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

Not Applicable

Completed

• Conditions: Meals; Social Isolation
• Interventions: Behavioral: Mealtime Intervention

• Registration Number: NCT02007551
• Lead Sponsor: University of Dublin, Trinity College

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.

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-11-28
• Study First Submitted QC: 2013-12-05
• Study First Posted: 2013-12-11
• Primary Completion: 2014-12
• Status Verified: 2015-05
• Study Completion: 2015-05
• Last Update Submitted: 2015-05-26
• Last Update Posted: 2015-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mealtime Intervention	Mealtime Intervention	The 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.

Primary Outcome Measures

Name	Time	Method
Change in Self-efficacy over 6 months	Assessed at baseline, in the week post-intervention, at 12-week and at 26-week follow-up	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.
Change in Food-related health beliefs over 6 months	At baseline, in the week post-intervention, at 12-week and 26-week follow-up	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.
Change in Energy intake over 6 months	Baseline, in the week post-intervention, at 12-week and 26-week follow-up	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.

Secondary Outcome Measures

Name	Time	Method
Change in Quality of Life over 6 months	Baseline, in the week post-intervention, at 12-week and 26-week follow-up	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.
Change in Cognitive function over 6 months	Baseline, in the week post-intervention, and at 12-week and 26-week follow-up	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).
Premorbid cognitive function	Baseline assessment	Premorbid cognitive function will be assessed using the National Adult Reading test (Bright, Jaldow \& Kopelman, 2002).
Change in Social Connectedness over 6 months	Baseline assessment, in the week post-intervention, and at 12-week and 26-week follow-up	Social connectedness will be measured using the Berkman Social Network Index (Berkman \& Syme, 1979).
Change in Psychological Wellbeing over 6 months	Baseline assessment, in the week post-intervention, at 12-week and 26-week follow-up	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).
Change in Nutritional Health over 6 months	Baseline assessment, in the week post-intervention, 12-week and 26-week follow-up	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).
Change in Body Mass Index over 6 months	Baseline assessment, in the week post-intervention and at 12-week and 26-week follow-up	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.
Change in Frailty over 6 months	Baseline assessment, in the week post-intervention, and at 12-week and 26-week follow-up	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.
Change in Overall Health over 6 months	Baseline assessment, in the week post-intervention, 12-week and 26-week follow-up	Overall health will be assessed using the Health Utilities Index (Horsman, Furlong, Feeny \& Torrance, 2003).
Change in Peer volunteer wellbeing pre and post intervention	Baseline and in the week 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).

Trial Locations

Locations (1)

Institute of Neuroscience, Trinity College Dublin; 🇮🇪 Dublin, Ireland