Expired Study
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Walnut, California 91789


Purpose:

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.


Study summary:

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.


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 - Exclusion Criteria:


Study is Available At:


Original ID:

2018_WS


NCT ID:

NCT03585244


Secondary ID:


Study Acronym:


Brief Title:

Weight Change in PWS Over Six Months


Official Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

12 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Foundation for Prader-Willi Research


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

180


Enrollment Type:

Actual


Study Dates

Start Date:June 15, 2018
Completion Date:April 30, 2019
Completion Type:Actual
Primary Completion Date:February 28, 2019
Primary Completion Type:Actual
Verification Date:August 2019
Last Changed Date:August 6, 2019
First Received Date:June 29, 2018

Study Outcomes

Outcome Type:Primary Outcome
Measure:Change in weight
Time Frame:6 months
Safety Issues:False
Description:weekly weight data will be collected via text for 6 months

Study Interventions

Intervention Type:Other
Name:weekly weight
Description:weekly weight data collection for six months
Arm Name:Individuals with Prader-Willi Syndrome

Study Arms

Study Arm Type:Other
Arm Name:Individuals with Prader-Willi Syndrome
Description:Individuals with Prader-Willi Syndrome aged 12 and over will be recruited to gather data on weekly weight over six months

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Foundation for Prader-Willi Research
Agency Class:Other
Agency Type:Collaborator
Agency Name:Prader-Willi Syndrome Association USA

Samples and Retentions

Study Population: Participants with PWS
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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