Viewing Study NCT04321135



Ignite Creation Date: 2024-05-06 @ 2:27 PM
Last Modification Date: 2024-10-26 @ 1:31 PM
Study NCT ID: NCT04321135
Status: COMPLETED
Last Update Posted: 2022-12-16
First Post: 2020-02-26

Brief Title: Avanzando Juntas Adapting an Evidence Based Weight Loss Program for Hispanic Breast Cancer Survivors
Sponsor: Medical College of Wisconsin
Organization: Medical College of Wisconsin

Study Overview

Official Title: Avanzando Juntas Adapting an Evidence Based Weight Loss Program for Hispanic Breast Cancer Survivors
Status: COMPLETED
Status Verified Date: 2022-12
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: This study examine the feasibility and efficacy of Avanzando Juntas a four-month community-based lifestyle intervention rooted in the evidence-based Moving Forward lifestyle intervention developed with and for AA breast cancer survivors This intervention was adapted in collaboration with HispanicLatina BC GC survivors It will offer twice-weekly sessions aimed at supporting adherence to ACS nutrition and physical activity guidelines to promote weight loss and improved quality of life
Detailed Description: Aim 1 To adapt the Moving Forward weight loss intervention for overweightobese Hispanic BCS using an iterative process engaging Hispanic BCS and a community advisory committee

Aim 2 To conduct a randomized pilot with 40 overweightobese Hispanic BCS to establish the feasibility of the adapted Moving Forward program based on recruitment adherence retention and efficacy

Aim 3 To explore the effects of the adapted Moving Forward program Avanzando Juntas on anthropometric weight body fat lean mass behavioral dietary intake physical activity psychosocial quality of life and biological cholesterol hemoglobin A1c adiponectin leptin inflammation insulin resistance outcomes

Hypothesis Women in the weight loss program will exhibit improvements in outcomes compared to women in the wait list control group

Avanzando Juntas supports BC GC survivors in adopting physical activity and eating patterns to promote weight loss bolster QOL and reduce the risk for comorbidities and potentially BC GC recurrence A strong multidisciplinary study team provides expertise in culturally competent programs for Hispanic BCS cognitive behavioral lifestyle interventions body composition breast cancer and program adaptation

This study is novel in its focus on weight loss among Hispanic BCS and the incorporation of anthropometric behavioral biological and psychosocial outcomes An additional strength is the foundation of community partnerships that will support the current studys efforts as well as those for a larger trial and if successful the dissemination of the program

Study Oversight

Has Oversight DMC: None
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?: None