Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-25 @ 9:22 PM
Study NCT ID:
NCT06184256
Status:
RECRUITING
Last Update Posted:
2025-02-24
First Post:
2023-12-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
BfedBwell Optimization Pilot
Sponsor:
University of Colorado, Denver
Organization:
Study Overview
Official Title:
BfedBwell: Multiphase Optimization Strategy Pilot Trial of a Nutrition Intervention for Cancer Survivors With Overweight and Obesity
Status:
RECRUITING
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Using the Multiphase Optimization Strategy (MOST) framework, an engineering-based approach to efficiently and systematically develop, optimize, and evaluate behavioral interventions, this study will test three components: (1) 1:1 counseling with a registered dietitian, (2) behavioral skills development, and (3) group support for delivery alongside a core nutrition curriculum within a clinical exercise oncology program.
Detailed Description:
Individuals with experience in delivery of lifestyle (e.g., diet, physical activity) interventions will be recruited to deliver and evaluate the integrated BfedBwell intervention.
Cancer survivors with overweight/obesity who have completed active treatment will be recruited from the University of Colorado Anschutz Medical Campus for participation in a 6-month cluster-randomized 2\^3-factorial pilot optimization trial of the BfedBwell intervention. Feasibility and acceptability will be evaluated. Exploration of intervention effect on adherence to cancer survivorship guidelines, body composition, and cardiometabolic indicators of health will be used to determine a set of components that demonstrate patterns of efficacy.
Cancer survivors with overweight/obesity who have completed active treatment will be recruited from the University of Colorado Anschutz Medical Campus for participation in a 6-month cluster-randomized 2\^3-factorial pilot optimization trial of the BfedBwell intervention. Feasibility and acceptability will be evaluated. Exploration of intervention effect on adherence to cancer survivorship guidelines, body composition, and cardiometabolic indicators of health will be used to determine a set of components that demonstrate patterns of efficacy.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1K99CA287061-01 | NIH | None | https://reporter.nih.gov/quic… | View |