Obesity
Conditions
Keywords
physical activity, older Black women, overweight, obesity, text messages
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.
Interventions
BEHAVIORALTOSS Feasibility + Fitbit Community = Reduced Obesity in Older Black Women
See arm description
Sponsors
National Institute on Minority Health and Health Disparities (NIMHD)
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
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.
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.
Eligibility
Sex/Gender
FEMALE
Age
60 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Physical Activity Behaviors From Baseline to 12 Weeks | Baseline and 12 weeks | number of steps |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
TOSS Feasibility + Fitbit Community = Reduced Obesity in Older Black Women: See arm description | 15 |
| 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
TOSS Feasibility + Fitbit Community = Reduced Obesity in Older Black Women: See arm description | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | Physical Activity Intervention Group | Total | Control Group |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 8 Participants | 17 Participants | 9 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 13 Participants | 6 Participants |
| Age, Continuous | 64.67 years | 65 years | 65.33 years |
| Body mass index | 34.52 kg/m^2 STANDARD_DEVIATION 4.2 | 34.93 kg/m^2 STANDARD_DEVIATION 5.08 | 35.33 kg/m^2 STANDARD_DEVIATION 5.95 |
| hemoglobin A1c | 6.18 percent of gylcosylated hemoglobin STANDARD_DEVIATION 2.18 | 6.29 percent of gylcosylated hemoglobin STANDARD_DEVIATION 1.57 | 6.39 percent of gylcosylated hemoglobin STANDARD_DEVIATION 0.58 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants | 30 Participants | 15 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 15 Participants | 30 Participants | 15 Participants |
| Sex: Female, Male Female | 15 Participants | 30 Participants | 15 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Steps per day | 6207.85 Daily steps STANDARD_DEVIATION 4315.71 | 6357.35 Daily steps STANDARD_DEVIATION 3855.08 | 6506.85 Daily steps STANDARD_DEVIATION 3480.18 |
| weight | 209.7 lbs STANDARD_DEVIATION 32.76 | 211.02 lbs STANDARD_DEVIATION 36.61 | 212.3 lbs STANDARD_DEVIATION 41.22 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
Change in Physical Activity Behaviors From Baseline to 12 Weeks
number of steps
Time frame: Baseline and 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Physical Activity Intervention Group | Change in Physical Activity Behaviors From Baseline to 12 Weeks | -736.71 change in daily steps (baseline - post) | Standard Deviation 4315.71 |
| Control Group | Change in Physical Activity Behaviors From Baseline to 12 Weeks | 218.79 change in daily steps (baseline - post) | Standard Deviation 3480.18 |
p-value: <0.05t-test, 2 sided