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OpenTrials
Completed

NCT Number: NCT03828812

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.

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Key information

Conditions

Body Composition Blood Pressure Mealtimes

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Breakfast promotion

Behavioral

Recommendation of having breakfast daily

Nighttime snack reduction

Behavioral

Recommendation of reducing frequency of nighttime snacking

Primary outcomes

  1. Body weight

    Time frame: 1 year

    Body weight in kilogram

  2. Standing height

    Time frame: 1 year

    Height in meters

  3. Body fat%

    Time frame: 1 year

    Bioimpedance method (TANITA BC-418)

  4. Body mass index

    Time frame: 1 year

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

  5. Systolic blood pressure

    Time frame: 1 year

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

  6. Diastolic blood pressure

    Time frame: 1 year

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

Secondary outcomes

  1. Frequency of breakfast per week

    Time frame: 1 year

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

  2. Frequency of nighttime snacking per week

    Time frame: 1 year

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

Other outcomes

  1. Sleep quality score

    Time frame: 1 year

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

  2. Mood status

    Time frame: 1 year

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

Sponsors and collaborators

Lead sponsor

National Yang Ming Chiao Tung University

Other

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Feb 4, 2019
Registry last updated
Jun 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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