University of North Carolina at Chapel Hill, UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States
NCT Number: NCT02030353
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.
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Notify Me18 year and older
Female
Interventional
Not applicable
Chapel Hill, North Carolina, 27599, United States
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Individual in-person session, digital smart scale, online intervention, and an activity monitor.
Individual in-person session, digital smart scale, and online intervention.
Time frame: 6 months
Proportion of participants who complete all 6-month online and in-clinic assessments.
Time frame: Baseline, 6 months
Change in weight, as measured objectively during in-clinic assessments, from baseline to 6 months.
Time frame: Baseline, 6 months
Change in dietary intake, as measured by the online Automated Self-Administered 24-hour recall, from baseline to 6 months.
Time frame: Baseline, 6 months
Change in physical activity, as measured by the Paffenbarger Exercise Habits Questionnaire, from baseline to 6 months.
Time frame: Baseline, 6 months
Change in waist circumference, as measured by objective clinic assessment, from baseline to 6 months.
Time frame: Baseline, 6 months
Change in blood pressure, as measured by objective clinic assessment, from baseline to 6 months.
Time frame: Baseline, 6 months
Change in cholesterol, as measured by objective clinic assessment, from baseline to 6 months.
Time frame: Baseline, 6 months
Change in hemoglobin A1c, as measured by objective clinic assessment, from baseline to 6 months.
Time frame: Baseline, 6 months
Change in triglycerides as measured by objective clinic assessment, from baseline to 6 months.
Time frame: 3 months
Proportion of participants who complete all 3-month online and in-clinic assessments.
UNC Lineberger Comprehensive Cancer Center
Other
Feasibility of Using Smart Scales for Weight Gain Prevention in African American Breast Cancer Survivors: a Randomized Pilot Study
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