Huntington's Disease (HD)FEEDhdNCT07299682
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
A study testing DoddleBags in people with Huntington's Disease (HD), run by University of Hull at 7 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Huntington's Disease (HD)
- What is being tested?
- DoddleBags
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 7 sitesUnited Kingdom
- Study dates
- 29 Nov 2024to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 cannot join
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United Kingdom7 sites
Cambridge University Hospitals
Cambridge
Cardiff University
Cardiff
NHS Greater Glasgow & Clyde
Glasgow
Leeds Teaching Hospitals
Leeds
Leicestershire Partnership NHS Trust
Leicester
Walton Centre NHST
Liverpool
Sheffield Children's Hospital
Sheffield
About this study
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.
Read more
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.
Read the detailed description
Study Procedure
- Design: Participants will be interviewed, complete questionnaires and use a food diary for a week to establish a baseline. Participants will then complete a food diary while using the DoddleBags for 11 weeks before completing the questionnaires and being interviewed again.
- Methods of data collection: The study makes use of a small battery of mood and eating questionnaires, as well as two semi-structured interviews and a food diary. The following questionnaires are proposed to form the battery:
- Adult Eating Behaviours Questionnaire (AEB-Q)
- Eating Attitude Test (EAT-26)
- HD Quality of Life Scale (HDQoL)
- HD-specific Eating Questionnaire (HD-EAT)
- Procedure: Participants will undergo a pre-intervention semi-structured interview with the research after completing the participants' ICF, participants 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 the participants' 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 the participant reasonably can, while completing the food diaries for a further 11 weeks.
After both 1 and 4 weeks of using the DoddleBags the study team will contact the participants to check in with how the participants are finding incorporating the DoddleBags into mealtimes. As with every contact, it should be established that the participant is still happy to participate in the study and as part of the researchers' duty of care, researchers should explore if participants would like to withdraw from the study if the participant strongly believes the participant is receiving no significant benefits from the DoddleBags.
The post-intervention semi-structured interview and questionnaire battery will be completed in a study visit arranged as soon as reasonably possible, and ideally within the following week after the 11 week intervention period, to ensure the participants experiences are still fresh. After this the participants will be debriefed and participation will be considered complete.
- Analysis: The semi-structured interviews will be transcribed and fed into NVivo, software designed to facilitate thematic analysis. the researchers will conduct a reflexive thematic analysis on the transcripts to identify commonalities between the responses of participants both before and after the intervention. The AEBQ, HD-EAT, and HDQoL are quantitative measures, so the researchers will use a variety of explorative quantitative analyses to analysis the pre/post-intervention differences.
End of Study The study will be closed to recruitment after completion of informed consent for the final participant. The study team anticipates that participant involvement in the study will last around 12-13 weeks depending on how quickly the post-intervention semi-structured interview can be arranged at a convenient time for the participant. The study will be considered complete as a concept upon publication and submission of study results.
- Conditions
- Huntington's Disease (HD)
- Being tested
- DoddleBags
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoddleBagsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: DoddleBags |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 12 weeks.
Secondary outcomes (2)
Attitudes Towards Mealtimes
To evaluate the impact of using DoddleBags on participants' attitudes towards mealtimes and eating, using the Eating Attitudes Test questionnaire.
Measured: From enrollment to the end of treatment at 12 weeks.
Perceived Quality of Life
To measure how incorporating DoddleBags into mealtimes affects participants' perceived quality of life, using the Huntington's Disease Quality of Life questionnaire (HDQoL).
Measured: From enrollment to the end of treatment at 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start29 Nov 2024
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Why it stopped: No recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Huntington's Disease (HD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- participants will provide baseline measurements for a defined period before all moving onto the intervention and providing further measurements after a second defined period.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hull
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07299682
- Sponsor's protocol ID
- FHS 23-24.95
- Other IDs
- 342883
- Acronym
- FEEDhd
- Status last verified
- May 2026
- First submitted
- 14 Jan 2025
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07299682
- Acronym / sponsor ID
- FEEDhd / FHS 23-24.95
- Conditions
- Huntington's Disease (HD)
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of HullUniversity, hospital or other
- Study start
- 29 Nov 2024 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 23 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Procedure
- Design: Participants will be interviewed, complete questionnaires and use a food diary for a week to establish a baseline. Participants will then complete a food diary while using the DoddleBags for 11 weeks before completing the questionnaires and being interviewed again.
- Methods of data collection: The study makes use of a small battery of mood and eating questionnaires, as well as two semi-structured interviews and a food diary. The following questionnaires are proposed to form the battery:
- Adult Eating Behaviours Questionnaire (AEB-Q)
- Eating Attitude Test (EAT-26)
- HD Quality of Life Scale (HDQoL)
- HD-specific Eating Questionnaire (HD-EAT)
- Procedure: Participants will undergo a pre-intervention semi-structured interview with the research after completing the participants' ICF, participants 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 the participants' 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 the participant reasonably can, while completing the food diaries for a further 11 weeks.
After both 1 and 4 weeks of using the DoddleBags the study team will contact the participants to check in with how the participants are finding incorporating the DoddleBags into mealtimes. As with every contact, it should be established that the participant is still happy to participate in the study and as part of the researchers' duty of care, researchers should explore if participants would like to withdraw from the study if the participant strongly believes the participant is receiving no significant benefits from the DoddleBags.
The post-intervention semi-structured interview and questionnaire battery will be completed in a study visit arranged as soon as reasonably possible, and ideally within the following week after the 11 week intervention period, to ensure the participants experiences are still fresh. After this the participants will be debriefed and participation will be considered complete.
- Analysis: The semi-structured interviews will be transcribed and fed into NVivo, software designed to facilitate thematic analysis. the researchers will conduct a reflexive thematic analysis on the transcripts to identify commonalities between the responses of participants both before and after the intervention. The AEBQ, HD-EAT, and HDQoL are quantitative measures, so the researchers will use a variety of explorative quantitative analyses to analysis the pre/post-intervention differences.
End of Study The study will be closed to recruitment after completion of informed consent for the final participant. The study team anticipates that participant involvement in the study will last around 12-13 weeks depending on how quickly the post-intervention semi-structured interview can be arranged at a convenient time for the participant. The study will be considered complete as a concept upon publication and submission of study results.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- participants will provide baseline measurements for a defined period before all moving onto the intervention and providing further measurements after a second defined period.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: DoddleBagsParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DoddleBagsDoddleBags 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. | Device | Intervention |
Primary outcome
Acceptability
Time frame: From enrollment to the end of treatment at 12 weeks.
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.
2 secondary outcomes
Attitudes Towards Mealtimes
Time frame: From enrollment to the end of treatment at 12 weeks.
Perceived Quality of Life
Time frame: From enrollment to the end of treatment at 12 weeks.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DoddleBags in people with Huntington's Disease (HD), run by University of Hull at 7 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability (time frame: From enrollment to the end of treatment at 12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.