Ignite Creation Date:
2024-05-06 @ 12:46 AM
Last Modification Date:
2024-10-26 @ 10:54 AM
Study NCT ID:
NCT01659749
Status:
RECRUITING
Last Update Posted:
2024-03-12
First Post:
2012-08-06
Brief Title:
Educational Social Support and Nutritional Interventions and Their Cumulative Effect on Pregnancy Outcomes and Quality of Life in Teen and Adult Women With Phenylketonuria
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Educational Social Support and Nutritional Interventions and Their Cumulative Effect on Pregnancy Outcomes and Quality of Life in Teen and Adult Women With Phenylketonuria PKU or Maple Syrup Urine Disease MSUD
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this project is to study the effectiveness of teaching teens and young women with Phenylketonuria PKU or Maple Syrup Urine Disease MSUD about their disease and nutrition related issues in a camp environment It will also look at pregnancy outcome results in women with PKU who attended Metabolic Camp and compare their results to other women with PKU who have not attended the Metabolic Camp
Detailed Description:
Metabolic Camp is an educational and social support program with research opportunities that was developed in 1995 by Rani H Singh PhD RD for females age 11 through adult with phenylketonuria PKU and maple syrup urine disease MSUD two inherited metabolic disorders IMD Camp provides a supportive environment for adolescent girls and women to learn about the importance of nutrition and diet self-management with the intention of arresting the disease process and minimizing the instances of miscarriages and severe birth defects which are high in this population After 20 years Metabolic Camp is established as a unique national program allowing up to 35 campers to live and learn during a week of nutritional support and productive activities while simultaneously providing researchers an opportunity to gather important data
The aims of Metabolic Camp are 1 to implement education curriculum and support activities as an intervention program for females with PKU and MSUD 2 to evaluate knowledge of disease and dietary management dietary treatment compliance quality of life and reproductive choice issues and assess change in outcomes post-Camp 3 to gather data through the implementation of a research protocol during baseline and post-Camp each year and 4 to provide clinical and research training in IMD for professionals from dietitians to medical students Campers must complete an informed consent process should they decide to participate in research activities All campers submit a three-day food record and blood samples to measure plasma amino acids on the first and last day of camp both of which are not classified as research activities but rather standard of care for their disorder Additional studies such as indirect calorimetry bone health markers anthropometric markers nutritional status mental and emotional wellbeing neurocognitive functioning access to disease specific care metabolomic profiling gut microbiota and blood and urine analysis have been and may continue to be assessed in those who participate in research pre and post-Camp These are novel investigations for the study of IMD and essential to understand the physiological effects of Camp
In over 20 years of Metabolic Camp the following data have been collected health history and demographics anthropometrics dietary intake compliance with medically prescribed diet quality of life physical activity plasma amino acids select blood and urine biomarkers and bone density Data are stored in REDCap allowing evaluation of short- and long-term outcomes on the life course of females with PKU and MSUD Each year phenylalanine Pheleucine Leu blood concentrations of campers decrease over the one week camp period demonstrating better metabolic control and compliance with diet Campers knowledge of disease etiology management and effects including Maternal PKU Syndrome MPKU are improved Social support networks are strengthened by meeting peers with the same or similar disorder The study protocol includes a comprehensive assessment of blood and urine biomarkers to examine PKU from a much broader approach compared to the traditional measurement of a single biomarker to assess patient status Beneficial to campers and clinicians alike Metabolic Camp is an invaluable experience to gain insight knowledge and stimulate new ideas related to research and optimal patient care
The aims of Metabolic Camp are 1 to implement education curriculum and support activities as an intervention program for females with PKU and MSUD 2 to evaluate knowledge of disease and dietary management dietary treatment compliance quality of life and reproductive choice issues and assess change in outcomes post-Camp 3 to gather data through the implementation of a research protocol during baseline and post-Camp each year and 4 to provide clinical and research training in IMD for professionals from dietitians to medical students Campers must complete an informed consent process should they decide to participate in research activities All campers submit a three-day food record and blood samples to measure plasma amino acids on the first and last day of camp both of which are not classified as research activities but rather standard of care for their disorder Additional studies such as indirect calorimetry bone health markers anthropometric markers nutritional status mental and emotional wellbeing neurocognitive functioning access to disease specific care metabolomic profiling gut microbiota and blood and urine analysis have been and may continue to be assessed in those who participate in research pre and post-Camp These are novel investigations for the study of IMD and essential to understand the physiological effects of Camp
In over 20 years of Metabolic Camp the following data have been collected health history and demographics anthropometrics dietary intake compliance with medically prescribed diet quality of life physical activity plasma amino acids select blood and urine biomarkers and bone density Data are stored in REDCap allowing evaluation of short- and long-term outcomes on the life course of females with PKU and MSUD Each year phenylalanine Pheleucine Leu blood concentrations of campers decrease over the one week camp period demonstrating better metabolic control and compliance with diet Campers knowledge of disease etiology management and effects including Maternal PKU Syndrome MPKU are improved Social support networks are strengthened by meeting peers with the same or similar disorder The study protocol includes a comprehensive assessment of blood and urine biomarkers to examine PKU from a much broader approach compared to the traditional measurement of a single biomarker to assess patient status Beneficial to campers and clinicians alike Metabolic Camp is an invaluable experience to gain insight knowledge and stimulate new ideas related to research and optimal patient care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None