Back to resultsPhysical Activity: Feasibility Study
Primary Purpose
Obesity, Physical Activity, Self-efficacy
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Physical Activity Self-efficacy (PAS) intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Obesity focused on measuring obesity, physical activity, self-efficacy, information and communication technology, accelerometers
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Physical Activity Self-efficacy (PAS) group
Usual Care (UC) group
Arm Description
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.
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.
Outcomes
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.
The feasibility of implementing the PAS online intervention for adults with obesity recruited from a local weight management center in the USA will be assessed with descriptive statistics. Descriptive statistics will include (a) recruitment rate, (b) eligibility rate, (c) consent rate, (d) participation rates, and (e) retention rates.
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.
The acceptability of implementing the PAS online intervention for adults with obesity recruited from a local weight management center in the USA will be assessed with descriptive statistics. Descriptive statistics will include acceptability of the PAS intervention (e.g., engagement behavior, subjective experience) and acceptability of accelerometer-based assessment of physical activity.
a preliminary effect size estimate for each direct effect depicted in the conceptual model for the PAS online intervention.
Within 7 days after the W1 and W3 survey battery, participants will be asked to enter a code into the PAS intervention website in order to start wearing a physical activity monitor for the next consecutive 7 days. They will be instructed to wear a research-grade accelerometer, ActiGraph wGT3X-BT, on their waist.
The primary measure of physical activity in this study will be the average minutes per day of Moderate to Vigorous Physical Activity (MVPA) based on both widely accepted recommendations for health-enhancing physical activity. Instruments designed to measure the acceptability of accelerometer-based assessment of physical activity and self-reported physical activity will also be included in the W1 and W3 physical activity monitoring.
Secondary Outcome Measures
Self-efficacy to engage
After completion of the introductory challenges, PAS participants will be asked at W2 to respond to the following item: How confident are you in your current ability to get yourself to complete at least 24 post-introductory challenges within the next four weeks?
Physical activity self-efficacy
Physical activity self-efficacy will be measured from participants at W1, W2, and W3 with the physical activity self-efficacy scale. The 48-item scale is a modified version of the exercise self-efficacy scale.
Self-efficacy to regulate physical activity
Self-efficacy to regulate physical activity will be measured from participants at W1, W2, and W3 with the self-efficacy to regulate physical activity scale. The 13-item scale is a modified version of the barriers self-efficacy scale.
Full Information
NCT ID
NCT05935111
First Posted
June 27, 2023
Last Updated
August 16, 2023
Sponsor
Binghamton University
Collaborators
Lehigh University, Ascension Health
1. Study Identification
Unique Protocol Identification Number
NCT05935111
Brief Title
Physical Activity: Feasibility Study
Official Title
Obesity and Physical Activity: Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2, 2023 (Anticipated)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Binghamton University
Collaborators
Lehigh University, Ascension Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 on 2 October 2023 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Physical Activity, Self-efficacy, Online Intervention, Accelerometers
Keywords
obesity, physical activity, self-efficacy, information and communication technology, accelerometers
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Physical Activity Self-efficacy (PAS) group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Usual Care (UC) group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Physical Activity Self-efficacy (PAS) intervention
Other Intervention Name(s)
PAS intervention
Intervention Description
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.).
Primary Outcome Measure Information:
Title
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.
Description
The feasibility of implementing the PAS online intervention for adults with obesity recruited from a local weight management center in the USA will be assessed with descriptive statistics. Descriptive statistics will include (a) recruitment rate, (b) eligibility rate, (c) consent rate, (d) participation rates, and (e) retention rates.
Time Frame
By Week 7
Title
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.
Description
The acceptability of implementing the PAS online intervention for adults with obesity recruited from a local weight management center in the USA will be assessed with descriptive statistics. Descriptive statistics will include acceptability of the PAS intervention (e.g., engagement behavior, subjective experience) and acceptability of accelerometer-based assessment of physical activity.
Time Frame
By Week 7
Title
a preliminary effect size estimate for each direct effect depicted in the conceptual model for the PAS online intervention.
Description
Within 7 days after the W1 and W3 survey battery, participants will be asked to enter a code into the PAS intervention website in order to start wearing a physical activity monitor for the next consecutive 7 days. They will be instructed to wear a research-grade accelerometer, ActiGraph wGT3X-BT, on their waist.
The primary measure of physical activity in this study will be the average minutes per day of Moderate to Vigorous Physical Activity (MVPA) based on both widely accepted recommendations for health-enhancing physical activity. Instruments designed to measure the acceptability of accelerometer-based assessment of physical activity and self-reported physical activity will also be included in the W1 and W3 physical activity monitoring.
Time Frame
By Week 14
Secondary Outcome Measure Information:
Title
Self-efficacy to engage
Description
After completion of the introductory challenges, PAS participants will be asked at W2 to respond to the following item: How confident are you in your current ability to get yourself to complete at least 24 post-introductory challenges within the next four weeks?
Time Frame
By Week 7
Title
Physical activity self-efficacy
Description
Physical activity self-efficacy will be measured from participants at W1, W2, and W3 with the physical activity self-efficacy scale. The 48-item scale is a modified version of the exercise self-efficacy scale.
Time Frame
By Week 3, By Week 7, By Week 14
Title
Self-efficacy to regulate physical activity
Description
Self-efficacy to regulate physical activity will be measured from participants at W1, W2, and W3 with the self-efficacy to regulate physical activity scale. The 13-item scale is a modified version of the barriers self-efficacy scale.
Time Frame
By Week 3, By Week 7, By Week 14
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
What is your gender?
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seungmin Lee, PhD
Phone
517-898-0020
Email
leeseung@binghamton.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Participants will be asked to provide some personally identifiable information (e.g., phone number) during enrollment in the study. This personally identifiable information and all other data collected online (e.g., online survey battery) will be collected via a secure website maintained by authorized research staff employed by Lehigh University. The research staff will share all data collected via the secure website with authorized research staff employed by Binghamton University. All data collected will be kept confidential to the maximum extent allowable by law. Data obtained from this research will be stored in such a way that human participants cannot be identified. Specifically, all account holders will be assigned a coded identification number in the stored data. The list connecting each participant with an identification number will be kept protected, encrypted, private, and only accessible to authorized research staff at Lehigh University and Binghamton University.
IPD Sharing Time Frame
10/02/2023 - 12/31/2024
IPD Sharing Access Criteria
authorized research staff employed by Lehigh University and Binghamton University
IPD Sharing URL
http://pasintervention.com/login
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Physical Activity: Feasibility Study
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