Trial Outcomes & Findings for Effectiveness of Four Popular Diet Strategies for Weight Loss and Cardiac Risk Reduction (NCT NCT02454127)
NCT ID: NCT02454127
Last Updated: 2016-10-31
Results Overview
Change from baseline body weight at 1 year, measured in kilograms
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
160 participants
Primary outcome timeframe
1 year
Results posted on
2016-10-31
Participant Flow
Participant milestones
| Measure |
Atkins Diet
Atkins Diet (dietary counseling)
Atkins Diet: Dietary counseling for 1 year
|
Zone Diet
Zone Diet (dietary counseling)
Zone Diet: Dietary counseling for 1 year
|
Weight Watchers Diet
Weight Watchers Diet (dietary counseling)
Weight Watchers Diet: Dietary counseling for 1 year
|
Ornish Diet
Ornish Diet (dietary counseling)
Ornish Diet: Dietary counseling for 1 year
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
40
|
40
|
|
Overall Study
COMPLETED
|
21
|
26
|
26
|
20
|
|
Overall Study
NOT COMPLETED
|
19
|
14
|
14
|
20
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness of Four Popular Diet Strategies for Weight Loss and Cardiac Risk Reduction
Baseline characteristics by cohort
| Measure |
Atkins Diet
n=40 Participants
Atkins Diet (dietary counseling)
Atkins Diet: Dietary counseling for 1 year
|
Zone Diet
n=40 Participants
Zone Diet (dietary counseling)
Zone Diet: Dietary counseling for 1 year
|
Weight Watchers Diet
n=40 Participants
Weight Watchers Diet (dietary counseling)
Weight Watchers Diet: Dietary counseling for 1 year
|
Ornish Diet
n=40 Participants
Ornish Diet (dietary counseling)
Ornish Diet: Dietary counseling for 1 year
|
Total
n=160 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
47 years
STANDARD_DEVIATION 12 • n=5 Participants
|
51 years
STANDARD_DEVIATION 9 • n=7 Participants
|
49 years
STANDARD_DEVIATION 10 • n=5 Participants
|
49 years
STANDARD_DEVIATION 12 • n=4 Participants
|
49 years
STANDARD_DEVIATION 11 • n=21 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
81 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
79 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
40 participants
n=7 Participants
|
40 participants
n=5 Participants
|
40 participants
n=4 Participants
|
160 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Intent-to-treat analysis. Missing data were replaced with baseline values.
Change from baseline body weight at 1 year, measured in kilograms
Outcome measures
| Measure |
Atkins Diet
n=40 Participants
Atkins Diet (dietary counseling)
Atkins Diet: Dietary counseling for 1 year
|
Zone Diet
n=40 Participants
Zone Diet (dietary counseling)
Zone Diet: Dietary counseling for 1 year
|
Weight Watchers Diet
n=40 Participants
Weight Watchers Diet (dietary counseling)
Weight Watchers Diet: Dietary counseling for 1 year
|
Ornish Diet
n=40 Participants
Ornish Diet (dietary counseling)
Ornish Diet: Dietary counseling for 1 year
|
|---|---|---|---|---|
|
Weight Loss
|
-2.1 kg
Standard Deviation 4.8
|
-3.2 kg
Standard Deviation 6.0
|
-3.0 kg
Standard Deviation 4.9
|
-3.3 kg
Standard Deviation 7.3
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Intent-to-treat analysis. Missing data were replaced with baseline data.
Change in total cholesterol from baseline at 1 year, measured in mg/dL
Outcome measures
| Measure |
Atkins Diet
n=40 Participants
Atkins Diet (dietary counseling)
Atkins Diet: Dietary counseling for 1 year
|
Zone Diet
n=40 Participants
Zone Diet (dietary counseling)
Zone Diet: Dietary counseling for 1 year
|
Weight Watchers Diet
n=40 Participants
Weight Watchers Diet (dietary counseling)
Weight Watchers Diet: Dietary counseling for 1 year
|
Ornish Diet
n=40 Participants
Ornish Diet (dietary counseling)
Ornish Diet: Dietary counseling for 1 year
|
|---|---|---|---|---|
|
Total Cholesterol
|
-4.3 mg/dL
Standard Deviation 23
|
-10.1 mg/dL
Standard Deviation 35
|
-8.2 mg/dL
Standard Deviation 24
|
-10.8 mg/dL
Standard Deviation 21
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Intent-to-treat analysis. Missing data were replaced with baseline values
Change from baseline LDL cholesterol at 1 year, measured in mg/dL
Outcome measures
| Measure |
Atkins Diet
n=40 Participants
Atkins Diet (dietary counseling)
Atkins Diet: Dietary counseling for 1 year
|
Zone Diet
n=40 Participants
Zone Diet (dietary counseling)
Zone Diet: Dietary counseling for 1 year
|
Weight Watchers Diet
n=40 Participants
Weight Watchers Diet (dietary counseling)
Weight Watchers Diet: Dietary counseling for 1 year
|
Ornish Diet
n=40 Participants
Ornish Diet (dietary counseling)
Ornish Diet: Dietary counseling for 1 year
|
|---|---|---|---|---|
|
LDL Cholesterol
|
-7.1 mg/dL
Standard Deviation 24
|
-11.8 mg/dL
Standard Deviation 34
|
-9.3 mg/dL
Standard Deviation 27
|
-12.6 mg/dL
Standard Deviation 19
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Intent-to-treat analysis. Missing data were replaced with baseline values.
