Back to resultsPersonalized Lifestyle Intervention and Weight Control
Primary Purpose
Weight Loss
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
personalized lifestyle intervention
general lifestyle intervention
Sponsored by
About this trial
This is an interventional treatment trial for Weight Loss
Eligibility Criteria
Inclusion Criteria:
- overweight or obese individuals
Exclusion Criteria:
- a past history of bariatric surgery or eating disorders
- currently pregnant or planning a pregnancy within 2 years
Sites / Locations
- Dongguk University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
personalized lifestyle intervention
general lifestyle intervention
Arm Description
to provide personalized lifestyle guidance for weight loss through SNP testing
to provide general lifestyle guidance for weight loss
Outcomes
Primary Outcome Measures
weight change (kg)
change in weight from the time of randomization
Secondary Outcome Measures
waist circumference (cm)
change in waist circumference from the time of randomization
Full Information
NCT ID
NCT04079972
First Posted
February 18, 2019
Last Updated
September 3, 2019
Sponsor
DongGuk University
Collaborators
National Research Foundation of Korea
1. Study Identification
Unique Protocol Identification Number
NCT04079972
Brief Title
Personalized Lifestyle Intervention and Weight Control
Official Title
Personalized Lifestyle Intervention Based on SNP Testing and Weight Control
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 11, 2019 (Actual)
Primary Completion Date
March 2020 (Anticipated)
Study Completion Date
March 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
DongGuk University
Collaborators
National Research Foundation of Korea
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
This trial aims to investigate whether tailored lifestyle consultation through SNP testing leads to more effective weight loss among overweight or obese individuals compared to general lifestyle guidance for weight control.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
personalized lifestyle intervention
Arm Type
Experimental
Arm Description
to provide personalized lifestyle guidance for weight loss through SNP testing
Arm Title
general lifestyle intervention
Arm Type
Active Comparator
Arm Description
to provide general lifestyle guidance for weight loss
Intervention Type
Behavioral
Intervention Name(s)
personalized lifestyle intervention
Intervention Description
Based on genotype of SNPs potentially relevant to weight control, tailored lifestyle guidance to facilitate weight loss will be provided.
Intervention Type
Behavioral
Intervention Name(s)
general lifestyle intervention
Intervention Description
Regardless of individuals' genetic make-up, general lifestyle guidance to facilitate weight loss will be provided.
Primary Outcome Measure Information:
Title
weight change (kg)
Description
change in weight from the time of randomization
Time Frame
at six months, 1 year, and 2 years after randomization
Secondary Outcome Measure Information:
Title
waist circumference (cm)
Description
change in waist circumference from the time of randomization
Time Frame
at six months, 1 year, and 2 years after randomization
Other Pre-specified Outcome Measures:
Title
body composition (% muscle)
Description
change in body composition from the time of randomization
Time Frame
at six months, 1 year, and 2 years after randomization
Title
body composition (% fat)
Description
change in body composition from the time of randomization
Time Frame
at six months, 1 year, and 2 years after randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
overweight or obese individuals
Exclusion Criteria:
a past history of bariatric surgery or eating disorders
currently pregnant or planning a pregnancy within 2 years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
NaNa Keum, ScD
Organizational Affiliation
DongGuk University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dongguk University
City
Goyang-si
State/Province
Kyungki Do
ZIP/Postal Code
10326
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Personalized Lifestyle Intervention and Weight Control
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