS intervention (e.g., engagement, accelerometer-based assessment of physical activity) for adults with obesity recruited from a local weight management center in the USA. [Time frame: By Week 7]
• a preliminary effect size estimate for each direct effect depicted in the conceptual model for the PAS online intervention. [Time frame: By Week 14]

Secondary outcome measures (3)

• Self-efficacy to engage [Time frame: By Week 7]
• Physical activity self-efficacy [Time frame: By Week 3, By Week 7, By Week 14]
• Self-efficacy to regulate physical activity [Time frame: By Week 3, By Week 7, By Week 14]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Supportive care

Study locations

United States · 1 center

• Guthrie — Binghamton

Publications

• Lee S, Lahoda K, Myers N, Horowitz A, Freeland M, Einav E, Buckingham-Schutt L, Welk G. Initial outcomes from the Confident Moves online intervention to promote physical activity in adults with obesity: a longitudinal feasibility and acceptability pilot trial. BMC Public Health. 2025 Oct 13;25(1):3466. doi: 10.1186/s12889-025-24763-0. PMID 41083971
• Lee S, Lahoda K, Myers ND, Horowitz A, Chiu K, Begdache L, Einav E. Physical activity self-efficacy online intervention for adults with obesity: protocol for a feasibility study. Pilot Feasibility Stud. 2024 Feb 26;10(1):40. doi: 10.1186/s40814-024-01468-6. PMID 38409075

Identifiers

NCT: NCT05935111 · RNY20230009

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