Trial Outcomes & Findings for Assessment of Energy Balance (NCT NCT01678885)
NCT ID: NCT01678885
Last Updated: 2017-05-31
Results Overview
A new method of digital photography of foods to measure the energy intake (EI) and macronutrient intake of free-living humans was tested. Digital photography (RFPM) EI was tested against measured food provisions during an in-feeding period and against EI measured with doubly labeled water (DLW) during free-living conditions for 1 week. EI measured by directly weighing food provisions in the clinic over two days and measuring food intake during free-living conditions over one week with the DLW.
COMPLETED
NA
87 participants
~6 days
2017-05-31
Participant Flow
Participant milestones
| Measure |
Phase I Sub-study 1 - Dig Photo First, Then IDEEA & Actical
Participants completed 2 phases of the study. Phase I included a 2-week doubly labeled water period where they also wore activity trackers for one week, and used a food photography method for the other week. Phase II was an 8-week partial supplement low-calorie diet (LCD). This diet plan was a 1000-1150 kcal/day diet composed of HealthOne shakes and prepackaged portion controlled foods or home-cooked meals that participants completed in a free-living environment. Participants returned to follow-up at six and twelve months after they completed the LCD. During these assessments, anthropometric and questionnaire data were collected.
|
Phase 1 Sub-study 1 - IDEEA & Actical First, Then Dig Photo
Participants completed 2 phases of the study. Phase I included a 2-week doubly labeled water period where they also wore activity trackers for one week, and used a food photography method for the other week. Phase II was an 8-week partial supplement low-calorie diet (LCD). This diet plan was a 1000-1150 kcal/day diet composed of HealthOne shakes and prepackaged portion controlled foods or home-cooked meals that participants completed in a free-living environment. Participants returned to follow-up at six and twelve months after they completed the LCD. During these assessments, anthropometric and questionnaire data were collected.
|
Phase 1 Sub Study 2 - Dig Photo First, Then Sensewear
Participants completed 2 phases of the study. Phase I included a 2-week doubly labeled water period where they also wore activity trackers for one week, and used a food photography method for the other week. Phase II was an 8-week partial supplement low-calorie diet (LCD). This diet plan was a 1000-1150 kcal/day diet composed of HealthOne shakes and prepackaged portion controlled foods or home-cooked meals that participants completed in a free-living environment. Participants returned to follow-up at six and twelve months after they completed the LCD. During these assessments, anthropometric and questionnaire data were collected.
|
Phase I Sub Study 2 - Sensewear First, Then Digital Photo
Phase 1- sensewear First, Then Digital Photography
|
Phase 2- Low-Calorie Diet
Participants from sub-study 1 and 2 had the chance to receive the low-calorie diet based on their eligibility; i.e., BMI level.
Participants completed 2 phases of the study. Phase I included a 2-week doubly labeled water period where they also wore activity trackers for one week, and used a food photography method for the other week. Phase II was an 8-week partial supplement low-calorie diet (LCD). This diet plan was a 1000-1150 kcal/day diet composed of HealthOne shakes and prepackaged portion controlled foods or home-cooked meals that participants completed in a free-living environment. Participants returned to follow-up at six and twelve months after they completed the LCD. During these assessments, anthropometric and questionnaire data were collected.
|
|---|---|---|---|---|---|
|
Phase I; 2 Wks Duration, Both Sub-study
STARTED
|
22
|
18
|
23
|
24
|
0
|
|
Phase I; 2 Wks Duration, Both Sub-study
COMPLETED
|
22
|
15
|
22
|
21
|
0
|
|
Phase I; 2 Wks Duration, Both Sub-study
NOT COMPLETED
|
0
|
3
|
1
|
3
|
0
|
|
Phase II; 8 Week Low Calorie Diet
STARTED
|
0
|
0
|
0
|
0
|
87
|
|
Phase II; 8 Week Low Calorie Diet
COMPLETED
|
0
|
0
|
0
|
0
|
70
|
|
Phase II; 8 Week Low Calorie Diet
NOT COMPLETED
|
0
|
0
|
0
|
0
|
17
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Assessment of Energy Balance
Baseline characteristics by cohort
| Measure |
Sub-study 1
n=40 Participants
During the first week of the doubly labeled water period (day 0 to 7), participants in group 1 will use digital photography of foods. During the second week of the doubly labeled water phase, participants in this group will wear the Intelligent Device for Energy Expenditure and Activity (IDEEA) monitor and an accelerometer.During the first week of the doubly labeled water period (day 0 to 7),participants in group 2 will wear the IDEEA monitor and accelerometer in the first week of the doubly labeled water period and digital photography of foods during the second week.Participants who complete Phase I of the study will receive a partial supplement low-calorie diet (LCD) for 8 weeks. Participants will return to follow-up at six and twelve months after they completed the LCD. During these assessments, anthropometric and questionnaire data will be collected.
