Weight Change, BodyNCT03585244
Weight Change in PWS Over Six Months
An observational study of Weight Change, Body, run by Foundation for Prader-Willi Research at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Weight Change, Body
- What is being tested?
- weekly weight
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2018to 30 Apr 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants with PWS
Who may be able to join
- 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
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Assess Change in Weight Over Six Months in Prader-Willi Syndrome
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.
Read the 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.
- Conditions
- Weight Change, Body
- Being tested
- weekly weight
- Medical subject headings
- Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
weekly weightOther
weekly weight data collection for six months
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: weekly weight |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Change in Weight
weekly weight data will be collected via text for 6 months
Measured: baseline and 6 months
Percent of Change in BMI
weekly weight and height data will be collected via text for 6 months
Measured: baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2018
- Study start15 Jun 2018
- Primary completion28 Feb 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Weight Change, BodyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation for Prader-Willi Research
- Sponsor type
- University, hospital or other
- Collaborators
- Prader-Willi Syndrome Association USA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03585244
- Sponsor's protocol ID
- 2018_WS
- Status last verified
- Jan 2021
- First submitted
- 29 Jun 2018
- Last updated
- 11 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess Change in Weight Over Six Months in Prader-Willi Syndrome
- ClinicalTrials.gov ID
- NCT03585244
- Acronym / sponsor ID
- 2018_WS
- Conditions
- Weight Change, Body
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Foundation for Prader-Willi ResearchUniversity, hospital or other
- Collaborators
- Prader-Willi Syndrome Association USA
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 12 Jul 2018 (actual)
- Results
- Posted 11 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals with Prader-Willi Syndrome | – | Other: weekly weightIndividuals with Prader-Willi Syndrome aged 12 and over will be recruited to gather data on weekly weight over six months |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants with PWS
Key inclusion criteria (2 listed)
- 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
- -
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| weekly weightweekly weight data collection for six months | Other | Individuals with Prader-Willi Syndrome |
Primary outcome
Percent of Change in Weight
Time frame: baseline and 6 months
weekly weight data will be collected via text for 6 months
Percent of Change in BMI
Time frame: baseline and 6 months
weekly weight and height data will be collected via text for 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Weight Change, Body, run by Foundation for Prader-Willi Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of Change in Weight (time frame: baseline and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2021.