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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
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.
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
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
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
Time frame: Baseline to 4 month
Change in intake of fruits and vegetables
ASA24 dietary analysis of self reported food consumption
Time frame: Baseline to 4 month
Change of intake of red meat/processed meat
ASA24 dietary analysis of self reported food consumption
Time frame: Baseline to 4 month
Change in levels of physical activity- minutes per week
Change of ActiGraph monitored activity
Time frame: Baseline to 4 month
Change in levels of physical activity- #times per week
Change of ActiGraph monitored activity
Time frame: Baseline to 4 month
Change in resistance training- Handgrip strength
Jamar Plus Digital Hand Dynamometer
Time frame: Baseline to 4 month
Change in resistance training- Strength and endurance
30-Second Chair Stand (Sit to Stand)
Time frame: Baseline to 4 month
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.
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NONE
Enrollment
40
Time frame: Baseline to 4 month
Changes in Systolic and Diastolic Blood Pressure
Participants systolic and diastolic blood pressure will be measured using a digital, automated unit
Time frame: Baseline to 4 month
Change in Biomarkers- Lipids
Lipid blood tests measured by Wisconsin Diagnostic Laboratory
Time frame: Baseline to 4 month
Change in Biomarkers- Glycohem
Glycohem blood tests measured by Wisconsin Diagnostic Laboratory
Time frame: Baseline to 4 month
Change in Biomarkers- Glucose
Glucose blood tests measured by Wisconsin Diagnostic Laboratory
Time frame: Baseline to 4 month
Change in Biomarkers- C-Peptide
C-Peptide blood tests measured by Wisconsin Diagnostic Laboratory
Time frame: Baseline to 4 month
Change in Biomarkers- Insulin
Insulin blood tests measured by Wisconsin Diagnostic Laboratory
Time frame: Baseline to 4 month
Change in Biomarkers- hs CRP
hs CRP blood tests measured by Wisconsin Diagnostic Laboratory
Time frame: Baseline to 4 month
Change in Biomarkers-Adipokines- Adiponectin
Adiponectin blood tests
Time frame: Baseline to 4 month
Change in Biomarkers-Adipokines- Leptin
Adiponectin blood tests
Time frame: Baseline to 4 month
Change in waist circumference
Change in waist circumference measurement
Time frame: Baseline to 4 month