Clinical trial NCT02007551: Evaluating the RelAte Mealtime Program as an Intervention to Treat Social Isolation and Improve Cooking Behaviour Among Older Adults Living Alone
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Isolation
Meals
Keywords: Social Isolation
Nutrition Assessments
Food Habits
Meals
Self Efficacy
Quality of Life
Peer Group
Lead sponsor: University of Dublin, Trinity College
Sponsor class: OTHER
Collaborators: name: Home Instead Inc
First posted: 2013-12-11
Enrollment: 100
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Intervention model: PARALLEL

Brief 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. The intervention will be delivered in the home of participants by a trained volunteer of a similar age.

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.

Eligibility criteria: Participants

Inclusion Criteria:

* Living alone
* Aged over 60
* Screen positive for Social Isolation (Lubben \& Gironda, 2004).

Exclusion Criteria:

* Screen positive for cognitive impairment using the TCogS (Telephone Cognitive Screen; Newkirk et al., 2004).
* Stroke
* Epilepsy
* Schizophrenia
* Bipolar affective disorder
* Recurrent psychotic depression
* 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

Inclusion Criteria:

* Provision of two character references
* Aged over 55
* Undergoes Garda (police) vetting to the satisfaction of the research team

Exclusion Criteria:

* Screen positive for cognitive impairment using the TCogS (Newkirk et al., 2004)

Primary outcomes:
measure: Change in Self-efficacy over 6 months
timeFrame: Assessed at baseline, in the week post-intervention, at 12-week and at 26-week follow-up
measure: Change in Food-related health beliefs over 6 months
timeFrame: At baseline, in the week post-intervention, at 12-week and 26-week follow-up
measure: Change in Energy intake over 6 months
timeFrame: Baseline, in the week post-intervention, at 12-week and 26-week follow-up
Secondary outcomes:
measure: Change in Quality of Life over 6 months
timeFrame: Baseline, in the week post-intervention, at 12-week and 26-week follow-up
measure: Change in Cognitive function over 6 months
timeFrame: Baseline, in the week post-intervention, and at 12-week and 26-week follow-up
measure: Premorbid cognitive function
timeFrame: Baseline assessment
measure: Change in Social Connectedness over 6 months
timeFrame: Baseline assessment, in the week post-intervention, and at 12-week and 26-week follow-up
measure: Change in Psychological Wellbeing over 6 months
timeFrame: Baseline assessment, in the week post-intervention, at 12-week and 26-week follow-up
measure: Change in Nutritional Health over 6 months
timeFrame: Baseline assessment, in the week post-intervention, 12-week and 26-week follow-up
measure: Change in Body Mass Index over 6 months
timeFrame: Baseline assessment, in the week post-intervention and at 12-week and 26-week follow-up
measure: Change in Frailty over 6 months
timeFrame: Baseline assessment, in the week post-intervention, and at 12-week and 26-week follow-up
measure: Change in Overall Health over 6 months
timeFrame: Baseline assessment, in the week post-intervention, 12-week and 26-week follow-up
measure: Change in Peer volunteer wellbeing pre and post intervention
timeFrame: Baseline and in the week post-intervention
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Institute of Neuroscience, Trinity College Dublin
Study officials:
affiliation: University of Dublin, Trinity College
name: Sabina Brennan, B.A., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Schwarzer R, Renner B. Health-specific self-efficacy scales. available from: RL: http://www. RalfSchwarzer. de
citation: 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.
citation: 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.
citation: 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.
citation: Lezak MD Neuropsychological Assessment.2004. New York: Oxford University Press
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Horsman J, Furlong W, Feeny D, Torrance G. The Health Utilities Index (HUI): concepts, measurement properties and applications. Health Qual Life Outcomes. 2003 Oct 16;1:54. doi: 10.1186/1477-7525-1-54.
citation: Weiss DJ, Dawis RV, England GW. Manual for the Minnesota Satisfaction Questionnaire. University of Minnesota: Minnesota Studies in Vocational Rehabilitation: 1967.
citation: de Jong Gierveld J, van Tilburg T. [A shortened scale for overall, emotional and social loneliness]. Tijdschr Gerontol Geriatr. 2008 Feb;39(1):4-15. doi: 10.1007/BF03078118. Dutch.
citation: Lubben J, Gironda M. Measuring social networks and assessing their benefits. In Philipson C, Allan G, Morgan DHJ. Social Networks and Social Exclusion: Sociological and Policy Perspectives. London, UK: Ashgate Publishing.
citation: Newkirk LA, Kim JM, Thompson JM, Tinklenberg JR, Yesavage JA, Taylor JL. Validation of a 26-point telephone version of the Mini-Mental State Examination. J Geriatr Psychiatry Neurol. 2004 Jun;17(2):81-7. doi: 10.1177/0891988704264534.
citation: McHugh J, Lee O, Aspell N, Lawlor BA, Brennan S. A shared mealtime approach to improving social and nutritional functioning among older adults living alone: study protocol for a randomized controlled trial. JMIR Res Protoc. 2015 Apr 21;4(2):e43. doi: 10.2196/resprot.4050.