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Completed

NCT Number: NCT06427473

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

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.

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Key information

Age range

20 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

National Yang Ming Chiao Tung University

Taipei, 112, Taiwan

About this study

[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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Dietary program

Behavioral

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

Exercise Program

Behavioral

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

Mindfulness program

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.

Primary outcomes

  1. Physiological indicator I

    Time frame: baseline, 8 weeks, 24 weeks, 48 weeks

    BMI in kg/m2 (weight in kilograms divided by height in meters squared)

  2. Physiological indicator II

    Time frame: baseline, 8 weeks, 24 weeks, 48 weeks

    Waist circumference in centimeter

  3. Physiological indicator III

    Time frame: baseline, 8 weeks, 24 weeks, 48 weeks

    Body fat in percentage

  4. Physiological indicator IV

    Time frame: baseline, 8 weeks, 24 weeks, 48 weeks

    Muscle mass in kilograms

  5. Food Intake Frequency

    Time frame: baseline, 8 weeks, 24 weeks, 48 weeks

    Food Frequency Questionnaire

  6. Mindful Awareness Attention

    Time frame: baseline, 8 weeks, 24 weeks, 48 weeks

    The minimum value is 1 and maximum value is 6, and higher scores mean a better outcome.

Secondary outcomes

  1. Weight Efficacy Lifestyle Questionnaire

    Time frame: baseline, 8 weeks, 24 weeks, 48 weeks

    The minimum value is 0 and maximum value is 10, and higher scores mean a better outcome.

  2. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire

    Time frame: baseline, 8 weeks, 24 weeks, 48 weeks

    • Item 1 to 28 the minimum value is 1 and maximum value is 4, and lower scores mean a better outcome.
    • Item 29 to 30 the minimum value is 1 and maximum value is 7, and higher scores mean a better outcome.
  3. Breast Cancer-Specific Quality of Life Questionnaire

    Time frame: baseline, 8 weeks, 24 weeks, 48 weeks

    The minimum value is 1 and maximum value is 4, and lower scores mean a better outcome.

Sponsors and collaborators

Lead sponsor

National Yang Ming Chiao Tung University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 24, 2024
Registry last updated
Jul 15, 2025

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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