Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000955213
Ethics application status
Approved
Date submitted
1/06/2018
Date registered
6/06/2018
Date last updated
21/01/2019
Date data sharing statement initially provided
21/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of Home-Delivered Meals on Older People`s Nutrient intake, Physical performance and Activity and Health-related Quality of life; the Power Meals trial
Scientific title
Effects of Home-Delivered Meals on Older People`s Nutrient intake, Physical performance and Activity and Health-related Quality of life; the Power Meals Randomized Controlled Trial
Secondary ID [1] 295028 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
low protein intake 308047 0
other nutritional deficiencies 308048 0
physical performance 308049 0
physical activity 308050 0
health-related quality of life 308051 0
Condition category
Condition code
Diet and Nutrition 307098 307098 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eight (8) week nutritional intervention with home-delivered meals. Three parallel intervention arms; two intervention groups, one control group.
Arm 1:
1/3 of participants allocated to intervention 1 (Arm 1).
Protein-enriched meal containing main dish, side dishes, salad/warm vegetables (20-25 g protein, meal size 350-380 g) and snack (10-15 g protein) and protein-rich bread (2 slices/day, 8-10 g protein) is offered at 7 days a week, 8 weeks. Participants fill daily a brief form about study meals, snack and bread; how much they ate meal components, was the taste and composition good, how many bread slices they consumed etc. One-day food diarys are also filled twice during the intervention (week 2 and 4) and three-day food diaries at week 8 .
Cold meals are delivered at home twice a week. Difference between Arm 1 and Arm 2 in protein intake is approx. + 30 g protein more in Arm 1.
Meals are prepared at Seniori Ateriat, which is a catering kitchen owned by Fazer Food Services in Finland. Meals are prepared with Cook&chill- method.

Arm 2:
1/3 of participants allocated to intervention 2 (Arm 2).
Normal home-meal with main dish, side dishes, salad/warm vegetables (17-19 g protein, meal size 350-380 g) is offered at 7 days a week, 8 weeks. Participants fill daily a brief form about study meals; how much they ate meal components, was the taste and composition good etc. One-day food diarys are also filled twice during the intervention (week 2 and 4) and three-day food diaries at week 8. Cold meals are delivered at home twice a week.
Meals are prepared at Seniori Ateriat, which is a catering kitchen owned by Fazer Food Services in Finland. Meals are prepared with Cook&chill- method.

Arm 3:
1/3 of participants allocated to control group (Arm 3).
Control group continues eating as usual (their normal own diet) for 8 weeks. No home-delivered meals during intervention.One-day food diarys are filled twice during the 8 weeks (week 2 and 4) and three-day food diaries at week 8 .
Intervention code [1] 301361 0
Prevention
Comparator / control treatment
Control group continues eating as before. No home-delivered meals during intervention. One-day food diarys are filled twice during the 8 weeks (week 2 and 4) and three-day food diaries at week 8 .
2 week free home-delivered meals are offered after final measurements.
Control group
Active

Outcomes
Primary outcome [1] 306059 0
Protein intake in g/kg(Body wight)/d assessed by three-day food diary.
Timepoint [1] 306059 0
Final intervention week --> 8 weeks post-enrolment
Primary outcome [2] 306060 0
Physical performance as assessed by chair stand test (seconds) in Short Physical Performance Battery (SPPB)
Timepoint [2] 306060 0
9 weeks post-enrolment
Secondary outcome [1] 347453 0
Physical performance as assessed by Short Physical Performance Battery (SPPB) (total score)
Timepoint [1] 347453 0
9 weeks post-enrolment
Secondary outcome [2] 347454 0
Physical performance as assessed by gait speed test (seconds) in Short Physical Performance Battery (SPPB)
Timepoint [2] 347454 0
9 weeks post-enrolment
Secondary outcome [3] 347455 0
Physical performance as assessed by Hand Grip Test
Timepoint [3] 347455 0
9 weeks post-enrolment
Secondary outcome [4] 347456 0
Health-related -related Quality of Life as measured by 15D
Timepoint [4] 347456 0
9 weeks post-enrolment
Secondary outcome [5] 347457 0
Physical Activity level as assessed by UKK RM42 accelerometer
Timepoint [5] 347457 0
Final intervention week --> 8 weeks post-enrolment

