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OpenTrials
Completed

NCT Number: NCT03585244

Weight Change in PWS Over Six Months

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.

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Key information

Conditions

Weight Change, Body Body Weight Body Weight Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Remote

Walnut, California, 91789, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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Exclusion criteria

Treatment and study plan

weekly weight

Other

weekly weight data collection for six months

Primary outcomes

  1. Percent of Change in Weight

    Time frame: baseline and 6 months

    weekly weight data will be collected via text for 6 months

  2. Percent of Change in BMI

    Time frame: baseline and 6 months

    weekly weight and height data will be collected via text for 6 months

Sponsors and collaborators

Lead sponsor

Foundation for Prader-Willi Research

Other

Collaborators

  • Prader-Willi Syndrome Association USA

Registry information

Official study title

A Study to Assess Change in Weight Over Six Months in Prader-Willi Syndrome

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 12, 2018
Registry last updated
Jan 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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