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The Use of Smart Scales for Weight Gain Prevention in African American Breast Cancer Survivors

UNC Lineberger Comprehensive Cancer Center logo

UNC Lineberger Comprehensive Cancer Center

Status

Completed

Conditions

Breast Neoplasms
Body Weight Changes

Treatments

Behavioral: Self-regulation plus activity monitoring
Behavioral: Self-regulation

Study type

Interventional

Funder types

Other

Identifiers

NCT02030353
LCCC1323

Details and patient eligibility

About

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.

Full description

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).

Enrollment

35 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

35 participants in 3 patient groups

Self-regulation plus activity monitoring
Experimental group
Description:
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.
Treatment:
Behavioral: Self-regulation plus activity monitoring
Self-regulation
Experimental group
Description:
Participants will receive an individual in-person session, digital smart scale, access to a website to view tracking information, weekly lessons, and tailored feedback.
Treatment:
Behavioral: Self-regulation
Delayed intervention control
No Intervention group
Description:
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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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