Addressing Modifiable Breast Cancer Risk Factors With Project CONECT

Weight Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02871388
• Other study ID #: MCC-16-12892
• Secondary ID: HM20008111
• Status: Completed
• Phase: N/A
• Start date: May 30, 2017
• Est. completion date: February 28, 2019

Study information

• Verified date: July 2019
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: February 28, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer Risk Factors
• Breast Neoplasms
• Weight Loss

Intervention

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

Locations

Country	Name	City	State
United States	Virginia Commonwealth University/Massey Cancer Center	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	change in waist circumference	waist circumference measured at 12 and 24 weeks.	12 and 24 weeks
Other	weight loss	percent weight loss at 12 weeks	12 weeks
Other	weight maintenance	for intervention group only, percent weight loss at 24 weeks	24 weeks
Primary	feasibility-participant engagement and retention	recruitment of 30 participants with 70% retention at 12 weeks	12 weeks
Primary	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	Change in autonomous motivation	Motivation assessment and feedback.	12 weeks and 24 weeks
Secondary	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
Secondary	Total minutes of weekly physical activity	assessed by 7 day Physical Activity Recall Scale (PAR)	12 and 24 weeks
Secondary	Daily caloric goals	assessed by Automated Self-Administered (ASA) 24	12 and 24 weeks