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

NCT07299682 | Recruiting

• 2 other identifiers: FHS 23-24.95342883
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Huntington's Disease (HD)

Outcome Measures

Primary Outcomes (1)

• Acceptability

  To assess the feasibility of using the DoddleBags feeding aid in people with HD, by 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.

  From enrollment to the end of treatment at 12 weeks.

Secondary Outcomes (2)

• Attitudes Towards Mealtimes

  From enrollment to the end of treatment at 12 weeks.

• Perceived Quality of Life

  From enrollment to the end of treatment at 12 weeks.

Study Arms (1)

Intervention

EXPERIMENTAL

Participants will undergo a pre-intervention semi-structured interview with the research after completing their ICF, they will also be asked to complete the questionnaire battery. Participants, with the aid of carers if appropriate, will then be asked to complete a food diary for one week to provide a baseline of their daily experiences. After this baseline week, participants will be asked to use the DoddleBags products in the preparation and execution of as many mealtimes as they reasonably can, while completing the food diaries for a further 11 weeks.

Device: DoddleBags

Interventions

DoddleBags DEVICE

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Hull: lead

Study Sites (7)

Cambridge University Hospitals

Cambridge, United Kingdom

RECRUITING

Cardiff University

Cardiff, United Kingdom

RECRUITING

NHS Greater Glasgow & Clyde

Glasgow, United Kingdom

RECRUITING

Leeds Teaching Hospitals

Leeds, United Kingdom

RECRUITING

Leicestershire Partnership NHS Trust

Leicester, United Kingdom

RECRUITING

Walton Centre NHST

Liverpool, United Kingdom

RECRUITING

Sheffield Children's Hospital

Sheffield, United Kingdom

RECRUITING

Central Study Contacts

Callum Schofield

CONTACT

+447875437057; c.schofield-2019@hull.ac.uk

David Smith, PhD

CONTACT

+44 01482 466457; d.r.smith@hull.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: participants will provide baseline measurements for a defined period before all moving onto the intervention and providing further measurements after a second defined period.

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: December 23, 2025
• Study Start: November 29, 2024
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (7)