Avanzando Juntas: Adapting an Evidence Based Weight Loss Program for Hispanic Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in Biomarkers- hs CRP
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Self-identify as Hispanic or Latina
- •Stage 0 -III Breast and Gynecological cancer survivors
- •Treatment (surgery, chemotherapy and/or radiation) completed at least three months before recruitment (ongoing hormonal therapy is acceptable)
- •Age >18 at time of diagnosis
- •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
排除标准
- •Plans to move from the community during the study
- •A medical condition limiting adherence to diet or physical activity components
- •History of significant mental illness
- •Currently pregnant, less than 3 months post-partum, or pregnancy anticipated during the study
- •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
结局指标
主要结局
Change in Biomarkers- hs CRP
时间窗: Baseline to 4 month
hs CRP blood tests measured by Wisconsin Diagnostic Laboratory
Change in Biomarkers- Glucose
时间窗: Baseline to 4 month
Glucose blood tests measured by Wisconsin Diagnostic Laboratory
Change of intake of red meat/processed meat
时间窗: Baseline to 4 month
ASA24 dietary analysis of self reported food consumption
Change in Biomarkers- C-Peptide
时间窗: Baseline to 4 month
C-Peptide blood tests measured by Wisconsin Diagnostic Laboratory
Change in Biomarkers-Adipokines- Adiponectin
时间窗: Baseline to 4 month
Adiponectin blood tests
Change in waist circumference
时间窗: Baseline to 4 month
Change in waist circumference measurement
Change in levels of physical activity- minutes per week
时间窗: Baseline to 4 month
Change of ActiGraph monitored activity
Change in resistance training- Strength and endurance
时间窗: Baseline to 4 month
30-Second Chair Stand (Sit to Stand)
Change in body composition
时间窗: Baseline to 4 month
Ratio of percent lean mass to percent adiposity as measured by Bio-electrical Impedance Analysis Scale. More lean mass and less adiposity is favorable
Change in resistance training- Handgrip strength
时间窗: Baseline to 4 month
Jamar Plus Digital Hand Dynamometer
Changes in Systolic and Diastolic Blood Pressure
时间窗: Baseline to 4 month
Participants systolic and diastolic blood pressure will be measured using a digital, automated unit
Change in Biomarkers- Lipids
时间窗: Baseline to 4 month
Lipid blood tests measured by Wisconsin Diagnostic Laboratory
Change in Biomarkers- Insulin
时间窗: Baseline to 4 month
Insulin blood tests measured by Wisconsin Diagnostic Laboratory
Change in intake of fruits and vegetables
时间窗: Baseline to 4 month
ASA24 dietary analysis of self reported food consumption
Change in levels of physical activity- #times per week
时间窗: Baseline to 4 month
Change of ActiGraph monitored activity
Change in Quality of Life- PROMIS (Patient Reported Outcomes Measurement Information System)
时间窗: Baseline to 4 month
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.
Change in Biomarkers- Glycohem
时间窗: Baseline to 4 month
Glycohem blood tests measured by Wisconsin Diagnostic Laboratory
Change in Biomarkers-Adipokines- Leptin
时间窗: Baseline to 4 month
Adiponectin blood tests
次要结局
未报告次要终点
研究者
Melinda Stolley
Associate Director for Cancer Prevention and Control
Medical College of Wisconsin