MindfulnessNCT03131128
The Effectiveness of Mindfulness-based Intervention as a Workplace Health Promotion Program on Weight Loss
A study testing Mindfulness-based Intervention and Health Education Intervention in people with Mindfulness and Weight Loss, run by Chung Shan Medical University at 1 site in Taiwan.
Trial summary
The present study will carry out a workplace health promotion via MBI with lessons of dietary behavior to help overweight or obese workers to loss weight. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Mindfulness, Weight Loss, Workplace
- What is being tested?
- Mindfulness-based Intervention and Health Education Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 May 2017to 1 Dec 2019
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adults aged 20 to 65 years old;
- full-time workers with BMI ≧ 24;
- motivated to participate in the study;
Who cannot join
- suffering from mental illness or in an acute episode;
- suffering from life threatening or other major physical illness;
- no motivation to participate in the study.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chung Shan Medical University
Taichung, 402
Shu-Ling Huang, Ph.D, +886-2473-0022 ext. 12301, shuling@csmu.edu.tw
About this study
Official title: A Pilot Study of the Effectiveness of Mindfulness-based Intervention as a Workplace Health Promotion Program on Weight Loss
The present study will carry out a workplace health promotion via MBI with lessons of dietary behavior to help overweight or obese workers to loss weight.
Read the detailed description
The study will adopt a longitudinal research design with randomized quasi- experimental trial. The workers with overweight or obesity (BMI≧24) provided by the company will be randomly assigned to Group A (four lessons of dietary behavior and six lessons of MBI) or Group B (four lessons of dietary behavior and six lessons of mental health). There will be 100 participants in each group. Data will be collected five times. The research questionnaire includes basic information (including BMI, waist circumference, etc), Perceived Stress Scale, The Five Facet Mindfulness Questionnaire, Food Cravings Questionnaire, the scale of physical activity and information regarding dietary behavior.
- Conditions
- Mindfulness, Weight Loss, Workplace, Health Promotion
- Being tested
- Mindfulness-based Intervention, Health Education Intervention
- Keywords
- Mindfulness-based intervention, Weight loss, Workplace health promotion, Obesity
- Medical subject headings
- Weight Loss, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based InterventionBehavioural
- Keeping mindful when selecting food.
- Be aware of hunger and satiety by the body clues.
- Understanding how stress affect diet and life, and learn how to cope with stress in life.
- Learning to identify overeating caused by mood, social stress and specific food.
Health Education InterventionBehavioural
- Identifying improper diet patterns and attitudes
- Understanding the impact of irrational cognition and attitudes on dietary behavior
- Training coping skills for stresses in real life and preventing the recurrence of bulimia.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-based Intervention | Experimental | 2 sessions of diet nutrition education and 6 sessions of Mindfulness-based intervention, 1.5 hours each session. Receives: Behavioral: Mindfulness-based Intervention |
| Health Education Intervention | Active comparator | 2 sessions of diet nutrition education and 6 sessions of Health Education, 1.5 hours each session. Receives: Behavioral: Health Education Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight
Body weight will be recorded during the study carried out.
Measured: Up to 10 months
Secondary outcomes (4)
Dietary Behavior
Using the Dietary Behavior Questionnaire to measure the intake of types and proportion of food.
Measured: Up to 10 months
Food Cravings
Measuring the level of food cravings, use the Likert six-point scoring method, from 1-6 points, a total of 21 questions. The higher scores indicate higher food cravings levels.
Measured: Up to 10 months
Perceived Stress
Measuring the level of perceived stress, using the Likert five-point scoring method, from 0-4 points, a total of 10 questions .The higher scores indicate higher pressure levels.
Measured: Up to 10 months
The level of Mindfulness
Measuring the level of Mindfulness, using the Likert five-point scoring method, a total of 39 questions, including the five concepts, namely: awareness (8 questions), description (8 questions), non-judging (8 questions), observation (8 questions), and non-reaction (7 questions). The higher scores indicate higher levels of mindfulness.