|
Sub-study 2
n=47 Participants
During the first week of the doubly labeled water period (day 0 to 7), participants in group 1 will use digital photography of foods. During the second week of the doubly labeled water phase, participants in this group will wear the Intelligent Device for Energy Expenditure and Activity (IDEEA) monitor and an accelerometer.During the first week of the doubly labeled water period (day 0 to 7),participants in group 2 will wear the IDEEA monitor and accelerometer in the first week of the doubly labeled water period and digital photography of foods during the second week.Participants who complete Phase I of the study will receive a partial supplement low-calorie diet (LCD) for 8 weeks. Participants will return to follow-up at six and twelve months after they completed the LCD. During these assessments, anthropometric and questionnaire data will be collected.
|
Total
n=87 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
40 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
47 participants
n=7 Participants
|
87 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: ~6 daysPopulation: Free-living energy intake data were analyzed from the 40 participants who completed the protocol and provided urine samples for doubly labeled water analysis. This primary outcome measure was limited to one sub-study.
A new method of digital photography of foods to measure the energy intake (EI) and macronutrient intake of free-living humans was tested. Digital photography (RFPM) EI was tested against measured food provisions during an in-feeding period and against EI measured with doubly labeled water (DLW) during free-living conditions for 1 week. EI measured by directly weighing food provisions in the clinic over two days and measuring food intake during free-living conditions over one week with the DLW.
Outcome measures
| Measure |
Phase 1
n=42 Participants
During the first week of the doubly labeled water period (day 0 to 7), participants in group 1 will use digital photography of foods (RFPM). During the second week of the doubly labeled water phase, participants in this group will wear the Intelligent Device for Energy Expenditure and Activity (IDEEA) monitor and an accelerometer. Participants in group 2 will wear the IDEEA monitor and accelerometer in the first week of the doubly labeled water period and digital photography of foods during the second week.
|
|---|---|
|
ENERGY BALANCE EQUATION, PHASE I, ONE SUB-STUDY
EI (kcal) Measured with DLW
|
2360 kCal
Standard Deviation 626
|
|
ENERGY BALANCE EQUATION, PHASE I, ONE SUB-STUDY
EI (kcal) Measured with RFPM
|
2208 kCal
Standard Deviation 665
|
|
ENERGY BALANCE EQUATION, PHASE I, ONE SUB-STUDY
Difference of EI (kcal) measured with DLW and RFPM
|
-152 kCal
Standard Deviation 694
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Weight change was evaluated from all participants who received the low calorie diet in sub-studies 1 and 2 combined.
The secondary aim was to test if posture allocation (the amount of time spent engaging in certain behaviors e.g., sitting, walking, running, changing positions and the energy burned during these activities) predicts weight change over one year following a period of weight loss.
Outcome measures
| Measure |
Phase 1
n=53 Participants
During the first week of the doubly labeled water period (day 0 to 7), participants in group 1 will use digital photography of foods (RFPM). During the second week of the doubly labeled water phase, participants in this group will wear the Intelligent Device for Energy Expenditure and Activity (IDEEA) monitor and an accelerometer. Participants in group 2 will wear the IDEEA monitor and accelerometer in the first week of the doubly labeled water period and digital photography of foods during the second week.
|
|---|---|
|
Weight Change
|
-6.3 kg
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: 1 weekPopulation: Of the 87 participants considered from phase 1 of sub-studies 1 and 2, five were excluded because they did not finish baseline accelerometry assessment, five were excluded because they did not enter the LCD due to BMI's \< 25. Seven were excluded because they did not successfully complete all aspects of the DLW dosing period.