Eligibility
Key inclusion criteria
- at least 65 years old
- protein intake under at baseline (< 1.0 g/kgBW/d) based on short protein screener
- living at home
- a customer of domiciliary care or a spouse/close relative of a domiciliary care client (if he/she is living in the same household), caregiver or a care recipient
- capable of filling up food diaries and queastionnaires
- willing to eat study meals (able to eat themselves)
- normal cognition (MMSE-points under 27 geriatric evaluation)
- no special diets or illnesses that can restrict eating study meals (kidney deficiency, difficult bowel disease etc). Geriatric evaluation.
-able to move (with or without rollator or wheelchair)
- no current home-meal services
- no illnessess that require hospitalization
- no travels etc that can interrupt study intervention
- able to heat up study meals
- informed consent given
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- under 65 years old
- cognitive impairment on the basis of MMSE-test Mini-Mental State Examination) (and geriatric evalution
- special diet or illness that restricts eating study meals (kidney deficiency, difficult bowel disease etc). Geriatric evaluation.
- unable to move (disabled)
- travels etc that interrupt study intervention
- cancer
- type 1 diabetes
- participating in another nutritional intervention at the same time
- needs liquid or pasty diet required
- BMI under 18,5 or above 40
- overuse of alcohol (Audit-points over 4 geriatric evaluation)
Geriatric evaluation in case of multiple diseases or mental disorders.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants are randomly allocated one by one to the intervention 1 or 2 (Arm 1 and 2) or the control group (Arm 3) according to a computer-generated, blocked randomization list. If there are two participants from the same household, they will be rndomized to same group. A person unrelated to the study carries out the randomization.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size was calculated based on expected change in protein intake in the intervention groups from 1,0 g/kgBW/d (SD 0,3) to 1,2 g/kgBW/d. Calculation based on Cohens effect size (f) in Variance analysis which was set on 0.25 - 0.30. Assumption was that protein intake will not chanhe in control group. Calculated sample size is 105 (35 per group) ß=0.85 and a=0.05. Sample size was estimated using G*Power (version 3.1.9.2) software.
SPSS version 25.0 (SPSS, Inc., Chicago, IL) and STATA 14.1 are used in statistical analyses.
The results are presented as means with SDs or as percentages, with 95% confidence intervals for the major outcomes. Statistical differences between the groups are determined by t-tests, Mann Whitney U-test, Chi Square test or Fisher´s exact test.
The main outcome measures are subjected to an analysis of covariance (ANCOVA) with appropriate covariates.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/07/2018
Actual
25/07/2018
Date of last participant enrolment
Anticipated
27/08/2018
Actual
24/08/2018
Date of last data collection
Anticipated
26/10/2018
Actual
26/10/2018
Sample size
Target
105
Accrual to date
Final
78
Recruitment outside Australia
Country [1] 10512 0
Finland
State/province [1] 10512 0
Pori

Funding & Sponsors
Funding source category [1] 299608 0
Commercial sector/Industry
Name [1] 299608 0
Oy Karl Fazer Ab
Country [1] 299608 0
Finland
Funding source category [2] 299685 0
Commercial sector/Industry
Name [2] 299685 0
Fazer Food Services Oy
Country [2] 299685 0
Finland
Primary sponsor type
Government body
Name
The Pori Social and Health Services
Address
The Pori Social and Health Services
Maantiekatu 31
28120 Pori, Finland
Country
Finland
Secondary sponsor category [1] 298929 0
None
Name [1] 298929 0
Address [1] 298929 0
Country [1] 298929 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300511 0
Ethics Committee of the Hospital District of Southwest Finland
Ethics committee address [1] 300511 0
Ethics committee country [1] 300511 0
Finland
Date submitted for ethics approval [1] 300511 0
27/04/2018
Approval date [1] 300511 0
22/05/2018
Ethics approval number [1] 300511 0
38 /1801/2018

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 83894 0
Mrs Susanna Kunvik
Address 83894 0
The Pori Social and Health Services
Maantiekatu 31, 1 th floor
28120 PORI, Finland
Country 83894 0
Finland
Phone 83894 0
+358503488782
Fax 83894 0
Email 83894 0
[email protected]
Contact person for public queries
Name 83895 0
Susanna Kunvik
Address 83895 0
The Pori Social and Health Services
Maantiekatu 31, 1 th floor
28120 PORI, Finland
Country 83895 0
Finland
Phone 83895 0
+358503488782
Fax 83895 0
Email 83895 0
[email protected]
Contact person for scientific queries
Name 83896 0
Susanna Kunvik
Address 83896 0
The Pori Social and Health Services
Maantiekatu 31, 1 th floor
28120 PORI, Finland
Country 83896 0
Finland
Phone 83896 0
+358503488782
Fax 83896 0
Email 83896 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Confidential information


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.