ObesityNCT05935111
Physical Activity: Feasibility Study
A study testing Physical Activity Self-efficacy (PAS) intervention in people with Obesity and Physical Activity, run by Binghamton University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Physical Activity, Self-efficacy
- What is being tested?
- Physical Activity Self-efficacy (PAS) intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Guthrie
Binghamton, New York, 13903
Seungmin Lee, 517-898-0020, leeseung@binghamton.edu
Seungmin Lee
About this study
Official title: Obesity and Physical Activity: Feasibility Study
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
- Being tested
- Physical Activity Self-efficacy (PAS) intervention
- Keywords
- obesity, physical activity, self-efficacy, information and communication technology, accelerometers
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Activity Self-efficacy (PAS) interventionBehavioural
Also called 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.).
| Study group | Role | What they receive |
|---|---|---|
| Physical Activity Self-efficacy (PAS) group | Active comparator | 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. Receives: Behavioral: Physical Activity Self-efficacy (PAS) intervention |
| Usual Care (UC) group | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: By Week 7
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.
Measured: By Week 14
Secondary outcomes (3)
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?
Measured: By Week 7
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.
Measured: By Week 3, By Week 7, By Week 14
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.
Measured: By Week 3, By Week 7, By Week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start1 Jan 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Binghamton University
- Sponsor type
- University, hospital or other
- Collaborators
- Lehigh University, Ascension Health
- Responsible party
- Principal investigator, Seungmin Lee, Binghamton University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05935111
- Sponsor's protocol ID
- RNY20230009
- Status last verified
- Aug 2024
- First submitted
- 27 Jun 2023
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 41083971Lee 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.
PubMed 38409075
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obesity and Physical Activity: Feasibility Study
- ClinicalTrials.gov ID
- NCT05935111
- Acronym / sponsor ID
- RNY20230009
- Conditions
- Obesity, Physical Activity, Self-efficacy, Online Intervention, Accelerometers
- Keywords
- obesity, physical activity, self-efficacy, information and communication technology, accelerometers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Binghamton UniversityUniversity, hospital or other
- Collaborators
- Lehigh University, Ascension Health
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 7 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Activity Self-efficacy (PAS) group | Active comparator | Behavioral: Physical Activity Self-efficacy (PAS) interventionParticipants 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. |
| Usual Care (UC) group | No 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 may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical Activity Self-efficacy (PAS) interventionAlso: PAS interventionThe 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.). | Behavioural | Physical Activity Self-efficacy (PAS) group |
Primary outcome
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 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.
Time frame: By Week 7
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.
Time frame: By Week 14
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.
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Derived from this study: PubMed 41083971Lee 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.
- Derived from this study: PubMed 38409075Lee 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity Self-efficacy (PAS) intervention in people with Obesity and Physical Activity, run by Binghamton University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seungmin Lee, PhD (517-898-0020, leeseung@binghamton.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05935111, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.