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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03131128
Other study ID # ChungShanMU
Secondary ID
Status Recruiting
Phase N/A
First received April 20, 2017
Last updated March 20, 2018
Start date May 1, 2017
Est. completion date December 1, 2019

Study information

Verified date March 2018
Source Chung Shan Medical University
Contact Chih-Chun Huang
Phone 886-930-556128
Email hilihuang7004@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date December 1, 2019
Est. primary completion date December 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 65 Years
Eligibility 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.

Study Design


Intervention

Behavioral:
Mindfulness-based Intervention
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 Intervention
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.

Locations

Country Name City State
Taiwan Chung Shan Medical University Taichung

Sponsors (2)

Lead Sponsor Collaborator
Chung Shan Medical University Changhua Christian Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Body Weight Body weight will be recorded during the study carried out. Up to 10 months
Secondary Dietary Behavior Using the Dietary Behavior Questionnaire to measure the intake of types and proportion of food. Up to 10 months
Secondary 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. Up to 10 months
Secondary 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. Up to 10 months
Secondary 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. Up to 10 months
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