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

Completed · Not applicable

Conditions studied: Body Weight Changes, Breast Neoplasms

In brief

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.

Key facts

Study ID

NCT02030353

Run by

UNC Lineberger Comprehensive Cancer Center

People needed

35

Starts

2014-01-01

Expected to finish

2015-06-01

Last updated by the study team

2016-01-20

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of North Carolina at Chapel Hill, UNC Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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