ObesityNCT03843190
Healthy Me: A Program for Older Women
A study testing Take of Pounds Sensibly (TOPS) in people with Obesity, run by Duke University at 1 site in United States.
Trial summary
The first phase of the study is a feasibility survey of eligible participants, completed prior to initiating the intervention. The intervention consists of a 6-month 1:1 randomized trial with a waitlist control that recruits 120 older AA women. Read more about this study
- Who is it for?
- Ages 55 to 99 years, women only
- Conditions the study is for
- Obesity
- What is being tested?
- Take of Pounds Sensibly (TOPS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2023to 17 Jan 2025
- 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 55 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- African American women aged ≥55
- BMI ≥27 kg/m2
- Stable body weight (± 2 kg for 6 months prior to study)
- Sedentary (not exercising more than 1 hour per week)
- Must have a primary care provider and provide contact information
- Conditional Inclusion Criteria:
- Participants with type 2 diabetes on insulin or sulfonylureas will be allowed to participate in the study only if their providers agree to manage the changing medications requirements associated with possible weight loss by signing a "Permission to Participate" form. It is important to include patients with type 2 diabetes on insulin and sulfonylureas because these participants can benefit greatly from weight loss.
Who cannot join
- Type 2 diabetes on insulin or sulfonylureas without provider approval
- current cancer diagnosis
- Provider did not approve participation
- use of medications thought to effect metabolism, body weight, energy expenditure, or appetite
- major psychiatric disorder
- current moderate to severe symptoms of depression
Show all 11Show fewer
- dementia
- neurological conditions causing functional limitations
- unstable medical illness such as unstable angina, recent MI, or congestive heart failure class III-IV
- terminal medical conditions
- Currently enrolled in a weight loss program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changes in Weight and Physical Function for Older African American Women in a National, Nonprofit, Community-Based, Peer-Led, Weight Loss Program
The first phase of the study is a feasibility survey of eligible participants, completed prior to initiating the intervention. The intervention consists of a 6-month 1:1 randomized trial with a waitlist control that recruits 120 older AA women. The rationale for these aims is that the successful completion is expected to provide evidence that a community-based, peer-led weight loss program with a national infrastructure can help a vulnerable, underserved population lose weight and improve their physical function. For older, obese, frail individuals, this could improve their CVD risk factors, quality of life, enhance their health; reduce their healthcare utilization, illness, and disability; and decrease their adverse geriatric outcomes. After completing these aims, the investigators expect that they will have proven that the community-based, peer-led weight loss program can improve both weight and physical function among older, obese AA women. This also could help other demographic groups with obesity and poor physical function. Eventually, it could help older adults maintain their health and independence in the community
Read the detailed description
Older African American (AA) women have the highest prevalence of both obesity and frailty. In academic, expert-led interventions, obese, frail, older individuals both lost weight and improved their physical function. However, because of high personnel costs and nonexistent nationwide infrastructure, large-scale implementation of these interventions is impractical. The long-term goals are to eliminate the health disparities of obesity and frailty in older AA women. This proposal's overall objective is to determine the effects of a low-cost, community-based, peer-led weight loss program with a national infrastructure on obesity, physical function, and healthcare utilization in older AA women. To treat obesity and frailty in older AA women, it is critical to test a weight loss intervention that 1) has preliminary evidence of benefit; 2) is acceptable to older AA women; 3) is affordable; and 4) can be broadly disseminated. Take Off Pounds Sensibly (TOPS) is a national, nonprofit, community-based, peer-led weight loss program that meets these criteria. First, the applicant's retrospective database analyses of TOPS showed two important results: 1) Participants who renew their annual membership lose and maintain significant weight loss (SWL) for up to 7 years; and 2) Compared to their younger counterparts, older women are more likely to achieve SWL. Second, the applicant started three TOPS chapters for older AA women in a successful pilot study. Though the study ended in 2012, one of the chapters is still active almost 6 years later. Third, TOPS is affordable; it only costs $120 annually. Finally, TOPS has a nationwide infrastructure with chapters in all 50 states. Since obese, frail, older individuals in academic, expert-led weight loss interventions can improve their physical function, the central hypothesis is that a low cost, community-based, peer-led weight loss program with a national infrastructure can provide SWL, improved physical function, and lower healthcare utilization for AA women, an underserved, vulnerable population. The rationale for the proposed research is that TOPS and academic, expert-led weight loss interventions share components critical to successful weight loss; therefore, TOPS can deliver similar outcomes. The central hypothesis will be tested by pursuing the following aims in obese, frail, older AA women: Determine the effect of TOPS on 1) weight change and cardiovascular disease risk factors; 2) physical function and quality of life; and 3) healthcare utilization. This project is innovative because it uses a "community to academia" approach to treat the health disparities; our study population focuses on older AA women with decreased physical function; our outcomes focus on weight, physical function, and healthcare utilization; and our unique study settings. The proposed research is significant because determining the real-world effectiveness of the TOPS program and its impact on weight, physical function, and healthcare utilization in AA women can have a widespread impact on the older population at large. Thus, it has the potential to reduce adverse geriatric outcomes among all older individuals.
