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

NCT06427473 | Completed DMC

• 1 other identifier: NYCU113018AE
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Weight Loss

Keywords

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

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (3)

• Weight Efficacy Lifestyle Questionnaire

  baseline, 8 weeks, 24 weeks, 48 weeks

• European Organization for Research and Treatment of Cancer Quality of Life Questionnaire

  baseline, 8 weeks, 24 weeks, 48 weeks

• Breast Cancer-Specific Quality of Life Questionnaire

  baseline, 8 weeks, 24 weeks, 48 weeks

Study Arms (2)

DEM model

EXPERIMENTAL

subjects participate diet, exercise and mindfulness programs

Behavioral: Dietary program; Behavioral: Exercise program; Behavioral: Mindfulness program

DE model

ACTIVE COMPARATOR

subjects participate diet and exercise programs

Behavioral: Dietary program; Behavioral: Exercise program

Interventions

Dietary program BEHAVIORAL

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

DE model; DEM model

Exercise program BEHAVIORAL

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

DE model; DEM model

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.

DEM model

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• stage I-III breast cancer and completed treatment
• Body mass index (BMI) is greater than or equal to 24 kg/m2
• possess a smartphone

You may not qualify if:

• Pregnant or planning to become pregnant within six months
• Those who are unable to walk

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead

Study Sites (1)

National Yang Ming Chiao Tung University

Taipei, 112, Taiwan

Location

MeSH Terms

Conditions

Breast Neoplasms; Weight Loss

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Associate Professor

  National Yang Ming Chiao Tung University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: May 24, 2024
• Study Start: June 4, 2024
• Primary Completion: July 9, 2025
• Study Completion: July 9, 2025
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)