Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| HM20008111 | Other Identifier | IRB |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CONECT | Experimental | 12 week program with additional follow up at 24 weeks. |
|
| Control | No Intervention | Waitlist control. No intervention for first 12 weeks. Participants given the option to participate in the program after 24 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CONECT | Behavioral | 1 monthly in person + 1 monthly telephone + 4 monthly email contact for behavior modification. Focus on motivation, self efficacy and information provision. |
|
| 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 |
| 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. |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Maria D Thomson, PhD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University/Massey Cancer Center | Richmond | Virginia | 23298 | United States |
Not provided
| ID | Term |
|---|---|
| D015431 | Weight Loss |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| 12 weeks |
| weight maintenance | for intervention group only, percent weight loss at 24 weeks | 24 weeks |
| D001519 | Behavior |