Breast CancerNCT06427473
Effectiveness of a Combined Diet and Mindfulness Program on Weight Loss in Breast Cancer Survivors
A study testing Dietary program, Exercise program and Mindfulness program in people with Breast Cancer and Weight Loss, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 20 to 65 years, women only
- Conditions the study is for
- Breast Cancer, Weight Loss
- What is being tested?
- Dietary program, Exercise program and Mindfulness program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTaiwan
- Study dates
- 4 Jun 2024to 9 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stage I-III breast cancer and completed treatment
- Body mass index (BMI) is greater than or equal to 24 kg/m2
- possess a smartphone
Who cannot join
- Pregnant or planning to become pregnant within six months
- Those who are unable to walk
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Breast Cancer, Weight Loss
- Being tested
- Dietary program, Exercise program, Mindfulness program
- Keywords
- weight management, breast cancer survivors, mindfulness, Food Frequency Questionnaire
- Medical subject headings
- Breast Neoplasms, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary programBehavioural
Participants will attend 8-week online dietary course. In addition to weekly classes, participants are required to photograph each meal.
Exercise programBehavioural
Everyday walking steps more than 4000 steps. To accurately track participants' daily step counts, the research team provided quailfied pedometers.
Mindfulness programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| DEM model | Experimental | subjects participate diet, exercise and mindfulness programs Receives: Behavioral: Dietary program; Behavioral: Exercise program; Behavioral: Mindfulness program |
| DE model | Active comparator | subjects participate diet and exercise programs Receives: Behavioral: Dietary program; Behavioral: Exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physiological indicator I
BMI in kg/m2 (weight in kilograms divided by height in meters squared)
Measured: baseline, 8 weeks, 24 weeks, 48 weeks
Physiological indicator II
Waist circumference in centimeter
Measured: baseline, 8 weeks, 24 weeks, 48 weeks
Physiological indicator III
Body fat in percentage
Measured: baseline, 8 weeks, 24 weeks, 48 weeks
Physiological indicator IV
Muscle mass in kilograms
Measured: baseline, 8 weeks, 24 weeks, 48 weeks
Food Intake Frequency
Food Frequency Questionnaire
Measured: 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.
Measured: baseline, 8 weeks, 24 weeks, 48 weeks
Secondary outcomes (3)
Weight Efficacy Lifestyle Questionnaire
The minimum value is 0 and maximum value is 10, and higher scores mean a better outcome.
Measured: 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.
Measured: 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.
Measured: baseline, 8 weeks, 24 weeks, 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start4 Jun 2024
- Primary completion9 Jul 2025
- Study completion9 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, I-Ching Hou, National Yang Ming Chiao Tung University
- Investigators
- Associate Professor, Principal investigator, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06427473
- Sponsor's protocol ID
- NYCU113018AE
- Status last verified
- Jul 2025
- First submitted
- 15 May 2024
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lin YF, Lokmic-Tomkins Z, Chang KJ, Hu ML, Feng HC, Cheng CP, Shun SC, Chang HJ, Hou IC. Preliminary effects of an online diet, walking, and mindfulness-integrated lifestyle intervention for breast cancer survivors with overweight or obesity: A pilot randomized controlled trial. Asia Pac J Oncol Nurs. 2026 Apr 28;13:100966. doi: 10.1016/j.apjon.2026.100966. eCollection 2026 Dec.
PubMed 42290885
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Combined Diet and Mindfulness Program on Weight Loss in Breast Cancer Survivors: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06427473
- Acronym / sponsor ID
- NYCU113018AE
- Conditions
- Breast Cancer, Weight Loss
- Keywords
- weight management, breast cancer survivors, mindfulness, Food Frequency Questionnaire
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 4 Jun 2024 (actual)
- Primary completion
- 9 Jul 2025 (actual)
- Study completion
- 9 Jul 2025 (actual)
- First posted
- 24 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DEM model | Experimental | Behavioral: Dietary program, Behavioral: Exercise program, Behavioral: Mindfulness programsubjects participate diet, exercise and mindfulness programs |
| DE model | Active comparator | Behavioral: Dietary program, Behavioral: Exercise programsubjects participate diet and exercise programs |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- stage I-III breast cancer and completed treatment
- Body mass index (BMI) is greater than or equal to 24 kg/m2
- possess a smartphone
Key exclusion criteria (2 listed)
- Pregnant or planning to become pregnant within six months
- Those who are unable to walk
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary programParticipants will attend 8-week online dietary course. In addition to weekly classes, participants are required to photograph each meal. | Behavioural | DE model, DEM model |
| Exercise programEveryday walking steps more than 4000 steps. To accurately track participants' daily step counts, the research team provided quailfied pedometers. | Behavioural | DE model, DEM model |
| Mindfulness programParticipants 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. | Behavioural | DEM model |
Primary outcome
Physiological indicator I
Time frame: baseline, 8 weeks, 24 weeks, 48 weeks
BMI in kg/m2 (weight in kilograms divided by height in meters squared)
Physiological indicator II
Time frame: baseline, 8 weeks, 24 weeks, 48 weeks
Waist circumference in centimeter
Physiological indicator III
Time frame: baseline, 8 weeks, 24 weeks, 48 weeks
Body fat in percentage
Physiological indicator IV
Time frame: baseline, 8 weeks, 24 weeks, 48 weeks
Muscle mass in kilograms
Food Intake Frequency
Time frame: baseline, 8 weeks, 24 weeks, 48 weeks
Food Frequency Questionnaire
Mindful Awareness Attention
Time frame: baseline, 8 weeks, 24 weeks, 48 weeks
The minimum value is 1 and maximum value is 6, and higher scores mean a better outcome.
3 secondary outcomes
Weight Efficacy Lifestyle Questionnaire
Time frame: baseline, 8 weeks, 24 weeks, 48 weeks
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire
Time frame: baseline, 8 weeks, 24 weeks, 48 weeks
Breast Cancer-Specific Quality of Life Questionnaire
Time frame: baseline, 8 weeks, 24 weeks, 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Derived from this study: PubMed 42290885Lin YF, Lokmic-Tomkins Z, Chang KJ, Hu ML, Feng HC, Cheng CP, Shun SC, Chang HJ, Hou IC. Preliminary effects of an online diet, walking, and mindfulness-integrated lifestyle intervention for breast cancer survivors with overweight or obesity: A pilot randomized controlled trial. Asia Pac J Oncol Nurs. 2026 Apr 28;13:100966. doi: 10.1016/j.apjon.2026.100966. eCollection 2026 Dec.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Associate Professor principal investigator
National Yang Ming Chiao Tung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary program, Exercise program and Mindfulness program in people with Breast Cancer and Weight Loss, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physiological indicator I (time frame: baseline, 8 weeks, 24 weeks, 48 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06427473, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025.