Addressing Modifiable Breast Cancer Risk Factors With Project CONECT

Virginia Commonwealth University (VCU)

Status: Completed

Conditions: Weight Loss; Breast Cancer Risk Factors

Treatments: Behavioral: CONECT

Study type: Interventional

Funder types: Other

Identifiers

NCT02871388

MCC-16-12892

HM20008111 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: Female

Ages: 40 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Female
2. 40-65 years of age,
3. Received a negative mammography screening result in the previous four weeks
4. Moderately sedentary lifestyle (less than 120 minutes/week moderate intensity activity),
5. Answer "no" to all questions on the Physical Activity Readiness Questionnaire (PAR-Q).
6. BMI 25-40 kg/m2
7. Has access to a computer or mobile device with wireless internet
8. Able to speak and read English (language requirements are necessary because we cannot accommodate additional languages in prototype development phase.)

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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14 participants in 2 patient groups

CONECT

Experimental group

Description:

12 week program with additional follow up at 24 weeks.

Treatment:

Behavioral: CONECT

Control

No Intervention group

Description:

Waitlist control. No intervention for first 12 weeks. Participants given the option to participate in the program after 24 weeks.