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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ANZCTR
Last refreshed on: 28 January 2019
Main ID:  ACTRN12618000955213
Date of registration: 06/06/2018
Prospective Registration: Yes
Primary sponsor: The Pori Social and Health Services
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
Date of first enrolment: 25/07/2018
Target sample size: 105
Recruitment status: Completed
URL:  https://anzctr.org.au/ACTRN12618000955213.aspx
Study type:  Interventional
Study design:  Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy;  
Phase:  Not Applicable
Countries of recruitment
Finland
Contacts
Name: Mrs Susanna Kunvik   
Address:  The Pori Social and Health Services Maantiekatu 31, 1 th floor 28120 PORI, Finland Finland
Telephone: +358503488782
Email: susanna.kunvik@gmail.com
Affiliation: 
Name: Mrs Susanna Kunvik   
Address:  The Pori Social and Health Services Maantiekatu 31, 1 th floor 28120 PORI, Finland Finland
Telephone: +358503488782
Email: susanna.kunvik@gmail.com
Affiliation: 
Key inclusion & exclusion criteria
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

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.


Age minimum: 65 Years
Age maximum: No limit
Gender: Both males and females
Health Condition(s) or Problem(s) studied
low protein intake;other nutritional deficiencies;physical performance;physical activity;health-related quality of life;
low protein intake
other nutritional deficiencies
physical performance
physical activity
health-related quality of life
Diet and Nutrition - Other diet and nutrition disorders
Intervention(s)
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
Primary Outcome(s)
Physical performance as assessed by chair stand test (seconds) in Short Physical Performance Battery (SPPB)

[9 weeks post-enrolment ]
Protein intake in g/kg(Body wight)/d assessed by three-day food diary.


[Final intervention week --> 8 weeks post-enrolment]
Secondary Outcome(s)
Physical Activity level as assessed by UKK RM42 accelerometer
[Final intervention week --> 8 weeks post-enrolment]
Physical performance as assessed by gait speed test (seconds) in Short Physical Performance Battery (SPPB)

[9 weeks post-enrolment ]
Physical performance as assessed by Short Physical Performance Battery (SPPB) (total score)


[9 weeks post-enrolment ]
Physical performance as assessed by Hand Grip Test
[9 weeks post-enrolment ]
Health-related -related Quality of Life as measured by 15D
[9 weeks post-enrolment ]
Secondary ID(s)
Nil known
Source(s) of Monetary Support
Fazer Food Services Oy
Oy Karl Fazer Ab
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date:
Contact:
Ethics Committee of the Hospital District of Southwest Finland
Results
Results available: Yes
Date Posted: 21/01/2019
Date Completed: 26/10/2018
URL:
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