Weight Change in PWS Over Six Months

NCT03585244 | Completed Results

• 1 other identifier: 2018_WS
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Weight Change, Body

Outcome Measures

Primary Outcomes (2)

• Percent of Change in Weight

  weekly weight data will be collected via text for 6 months

  baseline and 6 months

• Percent of Change in BMI

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

  baseline and 6 months

Study Arms (1)

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

Interventions

weekly weight OTHER

weekly weight data collection for six months

Individuals with Prader-Willi Syndrome

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with PWS

You may qualify if:

• 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

Sponsors & Collaborators

• Foundation for Prader-Willi Research: lead
• Prader-Willi Syndrome Association USA: collaborator

Study Sites (1)

Remote

Walnut, California, 91789, United States

Location

MeSH Terms

Conditions

Body Weight Changes

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This study was all text message based data collection so we were only able to collect limited information and did not collect race or ethnicity

Results Point of Contact

• Title: Theresa Strong, PhD - Director of Research Programs
• Organization: Foundation for Prader-Willi Research

theresa.strong@fpwr.org

888-322-5487

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2018
• First Posted: July 12, 2018
• Study Start: June 15, 2018
• Primary Completion: February 28, 2019
• Study Completion: April 30, 2019
• Last Updated: January 11, 2021
• Results First Posted: January 11, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)