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

NCT04114071 | Completed Results

• 2 other identifiers: IRB 300004159U54MD000502
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

physical activity; older Black women; overweight; obesity; text messages

Outcome Measures

Primary Outcomes (1)

• Change in Physical Activity Behaviors From Baseline to 12 Weeks

  number of steps

  Baseline and 12 weeks

Study Arms (2)

Physical Activity intervention group

EXPERIMENTAL

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.

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

Control group

ACTIVE COMPARATOR

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

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

Interventions

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

See arm description

Control group; Physical Activity intervention group

Eligibility Criteria

• Age: 60 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Black women
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Pamela G. Bowen

Birmingham, Alabama, 35127, United States

Location

Related 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.

  PMID: 35725141 RESULT

MeSH Terms

Conditions

Obesity; Motor Activity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Results Point of Contact

• Title: Dr. Pamela G. Bowen
• Organization: University of Alabama at Birmingham

pbowen@uab.edu

12059342778

Study Officials

• Pamela G. Bowen

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The researchers hypothesize that older overweight or obese Black women who participate in the PA intervention group (TOSS text messages plus Fitbit) will show increases in self-report and objective (assessed by accelerometer and a Fitbit) PA behaviors compared to the control group.

Study Record Dates

• First Submitted: October 1, 2019
• First Posted: October 3, 2019
• Study Start: July 16, 2020
• Primary Completion: December 28, 2020
• Study Completion: December 28, 2020
• Last Updated: September 8, 2023
• Results First Posted: October 14, 2022

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)