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Clinical Trials/NCT04114071
NCT04114071CompletedNot Applicable

TOSS Feasibility + Fitbit Community = Reduced Obesity in Older Black Women

University of Alabama at Birmingham2 sites in 1 country30 target enrollmentStarted: July 16, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
30
Locations
2
Primary Endpoint
Change in Physical Activity Behaviors From Baseline to 12 Weeks

Study Overview

Brief Summary

The primary goal of this proposed physical activity (PA) intervention is to develop a realistic and an economical intervention to promote regular PA among older, overweight or obese Black women. Physical inactivity is prevalent among older Black women and this lifestyle behavior is both a destructive and expensive public health issue. Because many in this population do not engage in sufficient amounts of regular PA, this group miss the cardio-protective effects that may reduce many chronic conditions that disproportionately affect Blacks such as hypertension, diabetes, and obesity. The proposed obesity-reduction intervention is aligned with Stage 1 of the National Institute on Aging Stage Model for Behaviors Interventions Development. For the proposed hypothesis, the investigators propose a 2-group randomized controlled pilot, feasibility study in which 30 women will be randomized to receive either the TOSS PA Text messages Plus Fitbit community or the Control group and followed for 12 weeks to detect intervention effect.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Single (Participant)

Masking Description

All participants will receive text messages during the 12-week intervention but the frequency, the content of the messages will be different for the control and intervention groups, and these differences will not be discussed.

Eligibility Criteria

Ages
60 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Black women
  • 60 years and older
  • Have a BMI ≥ 25 kg/m2
  • Do not meet the weekly 150 minutes of physical activity (PA)
  • No health conditions that would prevent or limit PA or walking
  • Able to read text messages
  • Access to a mobile phone with text receiving capability
  • Mobile phone with ability to download a Fitbit app.

Exclusion Criteria

  • Currently participating in another PA promotion program
  • Non-English speaking
  • A contraindication to exercise as indicated by the PA Readiness Questionnaire (PAR-Q) unless written permission was provided from the participant's primary care provider.

Outcomes

Primary Outcomes

Change in Physical Activity Behaviors From Baseline to 12 Weeks

Time Frame: Baseline and 12 weeks

number of steps

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Pamela G Bowen PhD, CRNP, FNP-BC, BBA

Associate Professor

University of Alabama at Birmingham

Study Sites (2)

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