Weight Change in PWS Over Six Months

Weight Change, Body Clinical Trial

Official title:

A Study to Assess Change in Weight Over Six Months in Prader-Willi Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03585244
• Other study ID #: 2018_WS
• Status: Completed
• Start date: June 15, 2018
• Est. completion date: April 30, 2019

Study information

• Verified date: January 2021
• Source: Foundation for Prader-Willi Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: April 30, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Body Weight
• Body Weight Changes
• Weight Change, Body

Intervention

Other:
• weekly weight
weekly weight data collection for six months

Locations

Country	Name	City	State
United States	Remote	Walnut	California

Sponsors (2)

Lead Sponsor	Collaborator
Foundation for Prader-Willi Research	Prader-Willi Syndrome Association USA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of Change in Weight	weekly weight data will be collected via text for 6 months	baseline and 6 months
Primary	Percent of Change in BMI	weekly weight and height data will be collected via text for 6 months	baseline and 6 months