Effectiveness of a Combined Diet and Mindfulness Program on Weight Loss in Breast Cancer Survivors

Trial Title: Effectiveness of a Combined Diet and Mindfulness Program on Weight Loss in Breast Cancer Survivors

NCT ID: NCT06427473

Condition: Breast Cancer
Weight Loss

Conditions: Official terms:
Breast Neoplasms
Body Weight
Weight Loss

Conditions: Keywords:
weight management
breast cancer survivors
mindfulness
Food Frequency Questionnaire

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Health Services Research

Masking: Single (Outcomes Assessor)

Intervention:

Intervention type: Behavioral
Intervention name: Dietary program
Description: Participants will attend 8-week online dietary course. In addition to weekly classes, participants are required to photograph each meal.
Arm group label: DE model
Arm group label: DEM model

Intervention type: Behavioral
Intervention name: Exercise program
Description: Everyday walking steps more than 4000 steps. To accurately track participants' daily step counts, the research team provided quailfied pedometers.
Arm group label: DE model
Arm group label: DEM model

Intervention type: Behavioral
Intervention name: Mindfulness program
Description: Participants will attend 8-week online mindfulness course. In addition to weekly classes, participants practiced mindfulness individually for 5 minutes each day and maintained a mindfulness diary.
Arm group label: DEM model

Summary: The study addresses the pressing issue of overweight and obesity among breast cancer patients, which exacerbates recurrence rates and mortality risks. Its primary objective is to assess the efficacy of two intervention models, the Diet, Exercise, and Mindfulness (DEM) model and the Diet and Exercise (DE) model, in facilitating weight loss, enhancing self-efficacy, mindfulness, and quality of life. The anticipated outcomes include long-term engagement in online self-learning, overcoming the limitations of ineffective self-management learning, and empowering healthcare professionals with scenario-based teaching materials. Through online platforms, patients can learn and review without constraints, ultimately achieving a holistic balance among physical, mental, and spiritual health.

Detailed description: [Research Background] Breast cancer ranks first among cancers in women worldwide, with overweight and obesity being one of the high-risk factors for breast cancer. Moreover, overweight individuals within the breast cancer patient population also face higher recurrence rates and mortality risks. Assisting overweight or obese breast cancer women in weight loss to promote their well-being was the initial idea behind this study. The most common weight loss strategies include dietary management and regular exercise. In recent years, more studies have shown that effective weight loss also requires psychological interventions. Therefore, this study will combine dietary, exercise, and mindfulness-related interventions to assist breast cancer patients in more effective weight management. [Research Objectives] To compare the effectiveness of two intervention measures, the Diet, Exercise, and Mindfulness (DEM) model and the Diet and Exercise (DE) model, on weight loss, self-efficacy, mindfulness tendency, and quality of life. [Research Method] The study will involve a quantitative study, which plans to carry out a randomized controlled trial (RCT). This trial will compare the effects of two intervention measures, the DEM model and the DE model, on weight loss, self-efficacy, mindfulness tendency, and quality of life. [Expected Results] Through the intervention provided by this study, patients can engage in long-term online self-learning and supplementary learning after returning home, reducing the limitations of ineffective self-management learning caused by negative emotions, treatment side effects, and sequelae in the early stages of cancer. Healthcare professionals can also use scenario-based teaching materials produced by this study to guide breast cancer survivors with ineffective weight self-management skills in practicing the necessary skills. Additionally, through online learning, patients can learn and review without pressure, saving time on transportation, easing carbon foot print and relearning effective weight management skills; even if they have faced major life threats in the past, they can turn adversity into blessings, achieving a balance among physical, mental, and spiritual health.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - stage I-III breast cancer and completed treatment - Body mass index (BMI) is greater than or equal to 24 kg/m2 - possess a smartphone Exclusion Criteria: - Pregnant or planning to become pregnant within six months - Those who are unable to walk

Gender: Female

Minimum age: 20 Years

Maximum age: 65 Years

Healthy volunteers: No

Locations:

Facility:
Name: National Yang Ming Chiao Tung University

Address:
City: Taipei
Zip: 112
Country: Taiwan

Contact:
Last name: I-Ching Hou

Phone: +886-2-28267315
Email: evita@nycu.edu.tw

Start date: June 14, 2024

Completion date: June 30, 2025

Lead sponsor:
Agency: National Yang Ming Chiao Tung University
Agency class: Other

Source: National Yang Ming Chiao Tung University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06427473