Clinical trial · Interventional
Addressing Modifiable Breast Cancer Risk Factors With Project CONECT
Addressing Modifiable Breast Cancer Risk Factors With Project CONECT [Connect Online to Engage Change Tool]
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Risk Factors | — | UNRESOLVED | — |
| Weight Loss | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CONECT | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- CONECT
- description
- 12 week program with additional follow up at 24 weeks.
- interventionNames
- Behavioral: CONECT
- type
- NO_INTERVENTION
- label
- Control
- description
- Waitlist control. No intervention for first 12 weeks. Participants given the option to participate in the program after 24 weeks.
Primary outcomes (2)
- measure
- feasibility-participant engagement and retention
- timeFrame
- 12 weeks
- description
- recruitment of 30 participants with 70% retention at 12 weeks
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available