NCT02007551

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 11, 2013

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

May 27, 2015

Status Verified

May 1, 2015

Enrollment Period

1.6 years

First QC Date

November 28, 2013

Last Update Submit

May 26, 2015

Conditions

Keywords

Social IsolationNutrition AssessmentsFood HabitsMealsSelf EfficacyQuality of LifePeer Group

Outcome Measures

Primary Outcomes (3)

  • Change in Self-efficacy over 6 months

    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

    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

    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 Outcomes (10)

  • Change in Quality of Life over 6 months

    Baseline, in the week post-intervention, at 12-week and 26-week follow-up

  • Change in Cognitive function over 6 months

    Baseline, in the week post-intervention, and at 12-week and 26-week follow-up

  • Premorbid cognitive function

    Baseline assessment

  • Change in Social Connectedness over 6 months

    Baseline assessment, in the week post-intervention, and at 12-week and 26-week follow-up

  • Change in Psychological Wellbeing over 6 months

    Baseline assessment, in the week post-intervention, at 12-week and 26-week follow-up

  • +5 more secondary outcomes

Study Arms (1)

Mealtime Intervention

EXPERIMENTAL

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

Interventions

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.

Mealtime Intervention

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Neuroscience, Trinity College Dublin

Dublin, Dublin 2, Ireland

Location

Related Publications (21)

  • Schwarzer R, Jerusalem M. Generalised self-efficacy scale. In Weinman J, Wright S, Johnston M: Measures in Health Psychology: A user's portfolio. Windsor, England: NFER-NELSON.

    BACKGROUND
  • Schwarzer R, Renner B. Health-specific self-efficacy scales. available from: RL: http://www. RalfSchwarzer. de

    BACKGROUND
  • Anderson ES, Winett RA, Wojcik JR. Self-regulation, self-efficacy, outcome expectations, and social support: social cognitive theory and nutrition behavior. Ann Behav Med. 2007 Nov-Dec;34(3):304-12. doi: 10.1007/BF02874555.

    PMID: 18020940BACKGROUND
  • Hyde M, Wiggins RD, Higgs P, Blane DB. A measure of quality of life in early old age: the theory, development and properties of a needs satisfaction model (CASP-19). Aging Ment Health. 2003 May;7(3):186-94. doi: 10.1080/1360786031000101157.

    PMID: 12775399BACKGROUND
  • Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.

    PMID: 15817019BACKGROUND
  • Lezak MD Neuropsychological Assessment.2004. New York: Oxford University Press

    BACKGROUND
  • Bright P, Jaldow E, Kopelman MD. The National Adult Reading Test as a measure of premorbid intelligence: a comparison with estimates derived from demographic variables. J Int Neuropsychol Soc. 2002 Sep;8(6):847-54. doi: 10.1017/s1355617702860131.

    PMID: 12240749BACKGROUND
  • Berkman LF, Syme SL. Social networks, host resistance, and mortality: a nine-year follow-up study of Alameda County residents. Am J Epidemiol. 1979 Feb;109(2):186-204. doi: 10.1093/oxfordjournals.aje.a112674.

    PMID: 425958BACKGROUND
  • Radloff L. The CES-D scale a self-report depression scale for research in the general population. Applied Psychological Measurement, 1(3): 385-401, 1977.

    BACKGROUND
  • Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

    PMID: 6880820BACKGROUND
  • Ryff CD, Keyes CL. The structure of psychological well-being revisited. J Pers Soc Psychol. 1995 Oct;69(4):719-27. doi: 10.1037//0022-3514.69.4.719.

    PMID: 7473027BACKGROUND
  • Vellas B, Guigoz Y, Garry PJ, Nourhashemi F, Bennahum D, Lauque S, Albarede JL. The Mini Nutritional Assessment (MNA) and its use in grading the nutritional state of elderly patients. Nutrition. 1999 Feb;15(2):116-22. doi: 10.1016/s0899-9007(98)00171-3.

    PMID: 9990575BACKGROUND
  • Stratton RJ, Hackston A, Longmore D, Dixon R, Price S, Stroud M, King C, Elia M. Malnutrition in hospital outpatients and inpatients: prevalence, concurrent validity and ease of use of the 'malnutrition universal screening tool' ('MUST') for adults. Br J Nutr. 2004 Nov;92(5):799-808. doi: 10.1079/bjn20041258.

    PMID: 15533269BACKGROUND
  • Vailas LI, Nitzke SA. Food enjoyment scale for older adults: development and application in a Wisconsin population. Journal of Nutrition for the Elderly 17(3): 59-64.

    BACKGROUND
  • Romero-Ortuno R, Walsh CD, Lawlor BA, Kenny RA. A frailty instrument for primary care: findings from the Survey of Health, Ageing and Retirement in Europe (SHARE). BMC Geriatr. 2010 Aug 24;10:57. doi: 10.1186/1471-2318-10-57.

    PMID: 20731877BACKGROUND
  • Horsman J, Furlong W, Feeny D, Torrance G. The Health Utilities Index (HUI): concepts, measurement properties and applications. Health Qual Life Outcomes. 2003 Oct 16;1:54. doi: 10.1186/1477-7525-1-54.

    PMID: 14613568BACKGROUND
  • Weiss DJ, Dawis RV, England GW. Manual for the Minnesota Satisfaction Questionnaire. University of Minnesota: Minnesota Studies in Vocational Rehabilitation: 1967.

    BACKGROUND
  • de Jong Gierveld J, van Tilburg T. [A shortened scale for overall, emotional and social loneliness]. Tijdschr Gerontol Geriatr. 2008 Feb;39(1):4-15. doi: 10.1007/BF03078118. Dutch.

    PMID: 18365511BACKGROUND
  • Lubben J, Gironda M. Measuring social networks and assessing their benefits. In Philipson C, Allan G, Morgan DHJ. Social Networks and Social Exclusion: Sociological and Policy Perspectives. London, UK: Ashgate Publishing.

    BACKGROUND
  • Newkirk LA, Kim JM, Thompson JM, Tinklenberg JR, Yesavage JA, Taylor JL. Validation of a 26-point telephone version of the Mini-Mental State Examination. J Geriatr Psychiatry Neurol. 2004 Jun;17(2):81-7. doi: 10.1177/0891988704264534.

    PMID: 15157348BACKGROUND
  • McHugh J, Lee O, Aspell N, Lawlor BA, Brennan S. A shared mealtime approach to improving social and nutritional functioning among older adults living alone: study protocol for a randomized controlled trial. JMIR Res Protoc. 2015 Apr 21;4(2):e43. doi: 10.2196/resprot.4050.

MeSH Terms

Conditions

Social IsolationFeeding Behavior

Condition Hierarchy (Ancestors)

Social BehaviorBehaviorBehavior, Animal

Study Officials

  • Sabina Brennan, B.A., Ph.D.

    University of Dublin, Trinity College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postdoctoral Research Fellow

Study Record Dates

First Submitted

November 28, 2013

First Posted

December 11, 2013

Study Start

May 1, 2013

Primary Completion

December 1, 2014

Study Completion

May 1, 2015

Last Updated

May 27, 2015

Record last verified: 2015-05

Locations