Addressing Modifiable Breast Cancer Risk Factors With Project CONECT [Connect Online to Engage Change Tool]

Virginia Commonwealth University1 site in 1 country14 target enrollmentMay 30, 2017

ConditionsWeight Loss Breast Cancer Risk Factors

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Weight Loss
Sponsor: Virginia Commonwealth University
Enrollment: 14
Locations: 1
Primary Endpoint: feasibility-participant engagement and retention
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this protocol is to adapt and pilot test an existing lifestyle modification intervention for weight loss for women with overweight or obesity who have had a recent false positive mammography screen. The purpose of this pilot trial is to establish feasibility of Connect Online to Engage Change Tool (CONECT) to promote weight loss through increased physical activity and diet change.

Registry

clinicaltrials.gov

Start Date

May 30, 2017

End Date

February 28, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Virginia Commonwealth University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•40-65 years of age,
•Received a negative mammography screening result in the previous four weeks
•Moderately sedentary lifestyle (less than 120 minutes/week moderate intensity activity),
•Answer "no" to all questions on the Physical Activity Readiness Questionnaire (PAR-Q).
•BMI 25-40 kg/m2
•Has access to a computer or mobile device with wireless internet
•Able to speak and read English (language requirements are necessary because we cannot accommodate additional languages in prototype development phase.)

Exclusion Criteria

•Previous history or current diagnosis of breast cancer
•Pregnancy or lactation
•Involvement in a weight loss program
•Major co-morbidities (e.g.,diabetes, hypertension, etc.)
•History of disordered eating
•Currently taking medication that may impact weight (e.g., synthroid, metformin)

Outcomes

Primary Outcomes

feasibility-participant engagement and retention

Time Frame: 12 weeks

recruitment of 30 participants with 70% retention at 12 weeks

feasibility-intervention adherence

Time Frame: 12 weeks

Completion of 80% of intention components including wearing Fitbit tracker, completed of the weekly weightings, answering emails, attending intervention sessions