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| Name | Class |
|---|---|
| Prader-Willi Syndrome Association USA | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| weekly weight | Other | weekly weight data collection for six months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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:
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Participants with PWS
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Remote | Walnut | California | 91789 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 weekly weight: weekly weight data collection for six months |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 weekly weight: weekly weight data collection for six months |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent of Change in Weight | weekly weight data will be collected via text for 6 months | Posted | Mean | Standard Deviation | Percent of change in weight | baseline and 6 months |
|
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 weekly weight: weekly weight data collection for six months |
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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
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Theresa Strong, PhD - Director of Research Programs | Foundation for Prader-Willi Research | 888-322-5487 | 702 | theresa.strong@fpwr.org |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 22, 2018 | Jan 5, 2021 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| ID | Term |
|---|---|
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Weight | Mean | Standard Deviation | Kilograms |
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| Height | Mean | Standard Deviation | Centimeters |
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| BMI | Median | Full Range | Kilograms/m^2 |
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| Primary | Percent of Change in BMI | weekly weight and height data will be collected via text for 6 months | Posted | Mean | Standard Deviation | Percent of change in BMI | baseline and 6 months |
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| 0 |
| 165 |
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| 165 |
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| 165 |
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