FEEDhd
Recruiting
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 Biomarker
Primary Purpose: Is the device practical
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.
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
