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The Effectiveness of Mindfulness-based Intervention as a Workplace Health Promotion Program on Weight Loss

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ClinicalTrials.gov Identifier: NCT03131128
Recruitment Status : Recruiting
First Posted : April 27, 2017
Last Update Posted : March 22, 2018
Sponsor:
Collaborator:
Changhua Christian Hospital
Information provided by (Responsible Party):
Yeh, Chung Shan Medical University

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.

Condition or disease Intervention/treatment Phase
Mindfulness Weight Loss Workplace Health Promotion Behavioral: Mindfulness-based Intervention Behavioral: Health Education Intervention Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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.
Primary Purpose: Supportive Care
Official Title: A Pilot Study of the Effectiveness of Mindfulness-based Intervention as a Workplace Health Promotion Program on Weight Loss
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine


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.
Behavioral: Mindfulness-based Intervention
  1. 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.

Active Comparator: Health Education Intervention
2 sessions of diet nutrition education and 6 sessions of Health Education, 1.5 hours each session.
Behavioral: Health Education Intervention
  1. 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.




Primary Outcome Measures :
  1. Body Weight [ Time Frame: Up to 10 months ]
    Body weight will be recorded during the study carried out.


Secondary Outcome Measures :
  1. Dietary Behavior [ Time Frame: Up to 10 months ]
    Using the Dietary Behavior Questionnaire to measure the intake of types and proportion of food.

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. adults aged 20 to 65 years old;
  2. full-time workers with BMI ≧ 24;
  3. motivated to participate in the study;

Exclusion Criteria:

  1. suffering from mental illness or in an acute episode;
  2. suffering from life threatening or other major physical illness;
  3. no motivation to participate in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03131128


Contacts
Contact: Chih-Chun Huang 886-930-556128 hilihuang7004@gmail.com
Contact: Shu-Ling Huang 886-04-24730022 ext 12301 shuling@csmu.edu.tw

Locations
Taiwan
Chung Shan Medical University Recruiting
Taichung, Taiwan, 402
Contact: Shu-Ling Huang, Ph.D    +886-2473-0022 ext 12301    shuling@csmu.edu.tw   
Sponsors and Collaborators
Chung Shan Medical University
Changhua Christian Hospital
Investigators
Principal Investigator: Feng-Cheng Tang Changhua Christian Hospital

Responsible Party: Yeh, Professor, Chung Shan Medical University
ClinicalTrials.gov Identifier: NCT03131128     History of Changes
Other Study ID Numbers: ChungShanMU
First Posted: April 27, 2017    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yeh, Chung Shan Medical University:
Mindfulness-based intervention
Weight loss
Workplace health promotion
Obesity

Additional relevant MeSH terms:
Body Weight
Weight Loss
Signs and Symptoms
Body Weight Changes