- Conditions
- Obesity
- Being tested
- Take of Pounds Sensibly (TOPS), Waitlist Control
- Keywords
- weight loss, african american women, physical function
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Take of Pounds Sensibly (TOPS)Behavioural
Dietitian-facilitated classes
Waitlist ControlOther
At end of study, offered peer-led classes to attend.
| Study group | Role | What they receive |
|---|---|---|
| Take Off Pounds Sensibly (TOPS) | Experimental | This group will receive TOPS intervention at the start of the study. Receives: Behavioral: Take of Pounds Sensibly (TOPS) |
| Waitlist control | Other | This group will be the control group for 6 months. Then at the completion of the study they will receive the vouchers to participate in TOPS chapters in the community. Receives: Other: Waitlist Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Change
Percent of body weight change over 6 months
Measured: Baseline to 6 months
Secondary outcomes (25)
Systolic Blood Pressure (BP)
A measure of cardiovascular disease (CVD) risk.
Measured: Baseline, 3 months, 6 months
Diastolic Blood Pressure (BP)
A measure of cardiovascular disease (CVD) risk.
Measured: Baseline, 3 months, 6 months
Waist Circumference (WC)
A measure of cardiovascular disease (CVD) risk.
Measured: Baseline, 3 months, 6 months
Hemoglobin A1c (HA1c)
Percentage of hemoglobin that is coated with glucose. A measure of cardiovascular disease (CVD) risk.
Measured: Baseline, 3 months, 6 months
HDL (High-Density Lipoprotein) Cholesterol
A measure of cardiovascular disease (CVD) risk.
Measured: Baseline, 3 months, 6 months
LDL (Low-Density Lipoprotein) Cholesterol, Calculated
A measure of cardiovascular disease (CVD) risk.
Measured: Baseline, 3 months, 6 months
LDL (Low-Density Lipoprotein) Cholesterol, Direct
A measure of cardiovascular disease (CVD) risk.
Measured: Baseline, 3 months, 6 months
Triglycerides
A measure of cardiovascular disease (CVD) risk.
Measured: Baseline, 3 months, 6 months
Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - General Health
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Measured: Baseline, 3 months, 6 months
Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Physical Functioning
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Measured: Baseline, 3 months, 6 months
Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Role Functioning/Physical
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Measured: Baseline, 3 months, 6 months
Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Role Functioning/Emotional
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Measured: Baseline, 3 months, 6 months
Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Energy/Fatigue
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Measured: Baseline, 3 months, 6 months
Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Emotional Well-being
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Measured: Baseline, 3 months, 6 months
Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Social Functioning
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Measured: Baseline, 3 months, 6 months
Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Pain
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Measured: Baseline, 3 months, 6 months
Healthcare Utilization as Measured by Number of Primary Care Visits
Number of primary care visits reported by participant in last month (baseline) or since last study visit (3 and 6 months).
Measured: Baseline, 3 months, 6 months
Healthcare Utilization as Measured by Number of Participants With Emergency Department Visits
Number of participants reporting emergency department visit(s) in last month (baseline) or since last study visit (3 and 6 months).
Measured: Baseline, 3 months, 6 months
Healthcare Utilization as Measured by Number of Participants With Hospitalizations
Number of participants reporting hospitalization(s) in last month (baseline) or since last study visit (3 and 6 months).
Measured: Baseline, 3 months, 6 months
Physical Function as Measured by Short Physical Performance Battery (SPPB)
The Short Physical Performance Battery (SPPB) is an objective measurement instrument of balance, lower extremity strength, and functional capacity in older adults. Scores range from zero to 12 possible points. Lower scores are associated with lower function.
Measured: Baseline, 3 months, 6 months
Physical Function as Measured by 8-ft Up and Go
The 8-foot up-and-go test is a timed test that measures balance, agility, and speed while walking or moving. Higher times are associated with worse physical function.
Measured: Baseline, 3 months, 6 months
Physical Function as Measured by Isometric Hand Grip, Right Hand
Decreased grip strength is a predictor of adverse outcomes in older adults.
Measured: Baseline, 3 months, 6 months
Physical Function as Measured by Isometric Hand Grip, Left Hand
Decreased grip strength is a predictor of adverse outcomes in older adults.
