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Completed

NCT Number: NCT04321135

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Gynecologic Cancer Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Primary outcomes

  1. Change in body composition

    Time frame: 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

  2. Change in intake of fruits and vegetables

    Time frame: Baseline to 4 month

    ASA24 dietary analysis of self reported food consumption

  3. Change of intake of red meat/processed meat

    Time frame: Baseline to 4 month

    ASA24 dietary analysis of self reported food consumption

  4. Change in levels of physical activity- minutes per week

    Time frame: Baseline to 4 month

    Change of ActiGraph monitored activity

  5. Change in levels of physical activity- #times per week

    Time frame: Baseline to 4 month

    Change of ActiGraph monitored activity

  6. Change in resistance training- Handgrip strength

    Time frame: Baseline to 4 month

    Jamar Plus Digital Hand Dynamometer

  7. Change in resistance training- Strength and endurance

    Time frame: Baseline to 4 month

    30-Second Chair Stand (Sit to Stand)

  8. Change in Quality of Life- PROMIS (Patient Reported Outcomes Measurement Information System)

    Time frame: 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.

  9. Changes in Systolic and Diastolic Blood Pressure

    Time frame: Baseline to 4 month

    Participants systolic and diastolic blood pressure will be measured using a digital, automated unit

  10. Change in Biomarkers- Lipids

    Time frame: Baseline to 4 month

    Lipid blood tests measured by Wisconsin Diagnostic Laboratory

  11. Change in Biomarkers- Glycohem

    Time frame: Baseline to 4 month

    Glycohem blood tests measured by Wisconsin Diagnostic Laboratory

  12. Change in Biomarkers- Glucose

    Time frame: Baseline to 4 month

    Glucose blood tests measured by Wisconsin Diagnostic Laboratory

  13. Change in Biomarkers- C-Peptide

    Time frame: Baseline to 4 month

    C-Peptide blood tests measured by Wisconsin Diagnostic Laboratory

  14. Change in Biomarkers- Insulin

    Time frame: Baseline to 4 month

    Insulin blood tests measured by Wisconsin Diagnostic Laboratory

  15. Change in Biomarkers- hs CRP

    Time frame: Baseline to 4 month

    hs CRP blood tests measured by Wisconsin Diagnostic Laboratory

  16. Change in Biomarkers-Adipokines- Adiponectin

    Time frame: Baseline to 4 month

    Adiponectin blood tests

  17. Change in Biomarkers-Adipokines- Leptin

    Time frame: Baseline to 4 month

    Adiponectin blood tests

  18. Change in waist circumference

    Time frame: Baseline to 4 month

    Change in waist circumference measurement

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Collaborators

  • Loyola University Chicago

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Mar 25, 2020
Registry last updated
Dec 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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