Changing Habits and Lifestyles in Older Individuals
1 other identifier
interventional
100
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2016
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2016
CompletedFirst Posted
Study publicly available on registry
May 19, 2016
CompletedStudy Start
First participant enrolled
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 29, 2017
CompletedResults Posted
Study results publicly available
July 29, 2019
CompletedJuly 29, 2019
June 1, 2019
11 months
May 17, 2016
May 3, 2018
June 3, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Egg Intake
Egg intake at the end of the intervention period, assessed using an adapted Food Frequency Questionnaire (FFQ)
Change from baseline to 12 weeks
Adverse Events
Self-declared adverse events over the intervention period, assessed by questionnaire
Change from baseline to 12 weeks
Secondary Outcomes (5)
Change in Dietary Protein Intake
Change from baseline to 12 weeks
Muscle Function
Change from baseline to 12 weeks
Lean Body Mass
Change from baseline to 12 weeks
Egg Intake
6 months
Number of Adverse Events Reported
6 months
Study Arms (2)
Intervention
EXPERIMENTAL6 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 INTERVENTIONDietary recommendations will be provided at the start of the study period, such that the intervention regards the recipes, not the recommendations
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bournemouth Universitylead
- British Egg Industry Councilcollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Anticipated, but small sample. Should be treated as a pilot study.
Results Point of Contact
- Title
- Prof. Katherine Appleton
- Organization
- Bournemouth University
Study Officials
- PRINCIPAL INVESTIGATOR
Katherine M Appleton, PhD
Bournemouth University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2016
First Posted
May 19, 2016
Study Start
June 1, 2016
Primary Completion
April 30, 2017
Study Completion
November 29, 2017
Last Updated
July 29, 2019
Results First Posted
July 29, 2019
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will not share
Group data will be made available on publication of the study