Clinical trial NCT02030353: The Use of Smart Scales for Weight Gain Prevention in African American Breast Cancer Survivors
Official title: Feasibility of Using Smart Scales for Weight Gain Prevention in African American Breast Cancer Survivors: a Randomized Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Weight Changes
Breast Neoplasms
Keywords: Lifestyle intervention
Internet intervention
Breast neoplasms
Body weight
Body weight changes
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2014-01-08
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of participants with completed assessments at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Weight change
timeFrame: Baseline, 6 months
measure: Change in dietary intake
timeFrame: Baseline, 6 months
measure: Change in physical activity
timeFrame: Baseline, 6 months
measure: Change in waist circumference
timeFrame: Baseline, 6 months
measure: Change in blood pressure
timeFrame: Baseline, 6 months
measure: Change in cholesterol
timeFrame: Baseline, 6 months
measure: Change in hemoglobin A1c
timeFrame: Baseline, 6 months
measure: Change in triglycerides
timeFrame: Baseline, 6 months
measure: Proportion of participants with completed assessments at 3 months
timeFrame: 3 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill, UNC Lineberger Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Carmina G. Valle, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: Deborah F. Tate, PhD
role: STUDY_DIRECTOR
References:
citation: 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.