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Completed

NCT Number: NCT02007551

Evaluating the RelAte Mealtime Program as an Intervention to Treat Social Isolation and Improve Cooking Behaviour 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.

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Key information

Conditions

Social Isolation Behavior Behavior, Animal Feeding Behavior Meals Social Behavior

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Neuroscience, Trinity College Dublin

Dublin, Dublin 2, Ireland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Mealtime Intervention

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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).

  3. Premorbid cognitive function

    Time frame: Baseline assessment

    Premorbid cognitive function will be assessed using the National Adult Reading test (Bright, Jaldow & Kopelman, 2002).

  4. 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).

  5. 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).

  6. 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).

  7. 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.

  8. 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.

  9. 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).

  10. 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).

Sponsors and collaborators

Lead sponsor

University of Dublin, Trinity College

Other

Collaborators

  • Home Instead Inc

Registry information

Official study 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.

Acronym: RelAte

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Dec 11, 2013
Registry last updated
May 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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