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

• Sponsor: National Yang Ming University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03828812
• Collaborator: (none)
• Enrollment: 125
• Arms: 3
• Actual Duration (Months): 41

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Body Composition; Blood Pressure; Mealtimes	Behavioral: Breakfast promotion; Behavioral: Nighttime snack reduction	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 125 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Temporal Patterns of Diet and the Changes in Body Composition and Blood Pressure
• Actual Study Start Date: Aug 1, 2015
• Actual Primary Completion Date: Oct 31, 2018
• Actual Study Completion Date: Dec 31, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Body weight [1 year]

   Body weight in kilogram

2. Standing height [1 year]

   Height in meters

3. Body fat% [1 year]

   Bioimpedance method (TANITA BC-418)

4. Body mass index [1 year]

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

5. Systolic blood pressure [1 year]

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

6. Diastolic blood pressure [1 year]

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

Secondary Outcome Measures

1. Frequency of breakfast per week [1 year]

   Self-report food frequency questionnaire(0-7 days/week)

2. Frequency of nighttime snacking per week [1 year]

   Self-report food frequency questionnaire(0-7 days/week)

Other Outcome Measures

1. Sleep quality score [1 year]

   Pittsburgh Sleep Questionnaire(0-21 points): The higher scores, the worse sleep quality

2. Mood status [1 year]

   Depression, Anxiety, Stress Scale (DASS): The higher scores, the worse moods

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• National Yang Ming University

Investigators

• Principal Investigator: Hsin-Jen Chen, PhD, National Yang Ming University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hsin-Jen Chen, Assistant Professor, National Yang Ming University
• ClinicalTrials.gov Identifier: NCT03828812
• Other Study ID Numbers: YM104136E
• First Posted: Feb 4, 2019
• Last Update Posted: Jun 25, 2020
• Last Verified: Jun 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jun 25, 2020