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Weight Change in PWS Over Six Months

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ClinicalTrials.gov Identifier: NCT03585244
Recruitment Status : Recruiting
First Posted : July 12, 2018
Last Update Posted : July 12, 2018
Sponsor:
Collaborator:
Prader-Willi Syndrome Association USA
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Weight Change, Body Other: weekly weight

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.


Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Study to Assess Change in Weight Over Six Months in Prader-Willi Syndrome
Actual Study Start Date : June 15, 2018
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : August 2019


Group/Cohort Intervention/treatment
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
Other: weekly weight
weekly weight data collection for six months




Primary Outcome Measures :
  1. Change in weight [ Time Frame: 6 months ]
    weekly weight data will be collected via text for 6 months



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants with PWS
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03585244


Contacts
Contact: Theresa Strong, PhD 888-322-5487 theresa.strong@fpwr.org

Locations
United States, California
Remote Recruiting
Walnut, California, United States, 91789
Contact: Priya Balasubramanian, PhD         
Sponsors and Collaborators
Foundation for Prader-Willi Research
Prader-Willi Syndrome Association USA

Responsible Party: Foundation for Prader-Willi Research
ClinicalTrials.gov Identifier: NCT03585244     History of Changes
Other Study ID Numbers: 2018_WS
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Body Weight
Body Weight Changes
Signs and Symptoms