NCT03131128

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 27, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

March 22, 2018

Status Verified

March 1, 2018

Enrollment Period

2.6 years

First QC Date

April 20, 2017

Last Update Submit

March 20, 2018

Conditions

Keywords

Mindfulness-based interventionWeight lossWorkplace health promotionObesity

Outcome Measures

Primary Outcomes (1)

  • Body Weight

    Body weight will be recorded during the study carried out.

    Up to 10 months

Secondary Outcomes (4)

  • Dietary Behavior

    Up to 10 months

  • Food Cravings

    Up to 10 months

  • Perceived Stress

    Up to 10 months

  • The level of Mindfulness

    Up to 10 months

Study Arms (2)

Mindfulness-based Intervention

EXPERIMENTAL

2 sessions of diet nutrition education and 6 sessions of Mindfulness-based intervention, 1.5 hours each session.

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.

Behavioral: Health Education Intervention

Interventions

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.

Mindfulness-based 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.

Health Education Intervention

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chung Shan Medical University

Taichung, 402, Taiwan

RECRUITING

MeSH Terms

Conditions

Weight LossObesity

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Feng-Cheng Tang

    Changhua Christian Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
The researchers will explain the purpose and steps of the study to all the participants and get their informed consent.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 20, 2017

First Posted

April 27, 2017

Study Start

May 1, 2017

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

March 22, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations