Improving caregivers nutrition and well-being with tailored nutrition counseling – a randomised, controlled trial (RCT)

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615001254583
• Date of registration: 16/11/2015
• Prospective Registration: No
• Primary sponsor: Social Services and Healthcare Centre of Pori
• 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.
• Date of first enrolment: 05/10/2015
• Target sample size: 102
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12615001254583.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Assignment: Parallel;Type of endpoint: Efficacy;

Countries of recruitment

Finland

Contacts

• Name: Mrs Merja Suominen

• Name: Mrs Susanna Kunvik

Key inclusion & exclusion criteria

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
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

Age minimum: 50 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Mental Health - Depression

Mental Health - Other mental health disorders

Diet and Nutrition - Other diet and nutrition disorders

Malnutrition ;Mental burden ;Poor quality of life;Loneliness;Depression;
Malnutrition

Mental burden

Poor quality of life
Loneliness
Depression

Intervention(s)

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 gr

Primary Outcome(s)

Health related quality of life with RAND-36 (Caregivers)[ assessed with RAND-36at 6 months post randomization]

Protein intake assessed by 3 day food diaries and analysed Fineli (www.fineli.fi) (Caregivers and persons receiving care)[Three day food diary completed at 6 months post randomization ]

Health related quality of life with 15D (persons receiving care)[ assessed with 15D at 6 months post randomization]

Secondary Outcome(s)

Nutritional status with MNA (Caregivers)[assessed with MNA at 6 months post randomization]

Social factors with Social Provision Scale (Caregivers)[assessed with Social Provision Scale at 6 months post randomization]

Health related quality of life with 15D (Caregivers)[assessed with 15D at 6 months post randomization]

Depression with GDS-15 (Caregivers)[assessed with GDS-15 at 6 months post randomization]

Secondary ID(s)

None

Source(s) of Monetary Support

Social Services and Healthcare Centre of Pori

National Institute for Health and Welfare

Ethics review

Status: Approved
Approval date:
Contact:

Ethics Committee of the Hospital District of Southwest Finland.