N/A
N=180
Weight Change in PWS Over Six Months
Weight Change, Body
Bottom Line
View on ClinicalTrials.gov: NCT03585244 ↗Enrolled (actual)
180
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Percent of Change in Weight — 2.35 Percent of change in weight
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- weekly weight (Other)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Foundation for Prader-Willi Research
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Change in Weight |
2.35 | — |
| PRIMARY Percent of Change in BMI |
1.42 | — |
Summary
This is a completely text-messaging based study and all data will be collected via surveys administered on a mobile phone. For this study, we will gather and analyze data on changes in body weight over a 6-month interval in individuals aged 12 and over. This will help us learn more about the normal variation in weight, over time, in the PWS population.
Eligibility Criteria
Inclusion Criteria
Participants with PWS are eligible for this study. Eligible PWS participants must be 12 years and older. Participant/legal representative of participant must have a text messaging enabled mobile phone in order to participate in the study Participants must reside in the U.S. or Canada
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Exclusion Criteria
Data sourced from ClinicalTrials.gov (NCT03585244). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.