Addressing Modifiable Breast Cancer Risk Factors With Project CONECT

Study Overview
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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.

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

Conditions
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Weight Loss, Breast Cancer Risk Factors

Intervention / Treatment
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* Behavioral: CONECT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female 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)

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CONECT<br>12 week program with additional follow up at 24 weeks. | Behavioral: CONECT<br>* 1 monthly in person + 1 monthly telephone + 4 monthly email contact for behavior modification. Focus on motivation, self efficacy and information provision.<br>|
| No Intervention: Control<br>Waitlist control. No intervention for first 12 weeks. Participants given the option to participate in the program after 24 weeks. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| feasibility-participant engagement and retention | recruitment of 30 participants with 70% retention at 12 weeks | 12 weeks | 
| feasibility-intervention adherence | Completion of 80% of intention components including wearing Fitbit tracker, completed of the weekly weightings, answering emails, attending intervention sessions | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in autonomous motivation | Motivation assessment and feedback. | 12 weeks and 24 weeks | 
| Steps per day | participants will be asked to use the Fitbit Heart Rate (HR) Physical Activity Monitor to track daily steps and minutes of physical activity. | 12 and 24 weeks | 
| Total minutes of weekly physical activity | assessed by 7 day Physical Activity Recall Scale (PAR) | 12 and 24 weeks | 
| Daily caloric goals | assessed by Automated Self-Administered (ASA) 24 | 12 and 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical activity, Diet, Nutrition, Breast cancer prevention, Mammography screening