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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04114071
• Other study ID #: IRB 300004159
• Secondary ID: U54MD000502
• Status: Completed
• Phase: N/A
• Start date: July 16, 2020
• Est. completion date: December 28, 2020

Study information

• Verified date: September 2023
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 28, 2020
• Est. primary completion date: December 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• TOSS Feasibility + Fitbit Community = Reduced Obesity in Older Black Women
See arm description

Locations

Country	Name	City	State
United States	Pamela G. Bowen	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Bowen PG, Affuso O, Opoku-Agyeman W, Mixon VR, Clay OJ. Texting Older Sisters to Step to Manage Obesity in Older Black Women: A Feasibility Study. Am J Prev Med. 2022 Jul;63(1 Suppl 1):S56-S66. doi: 10.1016/j.amepre.2022.03.014. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Physical Activity Behaviors From Baseline to 12 Weeks	number of steps	Baseline and 12 weeks