Eating BehaviourNCT02777918

Changing Habits and Lifestyles in Older Individuals

A study testing Recipe provision in people with Eating Behaviour, run by Bournemouth University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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.

Show all 11Show fewer

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

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 groups in NCT02777918
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.

1 Jun 201629 Nov 2017

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Recruiting
An Online Intuitive Eating Program for Pregnant Women With Obesity to Support Well-Being
Excessive Gestational Weight Gain, Pregnancy
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
Recruiting
Nutrition Outcomes Using a Randomized Intervention Via Smartphone on Dietary Habits
Healthy Adult Participants, Mindful Eating Intervention

All Eating Behaviour trials

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.

Detailed description

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

Results posted to the registry on 29 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention	53	50
Control	47	43

Primary outcome: Egg Intake

Time frame: Change from baseline to 12 weeks. Mean (Standard Deviation). Unit: eggs

Measure	Intervention n = 53	Control n = 47
Value	5 (20)	4 (20)

Population analysed: ITT

Primary outcome: Adverse Events

Time frame: Change from baseline to 12 weeks. Mean (Standard Deviation). Unit: Adverse events

Measure	Intervention n = 53	Control n = 47
Value	0.1 (1.9)	0.3 (1.3)

Population analysed: ITT

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention	0 of 53 (0%)	53 of 53 (100%)	0 of 53
Control	0 of 47 (0%)	47 of 47 (100%)	0 of 47

Limitations and caveats (from the sponsor): Anticipated, but small sample. Should be treated as a pilot study.

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

Related trials for Eating Behaviour

Recruiting
An Online Intuitive Eating Program for Pregnant Women With Obesity to Support Well-Being
Excessive Gestational Weight Gain, Pregnancy
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
Recruiting
Nutrition Outcomes Using a Randomized Intervention Via Smartphone on Dietary Habits
Healthy Adult Participants, Mindful Eating Intervention

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?

On the ClinicalTrials.gov record for NCT02777918.

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.