MedPath

Weight Change in PWS Over Six Months

Completed
Conditions
Weight Change, Body
Registration Number
NCT03585244
Lead Sponsor
Foundation for Prader-Willi Research
Brief 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.

Detailed Description

The incidence and natural history of several PWS symptoms are poorly defined. In this text-messaging based study we will gather and analyze data on changes in body weight over a 6-month interval, in individuals aged 12 and over. We would like to learn about the normal weight variation in the PWS population.

We anticipate that this study will inform future clinical trials for hyperphagia/obesity related therapies, and provide a basis for understanding how well potential therapies are working. For this study, there will be no intervention and the all data will be collected via texting.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
180
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

Exclusion Criteria

Not provided

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Percent of Change in Weightbaseline and 6 months

weekly weight data will be collected via text for 6 months

Percent of Change in BMIbaseline and 6 months

weekly weight and height data will be collected via text for 6 months

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Remote

🇺🇸

Walnut, California, United States

Remote
🇺🇸Walnut, California, United States

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