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

Primary Purpose

Body Weight Changes, Breast Neoplasms

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Self-regulation plus activity monitoring
Self-regulation
Sponsored by
UNC Lineberger Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Body Weight Changes focused on measuring Lifestyle intervention, Internet intervention, Breast neoplasms, Body weight, Body weight changes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Self-regulation plus activity monitoring

Self-regulation

Delayed intervention control

Arm 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.

Participants will receive an individual in-person session, digital smart scale, access to a website to view tracking information, weekly lessons, and tailored feedback.

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.

Outcomes

Primary Outcome Measures

Proportion of participants with completed assessments at 6 months
Proportion of participants who complete all 6-month online and in-clinic assessments.

Secondary Outcome Measures

Weight change
Change in weight, as measured objectively during in-clinic assessments, from baseline to 6 months.
Change in dietary intake
Change in dietary intake, as measured by the online Automated Self-Administered 24-hour recall, from baseline to 6 months.
Change in physical activity
Change in physical activity, as measured by the Paffenbarger Exercise Habits Questionnaire, from baseline to 6 months.
Change in waist circumference
Change in waist circumference, as measured by objective clinic assessment, from baseline to 6 months.
Change in blood pressure
Change in blood pressure, as measured by objective clinic assessment, from baseline to 6 months.
Change in cholesterol
Change in cholesterol, as measured by objective clinic assessment, from baseline to 6 months.
Change in hemoglobin A1c
Change in hemoglobin A1c, as measured by objective clinic assessment, from baseline to 6 months.
Change in triglycerides
Change in triglycerides as measured by objective clinic assessment, from baseline to 6 months.
Proportion of participants with completed assessments at 3 months
Proportion of participants who complete all 3-month online and in-clinic assessments.

Full Information

First Posted
December 17, 2013
Last Updated
January 19, 2016
Sponsor
UNC Lineberger Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT02030353
Brief Title
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

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNC Lineberger Comprehensive Cancer Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Weight Changes, Breast Neoplasms
Keywords
Lifestyle intervention, Internet intervention, Breast neoplasms, Body weight, Body weight changes

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Self-regulation plus activity monitoring
Arm Type
Experimental
Arm 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.
Arm Title
Self-regulation
Arm Type
Experimental
Arm 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.
Arm Title
Delayed intervention control
Arm Type
No Intervention
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Self-regulation plus activity monitoring
Intervention Description
Individual in-person session, digital smart scale, online intervention, and an activity monitor.
Intervention Type
Behavioral
Intervention Name(s)
Self-regulation
Intervention Description
Individual in-person session, digital smart scale, and online intervention.
Primary Outcome Measure Information:
Title
Proportion of participants with completed assessments at 6 months
Description
Proportion of participants who complete all 6-month online and in-clinic assessments.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Weight change
Description
Change in weight, as measured objectively during in-clinic assessments, from baseline to 6 months.
Time Frame
Baseline, 6 months
Title
Change in dietary intake
Description
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
Title
Change in physical activity
Description
Change in physical activity, as measured by the Paffenbarger Exercise Habits Questionnaire, from baseline to 6 months.
Time Frame
Baseline, 6 months
Title
Change in waist circumference
Description
Change in waist circumference, as measured by objective clinic assessment, from baseline to 6 months.
Time Frame
Baseline, 6 months
Title
Change in blood pressure
Description
Change in blood pressure, as measured by objective clinic assessment, from baseline to 6 months.
Time Frame
Baseline, 6 months
Title
Change in cholesterol
Description
Change in cholesterol, as measured by objective clinic assessment, from baseline to 6 months.
Time Frame
Baseline, 6 months
Title
Change in hemoglobin A1c
Description
Change in hemoglobin A1c, as measured by objective clinic assessment, from baseline to 6 months.
Time Frame
Baseline, 6 months
Title
Change in triglycerides
Description
Change in triglycerides as measured by objective clinic assessment, from baseline to 6 months.
Time Frame
Baseline, 6 months
Title
Proportion of participants with completed assessments at 3 months
Description
Proportion of participants who complete all 3-month online and in-clinic assessments.
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmina G. Valle, PhD, MPH
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Deborah F. Tate, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Study Director
Facility Information:
Facility Name
University of North Carolina at Chapel Hill, UNC Lineberger Comprehensive Cancer Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27631874
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.
Results Reference
derived

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

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