Measured: Up to 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2017
- Study start1 May 2017
- Primary completion1 Dec 2019 (estimated)
- Study completion1 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MindfulnessStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The workers with overweight or obesity provided by the company will be randomly assigned to Group A (by MBI) or Group B (by the intervention of health education).
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Changhua Christian Hospital
- Responsible party
- Principal investigator, Yeh, Chung Shan Medical University
- Investigators
- Feng-Cheng Tang, Principal investigator, Changhua Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03131128
- Sponsor's protocol ID
- ChungShanMU
- Status last verified
- Mar 2018
- First submitted
- 20 Apr 2017
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Effectiveness of Mindfulness-based Intervention as a Workplace Health Promotion Program on Weight Loss
- ClinicalTrials.gov ID
- NCT03131128
- Acronym / sponsor ID
- ChungShanMU
- Conditions
- Mindfulness, Weight Loss, Workplace, Health Promotion
- Keywords
- Mindfulness-based intervention, Weight loss, Workplace health promotion, Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Collaborators
- Changhua Christian Hospital
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 27 Apr 2017 (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 present study will carry out a workplace health promotion via MBI with lessons of dietary behavior to help overweight or obese workers to loss weight.
Detailed description
The study will adopt a longitudinal research design with randomized quasi- experimental trial. The workers with overweight or obesity (BMI≧24) provided by the company will be randomly assigned to Group A (four lessons of dietary behavior and six lessons of MBI) or Group B (four lessons of dietary behavior and six lessons of mental health). There will be 100 participants in each group. Data will be collected five times. The research questionnaire includes basic information (including BMI, waist circumference, etc), Perceived Stress Scale, The Five Facet Mindfulness Questionnaire, Food Cravings Questionnaire, the scale of physical activity and information regarding dietary behavior.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The workers with overweight or obesity provided by the company will be randomly assigned to Group A (by MBI) or Group B (by the intervention of health education).
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-based Intervention | Experimental | Behavioral: Mindfulness-based Intervention2 sessions of diet nutrition education and 6 sessions of Mindfulness-based intervention, 1.5 hours each session. |
| Health Education Intervention | Active comparator | Behavioral: Health Education Intervention2 sessions of diet nutrition education and 6 sessions of Health Education, 1.5 hours each session. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adults aged 20 to 65 years old;
- full-time workers with BMI ≧ 24;
- motivated to participate in the study;
Key exclusion criteria (3 listed)
- suffering from mental illness or in an acute episode;
- suffering from life threatening or other major physical illness;
- no motivation to participate in the study.
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 |
|---|---|---|
| Mindfulness-based Intervention1. Keeping mindful when selecting food. 2. Be aware of hunger and satiety by the body clues. 3. Understanding how stress affect diet and life, and learn how to cope with stress in life. 4. Learning to identify overeating caused by mood, social stress and specific food. | Behavioural | Mindfulness-based Intervention |
| Health Education Intervention1. Identifying improper diet patterns and attitudes 2. Understanding the impact of irrational cognition and attitudes on dietary behavior 3. Training coping skills for stresses in real life and preventing the recurrence of bulimia. | Behavioural | Health Education Intervention |
Primary outcome
Body Weight
Time frame: Up to 10 months
Body weight will be recorded during the study carried out.
4 secondary outcomes
Dietary Behavior
Time frame: Up to 10 months
Food Cravings
Time frame: Up to 10 months
Perceived Stress
Time frame: Up to 10 months
The level of Mindfulness
Time frame: Up to 10 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2018.
- 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.
Feng-Cheng Tang principal investigator
Changhua Christian Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based Intervention and Health Education Intervention in people with Mindfulness and Weight Loss, run by Chung Shan Medical 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 3 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: status not confirmed, as of the sponsor's last update on 22 Mar 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chih-Chun Huang (886-930-556128, hilihuang7004@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Weight (time frame: Up to 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Mar 2018.