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

NCT ID: NCT04114071

Last Updated: 2023-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-16
• Study Completion Date: 2020-12-28

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Physical Activity intervention group

Older overweight or obese Black women who participate in the physical activity intervention group will receive a daily text message from the TOSS study for 12 weeks, a Fitbit device plus have access to the Fitbit community option on their Fitbit app as an opportunity for virtual peer support. They will also receive an instruction pamphlet that describes the health benefits of regular physical activity (PA), safety instructions for PA, the national PA guidelines for older adults, suggested strategies to increase number of steps and an accelerometer pre and post-intervention.

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

See arm description

Control group

The control will only receive a weekly neutral text message during the 12-week intervention. For this project, a neutral text message is defined as a message that only provides facts about a topic.They will also receive a Fitbit device, an instruction pamphlet that describes the health benefits of regular physical activity (PA), safety instructions for PA, the national PA guidelines for older adults, suggested strategies to increase number of steps and an accelerometer pre and post-intervention

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: BEHAVIORAL

See arm description

Interventions

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

See arm description

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

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

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pamela G. Bowen

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

Pamela G. Bowen

Birmingham, Alabama, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 35725141 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

U54MD000502

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB 300004159

Identifier Type: -

Identifier Source: org_study_id