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| Name | Class |
|---|---|
| Loyola University Chicago | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Guided Lifestyle Program | Experimental | The Intervention will be conducted in a cohort of 20 (anticipated) and is designed to increase self-efficacy, social support and perceived access to healthy eating and exercise resources and promote weight loss. Participants assigned to the Guided Lifestyle Program will participate in twice weekly sessions - the first weekly session will be 120 minutes in length with the first hour addressing lifestyle change education and strategies. The second hour will be supervised exercise including aerobics and resistance training. The second weekly session will be a one-hour supervised exercise session. Participants will also receive 2-3 text messages weekly.They will also receive a participant informational binder with health and exercise information and tools as directed by ACS nutrition and physical activity guidelines.The Guided Lifestyle program is four months long (16 weeks). Please note, the Guided Lifestyle program participants will be offered a booster session off-study. |
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| Self-Guided Lifestyle Program | Active Comparator | 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. The study team will call these participants once a month to check in. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guided Lifestyle Program Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in intake of fruits and vegetables | ASA24 dietary analysis of self reported food consumption | Baseline to 4 month |
| Change of intake of red meat/processed meat | ASA24 dietary analysis of self reported food consumption | Baseline to 4 month |
| Change in levels of physical activity- minutes per week | Change of ActiGraph monitored activity | Baseline to 4 month |
| Change in levels of physical activity- #times per week | Change of ActiGraph monitored activity | Baseline to 4 month |
| Change in resistance training- Handgrip strength | Jamar Plus Digital Hand Dynamometer | Baseline to 4 month |
| Change in resistance training- Strength and endurance | 30-Second Chair Stand (Sit to Stand) | Baseline to 4 month |
| Change in Quality of Life- PROMIS (Patient Reported Outcomes Measurement Information System) |
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Inclusion Criteria:
Exclusion Criteria:
Female Breast and Gynecological study participants
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Participants will be randomized to either a guided or self-guided lifestyle intervention
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| Self-Guided Lifestyle Program (Control Arm) | Behavioral | 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 |
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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 |
| 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 |
| Change in Biomarkers- Lipids | Lipid blood tests measured by Wisconsin Diagnostic Laboratory | Baseline to 4 month |
| Change in Biomarkers- Glycohem | Glycohem blood tests measured by Wisconsin Diagnostic Laboratory | Baseline to 4 month |
| Change in Biomarkers- Glucose | Glucose blood tests measured by Wisconsin Diagnostic Laboratory | Baseline to 4 month |
| Change in Biomarkers- C-Peptide | C-Peptide blood tests measured by Wisconsin Diagnostic Laboratory | Baseline to 4 month |
| Change in Biomarkers- Insulin | Insulin blood tests measured by Wisconsin Diagnostic Laboratory | Baseline to 4 month |
| Change in Biomarkers- hs CRP | hs CRP blood tests measured by Wisconsin Diagnostic Laboratory | Baseline to 4 month |
| Change in Biomarkers-Adipokines- Adiponectin | Adiponectin blood tests | Baseline to 4 month |
| Change in Biomarkers-Adipokines- Leptin | Adiponectin blood tests | Baseline to 4 month |
| Change in waist circumference | Change in waist circumference measurement | Baseline to 4 month |
| D017437 |
| Skin and Connective Tissue Diseases |