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

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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02007551
Acronym
RelAte
Enrollment
100
Registered
2013-12-11
Start date
2013-05-31
Completion date
2015-05-31
Last updated
2015-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Meals, Social Isolation

Keywords

Social Isolation, Nutrition Assessments, Food Habits, Meals, Self Efficacy, Quality of Life, Peer Group

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.

Interventions

BEHAVIORALMealtime Intervention

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.

Sponsors

Home Instead Inc
CollaboratorUNKNOWN
University of Dublin, Trinity College
Lead SponsorOTHER

Study design

Intervention model
PARALLEL
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
Yes

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Change in Self-efficacy over 6 monthsAssessed at baseline, in the week post-intervention, at 12-week and at 26-week follow-upSelf-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.
Change in Food-related health beliefs over 6 monthsAt baseline, in the week post-intervention, at 12-week and 26-week follow-upThis 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.
Change in Energy intake over 6 monthsBaseline, in the week post-intervention, at 12-week and 26-week follow-upEnergy 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.

Secondary

MeasureTime frameDescription
Change in Social Connectedness over 6 monthsBaseline assessment, in the week post-intervention, and at 12-week and 26-week follow-upSocial connectedness will be measured using the Berkman Social Network Index (Berkman & Syme, 1979).
Change in Psychological Wellbeing over 6 monthsBaseline assessment, in the week post-intervention, at 12-week and 26-week follow-upPsychological 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).
Change in Nutritional Health over 6 monthsBaseline assessment, in the week post-intervention, 12-week and 26-week follow-upNutritional 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).
Change in Quality of Life over 6 monthsBaseline, in the week post-intervention, at 12-week and 26-week follow-upParticipant 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.
Change in Frailty over 6 monthsBaseline assessment, in the week post-intervention, and at 12-week and 26-week follow-upFrailty will be measured using the SHARE-Frailty Instrument (Romero-Ortuno, Walsh, Lawlor & Kenny, 2010) which includes measurement of grip strength using a clinical dynamometer.
Change in Overall Health over 6 monthsBaseline assessment, in the week post-intervention, 12-week and 26-week follow-upOverall health will be assessed using the Health Utilities Index (Horsman, Furlong, Feeny & Torrance, 2003).
Change in Peer volunteer wellbeing pre and post interventionBaseline and in the week post-interventionWe 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).
Change in Body Mass Index over 6 monthsBaseline assessment, in the week post-intervention and at 12-week and 26-week follow-upBody 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.
Change in Cognitive function over 6 monthsBaseline, in the week post-intervention, and at 12-week and 26-week follow-upCognitive 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).
Premorbid cognitive functionBaseline assessmentPremorbid cognitive function will be assessed using the National Adult Reading test (Bright, Jaldow & Kopelman, 2002).

Countries

Ireland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026