Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000420246
Ethics application status
Approved
Date submitted
6/12/2017
Date registered
22/03/2018
Date last updated
3/03/2020
Date data sharing statement initially provided
3/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Eating for Strong Ageing (ESA-study)
Scientific title
The effect of nutrition education and advice on protein intake, physical functioning and quality of life for older people in peer groups, randomized controlled trial
Secondary ID [1] 293547 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Frailty
 305762 0
Ageing
 306508 0
Condition category
Condition code
Diet and Nutrition 304984 304984 0 0
Other diet and nutrition disorders
Public Health 305621 305621 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
"Eating for strong ageing - ESA-study" concept includes four peer group meetings and home work instructioned by health professionals. Nutritionist educates health professionals before the trial. Each meeting lasts approx. two hours. Themes for the meetings are: 1. ageing and nutrition, 2. personal examining of food diaries and protein intake, 3. health impact of physical activity, 4. repetition of good nutrition from practical point of view and peer experiences. Meetings involve lectures, homework and discussion. Meetings last 2 hours within 2 months depending on the wishes from the group and practical arrangements. One group consists of 8-12 participants.Meetings will be administered by a nutritionist or a health professional who has received education and later counseling during the course if needed. Home work involves filling three days food diaries and assessing personal health related daily activities. Food diaries and other life style activities will be monitored in peer groups with the guidance of the professional group leader. The whole intervention is based on constructive learning theory.
Intervention code [1] 299788 0
Lifestyle
Comparator / control treatment
Members in control group receive the same group education after the 3 month intervention period..
Control group
Active

Outcomes
Primary outcome [1] 304147 0
Protein intake g/kg (body weight). Protein intake is assessed by three day food diaries. The nutritionist will count protein intake by using food record computer program.
Timepoint [1] 304147 0
Baseline assessments, then intervention and advice in peer groups, and final assessments after three months (+- 1-2 weeks) from the baseline (primary timepoint).
Primary outcome [2] 304148 0
Short Physical Performance Battery (SPPB)
Timepoint [2] 304148 0
Baseline assessments, then intervention and advice in peer groups, and final assessments after three months (+- 1-2 weeks) from the baseline (primary timepoint).
Secondary outcome [1] 341095 0
Index of Diet Quality, IDQ
Timepoint [1] 341095 0
Baseline assessments, then intervention and advice in peer groups, and final assessments after three months (+- 1-2 weeks) from the baseline.
Secondary outcome [2] 341096 0
Food diaries and nutrient intake
Timepoint [2] 341096 0
Baseline assessments, then intervention and advice in peer groups, and final assessments after three months (+- 1-2 weeks) from the baseline.
Secondary outcome [3] 341097 0
Weight and BMI. Participants weight is measured with the professional scale, hight is measured or asked from the participants. BMI is then counted based on the results.
Timepoint [3] 341097 0
Baseline assessments, then intervention and advice in peer groups, and final assessments after three months (+- 1-2 weeks) from the baseline.
Secondary outcome [4] 341098 0
Quality of life with 15D
Timepoint [4] 341098 0
Baseline assessments, then intervention and advice in peer groups, and final assessments after three months (+- 1-2 weeks) from the baseline.

Eligibility
Key inclusion criteria
- Age > 65 years
- Community-dwelling (with or without home care)
- SPPB score at baseline 4 - 9
- Able to eat independently
- Willing to eat protein-rich food products
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Bedridden or wheelchair bound
- Individuals who do not go outside
- Diagnosed severe kidney disease
- Diagnosed with type I diabetes mellitus
- History of active malignancy (with the exception of basal cell carcinoma)
- Low cognitive status (MMSE score, less than 24)
- Malnourished, defined as having a BMI < 18.5 kg/m2
- Obese, defined as having a BMI > 35 kg/m2
- Vegans
- Alcohol abuse
- Eating disorder (such bulimia, anorexia )
- Planned to move out of the study area or unavailable (due to for instance holidays) in the next 3 months

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/04/2018
Actual
2/04/2018
Date of last participant enrolment
Anticipated
Actual
30/08/2019
Date of last data collection
Anticipated
Actual
29/11/2019
Sample size
Target
128
Accrual to date
Final
89
Recruitment outside Australia
Country [1] 9414 0
Finland
State/province [1] 9414 0
Hämeenlinna, Kokkola, Helsinki, Vantaa

Funding & Sponsors
Funding source category [1] 298161 0
Charities/Societies/Foundations
Name [1] 298161 0
Foundation for Nutrition Research
Country [1] 298161 0
Finland
Funding source category [2] 298162 0
Government body
Name [2] 298162 0
Funding Centre for Social Welfare and Health Organisations (STEA)
Country [2] 298162 0
Finland
Primary sponsor type
Charities/Societies/Foundations
Name
Society for Gerontological Nutrition in Finland
Address
Malmin kauppatie 26
00700 Helsinki
Finland
Country
Finland
Secondary sponsor category [1] 297253 0
None
Name [1] 297253 0
Address [1] 297253 0
Country [1] 297253 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299177 0
Ethics Committee of Medicine
Ethics committee address [1] 299177 0
Ethics committee country [1] 299177 0
Finland
Date submitted for ethics approval [1] 299177 0
20/11/2017
Approval date [1] 299177 0
31/01/2018
Ethics approval number [1] 299177 0
3536/2017

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

Contacts
Principal investigator
Name 79554 0
A/Prof Merja Suominen
Address 79554 0
Society for Gerontological Nutrition in Finland
Malmin kauppatie 26
00700 Helsinki
Finland
Country 79554 0
Finland
Phone 79554 0
+358505841995
Fax 79554 0
Email 79554 0
[email protected]
Contact person for public queries
Name 79555 0
Merja Suominen
Address 79555 0
Society for Gerontological Nutrition in Finland
Malmin kauppatie 26
00700 Helsinki
Finland
Country 79555 0
Finland
Phone 79555 0
+358505841995
Fax 79555 0
Email 79555 0
[email protected]
Contact person for scientific queries
Name 79556 0
Merja Suominen
Address 79556 0
Society for Gerontological Nutrition in Finland
Malmin kauppatie 26
00700 Helsinki
Finland
Country 79556 0
Finland
Phone 79556 0
+358505841995
Fax 79556 0
Email 79556 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
We didn't include this possibility in our research plan


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
7216Study protocol  [email protected]
7217Statistical analysis plan  [email protected]
7218Informed consent form  [email protected]
7219Ethical approval  [email protected]



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.