ObesityNCT03236077
Increasing Exercise Enjoyment and Outcome Expectations Among Women With Obesity
A study testing Fit and Fab in people with Obesity, run by University at Buffalo at 1 site in United States.
Trial summary
Despite decades of physical activity (PA) research on inactive, obese individuals, we have not successfully moved the needle on exercise participation in this population. A recent review aptly referred to PA recommendations among obese individuals as "the public health guideline that is (almost) entirely ignored"[1]. Read more about this study
- Who is it for?
- Ages 18 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Fit and Fab
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2017to 30 Jun 2017
- 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
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female
- Aged 18-64
- BMI ≥ 30 (self-reported for initial screening and confirmed at informational session using direct measurement)
- Not currently participating in any regularly scheduled exercise (see definition in eligibility screener)
- Willing to come to the Ken-Ton YMCA 2-3x/week (Phase 1) or the Independent Health YMCA (Phase 2)
Who cannot join
- - Participants may not be pregnant or planning to become pregnant in the next 6 months
- Individuals with disabilities or health conditions that render them unable to participate in exercise or for whom exercise might be dangerous based on their answers to the Physical Activity Readiness Questionnaire or advisement form their physician
Trial locations and contacts
1 site in 1 country.
About this study
Despite decades of physical activity (PA) research on inactive, obese individuals, we have not successfully moved the needle on exercise participation in this population. A recent review aptly referred to PA recommendations among obese individuals as "the public health guideline that is (almost) entirely ignored"[1]. While we have previously had little understanding of why PA rates are so low in this population, Dr. Leone's research uncovered two possible explanations: (1) women with obesity are less likely to report enjoying exercise and (2) more likely than non-obese women to report exercising only when they are trying to lose weight. In order to affect change among obese women, we need interventions that not only address disparities in enjoyment and outcome expectations. Programs must also be practical and scalable; however, these types of evidence-based programs do not exist within the context that people generally exercise (e.g., community centers, gyms). We propose a novel approach to increasing exercise participation in this population by focusing on exercise enjoyment, increasing appreciation of the proximal benefits of PA rather than focusing on weight, and addressing changes to the exercise environment that make it conducive to this population. By delivering our intervention in partnership with the YMCA, we not only have the ability to make changes to a typical exercise context, but we also ensure that our findings can be used to help exercise-focused community organizations implement a scalable, research-tested program.
Read the detailed description
This is a pilot intervention study with two groups: an intervention group (targeted exercise program for women with obesity and YMCA membership) and a control group (YMCA membership only). The targeted exercise program will be delivered by a YMCA and will be evaluated by our team. The majority of women who are recruited to this study will be randomized to receive the intervention or the control condition. However, we also have a small group of women who has been serving as our community advisory committee (CAC) that will also participate in the intervention classes and receive the membership. They will serve as pilot testers for our data collection methods and provide ongoing qualitative feedback on the intervention as part of their role in the CAC.
The study will take place in two phases at two different YMCAs (Ken-Ton and Independent Health) with approximately half of participants recruited for the first and the other half for the second.
- Conditions
- Obesity
- Being tested
- Fit and Fab
- Keywords
- obesity, women, exercise, physical activity,
- 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.
Fit and FabBehavioural
participate in a targeted exercise program at the YMCA. Will include: Targeted exercise classes, Strength-training, Group support sessions
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Intervention | Experimental | Not described Receives: Behavioral: Fit and Fab |
What is being measured
The primary outcome is the main question the study is designed to answer.
YMCA attendance
YMCA attendance measured by swipes of member card
Measured: 3 motnhs
Secondary outcomes (1)
MVPA
Minutes/week of moderate-to-vigorous exercise measured via accelerometer
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2017
- Study start1 Feb 2017
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- Community Foundation of Greater Buffalo
- Responsible party
- Principal investigator, Lucia A Leone, University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03236077
- Sponsor's protocol ID
- 1134041
- Status last verified
- Jul 2025
- First submitted
- 28 Jul 2017
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Exercise Enjoyment and Outcome Expectations Among Women With Obesity
- ClinicalTrials.gov ID
- NCT03236077
- Acronym / sponsor ID
- 1134041
- Conditions
- Obesity
- Keywords
- obesity, women, exercise, physical activity,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University at BuffaloUniversity, hospital or other
- Collaborators
- Community Foundation of Greater Buffalo
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 1 Aug 2017 (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.
Despite decades of physical activity (PA) research on inactive, obese individuals, we have not successfully moved the needle on exercise participation in this population. A recent review aptly referred to PA recommendations among obese individuals as "the public health guideline that is (almost) entirely ignored"[1]. While we have previously had little understanding of why PA rates are so low in this population, Dr. Leone's research uncovered two possible explanations: (1) women with obesity are less likely to report enjoying exercise and (2) more likely than non-obese women to report exercising only when they are trying to lose weight. In order to affect change among obese women, we need interventions that not only address disparities in enjoyment and outcome expectations. Programs must also be practical and scalable; however, these types of evidence-based programs do not exist within the context that people generally exercise (e.g., community centers, gyms). We propose a novel approach to increasing exercise participation in this population by focusing on exercise enjoyment, increasing appreciation of the proximal benefits of PA rather than focusing on weight, and addressing changes to the exercise environment that make it conducive to this population. By delivering our intervention in partnership with the YMCA, we not only have the ability to make changes to a typical exercise context, but we also ensure that our findings can be used to help exercise-focused community organizations implement a scalable, research-tested program.
Detailed description
This is a pilot intervention study with two groups: an intervention group (targeted exercise program for women with obesity and YMCA membership) and a control group (YMCA membership only). The targeted exercise program will be delivered by a YMCA and will be evaluated by our team. The majority of women who are recruited to this study will be randomized to receive the intervention or the control condition. However, we also have a small group of women who has been serving as our community advisory committee (CAC) that will also participate in the intervention classes and receive the membership. They will serve as pilot testers for our data collection methods and provide ongoing qualitative feedback on the intervention as part of their role in the CAC.
The study will take place in two phases at two different YMCAs (Ken-Ton and Independent Health) with approximately half of participants recruited for the first and the other half for the second.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Intervention | Experimental | Behavioral: Fit and Fab |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female
- Aged 18-64
- BMI ≥ 30 (self-reported for initial screening and confirmed at informational session using direct measurement)
- Not currently participating in any regularly scheduled exercise (see definition in eligibility screener)
- Willing to come to the Ken-Ton YMCA 2-3x/week (Phase 1) or the Independent Health YMCA (Phase 2)
Key exclusion criteria (2 listed)
- - Participants may not be pregnant or planning to become pregnant in the next 6 months
- Individuals with disabilities or health conditions that render them unable to participate in exercise or for whom exercise might be dangerous based on their answers to the Physical Activity Readiness Questionnaire or advisement form their physician
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 |
|---|---|---|
| Fit and Fabparticipate in a targeted exercise program at the YMCA. Will include: Targeted exercise classes, Strength-training, Group support sessions | Behavioural | Intervention |
Primary outcome
YMCA attendance
Time frame: 3 motnhs
YMCA attendance measured by swipes of member card
1 secondary outcome
MVPA
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fit and Fab in people with Obesity, run by University at Buffalo 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?
The sponsor lists 5 inclusion and 2 exclusion criteria. 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: finished, as of the sponsor's last update on 15 Jul 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
YMCA attendance (time frame: 3 motnhs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jul 2025.