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

NCT02030353 | Completed DMC

• 1 other identifier: LCCC1323
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Body Weight Changes; Breast Neoplasms

Keywords

Lifestyle intervention; Internet intervention; Breast neoplasms; Body weight; Body weight changes

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with completed assessments at 6 months

  Proportion of participants who complete all 6-month online and in-clinic assessments.

  6 months

Secondary Outcomes (9)

• Weight change

  Baseline, 6 months

• Change in dietary intake

  Baseline, 6 months

• Change in physical activity

  Baseline, 6 months

• Change in waist circumference

  Baseline, 6 months

• Change in blood pressure

  Baseline, 6 months

Study Arms (3)

Self-regulation plus activity monitoring

EXPERIMENTAL

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

Self-regulation

EXPERIMENTAL

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

Delayed intervention control

NO INTERVENTION

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.

Interventions

Self-regulation plus activity monitoring BEHAVIORAL

Individual in-person session, digital smart scale, online intervention, and an activity monitor.

Self-regulation plus activity monitoring

Self-regulation BEHAVIORAL

Individual in-person session, digital smart scale, and online intervention.

Self-regulation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

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

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

• 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.

  PMID: 27631874 DERIVED

MeSH Terms

Conditions

Body Weight Changes; Breast Neoplasms; Body Weight

Interventions

Professional Autonomy

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Professional Practice; Organization and Administration; Health Services Administration

Study Officials

• Carmina G. Valle, PhD, MPH

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Deborah F. Tate, PhD

  University of North Carolina, Chapel Hill

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2013
• First Posted: January 8, 2014
• Study Start: January 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: January 20, 2016

Record last verified: 2016-01

Locations

US (1)