FPWR is conducting a text-messaging based research study to assess weight changes in Prader-Willi syndrome (PWS) over a period of six months. We’d like to learn more about the normal variation in weight, over time, in the PWS population.  We hope to recruit 150-300  individuals across the US and Canada to participate, so we can get a good picture of how weight changes over time.  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. Patients should not be enrolled in other clinical trials for the duration of this study. The study can be done from your home, with no visit to a clinic.

Study details

Despite the fact that several clinical trials of potential drugs and devices for hyperphagia (excess appetite) and obesity are being tested in PWS, we still don’t have a good understanding of how weight varies over time in the PWS population. Gathering data on this is essential not only to understand the ‘natural history’ of PWS, but also to understand if new therapies are having a beneficial effect.

For this study, we will gather and analyze data on changes in body weight over a 6month interval, roughly the time frame for a clinical trial.   We will focus on individuals aged 12 and over since that is the group most likely to recruited into clinical trials of hyperphagia and obesity. In addition, we will also ask participants about changes to their diet, medication, or food access over the time of the study, to see if these factors play a role in weight variability over the course of the study.

This study will be conducted entirely via text messaging on your mobile phone and will last 6-8 months in total. Participants/caregivers will provide a mobile phone number where they can receive and send text messages. They will receive three short surveys via text at the beginning, middle (3 months) and end (6 months) of the study.

Participants/caregivers will also receive text reminders once a week, every week, reminding them to record and report (via text) their/participant’s weight. All data collected will be stored on a secure database with restricted access. Only deidentified data will be reported. That is, nothing that can identify individual participants will be shared. Aggregated information about changes in weight over time will be shared back to the PWS community (families), and may also be reported to researchers, regulatory agencies (FDA) and pharmaceutical companies.

Who is eligible?

  • 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.

If you are interested in participating in this study, please click below  to read study details and sign an informed consent.

All participants will be entered in a drawing to win an iPad. Drawing will take place on December 15th, 2018. To be included, you must be actively participating in the study.

Participate in the PWS Weight Study

Frequently Asked Questions 

What is this study about and why is it important?

The goal of this study is to gather data on variability in weight over time for individuals with PWS as they go about their daily lives. Because we want to get a “real- world” picture of this variation, we’re not asking you to modify any aspect of the PWS participant’s daily routine for this study.

This study is important because it will allow us to obtain a better idea of the normal variation in weight in the PWS population. This information will be very useful for researchers when they develop clinical trials to test a drug. Also, if a drug is approved, we will be able to use this data as a comparison to understand how effective the drug is in the real-world.

My loved one with PWS is on a diet or exercise program and has excellent weight control. Should he/she still participate?

Yes! We would like to gather data from all eligible participants 12 years and older, whether they have excellent weight control or not. As explained above, we want to obtain a true picture of how weight varies over time for PWS participants.

My loved one with PWS is not currently on an effective weight control program and is struggling with weight. Should he/she still participate?

Yes! We’d like to get a good representation of all individuals with PWS, age 12 and over, whether they have good weight control or not. That way, we can have a true picture of how weight is in the PWS population. Note also that all data will be ‘anonymized’ – no identifying information will be associated with the weight data.

My loved one with PWS is currently enrolled in a clinical trial that is testing a hyperphagia/obesity drug. Should he/she still participate?

Thank you very much for your interest in the study. If the PWS participant is enrolled in a hyperphagia/obesity clinical trial, then they should not participate in this study as this could affect the data that is being collected.

We would like to participate but are traveling over the summer for a few weeks. Should we still enroll?

Yes! While we would like to gather weight data from every participant, every week over the six-month study period, we understand that this may not be feasible for all families. If you enroll in the study but need to take a week or two off from reporting, that’s OK, but please continue reporting again as soon as you can.

We do not reside in the U.S. or Canada. Can we still participate?

Thank you very much for your interest in the study. Unfortunately, the text messaging system is currently only set up for residents of the U.S. and Canada.

I still have questions. Whom should I contact?

Please feel free to reach out to Priya Balasubramanian at FPWR: priya@fpwr.org with any questions you may have about this study.

If you have questions, please contact:
Priya Balasubramanian, Ph.D.
Associate Director of Translational Research Programs
Foundation for Prader-Willi Research
priya@fpwr.org
phone: 888-322-5487