NCT04746664

Brief Summary

The world population is ageing rapidly as a result of low fertility and mortality rates and increasing life expectancies. Old age people (age 60 years and above) shared 962 million or 13% of the global population in 2017 and expected to be two billion by 2050. As individuals grow old, their dietary pattern changes and the risk of malnutrition estimated between 11.8% to 27% in the community elderly people. Ageing and nutrition are by far the number-one driver of the global burden of disease: every country is facing. Early assessment and management of malnutrition among old age people can minimize the negative consequences, extending to better health status and quality of life. Nutrition counselling is one of the first line of nutritional therapy. However, malnutrition in old age people remains under-detected, under-treated and under resourced, and is often overlooked in low-income countries like Ethiopia. Furthermore, nutritional interventions targeted to old age people are lacking in the country. Therefore, this study is intended to estimate the effects of nutrition counselling on old age people's nutritional status and quality of life in Bahir Dar City, Northwestern Ethiopia

Trial Health

87
On Track

Trial Health Score

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

Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 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

First Submitted

Initial submission to the registry

February 1, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 10, 2021

Completed
12 months until next milestone

Study Start

First participant enrolled

January 28, 2022

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 26, 2022

Completed
Last Updated

September 18, 2025

Status Verified

February 1, 2023

Enrollment Period

17 days

First QC Date

February 1, 2021

Last Update Submit

September 16, 2025

Conditions

Keywords

old age peoplemalnutritionnutrition counsellingquasi-experimentquality of lifeMNA toolEthiopia

Outcome Measures

Primary Outcomes (2)

  • Change from base line in the mean score of Mini nutritional assessment (MNA) in diagnosing Nutritional status after 3 months

    The Mini Nutritional Assessment (MNA®) is both a screening and assessment tool that was developed in 1989 by Nestle Nutrition Institute in Lausanne, Switzerland for elderly people. The original version consists of 18 questions/items grouped into four domains: Anthropometry measurements \[body mass index (BMI), weight loss, mid-upper arm and calf circumferences\], Dietary assessment (mode of feeding, quality and number of meals, fluid intake), Global health and social assessment (medications, mobility, pressure sores and skin ulcers, lifestyle, psychological stress or neuropsychological diseases), and Self- perception of health status and nutrition. The collective score of MNA ranges from 0 - 30 grouped into three types. The MNA scores of \< 17 show malnutrition, scores from 17 to 23.5 indicate the study participant is at risk of malnutrition, and any score of 24 ≥ is considered normal nutritional

    three months

  • Change from base line in the mean score of World Health Organization Quality of life for Elderly (WHOQOL-BREF)

    The quality of life will be assessed through World Health Organization Quality of Life-Brief Version (WHOQOL-BREF). It has 26-items in four domains of physical health (7 items), psychological (6 items), social relationships (3 items) and environment wellbeing (8 items) and two general questions about overall QoL and satisfaction with health. Each item of the tool is rated on a five-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). The higher total scores denote a higher quality of life. Then scores will be then transformed linearly to a 0-100-scale. Finally, the score quantiles will be created to categorize the QoL of each elderly as very poor, poor, undecided, good, and very good.

    three months

Secondary Outcomes (1)

  • Change in food intake

    thee months

Study Arms (1)

Nutrition counselling

OTHER

The intervention will be home-to-home-visit once per week lasting 30 minutes to one hour for one month period. The convenience day and time will be selected in the discussion.

Behavioral: Nutritional counselling

Interventions

Individual-based nutrition counselling guided with the health belief model (HBM) and the theory of planned behavior (TPB) will be implemented.

Nutrition counselling

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Community-dwelling old age people those who lived at least six months in the selected kebeles and those who want to live at least the next three months.

You may not qualify if:

  • Old age people who used therapeutic dietary supplements
  • Those seriously ill and/or unable to communicate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Public Health

Bahir Dar, Ethiopia

Location

Related Publications (1)

  • Seid AM, Babbel NF. Behavioral model-guided nutritional counseling could improve the dietary practice and nutritional status of elders in Ethiopia: a quasi-experimental study. BMC Geriatr. 2023 Nov 20;23(1):757. doi: 10.1186/s12877-023-04433-9.

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Ahmed Muhye Seid

    Bahir Dar University

    PRINCIPAL INVESTIGATOR
  • Netsanet Fentahun Babbel

    Bahir Dar University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Masking will not be possible due to the nature of the study.
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: The study design will be single-group pretest-posttest quasi-experimental (QE) design. The one-group pretest-posttest design is the QE design typically used when testing knowledge acquisition following a teaching project. Quasi-experimental studies use experiments that do not randomly assign interventions to assess the association between interventions and outcomes. The main advantage of QE studies is that they are cheaper and require less resources than randomized controlled trials (RCT). When randomization is considered unethical or unfeasible, QE research is appropriate.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 1, 2021

First Posted

February 10, 2021

Study Start

January 28, 2022

Primary Completion

February 14, 2022

Study Completion

May 26, 2022

Last Updated

September 18, 2025

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations