Addressing Modifiable Breast Cancer Risk Factors With Project CONECT

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

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.

Study Overview

• Status: Completed
• Conditions: Weight Loss; Breast Cancer Risk Factors
• Intervention / Treatment: Behavioral: CONECT

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University/Massey Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CONECT; 12 week program with additional follow up at 24 weeks.	Behavioral: CONECT; 1 monthly in person + 1 monthly telephone + 4 monthly email contact for behavior modification. Focus on motivation, self efficacy and information provision.
No Intervention: Control; 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?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in waist circumference	waist circumference measured at 12 and 24 weeks.	12 and 24 weeks
weight loss	percent weight loss at 12 weeks	12 weeks
weight maintenance	for intervention group only, percent weight loss at 24 weeks	24 weeks

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Investigators: Principal Investigator: Maria D Thomson, PhD, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2017
• Primary Completion (Actual): February 28, 2019
• Study Completion (Actual): February 28, 2019

Study Registration Dates

• First Submitted: August 15, 2016
• First Submitted That Met QC Criteria: August 15, 2016
• First Posted (Estimate): August 18, 2016

Study Record Updates

• Last Update Posted (Actual): July 9, 2019
• Last Update Submitted That Met QC Criteria: July 8, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Nutrition; Physical activity; Diet; Mammography screening; Breast cancer prevention
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Body Weight; Body Weight Changes; Breast Neoplasms; Weight Loss
• Other Study ID Numbers: MCC-16-12892; HM20008111 (Other Identifier: IRB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No