Trial Outcomes & Findings for Changing Habits and Lifestyles in Older Individuals (NCT NCT02777918)

NCT ID: NCT02777918

Last Updated: 2019-07-29

Results Overview

Egg intake at the end of the intervention period, assessed using an adapted Food Frequency Questionnaire (FFQ)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 100 participants
• Primary outcome timeframe: Change from baseline to 12 weeks
• Results posted on: 2019-07-29

Participant Flow

Participant milestones

Measure	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. Recipe provision: 6 recipes will be provided every 2 weeks by post for 12 weeks	Control Dietary recommendations will be provided at the start of the study period, such that the intervention regards the recipes, not the recommendations
Overall Study STARTED	53	47
Overall Study COMPLETED	50	43
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Measure	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. Recipe provision: 6 recipes will be provided every 2 weeks by post for 12 weeks	Control Dietary recommendations will be provided at the start of the study period, such that the intervention regards the recipes, not the recommendations
Overall Study Medical reasons	1	2
Overall Study Too busy / stressed	1	1
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Intervention n=53 Participants 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. Recipe provision: 6 recipes will be provided every 2 weeks by post for 12 weeks	Control n=47 Participants Dietary recommendations will be provided at the start of the study period, such that the intervention regards the recipes, not the recommendations	Total n=100 Participants Total of all reporting groups
Age, Continuous	70 years STANDARD_DEVIATION 8 • n=53 Participants	70 years STANDARD_DEVIATION 7 • n=47 Participants	70 years STANDARD_DEVIATION 7 • n=100 Participants
Sex: Female, Male Female	30 Participants n=53 Participants	24 Participants n=47 Participants	54 Participants n=100 Participants
Sex: Female, Male Male	23 Participants n=53 Participants	23 Participants n=47 Participants	46 Participants n=100 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	53 participants n=53 Participants	47 participants n=47 Participants	100 participants n=100 Participants

PRIMARY outcome

Timeframe: Change from baseline to 12 weeks

Population: ITT

Egg intake at the end of the intervention period, assessed using an adapted Food Frequency Questionnaire (FFQ)

Outcome measures

Measure	Intervention n=53 Participants 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. Recipe provision: 6 recipes will be provided every 2 weeks by post for 12 weeks	Control n=47 Participants Dietary recommendations will be provided at the start of the study period, such that the intervention regards the recipes, not the recommendations
Egg Intake	5 eggs Standard Deviation 20	4 eggs Standard Deviation 20

PRIMARY outcome

Timeframe: Change from baseline to 12 weeks

Population: ITT

Self-declared adverse events over the intervention period, assessed by questionnaire

Outcome measures

Measure	Intervention n=53 Participants 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. Recipe provision: 6 recipes will be provided every 2 weeks by post for 12 weeks	Control n=47 Participants Dietary recommendations will be provided at the start of the study period, such that the intervention regards the recipes, not the recommendations
Adverse Events	0.1 Adverse events Standard Deviation 1.9	0.3 Adverse events Standard Deviation 1.3

SECONDARY outcome

Timeframe: Change from baseline to 12 weeks

Population: ITT

Change in dietary protein intake over the intervention and follow-up period, assessed using an adapted FFQ

Outcome measures

Measure	Intervention n=53 Participants 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. Recipe provision: 6 recipes will be provided every 2 weeks by post for 12 weeks	Control n=47 Participants Dietary recommendations will be provided at the start of the study period, such that the intervention regards the recipes, not the recommendations
Change in Dietary Protein Intake	-3 g/day Standard Deviation 29	3 g/day Standard Deviation 35

SECONDARY outcome

Timeframe: Change from baseline to 12 weeks

Population: ITT

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.

Outcome measures

Measure	Intervention n=53 Participants 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. Recipe provision: 6 recipes will be provided every 2 weeks by post for 12 weeks	Control n=47 Participants Dietary recommendations will be provided at the start of the study period, such that the intervention regards the recipes, not the recommendations
Muscle Function	0.6 scores on a scale Standard Deviation 2.6	-0.2 scores on a scale Standard Deviation 2.1

SECONDARY outcome

Timeframe: Change from baseline to 12 weeks

Population: ITT

Lean body mass over the intervention and follow-up period, assessed using bioimpedance

Outcome measures

Measure	Intervention n=53 Participants 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. Recipe provision: 6 recipes will be provided every 2 weeks by post for 12 weeks	Control n=47 Participants Dietary recommendations will be provided at the start of the study period, such that the intervention regards the recipes, not the recommendations
Lean Body Mass	-0.1 g Standard Deviation 12.6	-0.3 g Standard Deviation 12.8

SECONDARY outcome

Timeframe: 6 months

Population: ITT

Egg intake over the follow-up period, assessed using an adapted FFQ.

Outcome measures

Measure	Intervention n=53 Participants 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. Recipe provision: 6 recipes will be provided every 2 weeks by post for 12 weeks	Control n=47 Participants Dietary recommendations will be provided at the start of the study period, such that the intervention regards the recipes, not the recommendations
Egg Intake	4 eggs Standard Deviation 22	1 eggs Standard Deviation 15

SECONDARY outcome

Timeframe: 6 months

Population: ITT

Self-declared adverse events over the follow-up period, assessed by questionnaire

Outcome measures

Measure	Intervention n=53 Participants 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. Recipe provision: 6 recipes will be provided every 2 weeks by post for 12 weeks	Control n=47 Participants Dietary recommendations will be provided at the start of the study period, such that the intervention regards the recipes, not the recommendations
Number of Adverse Events Reported	0.3 Number of adverse events reported Standard Deviation 1.5	0.5 Number of adverse events reported Standard Deviation 1.7

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 53 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 47 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Intervention n=53 participants at risk 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. Recipe provision: 6 recipes will be provided every 2 weeks by post for 12 weeks	Control n=47 participants at risk Dietary recommendations will be provided at the start of the study period, such that the intervention regards the recipes, not the recommendations
General disorders Questionnaire self-report	100.0% 53/53 • Number of events 53 • 6 months self-report questionnaire assessing number of unusual experiences of nausea, digestive issues (e.g. constipation or diarrhoea), stomach aches/cramps, hunger, bloating/uncomfortable fullness, thirst, headaches, fatigue/tiredness, restlessness, dizziness, or skin rashes.	100.0% 47/47 • Number of events 47 • 6 months self-report questionnaire assessing number of unusual experiences of nausea, digestive issues (e.g. constipation or diarrhoea), stomach aches/cramps, hunger, bloating/uncomfortable fullness, thirst, headaches, fatigue/tiredness, restlessness, dizziness, or skin rashes.

Additional Information

Prof. Katherine Appleton

Bournemouth University

Phone: +441202965985

Email: k.appleton@bournemouth.ac.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place