Trial Outcomes & Findings for Portion Control Treatment for Obesity (NCT NCT01451554)
NCT ID: NCT01451554
Last Updated: 2011-11-28
Results Overview
Weight change as a percentage of baseline at post 6 months.
COMPLETED
PHASE2/PHASE3
65 participants
6 months
2011-11-28
Participant Flow
Patients were referred to the study by their primary health care provider. Recruitment began on January 14, 2009 and ended on May 21, 2010.
Participant milestones
| Measure |
Portion Control Intervention
Individuals will be given a portion control plate and dietary counseling
|
Usual Care
Provided with self-help booklets on diet and exercise.
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
32
|
|
Overall Study
COMPLETED
|
19
|
23
|
|
Overall Study
NOT COMPLETED
|
14
|
9
|
Reasons for withdrawal
| Measure |
Portion Control Intervention
Individuals will be given a portion control plate and dietary counseling
|
Usual Care
Provided with self-help booklets on diet and exercise.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
14
|
9
|
Baseline Characteristics
Portion Control Treatment for Obesity
Baseline characteristics by cohort
| Measure |
Portion Control Intervention
n=33 Participants
Individuals will be given a portion control plate and dietary counseling
|
Usual Care
n=32 Participants
Provided with self-help booklets on diet and exercise.
|
Total
n=65 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
|
28 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Age Continuous
|
55.4 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
56.3 years
STANDARD_DEVIATION 10.7 • n=7 Participants
|
55.9 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Baseline Weight
|
97.6 Kg
STANDARD_DEVIATION 12.8 • n=5 Participants
|
98.8 Kg
STANDARD_DEVIATION 12.5 • n=7 Participants
|
98.2 Kg
STANDARD_DEVIATION 12.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Intent to treat population includes all randomzied subjects. Missing data were imputed using the last observation carried forward.
Weight change as a percentage of baseline at post 6 months.
Outcome measures
| Measure |
Portion Control Intervention
n=33 Participants
Individuals will be given a portion control plate and dietary counseling
|
Usual Care
n=32 Participants
Provided with self-help booklets on diet and exercise.
|
|---|---|---|
|
Weight Change at 6 Months
|
-1.2 percentage
Standard Deviation 3.1
|
-0.4 percentage
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Intent to treat population includes all randomzied subjects. Missing data were imputed using the last observation carried forward.
Percentage change in weight at 3 months post study baseline
Outcome measures
| Measure |
Portion Control Intervention
n=33 Participants
Individuals will be given a portion control plate and dietary counseling
|
Usual Care
n=32 Participants
Provided with self-help booklets on diet and exercise.
|
|---|---|---|
|
Weight Change at 3 Months
|
-1.7 percentage
Standard Deviation 3.3
|
-0.4 percentage
Standard Deviation 1.9
|
Adverse Events
Portion Control Intervention
Usual Care
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