Study Stopped
Recruitment was put on hold in March 2020 due to COVID
PsylliumRx Dietary Fiber Study
PsylliumRx: Use of Dietary Fiber in Severely Obese Children to Delay the Onset of Obesity-related Health Conditions - Pilot
1 other identifier
interventional
120
1 country
1
Brief Summary
The purpose of this pilot study is to assess the feasibility of a 3-month dietary fiber intervention: 1) engaging adolescents in regularly consuming a dietary fiber preparation (psyllium powder) and obtaining their parents' support, 2) recruit into a clinical pilot trial with liquid meal challenge test to study the metabolic effects of the dietary fiber preparation. A study modification will be submitted to add additional study arms for feasibility (strength training, coaching).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable obesity
Started Jul 2019
Typical duration for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 9, 2018
CompletedFirst Posted
Study publicly available on registry
August 14, 2018
CompletedStudy Start
First participant enrolled
July 31, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedJanuary 18, 2022
January 1, 2022
3.3 years
August 9, 2018
January 6, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Recruitment
Proportion of patients recruited/consented
3 year recruitment period
Retention
Proportion of participants remaining in study
3-mo study period
Study Arms (1)
Dietary Fiber Supplement
EXPERIMENTALParticipants will be instructed to consume 1 tea spoon of psyllium per day for 3 months and otherwise maintain their habitual diet.
Interventions
Participants will be instructed to consume 1 tea spoon of psyllium per day for 3 months and otherwise maintain their habitual diet. Participants will be asked to keep a diary assessing bowel movement and intestinal symptoms such as bloating and flatulence beginning two weeks prior to the intervention.
Eligibility Criteria
You may qualify if:
- Kaiser Permanente Southern California (KPSC) member for at least 12 months.
- KPSC members ages 12 to 21 years old.
- KPSC member with \>97th percentile of BMI for age.
- Minors with parents whose preferred language is English.
- to 21 year old members whose preferred language is English.
You may not qualify if:
- Has diagnosis of serious mental illness and/or cognitive impairment.
- Provider has concerns over participation.
- Minors with parent whose preferred language is not English.
- to 21 year old members whose preferred language is not English.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kaiser Permanente Clinical Research Center
Pasadena, California, 91101, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 9, 2018
First Posted
August 14, 2018
Study Start
July 31, 2019
Primary Completion
December 1, 2022
Study Completion
December 1, 2022
Last Updated
January 18, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share