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Body Weight ChangesNCT02030353

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

A study testing Self-regulation plus activity monitoring and Self-regulation in people with Body Weight Changes and Breast Neoplasms, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Body Weight Changes, Breast Neoplasms
What is being tested?
Self-regulation plus activity monitoring and Self-regulation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteUnited States
Study dates
Jan 2014to Jun 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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)
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

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

    Chapel Hill, North Carolina, 27599

Other trials in United States

About this study

Official title: Feasibility of Using Smart Scales for Weight Gain Prevention in African American Breast Cancer Survivors: a Randomized Pilot Study

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.

Read the 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).

Being tested
Self-regulation plus activity monitoring, Self-regulation
Keywords
Lifestyle intervention, Internet intervention, Breast neoplasms, Body weight, Body weight changes
Medical subject headings
Body Weight Changes, Breast Neoplasms, Body Weight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Self-regulation plus activity monitoringBehavioural

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

  • Self-regulationBehavioural

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

Study groups in NCT02030353
Study groupRoleWhat they receive
Self-regulation plus activity monitoringExperimentalParticipants 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.
Receives: Behavioral: Self-regulation plus activity monitoring
Self-regulationExperimentalParticipants will receive an individual in-person session, digital smart scale, access to a website to view tracking information, weekly lessons, and tailored feedback.
Receives: Behavioral: Self-regulation
Delayed intervention controlNo interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of participants with completed assessments at 6 months

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

    Measured: 6 months

Secondary outcomes (9)

  1. Weight change

    Change in weight, as measured objectively during in-clinic assessments, from baseline to 6 months.

    Measured: Baseline, 6 months

  2. Change in dietary intake

    Change in dietary intake, as measured by the online Automated Self-Administered 24-hour recall, from baseline to 6 months.

    Measured: Baseline, 6 months

  3. Change in physical activity

    Change in physical activity, as measured by the Paffenbarger Exercise Habits Questionnaire, from baseline to 6 months.

    Measured: Baseline, 6 months

  4. Change in waist circumference

    Change in waist circumference, as measured by objective clinic assessment, from baseline to 6 months.

    Measured: Baseline, 6 months

  5. Change in blood pressure

    Change in blood pressure, as measured by objective clinic assessment, from baseline to 6 months.

    Measured: Baseline, 6 months

  6. Change in cholesterol

    Change in cholesterol, as measured by objective clinic assessment, from baseline to 6 months.

    Measured: Baseline, 6 months

  7. Change in hemoglobin A1c

    Change in hemoglobin A1c, as measured by objective clinic assessment, from baseline to 6 months.

    Measured: Baseline, 6 months

  8. Change in triglycerides

    Change in triglycerides as measured by objective clinic assessment, from baseline to 6 months.

    Measured: Baseline, 6 months

  9. Proportion of participants with completed assessments at 3 months

    Proportion of participants who complete all 3-month online and in-clinic assessments.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2014 (estimated)
  2. Study startJan 2014
  3. Primary completionJun 2015
  4. Study completionJun 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02030353
Sponsor's protocol ID
LCCC1323
Status last verified
Jan 2016
First submitted
17 Dec 2013
Last updated
20 Jan 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 27631874

Questions about this trial

What is this clinical trial studying?

A study testing Self-regulation plus activity monitoring and Self-regulation in people with Body Weight Changes and Breast Neoplasms, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants with completed assessments at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02030353, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2016.

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