NCT02204735

Brief Summary

While eating the majority of energy earlier in the day appears to have a positive effect on weight and cardiometabolic outcomes, it is not clear how eating earlier in the day influences other behaviors that have a circadian rhythm (sleep), other energy balance behaviors important for weight loss (physical activity), and self-reported feelings of appetite control (hunger and fullness). Thus the purpose of this study is to examine the influence of timing of eating on sleep patterns, physical activity, and self-reported feelings of appetite control. It is hypothesized that those who eat the majority of their calories earlier in the day will have greater weight loss than those who eat the majority later in the day.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

July 1, 2014

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

July 28, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 30, 2014

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

April 5, 2018

Status Verified

April 1, 2018

Enrollment Period

3.3 years

First QC Date

July 28, 2014

Last Update Submit

April 3, 2018

Conditions

Keywords

Meal TimeWeight LossCircadian Rhythm

Outcome Measures

Primary Outcomes (1)

  • weight

    Weight will be assessed by an electronic scale, and height will be assessed using a stadiometer, using standard procedures, with participants wearing light clothing, without shoes. BMI (kg/m2) will be calculated from these measures.

    0 and 8 weeks

Secondary Outcomes (4)

  • physical activity

    0 and 8 weeks

  • sleep

    0 and 8 weeks

  • diet

    0 and 8 weeks

  • feelings of hunger and fullness

    0 and 8 weeks

Study Arms (2)

MORNING

EXPERIMENTAL

Participants will be instructed to consume 50% of their energy intake in their first eating bout, 30% in their second eating bout, and 20% in their third eating bout. For example, a participant prescribed a 1200 kcal/d diet needs to consume 600 kcal in their first eating bout, 360 kcal in their second bout, and 240 kcal in their third bout. Participants will be provided with sample meal plans meeting this prescription.

Behavioral: Eat majority of calories in the morning

EVENING

EXPERIMENTAL

Participants will be instructed to consume 20% of their energy intake in their first eating bout, 30% in their second eating bout, and 50% in their third eating bout. For example, a participant prescribed a 1200 kcal/d diet needs to consume 240 kcal in their first eating bout, 360 kcal in their second bout, and 600 kcal in their third bout. Participants will be provided with sample meal plans meeting this prescription.

Behavioral: Eat the majority of calories in the evening

Interventions

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • body mass index (BMI) between 27 and 45 kg/m2
  • normal self-reported daily (weekday and weekend) wake-up time between 5 am and 8 am
  • normal, self-reported weekend wake-up time within two hours of their normal, self-reported weekday wake-up time
  • regularly (at least five nights/week) get at least six total hours of self-reported sleep

You may not qualify if:

  • report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q)
  • report being unable to walk for 2 blocks (1/4 mile) without stopping
  • are currently participating in a weight loss program and/or taking weight loss medication or lost \> 5% of body weight during the past 6 months
  • are diagnosed with type 1 or 2 diabetes
  • have had bariatric surgery or are planning to have bariatric surgery within the next 4 months
  • intend to move outside of the metropolitan area within the time frame of the investigation
  • are pregnant, lactating, \< 6 months post-partum, or plan to become pregnant during the investigation
  • are taking mediation to aid in sleep
  • are shift workers/alternative shift workers that work outside of 7 am and 7 pm
  • have a metal allergy (which would prevent the ability of participant to wear the SenseWear® armband from BodyMedia® used in the proposed study).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univeristy of Tennessee--HEAL Lab

Knoxville, Tennessee, 37996, United States

Location

Related Links

MeSH Terms

Conditions

OverweightObesityWeight Loss

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Hollie Raynor, Ph, RD

    University of Tennessee

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 28, 2014

First Posted

July 30, 2014

Study Start

July 1, 2014

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

April 5, 2018

Record last verified: 2018-04

Locations