Weight Change in PWS Over Six Months

Completed

• Conditions: Weight Change, Body
• Interventions: Other: weekly weight

• Registration Number: NCT03585244
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2018-06-15
• Study First Submitted: 2018-06-29
• Study First Submitted QC: 2018-06-29
• Study First Posted: 2018-07-12
• Primary Completion: 2019-02-28
• Study Completion: 2019-04-30
• Results First Submitted: 2020-12-08
• Status Verified: 2021-01
• Results First Submitted QC: 2021-01-07
• Last Update Submitted: 2021-01-07
• Results First Posted: 2021-01-11
• Last Update Posted: 2021-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Individuals with Prader-Willi Syndrome	weekly weight	Individuals with Prader-Willi Syndrome aged 12 and over will be recruited to gather data on weekly weight over six months

Primary Outcome Measures

Name	Time	Method
Percent of Change in BMI	baseline and 6 months	weekly weight and height data will be collected via text for 6 months
Percent of Change in Weight	baseline and 6 months	weekly weight data will be collected via text for 6 months

Trial Locations

Locations (1)

Remote; 🇺🇸 Walnut, California, United States