Eating BehaviourNCT02777918
Changing Habits and Lifestyles in Older Individuals
A study testing Recipe provision in people with Eating Behaviour, run by Bournemouth University.
Trial summary
This is an intervention study, aiming to increase protein intake, by increasing egg consumption in community dwelling older adults aged 55 years and over, by providing recipes to increase flavour and variety in egg dishes. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Eating Behaviour
- What is being tested?
- Recipe provision
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2016to 29 Nov 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals can be considered for inclusion if they meet the following inclusion criteria:
- being over 55 years old
- living in the community
- being able to give consent
- not being allergic to eggs
- not suffering from known renal insufficiency, or having a pacemaker or defibrillator.
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- not suffering from known hypercholesterolaemia, or known familial hypercholesterolaemia.
- not having undergone chemotherapy or radiotherapy in the last 6 months
- not suffering from any condition, or receiving medication or treatment that the participants feel affects their eating or sense of flavour.
- being able to perform the physical performance tests (e.g. walk, sit on a chair)
- being able to read and understand English
Who cannot join
None listed.
About this study
This is an intervention study, aiming to increase protein intake, by increasing egg consumption in community dwelling older adults aged 55 years and over, by providing recipes to increase flavour and variety in egg dishes.
Read the detailed description
Individuals will be randomized to either receive the intervention or to a control group, where the intervention group will receive 6 recipes every two weeks for a 12 week period, and at the start, after 12 weeks and after 6 months egg intake, protein intake, body protein status, and various functional measures of muscle function will be assessed in both intervention and control group.
- Conditions
- Eating Behaviour
- Being tested
- Recipe provision
- Keywords
- food intake
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recipe provisionBehavioural
6 recipes will be provided every 2 weeks by post for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 6 recipes will be sent by post every 2 weeks for a 12 week period. Dietary recommendations will also be provided at the start of the intervention period to increase the relevance of the recipes. Receives: Behavioral: Recipe provision |
| Control | No intervention | Dietary recommendations will be provided at the start of the study period, such that the intervention regards the recipes, not the recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Egg Intake
Egg intake at the end of the intervention period, assessed using an adapted Food Frequency Questionnaire (FFQ)
Measured: Change from baseline to 12 weeks
Adverse Events
Self-declared adverse events over the intervention period, assessed by questionnaire
Measured: Change from baseline to 12 weeks
Secondary outcomes (5)
Change in Dietary Protein Intake
Change in dietary protein intake over the intervention and follow-up period, assessed using an adapted FFQ
Measured: Change from baseline to 12 weeks
Muscle Function
Muscle function over the intervention and follow-up period, assessed using the Short Physical Performance Battery (Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, Scherr PA, Wallace RB. (1994) A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol 49:M85-M94). Higher scores denote better ability - range - 5.0 to +5.0.
Measured: Change from baseline to 12 weeks
Lean Body Mass
Lean body mass over the intervention and follow-up period, assessed using bioimpedance
Measured: Change from baseline to 12 weeks
Egg Intake
Egg intake over the follow-up period, assessed using an adapted FFQ.
Measured: 6 months
Number of Adverse Events Reported
Self-declared adverse events over the follow-up period, assessed by questionnaire
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2016 (estimated)
- Study start1 Jun 2016
- Primary completion30 Apr 2017
- Study completion29 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Eating BehaviourStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bournemouth University
- Sponsor type
- University, hospital or other
- Collaborators
- British Egg Industry Council
- Responsible party
- Sponsor
- Investigators
- Katherine M Appleton, PhD, Principal investigator, Bournemouth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02777918
- Sponsor's protocol ID
- BUREC12036
- Status last verified
- Jun 2019
- First submitted
- 17 May 2016
- Last updated
- 29 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Group data will be made available on publication of the study
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changing Habits and Lifestyles in Older Individuals
- ClinicalTrials.gov ID
- NCT02777918
- Acronym / sponsor ID
- BUREC12036
- Conditions
- Eating Behaviour
- Keywords
- food intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Bournemouth UniversityUniversity, hospital or other
- Collaborators
- British Egg Industry Council
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 30 Apr 2017 (actual)
- Study completion
- 29 Nov 2017 (actual)
- First posted
- 19 May 2016 (estimated)
- Results
- Posted 29 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an intervention study, aiming to increase protein intake, by increasing egg consumption in community dwelling older adults aged 55 years and over, by providing recipes to increase flavour and variety in egg dishes.
Detailed description
Individuals will be randomized to either receive the intervention or to a control group, where the intervention group will receive 6 recipes every two weeks for a 12 week period, and at the start, after 12 weeks and after 6 months egg intake, protein intake, body protein status, and various functional measures of muscle function will be assessed in both intervention and control group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Recipe provision6 recipes will be sent by post every 2 weeks for a 12 week period. Dietary recommendations will also be provided at the start of the intervention period to increase the relevance of the recipes. |
| Control | No intervention | –Dietary recommendations will be provided at the start of the study period, such that the intervention regards the recipes, not the recommendations |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Individuals can be considered for inclusion if they meet the following inclusion criteria:
- being over 55 years old
- living in the community
- being able to give consent
- not being allergic to eggs
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Recipe provision6 recipes will be provided every 2 weeks by post for 12 weeks | Behavioural | Intervention |
Primary outcome
Egg Intake
Time frame: Change from baseline to 12 weeks
Egg intake at the end of the intervention period, assessed using an adapted Food Frequency Questionnaire (FFQ)
Adverse Events
Time frame: Change from baseline to 12 weeks
Self-declared adverse events over the intervention period, assessed by questionnaire
5 secondary outcomes
Change in Dietary Protein Intake
Time frame: Change from baseline to 12 weeks
Muscle Function
Time frame: Change from baseline to 12 weeks
Lean Body Mass
Time frame: Change from baseline to 12 weeks
Egg Intake
Time frame: 6 months
Number of Adverse Events Reported
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Group data will be made available on publication of the study
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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.
Katherine M Appleton, PhD principal investigator
Bournemouth University
Questions about this trial
What is this clinical trial studying?
A study testing Recipe provision in people with Eating Behaviour, run by Bournemouth University.
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 11 inclusion and 0 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: finished, as of the sponsor's last update on 29 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 29 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Egg Intake (time frame: Change from baseline to 12 weeks). The study lists 2 primary outcomes in all. 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 29 Jul 2019.