Breast Cancer Risk Factors, Weight Loss
Conditions
Keywords
Physical activity, Diet, Nutrition, Breast cancer prevention, Mammography screening
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.
Interventions
BEHAVIORALCONECT
1 monthly in person + 1 monthly telephone + 4 monthly email contact for behavior modification. Focus on motivation, self efficacy and information provision.
Sponsors
Virginia Commonwealth University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 65 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Change in autonomous motivation | 12 weeks and 24 weeks | Motivation assessment and feedback. |
| Total minutes of weekly physical activity | 12 and 24 weeks | assessed by 7 day Physical Activity Recall Scale (PAR) |
| Daily caloric goals | 12 and 24 weeks | assessed by Automated Self-Administered (ASA) 24 |
Other
| Measure | Time frame | Description |
|---|---|---|
| weight loss | 12 weeks | percent weight loss at 12 weeks |
| change in waist circumference | 12 and 24 weeks | waist circumference measured at 12 and 24 weeks. |
| weight maintenance | 24 weeks | for intervention group only, percent weight loss at 24 weeks |
Countries
United States
Outcome results
None listed