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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Weight Loss
• Intervention / Treatment: Behavioral: Dietary program; Behavioral: Exercise program; Behavioral: Mindfulness program

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.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 112
    • National Yang Ming Chiao Tung University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DEM model; subjects participate diet, exercise and mindfulness programs	Behavioral: Dietary program; Participants will attend 8-week online dietary course. In addition to weekly classes, participants are required to photograph each meal.; Behavioral: Exercise program; Everyday walking steps more than 4000 steps. To accurately track participants' daily step counts, the research team provided quailfied pedometers.; 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.
Active Comparator: DE model; subjects participate diet and exercise programs	Behavioral: Dietary program; Participants will attend 8-week online dietary course. In addition to weekly classes, participants are required to photograph each meal.; Behavioral: Exercise program; Everyday walking steps more than 4000 steps. To accurately track participants' daily step counts, the research team provided quailfied pedometers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physiological indicator I	BMI in kg/m2 (weight in kilograms divided by height in meters squared)	baseline, 8 weeks, 24 weeks, 48 weeks
Physiological indicator II	Waist circumference in centimeter	baseline, 8 weeks, 24 weeks, 48 weeks
Physiological indicator III	Body fat in percentage	baseline, 8 weeks, 24 weeks, 48 weeks
Physiological indicator IV	Muscle mass in kilograms	baseline, 8 weeks, 24 weeks, 48 weeks
Food Intake Frequency	Food Frequency Questionnaire	baseline, 8 weeks, 24 weeks, 48 weeks
Mindful Awareness Attention	The minimum value is 1 and maximum value is 6, and higher scores mean a better outcome.	baseline, 8 weeks, 24 weeks, 48 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight Efficacy Lifestyle Questionnaire	The minimum value is 0 and maximum value is 10, and higher scores mean a better outcome.	baseline, 8 weeks, 24 weeks, 48 weeks
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire	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.	baseline, 8 weeks, 24 weeks, 48 weeks
Breast Cancer-Specific Quality of Life Questionnaire	The minimum value is 1 and maximum value is 4, and lower scores mean a better outcome.	baseline, 8 weeks, 24 weeks, 48 weeks

Collaborators and Investigators

• Sponsor: National Yang Ming Chiao Tung University
• Investigators: Principal Investigator: Associate Professor, National Yang Ming Chiao Tung University

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2024
• Primary Completion (Actual): July 9, 2025
• Study Completion (Actual): July 9, 2025

Study Registration Dates

• First Submitted: May 15, 2024
• First Submitted That Met QC Criteria: May 22, 2024
• First Posted (Actual): May 24, 2024

Study Record Updates

• Last Update Posted (Actual): July 15, 2025
• Last Update Submitted That Met QC Criteria: July 10, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: mindfulness; weight management; Food Frequency Questionnaire; breast cancer survivors
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Body Weight Changes; Skin Diseases; Breast Diseases; Weight Loss; Body Weight; Breast Neoplasms
• Other Study ID Numbers: NYCU113018AE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No