Trial Outcomes & Findings for Weight Change in PWS Over Six Months (NCT NCT03585244)
NCT ID: NCT03585244
Last Updated: 2021-01-11
Results Overview
weekly weight data will be collected via text for 6 months
Recruitment status
COMPLETED
Target enrollment
180 participants
Primary outcome timeframe
baseline and 6 months
Results posted on
2021-01-11
Participant Flow
Participant milestones
| Measure |
Individuals With Prader-Willi Syndrome
Individuals with Prader-Willi Syndrome aged 12 and over will be recruited to gather data on weekly weight over six months
weekly weight: weekly weight data collection for six months
|
|---|---|
|
Overall Study
STARTED
|
180
|
|
Overall Study
COMPLETED
|
165
|
|
Overall Study
NOT COMPLETED
|
15
|
Reasons for withdrawal
| Measure |
Individuals With Prader-Willi Syndrome
Individuals with Prader-Willi Syndrome aged 12 and over will be recruited to gather data on weekly weight over six months
weekly weight: weekly weight data collection for six months
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
15
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Individuals With Prader-Willi Syndrome
n=165 Participants
Individuals with Prader-Willi Syndrome aged 12 and over will be recruited to gather data on weekly weight over six months
weekly weight: weekly weight data collection for six months
|
|---|---|
|
Age, Categorical
<=18 years
|
88 Participants
n=165 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
77 Participants
n=165 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=165 Participants
|
|
Age, Continuous
|
19.7 Years
STANDARD_DEVIATION 7.9 • n=165 Participants
|
|
Sex: Female, Male
Female
|
81 Participants
n=165 Participants
|
|
Sex: Female, Male
Male
|
84 Participants
n=165 Participants
|
|
Region of Enrollment
United States
|
150 participants
n=165 Participants
|
|
Region of Enrollment
Canada
|
15 participants
n=165 Participants
|
|
Weight
|
76.8 Kilograms
STANDARD_DEVIATION 30.7 • n=165 Participants
|
|
Height
|
157.2 Centimeters
STANDARD_DEVIATION 13.2 • n=165 Participants
|
|
BMI
|
28.6 Kilograms/m^2
n=165 Participants
|
PRIMARY outcome
Timeframe: baseline and 6 monthsweekly weight data will be collected via text for 6 months
Outcome measures
| Measure |
Individuals With Prader-Willi Syndrome
n=165 Participants
Individuals with Prader-Willi Syndrome aged 12 and over will be recruited to gather data on weekly weight over six months
weekly weight: weekly weight data collection for six months
|
|---|---|
|
Percent of Change in Weight
|
2.35 Percent of change in weight
Standard Deviation 5.3
|
PRIMARY outcome
Timeframe: baseline and 6 monthsweekly weight and height data will be collected via text for 6 months
Outcome measures
| Measure |
Individuals With Prader-Willi Syndrome
n=165 Participants
Individuals with Prader-Willi Syndrome aged 12 and over will be recruited to gather data on weekly weight over six months
weekly weight: weekly weight data collection for six months
|
|---|---|
|
Percent of Change in BMI
|
1.42 Percent of change in BMI
Standard Deviation 5.9
|
Adverse Events
Individuals With Prader-Willi Syndrome
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
Theresa Strong, PhD - Director of Research Programs
Foundation for Prader-Willi Research
Phone: 888-322-5487
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place