Measured: Baseline, 3 months, 6 months
Physical Function as Measured by 30 Second Chair Stands
Counts the number of times a participant goes from sitting to standing in 30 seconds. Tests leg strength and endurance. Higher number associated with higher leg strength and endurance.
Measured: Baseline, 3 months, 6 months
Physical Function as Measured by 6 Minute Walk Test
Measures distance walked in 6 minutes and assesses aerobic capacity and endurance. Higher number indicates higher aerobic capacity and endurance.
Measured: Baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study start17 May 2023
- Primary completion17 Jan 2025
- Study completion17 Jan 2025
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 Duke UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Nia S Mitchell, MD, MPH, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03843190
- Sponsor's protocol ID
- Pro00100588
- Other IDs
- R01AG058725
- Status last verified
- Apr 2026
- First submitted
- 29 Jan 2019
- Last updated
- 20 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mitchell NS, North R, Hung A, Porter Starr KN, Bales CW, Coffman CJ. Changes in weight and physical function for older African American women in Take Off Pounds Sensibly (TOPS): Study protocol for a randomized clinical trial. Contemp Clin Trials. 2025 Mar;150:107815. doi: 10.1016/j.cct.2025.107815. Epub 2025 Jan 18.
PubMed 39832532
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Weight and Physical Function for Older African American Women in a National, Nonprofit, Community-Based, Peer-Led, Weight Loss Program
- ClinicalTrials.gov ID
- NCT03843190
- Acronym / sponsor ID
- Pro00100588
- Conditions
- Obesity
- Keywords
- weight loss, african american women, physical function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 17 May 2023 (actual)
- Primary completion
- 17 Jan 2025 (actual)
- Study completion
- 17 Jan 2025 (actual)
- First posted
- 18 Feb 2019 (actual)
- Results
- Posted 20 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The first phase of the study is a feasibility survey of eligible participants, completed prior to initiating the intervention. The intervention consists of a 6-month 1:1 randomized trial with a waitlist control that recruits 120 older AA women. The rationale for these aims is that the successful completion is expected to provide evidence that a community-based, peer-led weight loss program with a national infrastructure can help a vulnerable, underserved population lose weight and improve their physical function. For older, obese, frail individuals, this could improve their CVD risk factors, quality of life, enhance their health; reduce their healthcare utilization, illness, and disability; and decrease their adverse geriatric outcomes. After completing these aims, the investigators expect that they will have proven that the community-based, peer-led weight loss program can improve both weight and physical function among older, obese AA women. This also could help other demographic groups with obesity and poor physical function. Eventually, it could help older adults maintain their health and independence in the community
Detailed description
Older African American (AA) women have the highest prevalence of both obesity and frailty. In academic, expert-led interventions, obese, frail, older individuals both lost weight and improved their physical function. However, because of high personnel costs and nonexistent nationwide infrastructure, large-scale implementation of these interventions is impractical. The long-term goals are to eliminate the health disparities of obesity and frailty in older AA women. This proposal's overall objective is to determine the effects of a low-cost, community-based, peer-led weight loss program with a national infrastructure on obesity, physical function, and healthcare utilization in older AA women. To treat obesity and frailty in older AA women, it is critical to test a weight loss intervention that 1) has preliminary evidence of benefit; 2) is acceptable to older AA women; 3) is affordable; and 4) can be broadly disseminated. Take Off Pounds Sensibly (TOPS) is a national, nonprofit, community-based, peer-led weight loss program that meets these criteria. First, the applicant's retrospective database analyses of TOPS showed two important results: 1) Participants who renew their annual membership lose and maintain significant weight loss (SWL) for up to 7 years; and 2) Compared to their younger counterparts, older women are more likely to achieve SWL. Second, the applicant started three TOPS chapters for older AA women in a successful pilot study. Though the study ended in 2012, one of the chapters is still active almost 6 years later. Third, TOPS is affordable; it only costs $120 annually. Finally, TOPS has a nationwide infrastructure with chapters in all 50 states. Since obese, frail, older individuals in academic, expert-led weight loss interventions can improve their physical function, the central hypothesis is that a low cost, community-based, peer-led weight loss program with a national infrastructure can provide SWL, improved physical function, and lower healthcare utilization for AA women, an underserved, vulnerable population. The rationale for the proposed research is that TOPS and academic, expert-led weight loss interventions share components critical to successful weight loss; therefore, TOPS can deliver similar outcomes. The central hypothesis will be tested by pursuing the following aims in obese, frail, older AA women: Determine the effect of TOPS on 1) weight change and cardiovascular disease risk factors; 2) physical function and quality of life; and 3) healthcare utilization. This project is innovative because it uses a "community to academia" approach to treat the health disparities; our study population focuses on older AA women with decreased physical function; our outcomes focus on weight, physical function, and healthcare utilization; and our unique study settings. The proposed research is significant because determining the real-world effectiveness of the TOPS program and its impact on weight, physical function, and healthcare utilization in AA women can have a widespread impact on the older population at large. Thus, it has the potential to reduce adverse geriatric outcomes among all older individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Take Off Pounds Sensibly (TOPS) | Experimental | Behavioral: Take of Pounds Sensibly (TOPS)This group will receive TOPS intervention at the start of the study. |
