Recruiting

TOPS

Sponsor:

Duke University

Code:

NCT06658912

Conditions

Breast Cancer

Weight Loss

Eligibility Criteria

Sex: Female

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

TOPS Classes

Study Details

Brief summary:

The purpose of this study is to help make a community led weight loss program known as Take Off Pounds Sensibly (TOPS) more relevant for breast cancer survivors.

This study is made up to two parts. The first part includes using focus groups to review current materials that the investigators plan to use in upcoming TOPS classes and provide feedback. Focus groups will be made up of women who are breast cancer survivors.

The second part includes taking the feedback received from these focus groups and use this feedback to tailor TOPS classes for breast cancer survivors.

This ClinicalTrials.gov record is specific to the second part of the study.

Conditions

Breast Cancer

Weight Loss

Study ID

NCT06658912

Start date

Aug 3, 2026

Status verified date

Apr, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 21 - 70+

Healthy Volunteers: Not accepted

Aim 2 Inclusion Criteria:

  • women diagnosed with breast cancer with BMI ≥ 25 kg/m2 after completion of primary therapy (surgery, radiation, adjuvant or neo-adjuvant chemotherapy).

Aim 2 Exclusion Criteria:

  • Those whose oncology providers do not agree with their participation in a weight loss program
  • History of Type II Diabetes Mellitus
  • those participating in another weight loss program
  • those taking a weight loss medication
  • those without smart phones or internet connections or the ability to attend meetings via Zoom

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

other: TOPS Classes

Interventions

TOPS Classes

Attend Dietician-Led Sessions

Primary outcome measure

  • Number of invitations sent through the electronic health record to get 25 individuals consented to the study [ Time Frame: 1-2 months ]
  • Percentage of TOPS group session attendance [ Time Frame: 12 months ]
  • Number of participants who stay in the study [ Time Frame: 3 months, 6 months, 9 months, 12 months ]
  • Number of participants who transition from the initiation phase to the maintenance phase [ Time Frame: 12 months ]
  • Number of participants who continue to transmit weight and BP data once they transition to the maintenance phase [ Time Frame: 9 months, 12 months ]
  • Percent of Weight Loss [ Time Frame: Up to 12 Months ]

Central Contacts and Locations

Central contacts

Nia S Mitchell, MD

833-637-8839nia.s.mitchell@duke.edu

Locations

Duke University

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Nia S Mitchell, MD

833-637-8839nia.s.mitchell@duke.edu

More Information

Sponsor

Duke University

Last update posted

Aug 5, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-08-05.