Clinical trial NCT04114071: TOSS Feasibility + Fitbit Community = Reduced Obesity in Older Black Women
Official title: TOSS Feasibility + Fitbit Community = Reduced Obesity in Older Black Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: physical activity
older Black women
overweight
obesity
text messages
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2019-10-03
Enrollment: 30
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Change in Physical Activity Behaviors From Baseline to 12 Weeks
timeFrame: Baseline and 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Pamela G. Bowen
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Pamela G. Bowen
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.