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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by UNC Lineberger Comprehensive Cancer Center
Sponsor:
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT02030353
First received: December 17, 2013
Last updated: February 14, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Body Weight Changes
Breast Neoplasms
Behavioral: Self-regulation plus activity monitoring
Behavioral: Self-regulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Feasibility of Using Smart Scales for Weight Gain Prevention in African American Breast Cancer Survivors: a Randomized Pilot Study

Resource links provided by NLM:


Further study details as provided by UNC Lineberger Comprehensive Cancer Center:

Primary Outcome Measures:
  • Proportion of participants with completed assessments at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Proportion of participants who complete all 6-month online and in-clinic assessments.


Secondary Outcome Measures:
  • Weight change [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
    Change in weight, as measured objectively during in-clinic assessments, from baseline to 6 months.

  • Change in dietary intake [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
    Change in dietary intake, as measured by the online Automated Self-Administered 24-hour recall, from baseline to 6 months.

  • Change in physical activity [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
    Change in physical activity, as measured by the Paffenbarger Exercise Habits Questionnaire, from baseline to 6 months.

  • Change in waist circumference [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
    Change in waist circumference, as measured by objective clinic assessment, from baseline to 6 months.

  • Change in blood pressure [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
    Change in blood pressure, as measured by objective clinic assessment, from baseline to 6 months.

  • Change in cholesterol [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
    Change in cholesterol, as measured by objective clinic assessment, from baseline to 6 months.

  • Change in hemoglobin A1c [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
    Change in hemoglobin A1c, as measured by objective clinic assessment, from baseline to 6 months.

  • Change in triglycerides [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
    Change in triglycerides as measured by objective clinic assessment, from baseline to 6 months.

  • Proportion of participants with completed assessments at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Proportion of participants who complete all 3-month online and in-clinic assessments.


Estimated Enrollment: 45
Study Start Date: January 2014
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Self-regulation plus activity monitoring
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.
Behavioral: Self-regulation plus activity monitoring
Individual in-person session, digital smart scale, online intervention, and an activity monitor.
Experimental: Self-regulation
Participants will receive an individual in-person session, digital smart scale, access to a website to view tracking information, weekly lessons, and tailored feedback.
Behavioral: Self-regulation
Individual in-person session, digital smart scale, and online intervention.
No Intervention: Delayed intervention control
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 3 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02030353

Locations
United States, North Carolina
University of North Carolina at Chapel Hill, UNC Lineberger Comprehensive Cancer Center Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Carmina G. Valle, PhD, MPH    919-843-4211    carmina.valle@unc.edu   
Principal Investigator: Carmina G. Valle, PhD, MPH         
Sub-Investigator: Deborah F. Tate, PhD         
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Investigators
Principal Investigator: Carmina G. Valle, PhD, MPH University of North Carolina, Chapel Hill
Study Director: Deborah F. Tate, PhD University of North Carolina, Chapel Hill
  More Information

No publications provided

Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02030353     History of Changes
Other Study ID Numbers: LCCC1323
Study First Received: December 17, 2013
Last Updated: February 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by UNC Lineberger Comprehensive Cancer Center:
Lifestyle intervention
Internet intervention
Breast neoplasms
Body weight
Body weight changes

Additional relevant MeSH terms:
Neoplasms
Body Weight
Breast Neoplasms
Weight Gain
Body Weight Changes
Signs and Symptoms
Neoplasms by Site
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 30, 2014