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

NCT ID: NCT06427473

Last Updated: 2025-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-04
• Study Completion Date: 2025-07-09

Brief 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.

Conditions

Breast Cancer; Weight Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

DEM model

subjects participate diet, exercise and mindfulness programs

Group Type: EXPERIMENTAL

Dietary program

Intervention Type: BEHAVIORAL

Participants will attend 8-week online dietary course. In addition to weekly classes, participants are required to photograph each meal.

Exercise program

Intervention Type: BEHAVIORAL

Everyday walking steps more than 4000 steps. To accurately track participants' daily step counts, the research team provided quailfied pedometers.

Mindfulness program

Intervention Type: BEHAVIORAL

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.

DE model

subjects participate diet and exercise programs

Group Type: ACTIVE_COMPARATOR

Dietary program

Intervention Type: BEHAVIORAL

Participants will attend 8-week online dietary course. In addition to weekly classes, participants are required to photograph each meal.

Exercise program

Intervention Type: BEHAVIORAL

Everyday walking steps more than 4000 steps. To accurately track participants' daily step counts, the research team provided quailfied pedometers.

Interventions

Dietary program

Participants will attend 8-week online dietary course. In addition to weekly classes, participants are required to photograph each meal.

Intervention Type: BEHAVIORAL

Exercise program

Everyday walking steps more than 4000 steps. To accurately track participants' daily step counts, the research team provided quailfied pedometers.

Intervention Type: BEHAVIORAL

Mindfulness program

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Yang Ming Chiao Tung University

OTHER

Sponsor Role: lead

Responsible Party

I-Ching Hou

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Associate Professor

Role: PRINCIPAL_INVESTIGATOR

National Yang Ming Chiao Tung University

Locations

National Yang Ming Chiao Tung University

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

NYCU113018AE

Identifier Type: -

Identifier Source: org_study_id