Weight Change in PWS Over Six Months

• Sponsor: Foundation for Prader-Willi Research (Other)
• Overall Status: Completed
• CT.gov ID: NCT03585244
• Collaborator: Prader-Willi Syndrome Association USA (Other)
• Enrollment: 180
• Location: 1
• Actual Duration (Months): 10.5
• Patients Per Site Per Month: 17.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Weight Change, Body	Other: weekly weight

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

• Study Type: Observational
• Actual Enrollment: 180 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Study to Assess Change in Weight Over Six Months in Prader-Willi Syndrome
• Actual Study Start Date: Jun 15, 2018
• Actual Primary Completion Date: Feb 28, 2019
• Actual Study Completion Date: Apr 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
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; weekly weight data collection for six months

Outcome Measures

Primary Outcome Measures

1. Percent of Change in Weight [baseline and 6 months]

   weekly weight data will be collected via text for 6 months

2. Percent of Change in BMI [baseline and 6 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

-

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Remote	Walnut	California	United States	91789

Sponsors and Collaborators

• Foundation for Prader-Willi Research
• Prader-Willi Syndrome Association USA

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Feb 22, 2018

More Information

Publications

None provided.

• Responsible Party: Foundation for Prader-Willi Research
• ClinicalTrials.gov Identifier: NCT03585244
• Other Study ID Numbers: 2018_WS
• First Posted: Jul 12, 2018
• Last Update Posted: Jan 11, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Body Weight; Body Weight Changes

Study Results

Participant Flow

Arm/Group Title	Individuals With Prader-Willi Syndrome
Arm/Group Description	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
Period Title: Overall Study
STARTED	180
COMPLETED	165
NOT COMPLETED	15

Baseline Characteristics

Arm/Group Title	Individuals With Prader-Willi Syndrome
Arm/Group Description	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
Overall Participants	165
Age (Count of Participants)
<=18 years	88 53.3%
Between 18 and 65 years	77 46.7%
>=65 years	0 0%
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	19.7 (7.9)
Sex: Female, Male (Count of Participants)
Female	81 49.1%
Male	84 50.9%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United States	150 90.9%
Canada	15 9.1%
Weight (Kilograms) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Kilograms]	76.8 (30.7)
Height (Centimeters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Centimeters]	157.2 (13.2)
BMI (Kilograms/m^2) [Median (Full Range) ]
Median (Full Range) [Kilograms/m^2]	28.6

Outcome Measures

1. Primary Outcome

Title	Percent of Change in Weight
Description	weekly weight data will be collected via text for 6 months
Time Frame	baseline and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Individuals With Prader-Willi Syndrome
Arm/Group Description	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
Measure Participants	165
Mean (Standard Deviation) [Percent of change in weight]	2.35 (5.3)

2. Primary Outcome

Title	Percent of Change in BMI
Description	weekly weight and height data will be collected via text for 6 months
Time Frame	baseline and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Individuals With Prader-Willi Syndrome
Arm/Group Description	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
Measure Participants	165
Mean (Standard Deviation) [Percent of change in BMI]	1.42 (5.9)

Adverse Events

Time Frame	6 months
Arm/Group Title	Individuals With Prader-Willi Syndrome
Arm/Group Description	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
All Cause Mortality
	Individuals With Prader-Willi Syndrome
	Affected / at Risk (%)	# Events
Total	0/165 (0%)
Serious Adverse Events
	Individuals With Prader-Willi Syndrome
	Affected / at Risk (%)	# Events
Total	0/165 (0%)
Other (Not Including Serious) Adverse Events
	Individuals With Prader-Willi Syndrome
	Affected / at Risk (%)	# Events
Total	0/165 (0%)

Limitations/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

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.