Avanzando Juntas: Adapting an Evidence Based Weight Loss Program for Hispanic Breast Cancer Survivors

Breast Cancer Clinical Trial

Official title:

Avanzando Juntas: Adapting an Evidence Based Weight Loss Program for Hispanic Breast Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04321135
• Other study ID #: PRO00030295
• Status: Completed
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: July 30, 2022

Study information

• Verified date: December 2022
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 Hispanic/Latina 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.

Description:

Aim 1. To adapt the Moving Forward weight loss intervention for overweight/obese Hispanic BCS using an iterative process engaging Hispanic BCS and a community advisory committee.

Aim 2. To conduct a randomized pilot with 40 overweight/obese 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 study's efforts, as well as those for a larger trial, and, if successful, the dissemination of the program.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 30, 2022
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Self-identify as Hispanic or Latina

2. Female

3. Stage 0 -III Breast and Gynecological cancer survivors

4. Treatment (surgery, chemotherapy and/or radiation) completed at least three months before recruitment (ongoing hormonal therapy is acceptable)

5. Age >18 at time of diagnosis

6. BMI at least 25 kg/m2 BMI between 25 and 55 - chosen because this will include only those participants who are overweight and would not be harmed by a 5% weight loss

Exclusion Criteria:

1. Plans to move from the community during the study

2. A medical condition limiting adherence to diet or physical activity components

3. History of significant mental illness

4. Currently pregnant, less than 3 months post-partum, or pregnancy anticipated during the study

5. Taking any medications prescribed by a doctor to lose weight participate in any organized weight loss programs or has undergone weight loss surgery or planning to undergo weight loss surgery in the next year

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Gynecologic Cancer
• Weight Loss

Intervention

Behavioral:
• Guided Lifestyle Program Intervention
The Guided Lifestyle Program will receive sessions that meet twice weekly and 2-3 text messages weekly.They will also receive a participant informational binder (wellness guide) with health and exercise information and tools as directed by ACS nutrition and physical activity guidelines.
• Self-Guided Lifestyle Program (Control Arm)
In the self-guided weight loss program, participants will be given the sane informational binder with health and exercise information and tools as directed by ACS nutrition and physical activity guidelines but they will not receive in-person classes or text messaging

Locations

Country	Name	City	State
United States	Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Medical College of Wisconsin	Loyola University Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body composition	Ratio of percent lean mass to percent adiposity as measured by Bio-electrical Impedance Analysis Scale. More lean mass and less adiposity is favorable	Baseline to 4 month
Primary	Change in intake of fruits and vegetables	ASA24 dietary analysis of self reported food consumption	Baseline to 4 month
Primary	Change of intake of red meat/processed meat	ASA24 dietary analysis of self reported food consumption	Baseline to 4 month
Primary	Change in levels of physical activity- minutes per week	Change of ActiGraph monitored activity	Baseline to 4 month
Primary	Change in levels of physical activity- #times per week	Change of ActiGraph monitored activity	Baseline to 4 month
Primary	Change in resistance training- Handgrip strength	Jamar Plus Digital Hand Dynamometer	Baseline to 4 month
Primary	Change in resistance training- Strength and endurance	30-Second Chair Stand (Sit to Stand)	Baseline to 4 month
Primary	Change in Quality of Life- PROMIS (Patient Reported Outcomes Measurement Information System)	Patient Reported Outcomes Measurement Information System (PROMIS) T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. PROMIS measures physical function, depression, anxiety, fatigue, sleep disturbance, social roles, pain interference, social isolation, cognitive function, support, self-efficacy and sexual function. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation (SD) of 10. A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like pain interference, a T-score of 60 is one SD worse than average. By comparison, a pain interference T-score of 40 is one SD better than average.	Baseline to 4 month
Primary	Changes in Systolic and Diastolic Blood Pressure	Participants systolic and diastolic blood pressure will be measured using a digital, automated unit	Baseline to 4 month
Primary	Change in Biomarkers- Lipids	Lipid blood tests measured by Wisconsin Diagnostic Laboratory	Baseline to 4 month
Primary	Change in Biomarkers- Glycohem	Glycohem blood tests measured by Wisconsin Diagnostic Laboratory	Baseline to 4 month
Primary	Change in Biomarkers- Glucose	Glucose blood tests measured by Wisconsin Diagnostic Laboratory	Baseline to 4 month
Primary	Change in Biomarkers- C-Peptide	C-Peptide blood tests measured by Wisconsin Diagnostic Laboratory	Baseline to 4 month
Primary	Change in Biomarkers- Insulin	Insulin blood tests measured by Wisconsin Diagnostic Laboratory	Baseline to 4 month
Primary	Change in Biomarkers- hs CRP	hs CRP blood tests measured by Wisconsin Diagnostic Laboratory	Baseline to 4 month
Primary	Change in Biomarkers-Adipokines- Adiponectin	Adiponectin blood tests	Baseline to 4 month
Primary	Change in Biomarkers-Adipokines- Leptin	Adiponectin blood tests	Baseline to 4 month
Primary	Change in waist circumference	Change in waist circumference measurement	Baseline to 4 month