Temporal Patterns of Diet and the Changes in Body Composition and Blood Pressure
1 other identifier
interventional
125
0 countries
N/A
Brief Summary
The study includes two parts: 1) an observational study examines the association of meal frequency, meal timing, and meal regularity with short-term changes in blood pressure and body composition; 2) a randomized controlled intervention examines the influence of recommendation of increase breakfast frequency and decrease nighttime snacking on 1-year changes in blood pressure and body composition.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2015
Longer than P75 for not_applicable
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
Study Start
First participant enrolled
August 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedFirst Submitted
Initial submission to the registry
January 30, 2019
CompletedFirst Posted
Study publicly available on registry
February 4, 2019
CompletedJune 25, 2020
June 1, 2020
3.3 years
January 30, 2019
June 23, 2020
Conditions
Outcome Measures
Primary Outcomes (6)
Body weight
Body weight in kilogram
1 year
Standing height
Height in meters
1 year
Body fat%
Bioimpedance method (TANITA BC-418)
1 year
Body mass index
Weight and height will be combined to report BMI in kg/m\^2
1 year
Systolic blood pressure
Measured in mmHg (Microlife BP 3MS1-4K)
1 year
Diastolic blood pressure
Measured in mmHg (Microlife BP 3MS1-4K)
1 year
Secondary Outcomes (2)
Frequency of breakfast per week
1 year
Frequency of nighttime snacking per week
1 year
Other Outcomes (2)
Sleep quality score
1 year
Mood status
1 year
Study Arms (3)
Breakfast promotion
ACTIVE COMPARATORReceiving the recommendation of daily breakfast
Nighttime snack reduction
ACTIVE COMPARATORReceiving the recommendation of reducing nighttime snack frequency
Breakfast promotion + nighttime snack reduction
EXPERIMENTALReceiving the recommendation of daily breakfast + reducing nighttime snack frequency
Interventions
Recommendation of having breakfast daily
Recommendation of reducing frequency of nighttime snacking
Eligibility Criteria
You may qualify if:
- Adult
- Willing to participate
You may not qualify if:
- Being pregnant
- hemodialysis patients
- clinical diagnosis of cardiovascular diseases
- clinical diagnosis of cancer
- clinical diagnosis of dementia
- clinical diagnosis of eating disorders
- having metal orthopedic implants
- having pacemaker implanted
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Chen HJ, Tsai YC, Hsu YT, Chu J. Effect of recommendations of breakfast and late-evening snack habits on body composition and blood pressure: A pilot randomized trial. Chronobiol Int. 2024 Jul;41(7):1021-1033. doi: 10.1080/07420528.2024.2363492. Epub 2024 Jun 11.
PMID: 38860554DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Hsin-Jen Chen, PhD
National Yang Ming Chiao Tung University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
January 30, 2019
First Posted
February 4, 2019
Study Start
August 1, 2015
Primary Completion
October 31, 2018
Study Completion
December 31, 2018
Last Updated
June 25, 2020
Record last verified: 2020-06