Changing Habits and Lifestyles in Older Individuals

Not Applicable

Completed

• Conditions: Eating Behaviour
• Interventions: Behavioral: Recipe provision

• Registration Number: NCT02777918
• Lead Sponsor: Bournemouth University

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.

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 Timeline

• Study First Submitted: 2016-05-17
• Study First Submitted QC: 2016-05-17
• Study First Posted: 2016-05-19
• Study Start: 2016-06-01
• Primary Completion: 2017-04-30
• Study Completion: 2017-11-29
• Results First Submitted: 2018-05-03
• Status Verified: 2019-06
• Results First Submitted QC: 2019-06-03
• Last Update Submitted: 2019-06-03
• Results First Posted: 2019-07-29
• Last Update Posted: 2019-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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.
• 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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Recipe provision	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.

Primary Outcome Measures

Name	Time	Method
Egg Intake	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	Change from baseline to 12 weeks	Self-declared adverse events over the intervention period, assessed by questionnaire

Secondary Outcome Measures

Name	Time	Method
Egg Intake	6 months	Egg intake over the follow-up period, assessed using an adapted FFQ.
Muscle Function	Change from baseline to 12 weeks	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.
Change in Dietary Protein Intake	Change from baseline to 12 weeks	Change in dietary protein intake over the intervention and follow-up period, assessed using an adapted FFQ
Lean Body Mass	Change from baseline to 12 weeks	Lean body mass over the intervention and follow-up period, assessed using bioimpedance
Number of Adverse Events Reported	6 months	Self-declared adverse events over the follow-up period, assessed by questionnaire