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 here  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

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