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

Medical College of Wisconsin

Status: Completed

Conditions: Breast Cancer; Gynecologic Cancer

Treatments: Behavioral: Guided Lifestyle Program Intervention; Behavioral: Self-Guided Lifestyle Program (Control Arm)

Study type: Interventional

Funder types: Other

Identifiers

NCT04321135

PRO00030295

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Self-identify as Hispanic or Latina
2. Female
3. Stage 0 -III Breast and Gynecological cancer survivors
4. Treatment (surgery, chemotherapy and/or radiation) completed at least three months before recruitment (ongoing hormonal therapy is acceptable)
5. Age >18 at time of diagnosis
6. 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

1. Plans to move from the community during the study
2. A medical condition limiting adherence to diet or physical activity components
3. History of significant mental illness
4. Currently pregnant, less than 3 months post-partum, or pregnancy anticipated during the study
5. 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Guided Lifestyle Program

Experimental group

Description:

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.

Treatment:

Behavioral: Guided Lifestyle Program Intervention

Self-Guided Lifestyle Program

Active Comparator group

Description:

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.

Treatment:

Behavioral: Self-Guided Lifestyle Program (Control Arm)