Addressing Modifiable Breast Cancer Risk Factors With Project CONECT

Not Applicable

Completed

• Conditions: Weight Loss; Breast Cancer Risk Factors
• Interventions: Behavioral: CONECT

• Registration Number: NCT02871388
• Lead Sponsor: Virginia Commonwealth University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-08-15
• Study First Submitted QC: 2016-08-15
• Study First Posted: 2016-08-18
• Study Start: 2017-05-30
• Primary Completion: 2019-02-28
• Study Completion: 2019-02-28
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-08
• Last Update Posted: 2019-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 14

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.)

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CONECT	CONECT	12 week program with additional follow up at 24 weeks.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Virginia Commonwealth University/Massey Cancer Center; 🇺🇸 Richmond, Virginia, United States