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Timing of Meals for Weight Loss (TIME)

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ClinicalTrials.gov Identifier: NCT02204735
Recruitment Status : Active, not recruiting
First Posted : July 30, 2014
Last Update Posted : July 17, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Overweight Obesity Weight Loss Behavioral: Eat majority of calories in the morning Behavioral: Eat the majority of calories in the evening

Detailed Description:
Thirty adults will be provided an 8-week standard lifestyle intervention, that includes a 1200-1500 kcal/day, < 30% energy from fat dietary prescription, and a physical activity goal of 200 minutes/week. Participants will be randomized to one of two conditions differing in timing of energy consumed during eating bouts. Both conditions will limit the number of eating bouts/day to three. Participants will be instructed to eat their first eating bout within one hour of awakening and to consume their second and third eating bouts within five or six hours of their previous bout. Participants will be discouraged from eating at least one hour prior to going to sleep. During the intervention, participants will be instructed to self-monitor the time they wake up, the time of the start of each eating bout, and time they go to bed, as well as foods and beverages, and portion sizes, consumed. One condition will consume more energy earlier in the day (MORNING), thus energy intake will be split amongst the three eating bouts with 50% in the first bout, 30% in the second bout, and 20% in the last bout. The second condition will consume more energy later in the day (EVENING), thus energy intake will be split amongst the three eating bouts with 20% in the first bout, 30% in the second bout, and 50% in the last bout.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Timing of Meals for Weight Loss
Actual Study Start Date : July 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: MORNING
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
Experimental: EVENING
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


Outcome Measures

Primary Outcome Measures :
  1. weight [ Time Frame: 0 and 8 weeks ]
    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.


Secondary Outcome Measures :
  1. physical activity [ Time Frame: 0 and 8 weeks ]
    the SenseWear® armband from BodyMedia will measure physical activity-related energy expenditure for the course of the study. Energy expenditure will be calculated using the corresponding software. This armband reports physical activity in total minutes and joules expended. Furthermore, this armband reports minutes of physical activity divided into 5 categories: sedentary activities (<1.5 METS), light physical activity (1.5-2.9 METS), moderate activity (3.0-5.9 METS), vigorous activity (6.0-8.9 METS), and very vigorous activity (≥9.0 METS). Minutes of active energy expenditure are also reported, which includes total number of minutes engaged in moderate, vigorous, or very vigorous activity. For each participant, mean minutes of sedentary, light, moderate, and vigorous activity (vigorous activity + very vigorous activity) will be calculated over the course of the 7 days.

  2. sleep [ Time Frame: 0 and 8 weeks ]
    participants will be instructed to wear the SenseWear® armband from BodyMedia® on their upper left arm for 7 days. Participants will be instructed to wear the armband for 23 hours a day for each of the 7-day time frames. The SenseWear® has been shown to be a reliable measurement for total sleep time in both individuals with and without obstructive sleep apnea. The SenseWear® armband recognizes the onset of sleep when there is a drop in the heat flux sensor (arm skin temperature).16 The BodyMedia® software then codes the output from the SenseWear® as either wake or sleep (regardless of sleep stage) binary codes,15 based on manufacturer sleep algorithms.16 The armband reports total minutes of lying down and total minutes wake/sleep during the lying down time, allowing sleep efficiency to be calculated. For each participant, minutes of sleep per 24 hrs and mean sleep efficiency will be calculated from the 7 days of measures.

  3. diet [ Time Frame: 0 and 8 weeks ]
    Energy and macronutrient intake overall and per eating bout will be assessed by 3 day (2 weekdays and 1 weekend) food records. Eating bouts will only be counted if at least 25 kcals were consumed. All foods and beverages, eaten within 1/2 h of the start of a meal, will be counted as a single eating bout. To determine dietary variables, each food record will be entered into the Nutrition Data System for Research (NDS-R) software developed by the Nutrition Coordinating Center, University of Minnesota, Minneapolis, Minnesota.

  4. feelings of hunger and fullness [ Time Frame: 0 and 8 weeks ]
    EMA protocol will be conducted over 7 continuous days using both semi-random and event-contingent sampling. Semi-random sampling will assess consumption cues (i.e. feelings of temptation, fullness, desire to eat, energy level and control over eating), along with feelings of hunger, satiation, and deprivation. Event-based sampling will assess these same cues and feelings, as well as reasons for initiating and terminating eating, Time-based and event-based sampling questions will be programmed and displayed using Satellite Forms™ MobileApp Designer software (Thacker Network Technologies Inc., Alberta, Canada).


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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).
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02204735


Locations
United States, Tennessee
Univeristy of Tennessee--HEAL Lab
Knoxville, Tennessee, United States, 37996
Sponsors and Collaborators
University of Tennessee
Investigators
Principal Investigator: Hollie Raynor, Ph, RD University of Tennessee
More Information

Additional Information:
Responsible Party: Hollie Raynor, Principal Investigator, University of Tennessee
ClinicalTrials.gov Identifier: NCT02204735     History of Changes
Other Study ID Numbers: UTK_9560 B
First Posted: July 30, 2014    Key Record Dates
Last Update Posted: July 17, 2017
Last Verified: July 2017

Keywords provided by Hollie Raynor, University of Tennessee:
Meal Time
Weight Loss
Circadian Rhythm

Additional relevant MeSH terms:
Body Weight
Overweight
Weight Loss
Signs and Symptoms
Body Weight Changes