Changing Habits and Lifestyles in Older Individuals

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.

Study Overview

• Status: Completed
• Conditions: Eating Behaviour
• Intervention / Treatment: Behavioral: Recipe provision

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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.	Behavioral: Recipe provision; 6 recipes will be provided every 2 weeks by post for 12 weeks
No Intervention: Control; Dietary recommendations will be provided at the start of the study period, such that the intervention regards the recipes, not the recommendations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bournemouth University
• Collaborators: British Egg Industry Council
• Investigators: Principal Investigator: Katherine M Appleton, PhD, Bournemouth University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): April 30, 2017
• Study Completion (Actual): November 29, 2017

Study Registration Dates

• First Submitted: May 17, 2016
• First Submitted That Met QC Criteria: May 17, 2016
• First Posted (Estimate): May 19, 2016

Study Record Updates

• Last Update Posted (Actual): July 29, 2019
• Last Update Submitted That Met QC Criteria: June 3, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: food intake
• Other Study ID Numbers: BUREC12036

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Group data will be made available on publication of the study