The Use of Smart Scales for Weight Gain Prevention in African American Breast Cancer Survivors
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Obesity Weight Loss, Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | January 2014 |
| End Date: | June 2015 |
Feasibility of Using Smart Scales for Weight Gain Prevention in African American Breast Cancer Survivors: a Randomized Pilot Study
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.
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).
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).
Inclusion Criteria:
- Female, age 18 or older
- Self-identify as African American or black
- Diagnosed with stage I-IIIA breast cancer within the last 10 years
- Body mass index of 20-45 kg/m²
- Completed cancer treatment (except endocrine treatment) with full recovery of any
treatment associated toxicities to ≤ Grade 1 or baseline
- No evidence of progressive disease or second primary cancers
- Have the ability to read, write and speak English
- Have access to the Internet and a computer on at least a weekly basis
- Possession and usage of an Internet e-mail address or willingness to sign up for a
free email account
- Willing to be randomized
- Physician approval to participate
Exclusion Criteria:
- History of heart attack or stroke within past 6 months
- Untreated hypertension, hyperlipidemia, or diabetes, unless permission is provided by
their health care provider
- Treatment of diabetes with insulin, due to the concerns about hypoglycemia
- Health problems which preclude ability to walk for physical activity (e.g., lower
limb amputation)
- Report a diagnosis of psychiatric diseases (schizophrenia, bipolar disorder,
depression leading to hospitalization in the past year), drug or alcohol dependency.
- Report a past diagnosis of or treatment for a Diagnostic and Statistical Manual of
Mental Disorders-Fourth Edition-Text Revision (DSM-IV-TR) eating disorder (anorexia
nervosa or bulimia nervosa)
- Plans for major surgery (including breast reconstruction) during the intervention
time frame
- Have lost and maintained a weight loss of > 10 pounds within the past 6 months or
currently participating in another weight loss program
- Currently using prescription weight loss medications
- Currently pregnant, pregnant within the past 6 months, or planning to become pregnant
within the next 6 months
- Inability to attend 3 assessment visits (baseline, 3 months, and 6 months) at the
University of North Carolina Weight Research Program center
We found this trial at
1
site
Chapel Hill, North Carolina 27599
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