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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06427473
• Other study ID #: NYCU113018AE
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 14, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2024
• Source: National Yang Ming Chiao Tung University
• Contact: I-Ching Hou
• Phone: +886-2-28267315
• Email: evita[@]nycu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Breast Cancer
• Breast Neoplasms
• Weight Loss

Intervention

Behavioral:
• Dietary program
Participants will attend 8-week online dietary course. In addition to weekly classes, participants are required to photograph each meal.
• Exercise program
Everyday walking steps more than 4000 steps. To accurately track participants' daily step counts, the research team provided quailfied pedometers.
• 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.

Locations

Country	Name	City	State
Taiwan	National Yang Ming Chiao Tung University	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Yang Ming Chiao Tung University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physiological indicator I	BMI in kg/m2 (weight in kilograms divided by height in meters squared)	baseline, 8 weeks, 24 weeks, 48 weeks
Primary	Physiological indicator II	Waist circumference in centimeter	baseline, 8 weeks, 24 weeks, 48 weeks
Primary	Physiological indicator III	Body fat in percentage	baseline, 8 weeks, 24 weeks, 48 weeks
Primary	Physiological indicator IV	Muscle mass in kilograms	baseline, 8 weeks, 24 weeks, 48 weeks
Primary	Food Intake Frequency	Food Frequency Questionnaire	baseline, 8 weeks, 24 weeks, 48 weeks
Primary	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	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
Secondary	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
Secondary	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