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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

Primary Objectives * To assess the acceptability of using the DoddleBags feeding aid in people with HD, by using a food diary to track food intake and using semi-structured interviews to ask questions about how easy or difficult it was to use a DoddleBag for each meal compared to not using one, and learn more about the impact of using DoddleBags on self-feeding behaviours. * To review the impact of using DoddleBags during mealtimes on the weight and BMI of each participant. * To review the impact of using DoddleBags during mealtimes on episodes of choking of each participant. Secondary Objectives * To evaluate the impact of using DoddleBags on participants' attitudes towards mealtimes and eating, using a short battery of mood and eating questionnaires. * To measure how incorporating DoddleBags into mealtimes affects participants' perceived quality of life, using a short battery of mood and eating questionnaires. * To assess the acceptability of the short battery of mood and eating questionnaires within a population of people with HD.

Who May Be Eligible (Plain English)

Who May Qualify: 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. Who Should NOT Join This Trial: 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 willing to sign a consent form. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 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. Exclusion Criteria: 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.

Treatments Being Tested

DEVICE

DoddleBags

DoddleBags are reusable flexible pouches that can be used as a feeding aid when filled with pureed textured food. They can be used with the included anti-choking cap or a spoon attachment as pictured. They are bisphenol A (BPA) free, leak proof and microwave and dishwasher safe.

Locations (7)

Cambridge University Hospitals
Cambridge, United Kingdom
Cardiff University
Cardiff, United Kingdom
NHS Greater Glasgow & Clyde
Glasgow, United Kingdom
Leeds Teaching Hospitals
Leeds, United Kingdom
Leicestershire Partnership NHS Trust
Leicester, United Kingdom
Walton Centre NHST
Liverpool, United Kingdom
Sheffield Children's Hospital
Sheffield, United Kingdom