Temporal Patterns of Diet and the Changes in Body Composition and Blood Pressure

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.

Study Overview

• Status: Completed
• Conditions: Body Composition; Blood Pressure; Mealtimes
• Intervention / Treatment: Behavioral: Breakfast promotion; Behavioral: Nighttime snack reduction

• Study Type: Interventional
• Enrollment (Actual): 125
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion criteria:

• Adult
• Willing to participate

Exclusion criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Breakfast promotion; Receiving the recommendation of daily breakfast	Behavioral: Breakfast promotion; Recommendation of having breakfast daily
Active Comparator: Nighttime snack reduction; Receiving the recommendation of reducing nighttime snack frequency	Behavioral: Nighttime snack reduction; Recommendation of reducing frequency of nighttime snacking
Experimental: Breakfast promotion + nighttime snack reduction; Receiving the recommendation of daily breakfast + reducing nighttime snack frequency	Behavioral: Breakfast promotion; Recommendation of having breakfast daily; Behavioral: Nighttime snack reduction; Recommendation of reducing frequency of nighttime snacking

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of breakfast per week	Self-report food frequency questionnaire(0-7 days/week)	1 year
Frequency of nighttime snacking per week	Self-report food frequency questionnaire(0-7 days/week)	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep quality score	Pittsburgh Sleep Questionnaire(0-21 points): The higher scores, the worse sleep quality	1 year
Mood status	Depression, Anxiety, Stress Scale (DASS): The higher scores, the worse moods	1 year

Collaborators and Investigators

• Sponsor: National Yang Ming University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Actual): October 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: January 30, 2019
• First Submitted That Met QC Criteria: February 1, 2019
• First Posted (Actual): February 4, 2019

Study Record Updates

• Last Update Posted (Actual): June 25, 2020
• Last Update Submitted That Met QC Criteria: June 23, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: YM104136E

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No