Evaluating the RelAte Mealtime Program as an Intervention to Treat Social Isolation and Improve Cooking Behaviour Among Older Adults Living Alone
RelAte
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.
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 28, 2013
CompletedFirst Posted
Study publicly available on registry
December 11, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedMay 27, 2015
May 1, 2015
1.6 years
November 28, 2013
May 26, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
Assessed at baseline, in the week post-intervention, at 12-week and at 26-week follow-up
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.
At baseline, in the week post-intervention, at 12-week and 26-week follow-up
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.
Baseline, in the week post-intervention, at 12-week and 26-week follow-up
Secondary Outcomes (10)
Change in Quality of Life over 6 months
Baseline, in the week post-intervention, at 12-week and 26-week follow-up
Change in Cognitive function over 6 months
Baseline, in the week post-intervention, and at 12-week and 26-week follow-up
Premorbid cognitive function
Baseline assessment
Change in Social Connectedness over 6 months
Baseline assessment, in the week post-intervention, and at 12-week and 26-week follow-up
Change in Psychological Wellbeing over 6 months
Baseline assessment, in the week post-intervention, at 12-week and 26-week follow-up
- +5 more secondary outcomes
Study Arms (1)
Mealtime Intervention
EXPERIMENTALThe 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Living alone
- Aged over 60
- Screen positive for Social Isolation (Lubben \& Gironda, 2004).
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Dublin, Trinity Collegelead
- Home Instead Inccollaborator
Study Sites (1)
Institute of Neuroscience, Trinity College Dublin
Dublin, Dublin 2, Ireland
Related Publications (21)
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BACKGROUNDAnderson 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.
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PMID: 7473027BACKGROUNDVellas 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.
PMID: 9990575BACKGROUNDStratton 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.
PMID: 15533269BACKGROUNDVailas 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.
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PMID: 18365511BACKGROUNDLubben 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.
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PMID: 15157348BACKGROUNDMcHugh 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.
PMID: 25900904DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sabina Brennan, B.A., Ph.D.
University of Dublin, Trinity College
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Postdoctoral Research Fellow
Study Record Dates
First Submitted
November 28, 2013
First Posted
December 11, 2013
Study Start
May 1, 2013
Primary Completion
December 1, 2014
Study Completion
May 1, 2015
Last Updated
May 27, 2015
Record last verified: 2015-05