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Social IsolationRelAteNCT02007551

Evaluating the RelAte Mealtime Program as an Intervention to Treat Social Isolation and Improve Cooking Behaviour Among Older Adults Living Alone

A study testing Mealtime Intervention in people with Social Isolation and Meals, run by University of Dublin, Trinity College at 1 site in Ireland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the impact of a psychosocial and nutritional intervention, entitled "RelAte", on cooking and mealtime behaviours of older adults who are living alone and at risk of social isolation. Read more about this study

Who is it for?
Ages 55 years and olderHealthy volunteers can take part
Conditions the study is for
Social Isolation, Meals
What is being tested?
Mealtime Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteIreland
Study dates
May 2013to May 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Living alone
  • Aged over 60
  • Screen positive for Social Isolation (Lubben \& Gironda, 2004).
  • Provision of two character references
  • Aged over 55
  • Undergoes Garda (police) vetting to the satisfaction of the research team

Who cannot join

  • Screen positive for cognitive impairment using the TCogS (Telephone Cognitive Screen; Newkirk et al., 2004).
  • Stroke
  • Epilepsy
  • Schizophrenia
  • Bipolar affective disorder
  • Recurrent psychotic depression
Show all 16Show fewer
  • Alcohol and drug abuse within the past 5 years
  • Anti-convulsants
  • Anti-psychotic medications
  • Significant hearing difficulties even when wearing hearing aid
  • Illness that caused permanent decrease in memory or other mental function
  • Blood borne infectious diseases
  • Contact based infectious diseases
  • Airborne infectious diseases
  • Peer Volunteers
  • Screen positive for cognitive impairment using the TCogS (Newkirk et al., 2004)

Trial locations and contacts

1 site in 1 country.

Ireland1 site

  • Institute of Neuroscience, Trinity College Dublin

    Dublin, Dublin 2

Other trials in Ireland

About this study

Official title: RelAte: An Investigator-blinded, Randomised, 8-week, Parallel-group, Controlled Stepped Wedge Design Study to Evaluate the Effectiveness of a Complex Nutritional, Cooking and Social Intervention Against a Control Group in the Improvement of Dietary Self-efficacy and Energy Intake Among Older Adults Living Alone.

The purpose of this study is to evaluate the impact of a psychosocial and nutritional intervention, entitled "RelAte", on cooking and mealtime behaviours of older adults who are living alone and at risk of social isolation. The intervention will be delivered in the home of participants by a trained volunteer of a similar age.

Read the detailed description

The trial employs a randomised controlled trial design to evaluate the impact of a novel mealtime intervention for older adults who are living alone and may be at risk of social isolation. The intervention combines social interaction, cooking, and shared mealtime behaviour, as well as nutritional education, in a once-weekly, mealtime visit, delivered by a peer volunteer. RelAte is grounded in psychological theory. It is expected that the RelAte intervention will have a beneficial impact on self-efficacy and on energy intake among participants. As an additional point, we will be looking at whether the intervention also impacts on physical and mental health among older adults over time. RelAte involves sharing a mealtime with a trained peer volunteer once a week for 8 weeks, as well as sharing the cooking and food preparation associated with the meal. The one-to-one intervention comprises social, nutritional and cooking components, and can be described as a complex intervention.

The intervention will run for 8 weeks and each participant will be matched with a peer volunteer for the duration. At baseline and at three follow-up points, participants will undergo a social cognitive, and nutritional assessment, as well as physical and mental health assessments, to ascertain whether the intervention has a lasting impact on defined primary outcomes. Participant outcomes will also be compared with the control group to assess the impact of the intervention. Volunteers will also undergo an assessment to investigate whether being a volunteer in an intervention has positive impact on psychological wellbeing and social connectedness.

Primarily the intention is to improve self-efficacy and energy intake among older adults, thus maintaining or improving general functioning, rather than treating an existing condition or syndrome. Thus the intervention aims to optimise functioning in older adults rather than to treat a pre-existing condition.

Being tested
Mealtime Intervention
Keywords
Social Isolation, Nutrition Assessments, Food Habits, Meals, Self Efficacy, Quality of Life, Peer Group
Medical subject headings
Social Isolation, Feeding Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mealtime InterventionBehavioural

    The mealtime intervention constitutes once a week visits from a trained volunteer for 8 weeks, each visit lasting 90 minutes and comprising of preparing and sharing a meal together with the participant.

Study groups in NCT02007551
Study groupRoleWhat they receive
Mealtime InterventionExperimentalThe mealtime intervention group will receive a trained peer volunteer to their home once weekly for 8 weeks to prepare and share a meal with them.
Receives: Behavioral: Mealtime Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Self-efficacy over 6 months

    Self-efficacy measured using the Generalised Self-efficacy scale (Schwarzer \& Jerusalem,1995) and the nutrition self-efficacy scale (Schwarzer \& Renner, 2000) will be assessed for all participants.

    Measured: Assessed at baseline, in the week post-intervention, at 12-week and at 26-week follow-up

  2. Change in Food-related health beliefs over 6 months

    This outcome measure is a social cognitive variable measured using the Health Beliefs Survey (Anderson, Winett \& Wojcik, 2007). The survey assess beliefs related to the impact of food on health, including food-related goals, outcome expectations, beliefs and strategies relating to food.

    Measured: At baseline, in the week post-intervention, at 12-week and 26-week follow-up

  3. Change in Energy intake over 6 months

    Energy intake will be measured using two 24-hour dietary recall metrics, whereby the participant is asked to recall on two occasions within the same week everything they have eaten or drank in the past 24 hours. The assessors will receive dietetic training in how to measure energy intake, e.g. the types of probes and questions that can help to achieve an accurate recall of dietary intake.

    Measured: Baseline, in the week post-intervention, at 12-week and 26-week follow-up

Secondary outcomes (10)

  1. Change in Quality of Life over 6 months

    Participant quality of life, measured using the CASP-19 (Control, Autonomy, Self-Realisation, Pleasure) Measure (Hyde, Wiggins, Higgs \& Blane, 2003) will be used as a secondary measure to evaluate whether RelAte intervention improves quality of life over time.

    Measured: Baseline, in the week post-intervention, at 12-week and 26-week follow-up

  2. Change in Cognitive function over 6 months

    Cognitive function in the participants will be assessed over time using 2 measures: the Montreal Cognitive Assessment (Nasreddine et al., 2005) and the Trail Making Test (Lezak, 2004).

    Measured: Baseline, in the week post-intervention, and at 12-week and 26-week follow-up

  3. Premorbid cognitive function

    Premorbid cognitive function will be assessed using the National Adult Reading test (Bright, Jaldow \& Kopelman, 2002).

    Measured: Baseline assessment

  4. Change in Social Connectedness over 6 months

    Social connectedness will be measured using the Berkman Social Network Index (Berkman \& Syme, 1979).

    Measured: Baseline assessment, in the week post-intervention, and at 12-week and 26-week follow-up

  5. Change in Psychological Wellbeing over 6 months

    Psychological wellbeing in participants will be assessed using the Centre for Epidemiological Studies depression scale (CES-D; Radloff,1977), the Hospital Anxiety \& Depression - Anxiety Subscale (HADS-A; Zigmond \& Snaith, 1983) and the Ryff scale of psychological wellbeing (Ryff \& Keyes,1995).

    Measured: Baseline assessment, in the week post-intervention, at 12-week and 26-week follow-up

  6. Change in Nutritional Health over 6 months

    Nutritional health and risk of malnutrition will be assessed using the Mini Nutritional Assessment (Vellas et al.,1999) the Malnutrition Universal Screening Tool (Stratton, 2004). as well as the Food Enjoyment Scale (Vailas \& Nitzke, 1998).

    Measured: Baseline assessment, in the week post-intervention, 12-week and 26-week follow-up

  7. Change in Body Mass Index over 6 months

    Body mass index for each participant will be measured using a clinical stadiometer and body composition weighing scales. Abdominal circumference will also be measured to further assess body composition.

    Measured: Baseline assessment, in the week post-intervention and at 12-week and 26-week follow-up

  8. Change in Frailty over 6 months

    Frailty will be measured using the SHARE-Frailty Instrument (Romero-Ortuno, Walsh, Lawlor \& Kenny, 2010) which includes measurement of grip strength using a clinical dynamometer.

    Measured: Baseline assessment, in the week post-intervention, and at 12-week and 26-week follow-up

  9. Change in Overall Health over 6 months

    Overall health will be assessed using the Health Utilities Index (Horsman, Furlong, Feeny \& Torrance, 2003).

