Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001254583
Ethics application status
Approved
Date submitted
14/09/2015
Date registered
16/11/2015
Date last updated
10/10/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Improving caregivers nutrition and well-being with tailored nutrition counseling – a randomised, controlled trial (RCT)
Scientific title
Nutritional intervention compared to normal care among elderly caregivers during six months period on protein intake and quality of life.
Secondary ID [1] 287183 0
None
Universal Trial Number (UTN)
Trial acronym
CareNutrition
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malnutrition
 295751 0
Mental burden
 295752 0
Poor quality of life 296637 0
Loneliness 296638 0
Depression 296639 0
Condition category
Condition code
Diet and Nutrition 296028 296028 0 0
Other diet and nutrition disorders
Mental Health 296989 296989 0 0
Depression
Mental Health 296990 296990 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The main participants in this study are caregivers aged 65 or older working at the area of the Social Services and Healthcare Centre of Pori. The caregivers are providing care in their own home. Caregivers are randomized into two groups; intervention and control groups.


On the basis of the caregivers`and patients`3-day food diaries, Mini Nutritional Assessment, home visit and nutritional survey, the nutritionist gives a individual nutrition counseling to the caregiver about their (caregiver and patient) nutrition and food habits. The patient can participate to the counseling if it is possible or/and wanted. The duration of the individual nutrition counseling session is 60-90 minutes. The objective is not to change their food habits completely, but to correct possible inadequacies in their diet and to motivate.

Intervention group will also have a group-based nutrition counseling 0-4 times during the half year period. The group counseling is tailored to each caregiver personally based on their needs and wishes. The patient will not attend to group counseling. The group counseling will be a small group counseling (three meetings and fourth if needed, duration two hours/session) or cooking courses (two meetings,duration 2,5 hours/session). Cooking courses will be arranged in Satakunta Martha organization. The third option is that the caregiver does not participate to the group meeting at all (if it is not possible or if they don`t want. A register of attendance at group sessions will be held.

All the participants in the intervention group have an opportunity to join the facebook group where they can discuss about nutrition, health, coping an overall well-being.

At the end of the study the intervention group is compared with the control group.
Intervention code [1] 292458 0
Lifestyle
Comparator / control treatment
Persons in the control group will receive standard care and a written nutrition booklet after randomization.

At the end of the trial trained nutritionist gives 1 individual nutrition counseling to the caregiver about their (caregiver and patient) nutrition and food habits.
The personal nutrition guidance will be given on the basis of the caregivers`and patients`3-day food diaries, Mini Nutritional Assessment, home visit and nutritional survey. The patient can participate to the counseling if it is possible or/and wanted. The duration of the individual nutrition counseling session is 60-90 minutes. The objective is not to change their food habits completely, but to correct possible inadequacies in their diet and to motivate.
Control group
Active

Outcomes
Primary outcome [1] 295698 0
Protein intake assessed by 3 day food diaries and analysed Fineli (www.fineli.fi) (Caregivers and persons receiving care)
Timepoint [1] 295698 0
Three day food diary completed at 6 months post randomization
Primary outcome [2] 295699 0
Health related quality of life with RAND-36 (Caregivers)
Timepoint [2] 295699 0
assessed with RAND-36at 6 months post randomization
Primary outcome [3] 295700 0
Health related quality of life with 15D (persons receiving care)
Timepoint [3] 295700 0
assessed with 15D at 6 months post randomization
Secondary outcome [1] 316266 0
Nutritional status with MNA (Caregivers)
Timepoint [1] 316266 0
assessed with MNA at 6 months post randomization
Secondary outcome [2] 316267 0
Depression with GDS-15 (Caregivers)
Timepoint [2] 316267 0
assessed with GDS-15 at 6 months post randomization
Secondary outcome [3] 316268 0
Health related quality of life with 15D (Caregivers)
Timepoint [3] 316268 0
assessed with 15D at 6 months post randomization
Secondary outcome [4] 316269 0
Social factors with Social Provision Scale (Caregivers)
Timepoint [4] 316269 0
assessed with Social Provision Scale at 6 months post randomization

Eligibility
Key inclusion criteria
Caregivers (main subjects): age 65 or more and working as a caregiver at home at the area of the Social Services and Healthcare Centre of Pori. Able to participate in group counseling. Normal cognition.

