Back to resultsTiming of Meals for Weight Loss (TIME)
Primary Purpose
Overweight, Obesity, Weight Loss
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Eat majority of calories in the morning
Eat the majority of calories in the evening
Sponsored by
About this trial
This is an interventional treatment trial for Overweight focused on measuring Meal Time, Weight Loss, Circadian Rhythm
Eligibility 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).
Sites / Locations
- Univeristy of Tennessee--HEAL Lab
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
MORNING
EVENING
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
physical activity
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.
sleep
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.
diet
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.
feelings of hunger and fullness
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).
Full Information
NCT ID
NCT02204735
First Posted
July 28, 2014
Last Updated
April 3, 2018
Sponsor
The University of Tennessee, Knoxville
1. Study Identification
Unique Protocol Identification Number
NCT02204735
Brief Title
Timing of Meals for Weight Loss
Acronym
TIME
Official Title
Timing of Meals for Weight Loss
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
July 2014 (Actual)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Tennessee, Knoxville
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity, Weight Loss
Keywords
Meal Time, Weight Loss, Circadian Rhythm
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MORNING
Arm Type
Experimental
Arm Description
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.
Arm Title
EVENING
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Eat majority of calories in the morning
Intervention Type
Behavioral
Intervention Name(s)
Eat the majority of calories in the evening
Primary Outcome Measure Information:
Title
weight
Description
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.
Time Frame
0 and 8 weeks
Secondary Outcome Measure Information:
Title
physical activity
Description
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.
Time Frame
0 and 8 weeks
Title
sleep
Description
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.
Time Frame
0 and 8 weeks
Title
diet
Description
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.
Time Frame
0 and 8 weeks
Title
feelings of hunger and fullness
Description
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).
Time Frame
0 and 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hollie Raynor, Ph, RD
Organizational Affiliation
University of Tennessee
Official's Role
Principal Investigator
Facility Information:
Facility Name
Univeristy of Tennessee--HEAL Lab
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37996
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Timing of Meals for Weight Loss
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