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

N

National Yang Ming Chiao Tung University

Status

Completed

Conditions

Weight Loss
Breast Cancer

Treatments

Behavioral: Dietary program
Behavioral: Exercise program
Behavioral: Mindfulness program

Study type

Interventional

Funder types

Other

Identifiers

NCT06427473
NYCU113018AE

Details and patient eligibility

About

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.

Full 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.

Enrollment

44 patients

Sex

Female

Ages

20 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

44 participants in 2 patient groups

DEM model
Experimental group
Description:
subjects participate diet, exercise and mindfulness programs
Treatment:
Behavioral: Mindfulness program
Behavioral: Exercise program
Behavioral: Dietary program
DE model
Active Comparator group
Description:
subjects participate diet and exercise programs
Treatment:
Behavioral: Exercise program
Behavioral: Dietary program

Trial contacts and locations

1

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Central trial contact

Yi-Fung Lin; I-Ching Hou

Data sourced from clinicaltrials.gov

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