Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2025-12-27 @ 6:28 AM
Study NCT ID:
NCT02690766
Status:
COMPLETED
Last Update Posted:
2023-05-16
First Post:
2016-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Translating Healthy Lifestyle Interventions for Cancer Survivors
Sponsor:
University of North Carolina, Chapel Hill
Organization:
Study Overview
Official Title:
Translating Healthy Lifestyle Interventions for Breast and Endometrial Cancer Survivors With Diabetes
Status:
COMPLETED
Status Verified Date:
2019-07
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:
Investigators proposed to refine and test the feasibility and acceptability of a 4-month multi-modal lifestyle intervention in African American female breast or endometrial cancer survivors diagnosed with type 2 diabetes.
Detailed Description:
Recent systematic reviews and meta-analyses of cohort studies show that physical activity can reduce mortality and morbidity in diabetes and obesity-related cancers. Yet, there have been few efforts to promote physical activity within the context of female cancer survivorship, particularly among women with diabetes. In response, investigators proposed to refine and test the feasibility and acceptability of a 4-month multi-modal lifestyle intervention in African Americans (AA) with diabetes and who are breast or endometrial cancer survivors. This web-based, lifestyle intervention, coupled with coaching calls and in-person exercise sessions, may be an effective way to promote physical activity and healthy survivorship. The primary goal is for participants to participate in 30 minutes of moderate-to-vigorous physical activity five times a week. The investigators' aims : i) refine a theory-driven healthy lifestyle intervention, that is delivered via computer technologies and periodic in-person group exercise sessions with appropriate content, literacy demand and graphics, ii) assess the preliminary effects of the intervention on the primary outcome of level of moderate to vigorous physical activity (MVPA), as measured by accelerometry; weight, glycosylated hemaglobin and evaluate the effect of eating behaviors, wellbeing/functioning (quality of life, depressive symptoms, self-efficacy), compliance/adherence to protocol and acceptability on response to the intervention.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|---|
| P30DK093002 | NIH | None | https://reporter.nih.gov/quic… | View |