ObesityNCT04114071
TOSS Feasibility + Fitbit Community = Reduced Obesity in Older Black Women
A study testing TOSS Feasibility + Fitbit Community = Reduced Obesity in Older Black Women in people with Obesity, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- TOSS Feasibility + Fitbit Community = Reduced Obesity in Older Black Women
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2020to 28 Dec 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- TOSS Feasibility + Fitbit Community = Reduced Obesity in Older Black Women
- Keywords
- physical activity, older Black women, overweight, obesity, text messages
- Medical subject headings
- Obesity, Motor Activity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TOSS Feasibility + Fitbit Community = Reduced Obesity in Older Black WomenBehavioural
See arm description
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Behavioral: TOSS Feasibility + Fitbit Community = Reduced Obesity in Older Black Women |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Physical Activity Behaviors From Baseline to 12 Weeks
number of steps
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start16 Jul 2020
- Primary completion28 Dec 2020
- Study completion28 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Pamela G Bowen PhD, CRNP, FNP-BC, BBA, University of Alabama at Birmingham
- Investigators
- Pamela G. Bowen, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04114071
- Sponsor's protocol ID
- IRB 300004159
- Other IDs
- U54MD000502
- Status last verified
- Sep 2023
- First submitted
- 1 Oct 2019
- Last updated
- 8 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35725141
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TOSS Feasibility + Fitbit Community = Reduced Obesity in Older Black Women
- ClinicalTrials.gov ID
- NCT04114071
- Acronym / sponsor ID
- IRB 300004159
- Conditions
- Obesity
- Keywords
- physical activity, older Black women, overweight, obesity, text messages
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 16 Jul 2020 (actual)
- Primary completion
- 28 Dec 2020 (actual)
- Study completion
- 28 Dec 2020 (actual)
- First posted
- 3 Oct 2019 (actual)
- Results
- Posted 14 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Physical Activity intervention group | Experimental | Behavioral: TOSS Feasibility + Fitbit Community = Reduced Obesity in Older Black WomenOlder 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. |
| Control group | Active comparator | Behavioral: TOSS Feasibility + Fitbit Community = Reduced Obesity in Older Black WomenThe 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 |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TOSS Feasibility + Fitbit Community = Reduced Obesity in Older Black WomenSee arm description | Behavioural | Control group, Physical Activity intervention group |
Primary outcome
Change in Physical Activity Behaviors From Baseline to 12 Weeks
Time frame: Baseline and 12 weeks
number of steps
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 35725141Bowen 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.
- Individual participant dataSharing planned: No
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pamela G. Bowen principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TOSS Feasibility + Fitbit Community = Reduced Obesity in Older Black Women in people with Obesity, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Physical Activity Behaviors From Baseline to 12 Weeks (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04114071, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2023.