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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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For women diagnosed with breast cancer, dietary, weight loss, and physical activity have been linked with clinically significant weight loss; decreased risk of death; reduced risk of breast cancer recurrence; fewer cardiovascular events; and improved physical function. The objectives of these aims are to a) determine if the TOPS materials and format are possible and accepted by overweight and obese African American breast cancer survivors; b) gather data for sample size calculations for a larger future study.
To meet these aims, we will collect data to see if participants enjoyed the TOPS program and suggestions for changes to the program to make it fit their needs. Other methods will measure recruitment, retention, and weight change.
Aim 1: Examine the feasibility and acceptability of a national, low-cost, community-based, peer-led, weight loss program (Take Off Pounds Sensibly, TOPS) for overweight and obese African American breast cancer survivors in the local chapter of a national African American breast cancer support group (Sisters Network Triangle North Carolina, SNTNC).
Aim 2: Assess the weight change of overweight and obese African American breast cancer survivors after 6 months in the TOPS program to gather data for sample size calculations for a future RCT (randomized controlled trial).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TOPS | Experimental | weight loss program (Take Off Pounds Sensibly, TOPS) for overweight and obese African American breast cancer survivors |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TOPS | Behavioral | weight loss program (Take Off Pounds Sensibly, TOPS) for overweight and obese African American breast cancer survivors in the local chapter of a national African American breast cancer support group (Sisters Network Triangle North Carolina, SNTNC). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Invited Women Who Attended the TOPS (Take Off Pounds Sensibly) Information Session | One-time invitation | |
| Number of Women Who Attended the Information Session and Joined the TOPS Program | One-time information session | |
| Number of Women Who Remained in the Program for 12 Weeks | Measured by the number of women who reported to the 12-week weigh in. | up to 12 weeks |
| Number of Women Who Remained in the Program for 24 Weeks | Measured by the number of women who reported to the 24-week weigh in. | up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Participants' Weight as Measured by Scale Reading | baseline, 3 months, 6 months, 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nia Mitchell, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Health System | Durham | North Carolina | 27710 | United States |
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Participants were recruited from the local chapter of a national African American breast cancer support group (Sisters Network Triangle North Carolina, SNTNC), which has a roster of 160 members.
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| ID | Title | Description |
|---|---|---|
| FG000 | TOPS | Weight loss program (Take Off Pounds Sensibly, TOPS) for overweight and obese African American breast cancer survivors TOPS: weight loss program (Take Off Pounds Sensibly, TOPS) for overweight and obese African American breast cancer survivors in the local chapter of a national African American breast cancer support group (Sisters Network Triangle North Carolina, SNTNC). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TOPS | Weight loss program (Take Off Pounds Sensibly, TOPS) for overweight and obese African American breast cancer survivors TOPS: weight loss program (Take Off Pounds Sensibly, TOPS) for overweight and obese African American breast cancer survivors in the local chapter of a national African American breast cancer support group (Sisters Network Triangle North Carolina, SNTNC). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Invited Women Who Attended the TOPS (Take Off Pounds Sensibly) Information Session | Women who were invited to attend the information session (all members of the Sisters Network Triangle North Carolina). | Posted | Count of Participants | Participants | One-time invitation |
|
|
Up to 12 months
Serious and Other (Not Including Serious) Adverse Events were not monitored/assessed.
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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 | TOPS | Weight loss program (Take Off Pounds Sensibly, TOPS) for overweight and obese African American breast cancer survivors TOPS: weight loss program (Take Off Pounds Sensibly, TOPS) for overweight and obese African American breast cancer survivors in the local chapter of a national African American breast cancer support group (Sisters Network Triangle North Carolina, SNTNC). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nia S. Mitchell, MD, MPH | Duke University | 919-668-7202 | nia.s.mitchell@duke.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 5, 2022 | Sep 8, 2023 | Prot_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 2, 2021 | Jan 11, 2023 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D001943 | Breast Neoplasms |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C015535 | TOPS |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
| Primary | Number of Women Who Attended the Information Session and Joined the TOPS Program | Number of women who attended the information session. | Posted | Count of Participants | Participants | One-time information session |
|
|
|
| Primary | Number of Women Who Remained in the Program for 12 Weeks | Measured by the number of women who reported to the 12-week weigh in. | Posted | Count of Participants | Participants | up to 12 weeks |
|
|
|
| Primary | Number of Women Who Remained in the Program for 24 Weeks | Measured by the number of women who reported to the 24-week weigh in. | Posted | Count of Participants | Participants | up to 24 weeks |
|
|
|
| Secondary | Percent Change in Participants' Weight as Measured by Scale Reading | Completers at each time point. | Posted | Mean | Standard Deviation | percentage of change | baseline, 3 months, 6 months, 12 months |
|
|
|
| 1 |
| 26 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001836 | Body Weight Changes |
|
| Baseline to 12 months |
|
|