Weight Change, Body
Conditions
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.
Interventions
OTHERweekly weight
weekly weight data collection for six months
Sponsors
Prader-Willi Syndrome Association USA
Foundation for Prader-Willi Research
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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 \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Change in Weight | baseline and 6 months | weekly weight data will be collected via text for 6 months |
| Percent of Change in BMI | baseline and 6 months | weekly weight and height data will be collected via text for 6 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 165 |
| Total | 165 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 15 |
Baseline characteristics
| Characteristic | Individuals With Prader-Willi Syndrome | — |
|---|---|---|
| Age, Categorical <=18 years | 88 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 77 Participants | — |
| Age, Continuous | 19.7 Years STANDARD_DEVIATION 7.9 | — |
| BMI | 28.6 Kilograms/m^2 | — |
| Height | 157.2 Centimeters STANDARD_DEVIATION 13.2 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Canada | 15 participants | — |
| Region of Enrollment United States | 150 participants | — |
| Sex: Female, Male Female | 81 Participants | — |
| Sex: Female, Male Male | 84 Participants | — |
| Weight | 76.8 Kilograms STANDARD_DEVIATION 30.7 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 165 |
| other Total, other adverse events | 0 / 165 |
| serious Total, serious adverse events | 0 / 165 |
Outcome results
Primary
Percent of Change in BMI
weekly weight and height data will be collected via text for 6 months
Time frame: baseline and 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Individuals With Prader-Willi Syndrome | Percent of Change in BMI | 1.42 Percent of change in BMI | Standard Deviation 5.9 |
Primary
Percent of Change in Weight
weekly weight data will be collected via text for 6 months
Time frame: baseline and 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Individuals With Prader-Willi Syndrome | Percent of Change in Weight | 2.35 Percent of change in weight | Standard Deviation 5.3 |