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

Sponsor

University of Dublin, Trinity College (Other)

Overall Status

Completed

CT.gov ID

NCT02007551

Collaborator

Home Instead Inc (Other)

100

Enrollment

Location

Arm

Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Social Isolation Meals	Behavioral: Mealtime Intervention	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

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 Start Date :

May 1, 2013

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

May 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: Mealtime 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.

Arm

Intervention/Treatment

Experimental: 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.

Behavioral: Mealtime 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.

Outcome Measures

Primary Outcome Measures

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

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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