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Clinical Trials/NCT03828812
NCT03828812CompletedNot Applicable

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

National Yang Ming Chiao Tung University0 sites125 target enrollmentStarted: August 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
125
Primary Endpoint
Standing height

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
20 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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

Arms & Interventions

Breakfast promotion

Active Comparator

Receiving the recommendation of daily breakfast

Intervention: Breakfast promotion (Behavioral)

Nighttime snack reduction

Active Comparator

Receiving the recommendation of reducing nighttime snack frequency

Intervention: Nighttime snack reduction (Behavioral)

Breakfast promotion + nighttime snack reduction

Experimental

Receiving the recommendation of daily breakfast + reducing nighttime snack frequency

Intervention: Breakfast promotion (Behavioral)

Breakfast promotion + nighttime snack reduction

Experimental

Receiving the recommendation of daily breakfast + reducing nighttime snack frequency

Intervention: Nighttime snack reduction (Behavioral)

Outcomes

Primary Outcomes

Standing height

Time Frame: 1 year

Height in meters

Diastolic blood pressure

Time Frame: 1 year

Measured in mmHg (Microlife BP 3MS1-4K)

Systolic blood pressure

Time Frame: 1 year

Measured in mmHg (Microlife BP 3MS1-4K)

Body mass index

Time Frame: 1 year

Weight and height will be combined to report BMI in kg/m\^2

Body weight

Time Frame: 1 year

Body weight in kilogram

Body fat%

Time Frame: 1 year

Bioimpedance method (TANITA BC-418)

Secondary Outcomes

  • Frequency of breakfast per week(1 year)
  • Frequency of nighttime snacking per week(1 year)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Hsin-Jen Chen

Assistant Professor

National Yang Ming Chiao Tung University

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