Persons receiving care (secondary subjects):caregiver participates the study, age 50 or more, living at home, no parenteral nutrition, no terminal phase illness
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Caregivers (main subjects): dementia, not able to participate to group counseling, age under 65

Persons receiving care (secondary subjects): terminal phase illness, parenteral nutiriton, under 50 years old

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
After the baseline measurements, subjects fulfilling inclusion criteria will be randomized either to intervention or control group using computer-generated randomly allocated numbers received from a randomization center.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be randomized in order they have returned their 3 day food diaries after the baseline measurements. The randomization will be performed using computer-generated randomly allocated numbers received from a randomization center. Every randomization result will appear in the program after the participants name has been written and the person executing the randomization has confirmed the process with initials. This assures that no one doing the randomization cannot influence the result.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
One intervention group and one control group
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size was calculated based on the primary outcome measure protein intake. To ensure 80 % power to detect a 0,2 grammes difference with standard deviation of 0,32 between the intervention and control groups at two-sided alfa 0,05, 42 participants are needed in each group. When drops outs are taken into account the target for intervention and control groups are 51 persons. (Caregivers)

All caregivers assessed at baseline and at 6 months will be included in the data analyses of the changes in protein intake, health related quality of life and other factors. The data will be presented as means or percentages. Statitical somparison between the groups are given for the most important outcomes and they will be performed using t-test, Mann-Whitney U-test or Chi square-test when appropriate. Additional statistical analyses, like ANCOVA, logistic regression analyses and other will be performed as appropriate.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
5/10/2015
Date of last participant enrolment
Anticipated
30/06/2016
Actual
16/06/2016
Date of last data collection
Anticipated
9/12/2016
Actual
31/12/2016
Sample size
Target
102
Accrual to date
Final
134
Recruitment outside Australia
Country [1] 7060 0
Finland
State/province [1] 7060 0
Pori

Funding & Sponsors
Funding source category [1] 291746 0
Hospital
Name [1] 291746 0
Social Services and Healthcare Centre of Pori
Country [1] 291746 0
Finland
Funding source category [2] 294766 0
Government body
Name [2] 294766 0
National Institute for Health and Welfare
Country [2] 294766 0
Finland
Primary sponsor type
Hospital
Name
Social Services and Healthcare Centre of Pori
Address
Maantiekatu 31, 28120 PORI
Country
Finland
Secondary sponsor category [1] 290416 0
None
Name [1] 290416 0
Address [1] 290416 0
Country [1] 290416 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293265 0
Ethics Committee of the Hospital District of Southwest Finland.
Ethics committee address [1] 293265 0
Ethics committee country [1] 293265 0
Finland
Date submitted for ethics approval [1] 293265 0
Approval date [1] 293265 0
04/08/2015
Ethics approval number [1] 293265 0

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

Contacts
Principal investigator
Name 59174 0
Mrs Susanna Kunvik
Address 59174 0
The Basic Security Center of Pori
Susanna Kunvik
Maantiekatu 31 Hallinnon rakennus, 2. kerros
28120 PORI
Country 59174 0
Finland
Phone 59174 0
+35844 701 6039
Fax 59174 0
Email 59174 0
[email protected]
Contact person for public queries
Name 59175 0
Susanna Kunvik
Address 59175 0
The Basic Security Center of Pori
Susanna Kunvik
Maantiekatu 31
Hallinnon rakennus, 2. kerros
28120 PORI
Country 59175 0
Finland
Phone 59175 0
+35844 701 6039
Fax 59175 0
Email 59175 0
[email protected]
Contact person for scientific queries
Name 59176 0
Merja Suominen
Address 59176 0
Gerontologinen ravitsemus Gery ry
Toinen linja 3, 4. krs.
00530 Helsinki
Country 59176 0
Finland
Phone 59176 0
+35844 701 6039
Fax 59176 0
Email 59176 0
[email protected]

No information has been provided regarding IPD availability


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.