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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06427473
Enrollment
44
Registered
2024-05-24
Start date
2024-06-04
Completion date
2025-07-09
Last updated
2025-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Weight Loss

Keywords

weight management, breast cancer survivors, mindfulness, Food Frequency Questionnaire

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.

Interventions

BEHAVIORALDietary program

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

BEHAVIORALExercise program

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

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.

Sponsors

National Yang Ming Chiao Tung University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mindful Awareness Attentionbaseline, 8 weeks, 24 weeks, 48 weeksThe minimum value is 1 and maximum value is 6, and higher scores mean a better outcome.
Physiological indicator IIIbaseline, 8 weeks, 24 weeks, 48 weeksBody fat in percentage
Physiological indicator IVbaseline, 8 weeks, 24 weeks, 48 weeksMuscle mass in kilograms
Food Intake Frequencybaseline, 8 weeks, 24 weeks, 48 weeksFood Frequency Questionnaire
Physiological indicator Ibaseline, 8 weeks, 24 weeks, 48 weeksBMI in kg/m2 (weight in kilograms divided by height in meters squared)
Physiological indicator IIbaseline, 8 weeks, 24 weeks, 48 weeksWaist circumference in centimeter

Secondary

MeasureTime frameDescription
European Organization for Research and Treatment of Cancer Quality of Life Questionnairebaseline, 8 weeks, 24 weeks, 48 weeks1. Item 1 to 28 the minimum value is 1 and maximum value is 4, and lower scores mean a better outcome. 2. Item 29 to 30 the minimum value is 1 and maximum value is 7, and higher scores mean a better outcome.
Breast Cancer-Specific Quality of Life Questionnairebaseline, 8 weeks, 24 weeks, 48 weeksThe minimum value is 1 and maximum value is 4, and lower scores mean a better outcome.
Weight Efficacy Lifestyle Questionnairebaseline, 8 weeks, 24 weeks, 48 weeksThe minimum value is 0 and maximum value is 10, and higher scores mean a better outcome.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026