Change from baseline HDL cholesterol at 1 year, measured in mg/dL
Outcome measures
| Measure |
Atkins Diet
n=40 Participants
Atkins Diet (dietary counseling)
Atkins Diet: Dietary counseling for 1 year
|
Zone Diet
n=40 Participants
Zone Diet (dietary counseling)
Zone Diet: Dietary counseling for 1 year
|
Weight Watchers Diet
n=40 Participants
Weight Watchers Diet (dietary counseling)
Weight Watchers Diet: Dietary counseling for 1 year
|
Ornish Diet
n=40 Participants
Ornish Diet (dietary counseling)
Ornish Diet: Dietary counseling for 1 year
|
|---|---|---|---|---|
|
HDL Cholesterol
|
3.4 mg/dL
Standard Deviation 7.1
|
3.3 mg/dL
Standard Deviation 10.3
|
3.4 mg/dL
Standard Deviation 9.9
|
-0.5 mg/dL
Standard Deviation 6.5
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Intent-to-treat analysis. Missing data were replaced with baseline values
Change from baseline triglycerides at 1 year, measured in mg/dL
Outcome measures
| Measure |
Atkins Diet
n=40 Participants
Atkins Diet (dietary counseling)
Atkins Diet: Dietary counseling for 1 year
|
Zone Diet
n=40 Participants
Zone Diet (dietary counseling)
Zone Diet: Dietary counseling for 1 year
|
Weight Watchers Diet
n=40 Participants
Weight Watchers Diet (dietary counseling)
Weight Watchers Diet: Dietary counseling for 1 year
|
Ornish Diet
n=40 Participants
Ornish Diet (dietary counseling)
Ornish Diet: Dietary counseling for 1 year
|
|---|---|---|---|---|
|
Triglycerides
|
-1.2 mg/dL
Standard Deviation 84
|
2.5 mg/dL
Standard Deviation 147
|
-12.7 mg/dL
Standard Deviation 61
|
5.6 mg/dL
Standard Deviation 36
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Intent-to-treat analysis. Missing data were replaced with baseline values.
Change from baseline glucose at 1 year, measured in mg/dL
Outcome measures
| Measure |
Atkins Diet
n=40 Participants
Atkins Diet (dietary counseling)
Atkins Diet: Dietary counseling for 1 year
|
Zone Diet
n=40 Participants
Zone Diet (dietary counseling)
Zone Diet: Dietary counseling for 1 year
|
Weight Watchers Diet
n=40 Participants
Weight Watchers Diet (dietary counseling)
Weight Watchers Diet: Dietary counseling for 1 year
|
Ornish Diet
n=40 Participants
Ornish Diet (dietary counseling)
Ornish Diet: Dietary counseling for 1 year
|
|---|---|---|---|---|
|
Glucose
|
1.4 mg/dL
Standard Deviation 30
|
-4.2 mg/dL
Standard Deviation 18
|
-4.7 mg/dL
Standard Deviation 19
|
-4.1 mg/dL
Standard Deviation 30
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Intent-to-treat analysis. Missing data were replaced with baseline values
Change from baseline insulin at 1 year, measured in microIU/mL
Outcome measures
| Measure |
Atkins Diet
n=40 Participants
Atkins Diet (dietary counseling)
Atkins Diet: Dietary counseling for 1 year
|
Zone Diet
n=40 Participants
Zone Diet (dietary counseling)
Zone Diet: Dietary counseling for 1 year
|
Weight Watchers Diet
n=40 Participants
Weight Watchers Diet (dietary counseling)
Weight Watchers Diet: Dietary counseling for 1 year
|
Ornish Diet
n=40 Participants
Ornish Diet (dietary counseling)
Ornish Diet: Dietary counseling for 1 year
|
|---|---|---|---|---|
|
Insulin
|
-1.2 microIU/ml
Standard Deviation 6.7
|
-5.4 microIU/ml
Standard Deviation 14
|
-2.6 microIU/ml
Standard Deviation 6.1
|
-3.0 microIU/ml
Standard Deviation 6.3
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Intent-to-treat analysis. Missing data were replaced with baseline values.
Change from baseline high-sensitivity CRP at 1 year, measured in mg/L
Outcome measures
| Measure |
Atkins Diet
n=40 Participants
Atkins Diet (dietary counseling)
Atkins Diet: Dietary counseling for 1 year
|
Zone Diet
n=40 Participants
Zone Diet (dietary counseling)
Zone Diet: Dietary counseling for 1 year
|
Weight Watchers Diet
n=40 Participants
Weight Watchers Diet (dietary counseling)
Weight Watchers Diet: Dietary counseling for 1 year
|
Ornish Diet
n=40 Participants
Ornish Diet (dietary counseling)
Ornish Diet: Dietary counseling for 1 year
|
|---|---|---|---|---|
|
C-reactive Protein
|
-0.70 mg/L
Standard Deviation 2.1
|
-0.58 mg/L
Standard Deviation 2.1
|
-0.58 mg/L
Standard Deviation 1.3
|
-0.88 mg/L
Standard Deviation 2.4
|
Adverse Events
Atkins Diet
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Zone Diet
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Weight Watchers Diet
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ornish Diet
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place