Bland-Altman analyses compared the TDEE and AEE from the Sensewear® and IDEEA and Actical monitors to the DLW data from the week participants wore the monitors. Only the week of DLW data that corresponded with the wearing of the monitors was used for this analysis.
Outcome measures
| Measure |
Phase 1
n=70 Participants
During the first week of the doubly labeled water period (day 0 to 7), participants in group 1 will use digital photography of foods (RFPM). During the second week of the doubly labeled water phase, participants in this group will wear the Intelligent Device for Energy Expenditure and Activity (IDEEA) monitor and an accelerometer. Participants in group 2 will wear the IDEEA monitor and accelerometer in the first week of the doubly labeled water period and digital photography of foods during the second week.
|
|---|---|
|
Total Energy Expenditure (TEE) and Activity Energy Expenditure (AEE) Predictions From Actical, IDEEA, and Sensewear Monitors (kcal/Day)
kcal/day, IDEEA AEE
|
108.77 kcal/day
Standard Deviation 436.8
|
|
Total Energy Expenditure (TEE) and Activity Energy Expenditure (AEE) Predictions From Actical, IDEEA, and Sensewear Monitors (kcal/Day)
kcal/day; Sensewear TEE
|
-59.98 kcal/day
Standard Deviation 411.5
|
|
Total Energy Expenditure (TEE) and Activity Energy Expenditure (AEE) Predictions From Actical, IDEEA, and Sensewear Monitors (kcal/Day)
kcal/day, IDEEA TEE
|
121.72 kcal/day
Standard Deviation 467.8
|
|
Total Energy Expenditure (TEE) and Activity Energy Expenditure (AEE) Predictions From Actical, IDEEA, and Sensewear Monitors (kcal/Day)
kcal/day, Actical Waist AEE
|
-111.38 kcal/day
Standard Deviation 354.1
|
|
Total Energy Expenditure (TEE) and Activity Energy Expenditure (AEE) Predictions From Actical, IDEEA, and Sensewear Monitors (kcal/Day)
kcal/day, Actical Wrist AEE
|
194.52 kcal/day
Standard Deviation 454.0
|
|
Total Energy Expenditure (TEE) and Activity Energy Expenditure (AEE) Predictions From Actical, IDEEA, and Sensewear Monitors (kcal/Day)
kcal/day, Sensewear AEE
|
-416.95 kcal/day
Standard Deviation 370.6
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Participants from sub-study 1 and 2 combined were used in this analysis.
This secondary aim of the study was evaluated with linear regression analysis to determine if TEE, AEE, or measures of posture allocation predicted weight loss during the 8-week LCD. Percent weight change from diet initiation to termination was the dependent variable for the weight loss regressions. Of the 87 participants considered for these secondary analyses, five were excluded because they did not finish baseline accelerometry assessment, and an additional five were excluded because they did not enter the LCD phase due to BMI's \< 25. Finally, seven more participants from this original sample were excluded because they did not successfully complete all aspects of the DLW dosing period. Finally, an additional 4 subjects were lost to follow up during the 8-week LCD period. Thus, 66 participants were included in the analysis
Outcome measures
| Measure |
Phase 1
n=66 Participants
During the first week of the doubly labeled water period (day 0 to 7), participants in group 1 will use digital photography of foods (RFPM). During the second week of the doubly labeled water phase, participants in this group will wear the Intelligent Device for Energy Expenditure and Activity (IDEEA) monitor and an accelerometer. Participants in group 2 will wear the IDEEA monitor and accelerometer in the first week of the doubly labeled water period and digital photography of foods during the second week.
|
|---|---|
|
Device Predictions of % Weight Change During and After an 8-week LCD
Actical (waist) AEE
|
0.00 R squared
|
|
Device Predictions of % Weight Change During and After an 8-week LCD
IDEEA TEE
|
.03 R squared
|
|
Device Predictions of % Weight Change During and After an 8-week LCD
Actical (wrist) AEE
|
0.00 R squared
|
|
Device Predictions of % Weight Change During and After an 8-week LCD
Sensewear TEE
|
0.00 R squared
|
|
Device Predictions of % Weight Change During and After an 8-week LCD
Sensewear AEE
|
0.10 R squared
|
Adverse Events
Sub-study 1
Sub-study 2
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Corby Martin, Ph.D.
Pennington Biomedical Research Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place