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Increasing Exercise Enjoyment and Outcome Expectations Among Women With Obesity

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fit and Fab
Sponsored by
University at Buffalo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring obesity, women, exercise, physical activity,

Eligibility Criteria

18 Years - 64 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • - 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

Sites / Locations

  • University at Buffalo

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Intervention

Arm Description

Outcomes

Primary Outcome Measures

YMCA attendance
YMCA attendance measured by swipes of member card

Secondary Outcome Measures

MVPA
Minutes/week of moderate-to-vigorous exercise measured via accelerometer

Full Information

First Posted
July 28, 2017
Last Updated
October 21, 2021
Sponsor
University at Buffalo
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1. Study Identification

Unique Protocol Identification Number
NCT03236077
Brief Title
Increasing Exercise Enjoyment and Outcome Expectations Among Women With Obesity
Official Title
Increasing Exercise Enjoyment and Outcome Expectations Among Women With Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
June 30, 2017 (Actual)
Study Completion Date
June 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University at Buffalo

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
obesity, women, exercise, physical activity,

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Title
Intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Fit and Fab
Intervention Description
participate in a targeted exercise program at the YMCA. Will include: Targeted exercise classes, Strength-training, Group support sessions
Primary Outcome Measure Information:
Title
YMCA attendance
Description
YMCA attendance measured by swipes of member card
Time Frame
3 motnhs
Secondary Outcome Measure Information:
Title
MVPA
Description
Minutes/week of moderate-to-vigorous exercise measured via accelerometer
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Exercise Enjoyment
Description
Report greater enjoyment and acceptability of the exercise measured by the Physical Activity Enjoyment Scale (PACES)
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: - 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
Facility Information:
Facility Name
University at Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14222
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Increasing Exercise Enjoyment and Outcome Expectations Among Women With Obesity

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