NCT03240094

Brief Summary

An optimal nutritional status is essential for healthy ageing. Telemonitoring might contribute to maintaining or improving nutritional status in elderly people.The objectives of this effect study are to test the feasibility and effectiveness of telemonitoring of nutritional parameters in community-dwelling older adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
213

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2016

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

February 26, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 9, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 9, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 4, 2017

Completed
Last Updated

August 4, 2017

Status Verified

July 1, 2017

Enrollment Period

1.2 years

First QC Date

July 24, 2017

Last Update Submit

August 3, 2017

Conditions

UndernutritionAging

Keywords

EhealthOlder adultsUndernutrition

Outcome Measures

Primary Outcomes (1)

  • Nutritional status (MNA)

    Measured by Mini Nutritional Assessment

    6 months

Secondary Outcomes (13)

  • Behavioural determinant: Knowledge

    6 months

  • Behavioural determinant: Goalsetting

    6 months

  • Behavioural determinant: Intention to eat healthy

    6 months

  • Behavioural determinant: Intention to improve physical activity

    6 months

  • Behavioural determinant: Self efficacy

    6 months

  • +8 more secondary outcomes

Study Arms (2)

Nutritional telemonitoring

EXPERIMENTAL

Participants in the intervention group receive a telemonitoring intervention, including self-measurements of body weight, nutritional status, appetite, diet quality, and physical activity. Additionally, participants receive guidance on nutrition and physical activity by means of customized and general television messages and/or if necessary personal guidance by a nurse.

Other: Nutritional telemonitoring

Usual care

NO INTERVENTION

Participants in the control group receive usual care.

Interventions

Nutritional telemonitoringOTHER

Participants receive a weighing scale, pedometer and television channel in order to perform self measurements and receive guidance on nutrition and physical activity. Nurses use a website in order to receive telemonitoring measurements and decide about proper follow-up. In case of risk of undernutrition, nurses provide personal advice to optimize nutritional status of the participant.

Nutritional telemonitoring

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Having a care referral for at least one of the following types of care:
  • Domestic care
  • Personal care
  • Nursing care
  • Individual or group support
  • Living in a sheltered home or service flat

You may not qualify if:

  • Severe cognitive impairment (Mini Mental State Examination (MMSE) \< 20)
  • Receiving terminal care
  • Not having a television at home
  • Clients with a visual impairment (not able to watch the television screen)
  • Clients with a physical impairment in such a way, that they are not able to use the telemonitoring system
  • Clients with nursing home care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wageningen University & Research

Wageningen, 6700AA, Netherlands

Location

Related Publications (2)

  • van Doorn-van Atten MN, Haveman-Nies A, Pilichowski P, Roca R, de Vries JHM, de Groot CPGM. Telemonitoring to improve nutritional status in community-dwelling elderly: design and methods for process and effect evaluation of a non-randomized controlled trial. BMC Geriatr. 2018 Nov 16;18(1):284. doi: 10.1186/s12877-018-0973-2.

    PMID: 30445922DERIVED

  • van Doorn-van Atten MN, Haveman-Nies A, van Bakel MM, Ferry M, Franco M, de Groot LCPGM, de Vries JHM. Effects of a multi-component nutritional telemonitoring intervention on nutritional status, diet quality, physical functioning and quality of life of community-dwelling older adults. Br J Nutr. 2018 May;119(10):1185-1194. doi: 10.1017/S0007114518000843.

    PMID: 29759110DERIVED

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Lisette de Groot, Professor

    Wageningen University & Research

    STUDY CHAIR

  • Marije van Doorn, MSc

    Wageningen University & Research

    PRINCIPAL INVESTIGATOR

  • Jeanne de Vries, PhD

    Wageningen University & Research

    PRINCIPAL INVESTIGATOR

  • Annemien Haveman, PhD

    Wageningen University & Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2017

First Posted

August 4, 2017

Study Start

February 26, 2016

Primary Completion

May 9, 2017

Study Completion

May 9, 2017

Last Updated

August 4, 2017

Record last verified: 2017-07

Locations

NL(1)