    Measured: Baseline assessment, in the week post-intervention, 12-week and 26-week follow-up

  10. Change in Peer volunteer wellbeing pre and post intervention

    We will also assess the wellbeing of the peer volunteers trained to deliver the intervention, measured using the Ryff scale (Ryff \& Keyes,1995). T the Minnesota Satisfaction Questionnaire (Weiss, Dawis \& England, 1967), the de Jong loneliness scale (De Jong Gierveld \& Van Tilburg, 2006) and the Social Network Index (Berkman \& Syme,1979).

    Measured: Baseline and in the week post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2013 (estimated)
  2. Study startMay 2013
  3. Primary completionDec 2014
  4. Study completionMay 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02007551
Sponsor's protocol ID
RelAte-12122
Acronym
RelAte
Status last verified
May 2015
First submitted
28 Nov 2013
Last updated
27 May 2015
Results posted
No
Data monitoring committee
No

Publications

  • Schwarzer R, Jerusalem M. Generalised self-efficacy scale. In Weinman J, Wright S, Johnston M: Measures in Health Psychology: A user's portfolio. Windsor, England: NFER-NELSON.

  • Schwarzer R, Renner B. Health-specific self-efficacy scales. available from: RL: http://www. RalfSchwarzer. de

  • Anderson ES, Winett RA, Wojcik JR. Self-regulation, self-efficacy, outcome expectations, and social support: social cognitive theory and nutrition behavior. Ann Behav Med. 2007 Nov-Dec;34(3):304-12. doi: 10.1007/BF02874555.

    PubMed 18020940

  • Hyde M, Wiggins RD, Higgs P, Blane DB. A measure of quality of life in early old age: the theory, development and properties of a needs satisfaction model (CASP-19). Aging Ment Health. 2003 May;7(3):186-94. doi: 10.1080/1360786031000101157.

    PubMed 12775399

  • Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.

    PubMed 15817019

  • Lezak MD Neuropsychological Assessment.2004. New York: Oxford University Press

  • Bright P, Jaldow E, Kopelman MD. The National Adult Reading Test as a measure of premorbid intelligence: a comparison with estimates derived from demographic variables. J Int Neuropsychol Soc. 2002 Sep;8(6):847-54. doi: 10.1017/s1355617702860131.

    PubMed 12240749

  • Berkman LF, Syme SL. Social networks, host resistance, and mortality: a nine-year follow-up study of Alameda County residents. Am J Epidemiol. 1979 Feb;109(2):186-204. doi: 10.1093/oxfordjournals.aje.a112674.

    PubMed 425958

  • Radloff L. The CES-D scale a self-report depression scale for research in the general population. Applied Psychological Measurement, 1(3): 385-401, 1977.

  • Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

    PubMed 6880820

  • Ryff CD, Keyes CL. The structure of psychological well-being revisited. J Pers Soc Psychol. 1995 Oct;69(4):719-27. doi: 10.1037//0022-3514.69.4.719.

    PubMed 7473027

  • Vellas B, Guigoz Y, Garry PJ, Nourhashemi F, Bennahum D, Lauque S, Albarede JL. The Mini Nutritional Assessment (MNA) and its use in grading the nutritional state of elderly patients. Nutrition. 1999 Feb;15(2):116-22. doi: 10.1016/s0899-9007(98)00171-3.

    PubMed 9990575

  • Stratton RJ, Hackston A, Longmore D, Dixon R, Price S, Stroud M, King C, Elia M. Malnutrition in hospital outpatients and inpatients: prevalence, concurrent validity and ease of use of the 'malnutrition universal screening tool' ('MUST') for adults. Br J Nutr. 2004 Nov;92(5):799-808. doi: 10.1079/bjn20041258.

    PubMed 15533269

  • Vailas LI, Nitzke SA. Food enjoyment scale for older adults: development and application in a Wisconsin population. Journal of Nutrition for the Elderly 17(3): 59-64.

  • Romero-Ortuno R, Walsh CD, Lawlor BA, Kenny RA. A frailty instrument for primary care: findings from the Survey of Health, Ageing and Retirement in Europe (SHARE). BMC Geriatr. 2010 Aug 24;10:57. doi: 10.1186/1471-2318-10-57.

    PubMed 20731877

Questions about this trial

What is this clinical trial studying?

A study testing Mealtime Intervention in people with Social Isolation and Meals, run by University of Dublin, Trinity College at 1 site in Ireland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Self-efficacy over 6 months (time frame: Assessed at baseline, in the week post-intervention, at 12-week and at 26-week follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02007551, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2015.

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