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

May 26, 2015 updated by: Joanna McHugh, University of Dublin, Trinity College

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Dublin, Ireland, Dublin 2
        • Institute of Neuroscience, Trinity College Dublin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Self-efficacy over 6 months
Time Frame: 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.
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
Time Frame: 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.
At baseline, in the week post-intervention, at 12-week and 26-week follow-up
Change in Energy intake over 6 months
Time Frame: 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.
Baseline, in the week post-intervention, at 12-week and 26-week follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Quality of Life over 6 months
Time Frame: 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.
Baseline, in the week post-intervention, at 12-week and 26-week follow-up
Change in Cognitive function over 6 months
Time Frame: 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).
Baseline, in the week post-intervention, and at 12-week and 26-week follow-up
Premorbid cognitive function
Time Frame: Baseline assessment
Premorbid cognitive function will be assessed using the National Adult Reading test (Bright, Jaldow & Kopelman, 2002).
Baseline assessment
Change in Social Connectedness over 6 months
Time Frame: 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).
Baseline assessment, in the week post-intervention, and at 12-week and 26-week follow-up
Change in Psychological Wellbeing over 6 months
Time Frame: 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).
Baseline assessment, in the week post-intervention, at 12-week and 26-week follow-up
Change in Nutritional Health over 6 months
Time Frame: 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).
Baseline assessment, in the week post-intervention, 12-week and 26-week follow-up
Change in Body Mass Index over 6 months
Time Frame: 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.
Baseline assessment, in the week post-intervention and at 12-week and 26-week follow-up
Change in Frailty over 6 months
Time Frame: 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.
Baseline assessment, in the week post-intervention, and at 12-week and 26-week follow-up
Change in Overall Health over 6 months
Time Frame: 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).
Baseline assessment, in the week post-intervention, 12-week and 26-week follow-up
Change in Peer volunteer wellbeing pre and post intervention
Time Frame: 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).
Baseline and in the week post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Dublin, Trinity College

Collaborators

Home Instead Inc

Investigators

  • Principal Investigator: Sabina Brennan, B.A., Ph.D., University of Dublin, Trinity College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

November 28, 2013

First Submitted That Met QC Criteria

December 5, 2013

First Posted (Estimate)

December 11, 2013

Study Record Updates

Last Update Posted (Estimate)

May 27, 2015

Last Update Submitted That Met QC Criteria

May 26, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RelAte-12122

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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