- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04321135
Avanzando Juntas: Adapting an Evidence Based Weight Loss Program for Hispanic Breast Cancer Survivors
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- Medical College of Wisconsin
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Self-identify as Hispanic or Latina
- Female
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Guided Lifestyle Program
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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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.
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ACTIVE_COMPARATOR: Self-Guided Lifestyle Program
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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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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in body composition
Time Frame: Baseline to 4 month
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Ratio of percent lean mass to percent adiposity as measured by Bio-electrical Impedance Analysis Scale.
More lean mass and less adiposity is favorable
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Baseline to 4 month
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Change in intake of fruits and vegetables
Time Frame: Baseline to 4 month
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ASA24 dietary analysis of self reported food consumption
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Baseline to 4 month
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Change of intake of red meat/processed meat
Time Frame: Baseline to 4 month
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ASA24 dietary analysis of self reported food consumption
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Baseline to 4 month
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Change in levels of physical activity- minutes per week
Time Frame: Baseline to 4 month
|
Change of ActiGraph monitored activity
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Baseline to 4 month
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Change in levels of physical activity- #times per week
Time Frame: Baseline to 4 month
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Change of ActiGraph monitored activity
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Baseline to 4 month
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Change in resistance training- Handgrip strength
Time Frame: Baseline to 4 month
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Jamar Plus Digital Hand Dynamometer
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Baseline to 4 month
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Change in resistance training- Strength and endurance
Time Frame: Baseline to 4 month
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30-Second Chair Stand (Sit to Stand)
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Baseline to 4 month
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Change in Quality of Life- PROMIS (Patient Reported Outcomes Measurement Information System)
Time Frame: Baseline to 4 month
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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.
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Baseline to 4 month
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Changes in Systolic and Diastolic Blood Pressure
Time Frame: Baseline to 4 month
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Participants systolic and diastolic blood pressure will be measured using a digital, automated unit
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Baseline to 4 month
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Change in Biomarkers- Lipids
Time Frame: Baseline to 4 month
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Lipid blood tests measured by Wisconsin Diagnostic Laboratory
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Baseline to 4 month
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Change in Biomarkers- Glycohem
Time Frame: Baseline to 4 month
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Glycohem blood tests measured by Wisconsin Diagnostic Laboratory
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Baseline to 4 month
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Change in Biomarkers- Glucose
Time Frame: Baseline to 4 month
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Glucose blood tests measured by Wisconsin Diagnostic Laboratory
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Baseline to 4 month
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Change in Biomarkers- C-Peptide
Time Frame: Baseline to 4 month
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C-Peptide blood tests measured by Wisconsin Diagnostic Laboratory
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Baseline to 4 month
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Change in Biomarkers- Insulin
Time Frame: Baseline to 4 month
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Insulin blood tests measured by Wisconsin Diagnostic Laboratory
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Baseline to 4 month
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Change in Biomarkers- hs CRP
Time Frame: Baseline to 4 month
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hs CRP blood tests measured by Wisconsin Diagnostic Laboratory
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Baseline to 4 month
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Change in Biomarkers-Adipokines- Adiponectin
Time Frame: Baseline to 4 month
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Adiponectin blood tests
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Baseline to 4 month
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Change in Biomarkers-Adipokines- Leptin
Time Frame: Baseline to 4 month
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Adiponectin blood tests
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Baseline to 4 month
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Change in waist circumference
Time Frame: Baseline to 4 month
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Change in waist circumference measurement
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Baseline to 4 month
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRO00030295
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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