NCT03236077

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

July 28, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 1, 2017

Completed
Last Updated

July 15, 2025

Status Verified

July 1, 2025

Enrollment Period

5 months

First QC Date

July 28, 2017

Last Update Submit

July 10, 2025

Conditions

Keywords

obesity, women, exercise, physical activity,

Outcome Measures

Primary Outcomes (1)

  • YMCA attendance

    YMCA attendance measured by swipes of member card

    3 motnhs

Secondary Outcomes (1)

  • MVPA

    3 months

Other Outcomes (1)

  • Exercise Enjoyment

    3 months

Study Arms (2)

Control

NO INTERVENTION

Intervention

EXPERIMENTAL
Behavioral: Fit and Fab

Interventions

Fit and FabBEHAVIORAL

participate in a targeted exercise program at the YMCA. Will include: Targeted exercise classes, Strength-training, Group support sessions

Intervention

Eligibility Criteria

Age18 Years - 64 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University at Buffalo

Buffalo, New York, 14222, United States

Location

MeSH Terms

Conditions

ObesityMotor Activity

Interventions

Immunoglobulin Fab Fragments

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Immunoglobulin FragmentsPeptide FragmentsPeptidesAmino Acids, Peptides, and ProteinsImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 28, 2017

First Posted

August 1, 2017

Study Start

February 1, 2017

Primary Completion

June 30, 2017

Study Completion

June 30, 2017

Last Updated

July 15, 2025

Record last verified: 2025-07

Locations