- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03131128
The Effectiveness of Mindfulness-based Intervention as a Workplace Health Promotion Program on Weight Loss
March 20, 2018 updated by: Yeh, Chung Shan Medical University
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Taichung, Taiwan, 402
- Recruiting
- Chung Shan Medical University
-
Contact:
- Shu-Ling Huang, Ph.D
- Phone Number: 12301 +886-2473-0022
- Email: shuling@csmu.edu.tw
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- adults aged 20 to 65 years old;
- full-time workers with BMI ≧ 24;
- motivated to participate in the study;
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mindfulness-based Intervention
2 sessions of diet nutrition education and 6 sessions of Mindfulness-based intervention, 1.5 hours each session.
|
|
Active Comparator: Health Education Intervention
2 sessions of diet nutrition education and 6 sessions of Health Education, 1.5 hours each session.
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body Weight
Time Frame: Up to 10 months
|
Body weight will be recorded during the study carried out.
|
Up to 10 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dietary Behavior
Time Frame: Up to 10 months
|
Using the Dietary Behavior Questionnaire to measure the intake of types and proportion of food.
|
Up to 10 months
|
Food Cravings
Time Frame: Up to 10 months
|
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.
|
Up to 10 months
|
Perceived Stress
Time Frame: Up to 10 months
|
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.
|
Up to 10 months
|
The level of Mindfulness
Time Frame: Up to 10 months
|
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.
|
Up to 10 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Feng-Cheng Tang, Changhua Christian Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2017
Primary Completion (Anticipated)
December 1, 2019
Study Completion (Anticipated)
December 1, 2019
Study Registration Dates
First Submitted
April 20, 2017
First Submitted That Met QC Criteria
April 24, 2017
First Posted (Actual)
April 27, 2017
Study Record Updates
Last Update Posted (Actual)
March 22, 2018
Last Update Submitted That Met QC Criteria
March 20, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ChungShanMU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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