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Addressing Modifiable Breast Cancer Risk Factors With Project CONECT

Primary Purpose

Weight Loss, Breast Cancer Risk Factors

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CONECT
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Weight Loss focused on measuring Physical activity, Diet, Nutrition, Breast cancer prevention, Mammography screening

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)FemaleAccepts 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)

Sites / Locations

  • Virginia Commonwealth University/Massey Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CONECT

Control

Arm Description

12 week program with additional follow up at 24 weeks.

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

Outcomes

Primary Outcome Measures

feasibility-participant engagement and retention
recruitment of 30 participants with 70% retention at 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

Secondary Outcome Measures

Change in autonomous motivation
Motivation assessment and feedback.
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.
Total minutes of weekly physical activity
assessed by 7 day Physical Activity Recall Scale (PAR)
Daily caloric goals
assessed by Automated Self-Administered (ASA) 24

Full Information

First Posted
August 15, 2016
Last Updated
July 8, 2019
Sponsor
Virginia Commonwealth University
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1. Study Identification

Unique Protocol Identification Number
NCT02871388
Brief Title
Addressing Modifiable Breast Cancer Risk Factors With Project CONECT
Official Title
Addressing Modifiable Breast Cancer Risk Factors With Project CONECT [Connect Online to Engage Change Tool]
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
May 30, 2017 (Actual)
Primary Completion Date
February 28, 2019 (Actual)
Study Completion Date
February 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss, Breast Cancer Risk Factors
Keywords
Physical activity, Diet, Nutrition, Breast cancer prevention, Mammography screening

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CONECT
Arm Type
Experimental
Arm Description
12 week program with additional follow up at 24 weeks.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Waitlist control. No intervention for first 12 weeks. Participants given the option to participate in the program after 24 weeks.
Intervention Type
Behavioral
Intervention Name(s)
CONECT
Intervention Description
1 monthly in person + 1 monthly telephone + 4 monthly email contact for behavior modification. Focus on motivation, self efficacy and information provision.
Primary Outcome Measure Information:
Title
feasibility-participant engagement and retention
Description
recruitment of 30 participants with 70% retention at 12 weeks
Time Frame
12 weeks
Title
feasibility-intervention adherence
Description
Completion of 80% of intention components including wearing Fitbit tracker, completed of the weekly weightings, answering emails, attending intervention sessions
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in autonomous motivation
Description
Motivation assessment and feedback.
Time Frame
12 weeks and 24 weeks
Title
Steps per day
Description
participants will be asked to use the Fitbit Heart Rate (HR) Physical Activity Monitor to track daily steps and minutes of physical activity.
Time Frame
12 and 24 weeks
Title
Total minutes of weekly physical activity
Description
assessed by 7 day Physical Activity Recall Scale (PAR)
Time Frame
12 and 24 weeks
Title
Daily caloric goals
Description
assessed by Automated Self-Administered (ASA) 24
Time Frame
12 and 24 weeks
Other Pre-specified Outcome Measures:
Title
change in waist circumference
Description
waist circumference measured at 12 and 24 weeks.
Time Frame
12 and 24 weeks
Title
weight loss
Description
percent weight loss at 12 weeks
Time Frame
12 weeks
Title
weight maintenance
Description
for intervention group only, percent weight loss at 24 weeks
Time Frame
24 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria D Thomson, PhD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University/Massey Cancer Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

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Addressing Modifiable Breast Cancer Risk Factors With Project CONECT

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