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University of Hull

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Official title: Facilitating Effective Eating With DoddleBags: A Single-Arm Acceptability Study Of DoddleBags to Assess Impact on Self Feeding Behaviours in a Huntington’s Disease Population

The purposes of this trial are:
To see if people find DoddleBags acceptable and easy to use.
Participants will keep a food diary to record what they eat and will take part in informal interviews. We will ask how easy or difficult it was to use a DoddleBag at each meal compared to eating without it, and whether it affected their ability to feed themselves independently.
To look at changes in weight and Body Mass Index (BMI).
We will monitor each participant’s weight to see whether using DoddleBags at mealtimes has any effect on their weight or overall nutritional status.
To monitor choking episodes.
We will record any episodes of choking to see whether using DoddleBags makes eating safer, has no effect, or changes how often choking occurs.
To understand how DoddleBags affect feelings about eating and mealtimes.
Participants will complete a short set of questionnaires about mood and eating habits. This will help us see whether using DoddleBags makes mealtimes feel more positive, less stressful, or more manageable.
To measure any changes in quality of life.
The same short set of questionnaires will help us understand whether using DoddleBags has an impact on participants’ overall wellbeing and daily life.
To check whether the questionnaires are suitable for people with Huntington’s disease.
We will also assess whether these questionnaires are clear, manageable, and appropriate for people living with Huntington’s disease.

Doddlebags are versatile, eco-friendly, reusable pouches designed for easy, mess-free feeding

 

This an open label.

Phase: not applicable
Subtype: Interventional Therapeutic
Primary Purpose: Device Feasibility
Primary Intervention: Doddlebags
Duration: 12-13 weeks

 
 
 

Ages Eligible
for Study:

18 Years and older 

Sexes Eligible
for Study:

All

Accepts Healthy Volunteers:

No

Aged 18 or over at the time of recruitment.

Genetic confirmation of the HD gene expansion, defined as a CAG repeat length of ≥40 CAG repeats on the long allele.

Chorea, uncontrollable bodily movements, to the extent that it, in the opinion of the participant, inhibits normal or typical use of an eating utensil such as a fork or spoon.

AND/OR Cognitive issues that make it impractical for the participant to engage in self-feeding behaviours in a safe and effective manner, perhaps but not necessarily requiring the input of a carer or companion to feed the participant.

Failing to meet the inclusion criteria.

The presence of a pre-existing neurological or movement disorder that could mimic, mask, or otherwise occlude the symptoms of Huntington’s Disease.

Current use of DoddleBags as a feeding aid outside of this research.

Ability to regularly self-feed in a safe and effective manner rendering the integration of DoddleBags into one’s lifestyle moot.

Use of a mandated/recommended diet that would be incompatible with DoddleBags, such as mandated use of non-pureed or non-soft foods.

Inability or unwillingness to engage with any specific aspects of the research, including completion of the food diaries, interviews or questionnaires, as well as being unable to provide informed consent.

Ages Eligible for Study
18 Years and older (Adult,  Older Adult )
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No

LOCATIONS

COUNTRIES

United Kingdom

TRIAL SITE: Cambridge University Hospitals

Contact: HD Research Team
+44(0)1223 805000 
Email: esra.rashid@nhs.net

TRIAL SITE: Cardiff University 

Contact: HD Research Team
+44 (0)29 2068 8237  
Email:drewc5@cardiff.ac.uk

TRIAL SITE: NHS Greater Glasgow & Clyde

Contact: HD Research Team
+44(0)141 201 4444  
Email: j.herron@nhs.net

TRIAL SITE: Leeds Teaching Hospitals

Contact: HD Research Team
+44 (0)113 2433 144  
Email:jeremycosgrove@nhs.net

TRIAL SITE:Leicestershire Partnership NHS Trust

Contact: HD Research Team
+44 (0)116 225 6000  
Email:joy.fellows@nhs.net

TRIAL SITE: Liverpool Walton Centre NHST

Contact: HD Research Team
+44 (0)151 525 3611
Email:wcft.rdi@nhs.net

TRIAL SITE:Sheffield Children’s Hospital

Contact: HD Research Team
+44( 0)114 271 7000   
Email:p.bayliss@nhs.net

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phenoptype

Phenotype refers to an individual’s observable traits, such as height, eye color and blood type. A person’s phenotype is determined by both their genomic makeup (genotype) and environmental factors.

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oxidative seres

an imbalance between unstable molecules called “free radicals” and protective “antioxidants” in your body

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Metabolism & bioenergetics

describe how your body turns food into fuel and uses that energy to live. 

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Small Molecule

a tiny chemical compound, much smaller than big biological structures like proteins, that can easily travel inside our cells to act as medicine (like aspirin or ibuprofen), a building block (like glucose), or a signaling tool in the body, often taken as pills because they’re easy to absorb and distribute

 

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Nucleic acid

(DNA and RNA) are the essential information-carrying molecules in all life, acting like blueprints that store and transmit genetic instructions for building and operating cells, directing everything from growth to protein production, and passing traits from parents to offspring.

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SNP-single nucleotide polymorphisms

a single-letter spelling difference in a gene. SNPs, pronounced ‘snips’, are common and most don’t change the function of the gene.

 
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at risk

You do not know if you carry the genetic mutation for HD gene 

 
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TFC-total functional capacity

A standardized rating scale for function in HD, used to assess capacity to work, handle finances, perform domestic chores and self-care tasks.
Scores range from 0 to 13, with higher scores indicating better functional capacity. 

 
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Double-blinded

 means that neither the participant nor the clinical trial doctor can choose or know the group the participant is in until the trial is over. This approach helps to prevent bias.

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Open label

A trial in which the patient and doctor know what drug is being used. Open label trials are susceptible to bias through placebo effects.

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Gene therapy

a technique that aims to treat or prevent diseases by modifying a person’s genes. It involves introducing, removing, or changing genetic material (DNA or RNA) within a patient’s cells.

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UHDRS- Unified Huntington Disease Rating Scale

A standardized neurological examination that aims to provide a uniform assessment of the clinical features of HD

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CAG repeat

The stretch of DNA at the beginning of the HD gene, which contains the sequence CAG repeated many times, and is abnormally long in people who will develop HD

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Wild-type

the opposite of ‘mutant’. Wild-type huntingtin, for example, is the ‘normal’, ‘healthy’ protein

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Tolerabilty

How well a person can handle a treatment without having serious or uncomfortable side effects.

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Striatum

Part of the brain that  coordinates multiple aspects of cognition, including both motor and action planning, decision-making, motivation, reinforcement, and reward system.

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Randomized allocation

A type of allocation strategy in which participants are assigned to the arms of a clinical trial by chance.

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Radioligand

a radioactive substance that binds to a specific target in the body, allowing visualization of that target’s distribution and activity

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Protein

Protein builds, maintains, and replaces the tissues in your body. The building blocks of life.

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Premanifest / Prodromal

Prior to onset or diagnosis of movement symptoms.

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Placebo

A placebo is a dummy medicine containing no active ingredients. The placebo effect is a psychological effect that causes people to feel better even if they’re taking a pill that doesn’t work.

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PK - Pharmacokinetics

The movement of drugs through the body

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PD - Pharmacodynamics

The body’s biological response to drugs

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PET scan

Positron emission tomography which produces detailed 3-dimensional images of the inside of the body.

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Neuron

Brain cells that store and transmit information

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MRI

Magentic resonance imaging: A technique using powerful magnetic fields to produce detailed images and visualizes the structure of organs, tissues, and bones 

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mHTT

Mutant huntingtin protein. The protein produced by the faulty HD gene.

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Manifest

after HD diagnosis, or when symptoms are already showing

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Longitudinal study

A study where each participant is looked at several times over a time period – unlike a cross-sectional study, where each participant is looked at only once

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HTT

one abbreviation for the gene that causes Huntington’s disease. The same gene is also called HD and IT-15

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fMRI

functional MRI:As with MRI, a technique using powerful magnetic fields  but focusing on brain function by measuring and mapping changes in blood flow, revealing which areas of the brain are active during specific tasks or cognitive processes

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CSF - cerebrospinal fluid

A clear fluid produced by the brain, which surrounds and supports the brain and spinal cord.

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Efficacy

A measure of whether a treatment works or not

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ASO(Antisense oligonucleotides)

A type of gene silencing treatment in which specially designed DNA molecules are used to switch off a gene

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Biomarker

a test of any kind – including blood tests, thinking tests and brain scans – that can measure or predict the progression of a disease like HD. Biomarkers may make clinical trials of new drugs quicker and more reliable

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BDNF

Brain-derived neurotrophic factor: a growth factor that may be able to protect neurons in HD.

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Allele

one of the two copies of a gene

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Plasma

Liquid component of the blood.

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Gene

The basic unit of heredity passed from parent to child. Genes are made up of sequences of DNA and are arranged, one after another, at specific locations on chromosomes in the nucleus of cells.

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Phase

Clinical trial phases are different stages of research that assess the safety and effectiveness of a new medical treatment or intervention in humans.

Each phase has a specific goal and involves a different number of participants. Generally, there are 4 phases (I-IV), with Phase I focusing on safety and dosage, Phase II on efficacy and side effects, Phase III on comparing the new treatment with standard treatments, and Phase IV on long-term safety monitoring.