## Protocol Section
### Identification Module
**NCT ID:** NCT06427473

**Brief Title:** Effectiveness of a Combined Diet and Mindfulness Program on Weight Loss in Breast Cancer Survivors

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

#### Organization Study ID Info
**ID:** NYCU113018AE
#### Organization
**Class:** OTHER
**Full Name:** National Yang Ming Chiao Tung University
### Status Module
#### Completion Date
**Date:** 2025-06-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-06-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-14

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** National Yang Ming Chiao Tung University

#### Responsible Party

**Investigator Affiliation:** National Yang Ming Chiao Tung University

**Investigator Full Name:** I-Ching Hou

**Investigator Title:** Associate Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Breast Cancer

- Weight Loss

**Keywords:**

- weight management

- breast cancer survivors

- mindfulness

- Food Frequency Questionnaire

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** HEALTH_SERVICES_RESEARCH

#### Enrollment Info

**Count:** 40

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** subjects participate diet, exercise and mindfulness programs

**Intervention Names:**

- Behavioral: Dietary program

- Behavioral: Exercise program

- Behavioral: Mindfulness program

**Label:** DEM model

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** subjects participate diet and exercise programs

**Intervention Names:**

- Behavioral: Dietary program

- Behavioral: Exercise program

**Label:** DE model

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- DE model

- DEM model

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

**Name:** Dietary program

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- DE model

- DEM model

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

**Name:** Exercise program

**Type:** BEHAVIORAL

#### Intervention 3

**Arm Group Labels:**

- DEM model

**Description:** 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.

**Name:** Mindfulness program

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Physiological indicator I

**Time Frame:** baseline, 8 weeks, 24 weeks, 48 weeks

**Description:** Waist circumference in centimeter

**Measure:** Physiological indicator II

**Time Frame:** baseline, 8 weeks, 24 weeks, 48 weeks

**Description:** Body fat in percentage

**Measure:** Physiological indicator III

**Time Frame:** baseline, 8 weeks, 24 weeks, 48 weeks

**Description:** Muscle mass in kilograms

**Measure:** Physiological indicator IV

**Time Frame:** baseline, 8 weeks, 24 weeks, 48 weeks

**Description:** Food Frequency Questionnaire

**Measure:** Food Intake Frequency

**Time Frame:** baseline, 8 weeks, 24 weeks, 48 weeks

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

**Measure:** Mindful Awareness Attention

**Time Frame:** baseline, 8 weeks, 24 weeks, 48 weeks

#### Secondary Outcomes

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

**Measure:** Weight Efficacy Lifestyle Questionnaire

**Time Frame:** baseline, 8 weeks, 24 weeks, 48 weeks

**Description:** 1. 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.

**Measure:** European Organization for Research and Treatment of Cancer Quality of Life Questionnaire

**Time Frame:** baseline, 8 weeks, 24 weeks, 48 weeks

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

**Measure:** Breast Cancer-Specific Quality of Life Questionnaire

**Time Frame:** baseline, 8 weeks, 24 weeks, 48 weeks

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 65 Years

**Minimum Age:** 20 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** evita@nycu.edu.tw

**Name:** I-Ching Hou

**Phone:** +886-2-28267315

**Role:** CONTACT

**Contact 2:**

**Email:** harper.y@nycu.edu.tw

**Name:** Yi-Fung Lin

**Phone:** +886-958080852

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Taipei

**Contacts:**

***Contact 1:***

- **Email:** evita@nycu.edu.tw

- **Name:** I-Ching Hou

- **Phone:** +886-2-28267315

- **Role:** CONTACT

**Country:** Taiwan

**Facility:** National Yang Ming Chiao Tung University

**Zip:** 112

#### Overall Officials

**Official 1:**

**Affiliation:** National Yang Ming Chiao Tung University

**Name:** Associate Professor

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000001941

- Term: Breast Diseases

- ID: D000012871

- Term: Skin Diseases

- ID: D000001836

- Term: Body Weight Changes

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M5220

- Name: Breast Neoplasms

- Relevance: HIGH

- As Found: Breast Cancer

- ID: M18102

- Name: Weight Loss

- Relevance: HIGH

- As Found: Weight Loss

- ID: M5114

- Name: Body Weight

- Relevance: HIGH

- As Found: Weight

- ID: M5218

- Name: Breast Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5115

- Name: Body Weight Changes

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001943

- Term: Breast Neoplasms

- ID: D000001835

- Term: Body Weight

- ID: D000015431

- Term: Weight Loss

### Misc Info Module

- Version Holder: 2024-05-31
