Addressing Modifiable Breast Cancer Risk Factors With Project CONECT

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-30

Study Completion Date

2019-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Weight Loss Breast Cancer Risk Factors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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CONECT

12 week program with additional follow up at 24 weeks.

Group Type EXPERIMENTAL

CONECT

Intervention Type BEHAVIORAL

1 monthly in person + 1 monthly telephone + 4 monthly email contact for behavior modification. Focus on motivation, self efficacy and information provision.

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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CONECT

1 monthly in person + 1 monthly telephone + 4 monthly email contact for behavior modification. Focus on motivation, self efficacy and information provision.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)

Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes