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

The University of Alabama at Birmingham

Status: Completed

Conditions: Obesity

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04114071

U54MD000502 (U.S. NIH Grant/Contract)

IRB 300004159

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: Female

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Physical Activity intervention group

Experimental group

Description:

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.

Treatment:

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

Control group

Active Comparator group

Description:

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

Treatment:

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