| Waitlist control | Other | Other: Waitlist ControlThis group will be the control group for 6 months. Then at the completion of the study they will receive the vouchers to participate in TOPS chapters in the community. |
Who may qualify
- Ages
- 55 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- African American women aged ≥55
- BMI ≥27 kg/m2
- Stable body weight (± 2 kg for 6 months prior to study)
- Sedentary (not exercising more than 1 hour per week)
- Must have a primary care provider and provide contact information
Key exclusion criteria (11 listed)
- Type 2 diabetes on insulin or sulfonylureas without provider approval
- current cancer diagnosis
- Provider did not approve participation
- use of medications thought to effect metabolism, body weight, energy expenditure, or appetite
- major psychiatric disorder
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 |
|---|---|---|
| Take of Pounds Sensibly (TOPS)Dietitian-facilitated classes | Behavioural | Take Off Pounds Sensibly (TOPS) |
| Waitlist ControlAt end of study, offered peer-led classes to attend. | Other | Waitlist control |
Primary outcome
Weight Change
Time frame: Baseline to 6 months
Percent of body weight change over 6 months
25 secondary outcomes
Systolic Blood Pressure (BP)
Time frame: Baseline, 3 months, 6 months
Diastolic Blood Pressure (BP)
Time frame: Baseline, 3 months, 6 months
Waist Circumference (WC)
Time frame: Baseline, 3 months, 6 months
Hemoglobin A1c (HA1c)
Time frame: Baseline, 3 months, 6 months
HDL (High-Density Lipoprotein) Cholesterol
Time frame: Baseline, 3 months, 6 months
LDL (Low-Density Lipoprotein) Cholesterol, Calculated
Time frame: Baseline, 3 months, 6 months
LDL (Low-Density Lipoprotein) Cholesterol, Direct
Time frame: Baseline, 3 months, 6 months
Triglycerides
Time frame: Baseline, 3 months, 6 months
Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - General Health
Time frame: Baseline, 3 months, 6 months
Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Physical Functioning
Time frame: Baseline, 3 months, 6 months
Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Role Functioning/Physical
Time frame: Baseline, 3 months, 6 months
Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Role Functioning/Emotional
Time frame: Baseline, 3 months, 6 months
Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Energy/Fatigue
Time frame: Baseline, 3 months, 6 months
Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Emotional Well-being
Time frame: Baseline, 3 months, 6 months
Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Social Functioning
Time frame: Baseline, 3 months, 6 months
Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Pain
Time frame: Baseline, 3 months, 6 months
Healthcare Utilization as Measured by Number of Primary Care Visits
Time frame: Baseline, 3 months, 6 months
Healthcare Utilization as Measured by Number of Participants With Emergency Department Visits
Time frame: Baseline, 3 months, 6 months
Healthcare Utilization as Measured by Number of Participants With Hospitalizations
Time frame: Baseline, 3 months, 6 months
Physical Function as Measured by Short Physical Performance Battery (SPPB)
Time frame: Baseline, 3 months, 6 months
Physical Function as Measured by 8-ft Up and Go
Time frame: Baseline, 3 months, 6 months
Physical Function as Measured by Isometric Hand Grip, Right Hand
Time frame: Baseline, 3 months, 6 months
Physical Function as Measured by Isometric Hand Grip, Left Hand
Time frame: Baseline, 3 months, 6 months
Physical Function as Measured by 30 Second Chair Stands
Time frame: Baseline, 3 months, 6 months
Physical Function as Measured by 6 Minute Walk Test
Time frame: Baseline, 3 months, 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39832532Mitchell NS, North R, Hung A, Porter Starr KN, Bales CW, Coffman CJ. Changes in weight and physical function for older African American women in Take Off Pounds Sensibly (TOPS): Study protocol for a randomized clinical trial. Contemp Clin Trials. 2025 Mar;150:107815. doi: 10.1016/j.cct.2025.107815. Epub 2025 Jan 18.
- Individual participant dataSharing planned: No
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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.
Nia S Mitchell, MD, MPH principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Take of Pounds Sensibly (TOPS) in people with Obesity, run by Duke University 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 7 inclusion and 11 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 20 May 2026. 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 20 May 2026). 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?
Weight Change (time frame: Baseline to 6 months). 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 NCT03843190, 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 20 May 2026; AzTrials last refreshed its copy on 1 Nov 2026.