COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Weight Change in PWS Over Six Months

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03585244
Recruitment Status : Completed
First Posted : July 12, 2018
Last Update Posted : August 7, 2019
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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 180 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
Actual Primary Completion Date : February 28, 2019
Actual Study Completion Date : April 30, 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
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

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 identifier (NCT number): NCT03585244

Layout table for location information
United States, California
Walnut, California, United States, 91789
Sponsors and Collaborators
Foundation for Prader-Willi Research
Prader-Willi Syndrome Association USA
Layout table for additonal information
Responsible Party: Foundation for Prader-Willi Research Identifier: NCT03585244    
Other Study ID Numbers: 2018_WS
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Body Weight
Body Weight Changes
Signs and Symptoms