NCT04255654

Brief Summary

1 in 10 people in the UK cannot afford enough nutritious food to eat, to help them and their family stay healthy. We aim to find out what it would be like for both dietitians and their clients to be asked, routinely in a dietetic appointment, about having enough food to eat. Your dietitian will ask you 2 questions about your access to food and, if you want, they will discuss some options which might be helpful for you if your access to food is limited. Some of the discussions that take place (regarding the intervention only) will be audio recorded with your consent to check they are being done correctly. If options which might be helpful for you to get more access to food were required you will then be asked to take part in a telephone interview, which will be audio recorded and will involve discussing your experience of the intervention and what you did with the information provided. After this telephone interview, this will be the end of the study for you.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 28, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2020

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
Last Updated

April 8, 2020

Status Verified

April 1, 2020

Enrollment Period

5 months

First QC Date

January 17, 2020

Last Update Submit

April 7, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Feasibility of the intervention

    Feasibility is to be measured by the number of dietetic service users consenting to take part, the number of completed brief interventions and the number of dietetic service users identified with food insecurity.

    6 months

Secondary Outcomes (2)

  • Dietitian User Acceptability

    6 months

  • Dietitian Acceptability

    6 months

Study Arms (1)

Brief Intervention

EXPERIMENTAL

There is only 1 intervention for this study. They will have the brief intervention completed on them. There is no control group.

Other: Brief Intervention for Food Insecurity

Interventions

2 item screening tool (brief intervention)

Brief Intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Attending dietitian clinic
  • Is ≥18 years of age or their main care giver is ≥18 years of age
  • Is willing and able to provide informed consent to participate and comply with the study procedures
  • Is able to understand English

You may not qualify if:

  • The dietitian deems it inappropriate to make an opportunistic brief intervention on food insecurity. This includes personal and medical reasons known to the dietitian or reasons related to the consultation (for example the dietitian service user has become distressed and it would seem insensitive to complete the intervention at that time).
  • Is \<18 years of age and their main care giver is \<18 years of age
  • No interpreter present, therefore the potential participant is unable to understand and speak English sufficiently to give informed consent
  • Lacks capacity to give informed consent.
  • Has a diagnosed severe eating disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Coventry University

Coventry, England, CV1 5FB, United Kingdom

Location

MeSH Terms

Interventions

Crisis InterventionFood Insecurity

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and ActivitiesFood SupplyFood IndustryIndustryTechnology, Industry, and Agriculture

Study Officials

  • Deborah Lycett, Prof

    Coventry University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Religious Health Interventions & Dietetic Practice

Study Record Dates

First Submitted

January 17, 2020

First Posted

February 5, 2020

Study Start

August 28, 2019

Primary Completion

January 21, 2020

Study Completion

January 21, 2020

Last Updated

April 8, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations