200 Participants Needed

Metabolic Camp for Pregnant Women with Phenylketonuria

RH
KN
Overseen ByKristen Narlow, MS RD
Age: Any Age
Sex: Female
Trial Phase: Academic
Sponsor: Emory University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Metabolic Camp for Pregnant Women with Phenylketonuria?

Research shows that nutrition and lifestyle changes, including diet and exercise, can positively influence metabolic health during pregnancy, which may help manage conditions like phenylketonuria. Nutritional education and support programs have been effective in managing gestational diabetes, suggesting similar benefits for metabolic conditions in pregnancy.12345

How does the Metabolic Camp treatment for pregnant women with phenylketonuria differ from other treatments?

The Metabolic Camp for pregnant women with phenylketonuria is unique because it combines education, social support, and active involvement in food preparation to improve adherence to a low-phenylalanine diet, which is crucial for managing PKU during pregnancy. This approach not only helps in reducing blood phenylalanine levels but also addresses the psychological and social aspects of dietary management, which are often overlooked in traditional treatments.678910

What is the purpose of this trial?

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.

Research Team

RH

Rani H Singh, PhD RD

Principal Investigator

Emory University

Eligibility Criteria

This trial is for females aged 11 or older diagnosed with Phenylketonuria (PKU) or similar amino acid disorders, who can understand and agree to the study's terms. It includes adult camp counselors in good health willing to follow camp rules and study procedures.

Inclusion Criteria

Willing and able to provide written informed consent
Willing and able to comply with relevant camp guidelines and study procedures
I am an adult camp counselor or staff in good health.
See 1 more

Exclusion Criteria

Those not fitting the inclusion criteria

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Metabolic Camp

Participants attend a week-long educational and social support program focusing on nutrition and diet self-management for PKU and MSUD.

1 week
7 days (in-person)

Follow-up

Participants are monitored for changes in dietary intake and plasma amino acid concentration post-camp.

4 weeks

Treatment Details

Interventions

  • Metabolic camp
Trial Overview The effectiveness of an educational Metabolic Camp designed to teach teens and young women about PKU/MSUD and nutrition. The study will compare pregnancy outcomes between attendees of this camp and those with PKU who haven't attended.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Metabolic CampExperimental Treatment1 Intervention
Metabolic Camp is an educational and social support program 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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials
1,735
Recruited
2,605,000+

Findings from Research

Nutrition plays a crucial role in influencing gene expression related to metabolism, particularly during pregnancy, where dietary factors can affect the developmental health of the fetus and later susceptibility to obesity and diabetes.
Exercise is highlighted as a key non-pharmacological intervention that can help counteract the negative effects of poor nutrition, potentially reducing the risk of metabolic diseases like obesity and type 2 diabetes in both mothers and their children.
Maternal diet, bioactive molecules, and exercising as reprogramming tools of metabolic programming.Mathias, PC., Elmhiri, G., de Oliveira, JC., et al.[2021]
High gestational weight gain is the strongest predictor of maternal overweight or obesity after pregnancy, and both high and low weight gains during pregnancy are linked to an increased risk of childhood obesity.
Despite revised guidelines from the US Institute of Medicine in 2009, less than one third of pregnant women meet the recommended weight gain levels, highlighting the need for effective interventions to optimize weight gain during pregnancy to prevent obesity in mothers and their children.
Optimizing weight gain in pregnancy to prevent obesity in women and children.Herring, SJ., Rose, MZ., Skouteris, H., et al.[2023]
The implementation of a structured model of care for gestational diabetes in regional Australian sites significantly increased the proportion of women receiving best practice nutrition therapy from 3.5% to 87.8% at Site 1, demonstrating the efficacy of the approach.
Despite challenges such as organizational barriers, the project successfully reduced the number of women requiring medication for gestational diabetes, indicating improved management of the condition through enhanced support and resources.
Clinically relevant improvements achieved from a facilitated implementation of a gestational diabetes model of care.Wilkinson, SA., McCray, SJ., Kempe, A., et al.[2019]

References

Maternal diet, bioactive molecules, and exercising as reprogramming tools of metabolic programming. [2021]
Optimizing weight gain in pregnancy to prevent obesity in women and children. [2023]
Clinically relevant improvements achieved from a facilitated implementation of a gestational diabetes model of care. [2019]
Position of the Academy of Nutrition and Dietetics: Obesity, Reproduction, and Pregnancy Outcomes. [2022]
Diabetes in pregnancy--dietary management. [2016]
[Dietary recommendations for pregnant women affected with phenylketonuria]. [2019]
The Resource Mothers Study of Maternal Phenylketonuria: preliminary findings. [2022]
The International Collaborative Study on maternal phenylketonuria: organization, study design and description of the sample. [2019]
Preventing maternal phenylketonuria (PKU) syndrome: important factors to achieve good metabolic control throughout pregnancy. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Social factors and the meaning of food in adherence to medical diets: results of a maternal phenylketonuria summer camp. [2019]
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