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The purpose of this study is to test the feasibility of two 6-month behavioral interventions for weight gain prevention (self-regulation plus activity monitoring or self-regulation) among African American breast cancer survivors along with a delayed control group. Participants will be 45 African American post-treatment breast cancer survivors. Intervention content will be delivered online with one face-to-face individual meeting. Weight, clinical and psychosocial measures will be assessed at baseline, 3 and 6 months. It is hypothesized that it is feasible to deliver the two weight gain prevention interventions among African American breast cancer survivors, and participants in the two intervention groups will have a lower magnitude of weight gain at 6-month follow-up relative to those in the delayed control group.
Breast cancer is the most commonly diagnosed cancer among African American women in the United States, and in North Carolina (NC), African American women are more likely to die from breast cancer compared to women of other races/ethnicities. Given this disparity and with approximately 90,000 African American breast cancer survivors in NC, it is important to identify modifiable factors that can help improve survival among this population. Behavioral interventions that promote weight management among breast cancer survivors can help reduce risks for prevalent comorbidities, such as cardiovascular disease and diabetes, and potentially improve prognosis and survival. While lifestyle interventions have shown promise in improving body weight in breast cancer survivors, none have focused on weight gain prevention in African American breast cancer survivors, nor evaluated the use of frequent self-weighing as a self-regulation strategy.
Regular self-weighing has been effectively used as an approach for weight maintenance that helps individuals monitor daily weight fluctuations and make small changes in energy balance behaviors. Given that the frequency of self-weighing among breast cancer survivors is unknown, and the importance of self-regulation behaviors for weight maintenance is well established, extending previous work to prevent weight gain among breast cancer survivors is a critical next step for optimizing cancer outcomes. It is unknown whether self-weighing and activity monitoring is a feasible strategy for breast cancer survivors to monitor weight changes and regulate their energy balance. Thus, this three-arm, pilot randomized controlled trial will evaluate two behavioral self-regulation interventions for weight gain prevention (self-regulation or self-regulation plus activity monitoring) compared to a delayed control group among 45 female African-American post-treatment breast cancer survivors. Participants will be randomly assigned to one of three groups: Self-regulation intervention with activity monitoring (n=15); Self-regulation intervention (n=15); and Delayed control (n=15).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self-regulation plus activity monitoring | Experimental | Participants will receive an individual in-person session, digital smart scale, access to a website to view tracking information, weekly lessons, tailored feedback, and activity monitoring. |
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| Self-regulation | Experimental | Participants will receive an individual in-person session, digital smart scale, access to a website to view tracking information, weekly lessons, and tailored feedback. |
|
| Delayed intervention control | No Intervention | Participants will receive an individual in-person session and a digital smart scale, and a modified version of the self-regulation intervention after the 6-month assessment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-regulation plus activity monitoring | Behavioral | Individual in-person session, digital smart scale, online intervention, and an activity monitor. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with completed assessments at 6 months | Proportion of participants who complete all 6-month online and in-clinic assessments. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Weight change | Change in weight, as measured objectively during in-clinic assessments, from baseline to 6 months. | Baseline, 6 months |
| Change in dietary intake | Change in dietary intake, as measured by the online Automated Self-Administered 24-hour recall, from baseline to 6 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carmina G. Valle, PhD, MPH | University of North Carolina, Chapel Hill | Principal Investigator |
| Deborah F. Tate, PhD | University of North Carolina, Chapel Hill | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill, UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | 27599 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27631874 | Derived | Valle CG, Deal AM, Tate DF. Preventing weight gain in African American breast cancer survivors using smart scales and activity trackers: a randomized controlled pilot study. J Cancer Surviv. 2017 Feb;11(1):133-148. doi: 10.1007/s11764-016-0571-2. Epub 2016 Sep 8. |
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| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001943 | Breast Neoplasms |
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D017009 | Professional Autonomy |
| ID | Term |
|---|---|
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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| Self-regulation | Behavioral | Individual in-person session, digital smart scale, and online intervention. |
|
| Baseline, 6 months |
| Change in physical activity | Change in physical activity, as measured by the Paffenbarger Exercise Habits Questionnaire, from baseline to 6 months. | Baseline, 6 months |
| Change in waist circumference | Change in waist circumference, as measured by objective clinic assessment, from baseline to 6 months. | Baseline, 6 months |
| Change in blood pressure | Change in blood pressure, as measured by objective clinic assessment, from baseline to 6 months. | Baseline, 6 months |
| Change in cholesterol | Change in cholesterol, as measured by objective clinic assessment, from baseline to 6 months. | Baseline, 6 months |
| Change in hemoglobin A1c | Change in hemoglobin A1c, as measured by objective clinic assessment, from baseline to 6 months. | Baseline, 6 months |
| Change in triglycerides | Change in triglycerides as measured by objective clinic assessment, from baseline to 6 months. | Baseline, 6 months |
| Proportion of participants with completed assessments at 3 months | Proportion of participants who complete all 3-month online and in-clinic assessments. | 3 months |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |