The Effectiveness of Mindfulness-based Intervention as a Workplace Health Promotion Program on Weight Loss
Primary Purpose
Mindfulness, Weight Loss, Workplace
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Mindfulness-based Intervention
Health Education Intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Mindfulness focused on measuring Mindfulness-based intervention, Weight loss, Workplace health promotion, Obesity
Eligibility Criteria
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.
Sites / Locations
- Chung Shan Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mindfulness-based Intervention
Health Education Intervention
Arm Description
2 sessions of diet nutrition education and 6 sessions of Mindfulness-based intervention, 1.5 hours each session.
2 sessions of diet nutrition education and 6 sessions of Health Education, 1.5 hours each session.
Outcomes
Primary Outcome Measures
Body Weight
Body weight will be recorded during the study carried out.
Secondary Outcome Measures
Dietary Behavior
Using the Dietary Behavior Questionnaire to measure the intake of types and proportion of food.
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.
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.
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.
Full Information
NCT ID
NCT03131128
First Posted
April 20, 2017
Last Updated
March 20, 2018
Sponsor
Chung Shan Medical University
Collaborators
Changhua Christian Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03131128
Brief Title
The Effectiveness of Mindfulness-based Intervention as a Workplace Health Promotion Program on Weight Loss
Official Title
A Pilot Study of the Effectiveness of Mindfulness-based Intervention as a Workplace Health Promotion Program on Weight Loss
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
December 1, 2019 (Anticipated)
Study Completion Date
December 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chung Shan Medical University
Collaborators
Changhua Christian Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mindfulness, Weight Loss, Workplace, Health Promotion
Keywords
Mindfulness-based intervention, Weight loss, Workplace health promotion, Obesity
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Masking Description
The researchers will explain the purpose and steps of the study to all the participants and get their informed consent.
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness-based Intervention
Arm Type
Experimental
Arm Description
2 sessions of diet nutrition education and 6 sessions of Mindfulness-based intervention, 1.5 hours each session.
Arm Title
Health Education Intervention
Arm Type
Active Comparator
Arm Description
2 sessions of diet nutrition education and 6 sessions of Health Education, 1.5 hours each session.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-based Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Health Education Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Body Weight
Description
Body weight will be recorded during the study carried out.
Time Frame
Up to 10 months
Secondary Outcome Measure Information:
Title
Dietary Behavior
Description
Using the Dietary Behavior Questionnaire to measure the intake of types and proportion of food.
Time Frame
Up to 10 months
Title
Food Cravings
Description
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.
Time Frame
Up to 10 months
Title
Perceived Stress
Description
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.
Time Frame
Up to 10 months
Title
The level of Mindfulness
Description
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.
Time Frame
Up to 10 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chih-Chun Huang
Phone
886-930-556128
Email
hilihuang7004@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Shu-Ling Huang
Phone
886-04-24730022
Ext
12301
Email
shuling@csmu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Feng-Cheng Tang
Organizational Affiliation
Changhua Christian Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chung Shan Medical University
City
Taichung
ZIP/Postal Code
402
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shu-Ling Huang, Ph.D
Phone
+886-2473-0022
Ext
12301
Email
shuling@csmu.edu.tw
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effectiveness of Mindfulness-based Intervention as a Workplace Health Promotion Program on Weight Loss
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