ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Frailty

Ageing

Condition category

Condition code

Diet and Nutrition

Other diet and nutrition disorders

Public Health

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]

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]

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]

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]

Short Physical Performance Battery (SPPB)

Timepoint [2]

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]

Index of Diet Quality, IDQ

Timepoint [1]

Baseline assessments, then intervention and advice in peer groups, and final assessments after three months (+- 1-2 weeks) from the baseline.

Secondary outcome [2]

Food diaries and nutrient intake

Timepoint [2]

Baseline assessments, then intervention and advice in peer groups, and final assessments after three months (+- 1-2 weeks) from the baseline.

Secondary outcome [3]

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]

Baseline assessments, then intervention and advice in peer groups, and final assessments after three months (+- 1-2 weeks) from the baseline.

Secondary outcome [4]

Quality of life with 15D

Timepoint [4]

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

Recruitment outside Australia

Country [1]

Finland

State/province [1]

Hämeenlinna, Kokkola, Helsinki, Vantaa

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Foundation for Nutrition Research

Address [1]

c/o Valio Ltd, Renewal
PO Box 10, FIN00039 VALIO
Finland

Country [1]

Finland

Funding source category [2]

Government body

Name [2]

Funding Centre for Social Welfare and Health Organisations (STEA)

Address [2]

PO Box 33, FI-00023 Government

Country [2]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ethics Committee of Medicine

Ethics committee address [1]

Biomedicum Helsinki 2 C, PO 705, 00029 HUS, Finland

Ethics committee country [1]

Finland

Date submitted for ethics approval [1]

20/11/2017

Approval date [1]

31/01/2018

Ethics approval number [1]

3536/2017

Summary

Brief summary

The Finnish population is ageing rapidly: the estimated amount and portion of older people is greatly increasing in the coming years. Lower nutritional status and food intake related to ageing lead to weakening of physical functioning and quality of life and delayed recovery from illnesses. Often small changes or enhancements in diet may impact positively on health, physical functioning and quality of life. In turn, these will support living at home and recovering from illnesses. New, effective and cost-efficient ways for nutrition education are needed.
In this study, the aim is to investigate the effect of nutrition education and advice, targeted to community dwelling older people and implemented in peer groups, on protein and food intake, physical functioning, quality of diet, weight and body mass index, and quality of life. 
The study participants are over 65 years old who live at home. Other inclusion criteria are SPPB-score 4-9 and MMSE-score over 24. Exclusion criteria are individuals who don’t go outside, severe kidney disease, type I diabetes, malignant tumors, BMI <18,5 or >35 and alcohol abuse.
The participants are randomized into intervention and control groups. The length of intervention is three months. People in intervention group take part into the Eating for Strong Ageing -education group after the baseline measurements. People in control group can take part into the education after final measurements.
At baseline, we gather background information from the participants. Also, protein and food intake (3-day food diaries), quality of diet (IDQ, Index of Diet Quality), nutritional status (MNA), physical functioning (SPPB, Short Physical Performance Battery), cognitive functioning (MMSE), weight, height, body mass index and quality of life (15D) are examined. Three months after baseline, we examine the protein and food intake, quality of diet, physical functioning, weight, body mass index and quality of life.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Merja Suominen

Address

Society for Gerontological Nutrition in Finland
Malmin kauppatie 26
00700 Helsinki
Finland

Country

Finland

Phone

+358505841995

Fax

merja.suominen@gery.fi

Contact person for public queries

Name

Merja Suominen

Address

Society for Gerontological Nutrition in Finland
Malmin kauppatie 26
00700 Helsinki
Finland

Country

Finland

Phone

+358505841995

Fax

merja.suominen@gery.fi

Contact person for scientific queries

Name

Merja Suominen

Address

Society for Gerontological Nutrition in Finland
Malmin kauppatie 26
00700 Helsinki
Finland

Country

Finland

Phone

+358505841995

Fax

merja.suominen@gery.fi

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Email
7216	Study protocol	merja.suominen@gery.fi
7217	Statistical analysis plan	merja.suominen@gery.fi
7218	Informed consent form	merja.suominen@gery.fi
7219	Ethical approval	merja.suominen@gery.fi

Results publications and other study-related documents

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No additional documents have been identified.

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