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| ID | Type | Description | Link |
|---|---|---|---|
| U54MD000502 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TOSS Feasibility + Fitbit Community = Reduced Obesity in Older Black Women | Behavioral | See arm description |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Physical Activity Behaviors From Baseline to 12 Weeks | number of steps | Baseline and 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pamela G. Bowen | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pamela G. Bowen | Birmingham | Alabama | 35127 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35725141 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Physical Activity Behaviors From Baseline to 12 Weeks | number of steps | Posted | Mean | Standard Deviation | change in daily steps (baseline - post) | Baseline and 12 weeks |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 No adverse events in this group. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Pamela G. Bowen | University of Alabama at Birmingham | 12059342778 | pbowen@uab.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 12, 2019 | Sep 19, 2022 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 12, 2019 | Sep 19, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D009043 | Motor Activity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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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.
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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.
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Body mass index | Mean | Standard Deviation | kg/m^2 |
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| hemoglobin A1c | Mean | Standard Deviation | percent of gylcosylated hemoglobin |
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| weight | Mean | Standard Deviation | lbs |
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| Steps per day | Mean | Standard Deviation | Daily steps |
|
| OG001 | 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 |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | 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 No adverse events in this group. | 0 | 15 | 0 | 15 | 0 | 15 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |