Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04746664 |
| Other study ID # |
BDU |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 4, 2021 |
| Est. completion date |
December 2021 |
Study information
| Verified date |
October 2021 |
| Source |
Bahir Dar University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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
Description:
Introduction The chronological age of 60 or 65 years is conventionally the beginning of old
age in the world. Still, the United Nations (UN) and the world health organization (WHO)
define older people or elderly as people who are 60 years and above for developing countries.
Furthermore, age 60 years and above has also accepted in Ethiopia as it corresponds to the
country's official retirement age. This study also used the chronological age of 60 years and
above to refers to old age people.
Old age people are the world's fastest-growing population group. Yet, they are not positively
healthier than earlier. This cause the potential to worsen the overall health of elders by
limiting their nutritional status, productivity, and quality of life (QoL). Furthermore, the
number of years lived with chronic diseases and disabilities are raising concurrently that
greatly affecting our living arrangements, economies, and personal and professional
aspirations.
Malnutrition and quality of life are an overall issue and influences a large portion of the
total population. Nevertheless, people who are most vulnerable include old age people and
people in poverty. Ageing and nutrition are by far the number-one driver of the global burden
of disease. However, the malnutrition prevalence among old age people varies based on the
definition used, screening tools, study settings (community or institutionalized),
heterogeneity of study participants and geographical location. Even the prevalence rates vary
widely between study samples using the same definition in the same health-care setting. This
impedes the comparison between studies. Similarly, measuring and finding ways to improve QoL
in old age is a challenging task. This is due to the complexity concept of QoL,
identification of various instruments, and subjectivity of how elder patients rate their own
health and the way healthcare providers rate their patient's health.
Even so, the global reported prevalence malnutrition among old age people ranged from 3% to
62%. Likewise, the mean score of QoL among elderly people reported from 47.72 to 53.60. The
scores also varies within the physical, psychological, social, and environmental health
domains. Moreover, apart from prevalent malnutrition, a large proportion of older people are
at risk of developing malnutrition in all settings. The estimate ranges between 11.8% to 27%
in the community/outpatients and 50% to 62% in all other health-care settings.
While a substantial share of the population in low and middle-income countries (LMICs)
remains chronically undernourished and suffers from widespread micronutrient deficiencies, a
rapidly growing share suffers from overweight/obesity and diet-related noncommunicable
diseases (NCDs). In numerous nations, a deficiency of supply and low levels of utilization of
solid dietary components such as fresh vegetables, natural products, and nuts is examined,
whereas an overabundance of undesirable components, such as sugar-sweetened refreshments,
immersed and trans fats, sodium, and ultra-processed meats, is increasing.
Besides, the causes and effects of malnutrition and QoL in elderly individuals follow a
vicious path-one leading to the other and perpetuating each. Increased age by itself
increases the risk of malnutrition and disease. Normally, ageing comes with a number of
physiological, pathological, psychosocial, and social changes that make it more difficult for
nutritional needs to be met. While, hospitalization aggravates the preexisting malnutrition
or causes new-onset nutritional complications.
Even though the progression of ageing, illnesses and disabilities of old age people cannot be
totally prohibited, appropriate measures can be taken to delay this progress and conserving
their QoL. Appropriate nutrition assessment followed by timely intervention and regular
follow up improves the nutritional status and QoL in old age people. Common nutrition
interventions, such as dietary advice and/or counselling, oral nutritional supplements (ONS),
have shown positive nutritional and health outcomes in old age people. However, nutritional
problems and QoL are multifaceted and differ between individuals. Additionally, old age
people are heterogeneous regarding a health condition, nutritional needs, preferences, and
individual goals. Thus, it needs to adjust nutritional interventions individually. Yet, in
many LMICs including Ethiopia, there is a shortage of data on the nutritional status, QoL and
intervention outcomes of the aged people. There is low attention to malnutrition and QoL care
services in Africa. Malnutrition and QoL remain under-detected, under-treated and
under-resourced, and are often overlooked by those working with and for older people in the
community. Based on the belief that there is no treatment available for their problems, older
people disengage from services, not attend health care clinics and/or not adhere to
treatment. Furthermore, nutritional intervention in sub-Saharan Africa (SSA) primarily
targets pregnant and lactating women, infants and young children than on the aged who are
equally as vulnerable as to changes in social and economic conditions. Equally, the
traditional supports given to older persons from families and communities have declined
largely due to widespread poverty, urbanization, and globalization.
Therefore, this dissertation is proposed to estimate the effects of nutrition counselling on
old age people's nutrition and health outcome in Bahir Dar City, Northwestern Ethiopia from
April to July, 2021. The results will be vital for government policy-makers, academics at
institutions of higher learning, non-governmental organizations, as well as any other
agencies concerned with issues of ageing to develop comprehensive community-based approaches
to old age people.
Research Question Does nutrition counselling intervention make a change in the old age
people's nutritional status and quality of life in old age people? Methods and Materials
Sample size determination The sample size is calculated following sample size for
before-after study (Paired T-test) with the assumption of 95% confidence level, 80% power,
20% effect size and one standard deviation (SD) of the change in the outcome since no
previous study is found. There is evidence that when there is no previous information about
the relative effect size, the smaller effect usually corresponds to = 0.2, the medium = 0.5,
and the larger = 0.8. The smaller the effect size, the larger the sample size of the
research.
n=(〖σ_d〗^2 (Z_β+Z_α"/2" )^2)/〖ES〗^2 Where n= sample size σd2 = the standard deviation of the
change in outcome (1.0) Zβ = probability to find a statistically significant difference (for
80% power = 0.84) Zα/2 = probabilities of the standard normal distribution (for 95% CI =
1.96) ES= is the effect size (= 0.2) The calculated sample becomes 196. While considering 10%
of the loss to follow up, the final sample size will be 216.
Sampling procedure Cluster random sampling will be used to select the kebeles, the smallest
administrative unit in Ethiopia. Then, all eligible study participants will be requested to
participate in the study. If the selected household is closed or not available during the
data collection time, another one repeated visit will be tried to get the participant.
Data collection instruments and procedures Once the potential research participant is
contacted, the data collector will explain the purpose of the research and invite her/him to
participate in the research. Those who are voluntary and literate will sign the informed
consent form, while those who are unable to sign will be fingerprinted before conducting the
research.
Data collection will be carried out using structured interviewer-administered questionnaires
and anthropometric measurements. The questionnaires are divided into the socio-demographic
characteristics, questionnaires of mini nutritional assessment (MNA), World Health
Organization Quality of Life-Brief Version (WHOQOL-BREF), nutritional knowledge, health
belief model (HBM), and theory of planned behavior (TPB) constructs.
General nutritional knowledge questionnaire will be used to assess the nutritional knowledge
of the study participants. The questionnaire 14 items adapted from previous studies. Each
true answer will get one point, and each false answer and "I do not know" will get zero.
Moreover, the HBM constructs will be assessed with three items for perceived susceptibility,
four items for perceived severity, five items for perceived benefits, 12 items for perceived
barrier, and four items for perceived self-efficacy. A five-point Likert scale ranging from 0
(strongly disagree) to 5 (strongly agree) will be utilized to measure the HBM constructs.
Similarly, the TPB constructs will be assessed using 13 items for behavioral beliefs
(attitude), four items for normative beliefs, and four items for intentions. Ten experts from
the fields of epidemiology, health education, and nutrition will evaluate the validity of
nutritional knowledge and the HBM and TPB construct questionnaires. The feedback will involve
wording, clarity of the items, and response bias. Items will be modified according to the
expertise' suggestions. In addition, the internal consistency of these questionnaires will be
determined by Cronbach's alpha (α) in a pilot study of 30 old age people. A factor analysis
will be performed using eigenvalues > 1 and load factor > 0.4 to ensure the construct
validity of each questionnaire.
All data will be taken before and after the implementation of the intervention. Those old age
people who did not attend all consultation sessions will be considered as "not adhere to the
guideline", while those who dropped out of the study will be considered as "lost to
follow-up." There will be six nurses as data collectors and three master nutritionists as
supervisors. Besides, six experienced nurses will be enrolled as counsellors. The recruited
team will receive two days of training, focusing on data collection tools, procedures, and
ethical issues.
Intervention Fidelity Intervention fidelity refers to the methods and strategies used to
monitor and enhance the reliability and validity of behavioral interventions. Basically,
intervention fidelity is very important for monitoring the degree of the intervention's
conception and plan, in order to draw valid conclusions about its effectiveness in achieving
the target outcomes. The following methods are developed to enhance and assess the
intervention fidelity based on the best practice recommendations of the National Institutes
of Health Behavior Change Consortium (NIHBCC) framework.
Intervention Design Individual-based nutrition counselling guided with the health belief
model (HBM) and the theory of planned behavior (TPB) will be implemented. Behavioral theories
and models have been increasingly used to guide nutrition research to improve the
effectiveness of interventions. Common such theoretical frameworks that have been applied
include health belief model (HBM) and theoretical planned behavior (TPB).
The HBM aims to explain and predict health-related behaviors. When an individual thinks that
she or he is susceptible to a specific problem, that her/his problem is serious, and that the
benefit exceeds the obstacle, s/he will take measures to change her/his behavior. The premise
of including self-efficacy in HBM is that the possibility of taking action is not only a
function of beliefs related to the outcome, but also a person's capability that he or she can
achieve the expected results. Similarly, the TPB proposes that the possibility of a person
performing a certain behavior depends on the strength of her/his intentions for certain
behavior. The attitudes, subjective norms, and behavioral control over specific behaviors are
bases of intentions to change behavior.
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.
Randomization and masking will not be carried out due to the practical impossibilities and
the nature of the intervention. There will be four follow up sessions for additional two
months.
Training of Counsellors Six experienced Nurses will give the nutritional counselling and
three master nutritionists will supervision the process. Counsellors will be trained in
groups using a standardized training manual. The skill acquisition of the counsellors will be
assessed through role plays and simulating consulting practice with standardized patients
followed by feedback to the provider and score provider adherence to both intervention
content and process using validated performance criteria. In addition, a written
pre-post-test training will be utilized to evaluate the knowledge and skill acquisition of
the counsellors. Minimum of 80% will be required and those who scored below this will take
remedial training.
Delivery of Counselling Each counselling session will be face to face talks and discussions
to develop a comprehensive understanding of nutritional issues and support favorable
health-promoting eating habits. The nutrition counselling package was adapted from a
recommendation of previous studies and validated tool for old age people. The main contents
of the intervention will be to increase awareness of the importance of balanced diet intake,
improve the regularity of food intake (three major meals as breakfast, lunch, and dinner)
with the addition of snacks between them; drink at least eight glasses of water; increase
consumption of food varieties especially fruits and vegetables, whole grains, and
protein-rich foods without avoiding any specific foods; and control the amount of noncaloric
beverages took per day. In addition, advice to consume fewer foods with sodium, added sugar,
saturated fat, trans-fat, cholesterol, or refined grains and the importance of the daily need
of fiber, vitamins, and minerals and explain their sources.
Core message will be prepared in flyers and appropriate pictures with the local language
(Amharic) and distributed to every study participant. For those who cannot read, anyone in
the family or neighborhood will be requested to read the flyer to the old age people and/or
other family members. Furthermore, each consultation process will consider the knowledge,
attitudes, subjective norms, self-efficacy, and intentions of the study participants.
Besides, the consultation will discuss the susceptibility and severity of the insufficient
nutrition intake as well as barriers of the balanced diet intake. Then, counselling will be
given based on the determined gap and family income. The objective of the intervention is not
to change completely the participants' or family's food habits, but to correct possible
shortfalls in their diet based on the food items that they are familiar with and that are
already part of their daily diet. The counsellor will modify the diet plan at each visit
based on the participant's adherence and feedback. The supervisors will monitor the deliver
process. In addition, they will coach and evaluate randomly selected consulting sessions for
each counselor. The evaluator will use a "yes/no" rating system to check items such as the
use of the counselling guide, the provision of all the content, the duration and frequency of
the counselling, and the ability to answer questions correctly. Besides, participants exist
interview (satisfaction survey) will be taken after a week. Feedback will be given to the
counsellors after each assessment to improve the observed gaps.
Receipt of Counselling The nutritional knowledge, attitudes, subjective norms, self-efficacy,
and intentions of the study participants will be assessed through pre- and post-test. Each
community-dwelling old age person will receive the same number and frequency of
consultations, and the contact time will be similar to the standardized procedure.
Counsellors will repeat the nutrition information (counselling) using verbal, pictures, and
written formats. The study participants will be inquired for their understanding of the
consultation and material covered in the session. Moreover, counsellors will record
participant attendance and self-report of knowledge measures at the end of counselling
session.
Enactment of Counselling Homework tasks will be set at the end of each session to reflect the
discussions in that session. In the following lesson, the counsellor will review the homework
with the participant. The reasons for not completing homework will be explored, as these
reasons may indicate a lack of understanding or hinder the implementation of learning skills.
In addition, the intervention enactment or implementation of knowledge acquired from the
intervention will be assessed through participants self-report. The study participants will
interview about the change of their dietary intake, meal frequency and varieties following
the nutrition consultations. Furthermore, participant enactment will be assessed through
brief questionnaires delivered with the post intervention process evaluation.
Data Processing and Analysis The data will be entered into Epi-Data version 3.1 and exported
to SPSS version 23 for data cleaning and analysis. The HBM construct questions with negative
wording will be reversely-scored. Descriptive statistics for categorical data will be
expressed in frequencies and percentages while continuous data as mean and standard deviation
or median and interquartile range, depending on the normality of the data. The reliability of
the knowledge and behavior parts of the questionnaire will be determined using Spearman's
correlation coefficient. In addition, Cronbach's alpha test will be used to check the
reliability of the HBM constructs. The higher the score of HBM items, the higher the degree
of health belief.
The effect of the intervention on primary and secondary outcomes will be evaluated using a
Wilcoxon signed-rank test. While ordinal logistic regression will be used to identify the
association of independent variables and the dependent variables. The composite likelihood
method will be used to estimate the model parameters. All assumptions will be checked before
each test and the P-value of less than 0.05 will be considered as statistically significant.
Data quality management The study will be registered at the ClinicalTrials.gov and the
transparent reporting of evaluation with nonrandomized designs (TREND) will be used as a
guide-line for the report of the results.
The study hypothesis will not be exposed to the study participants, data collectors, and
counsellors. Furthermore, both before and after intervention measurements will be conducted
using the same set of materials. Since the study participants will be approximately the same
age so that their respective maturity statuses are approximately the same, and that they are
from the same location so that time-trends do not have different effects on them. The data
collectors and supervisors will take two days training on the study purpose and utilization
of data collection tools. Anthropometric guidelines and recommendation will be strictly
followed. The weight scale will be validated by using standardized weight before the actual
weighing of each study participant. The supervisors and principal investigator will
frequently monitor the data collection and counselling process. Collected questionnaires will
be examined for completeness and consistency at the end of each day and returned to the data
collectors for correction as needed.
Ethical Considerations Ethical clearance will be obtained from the Institutional Ethical
Review Board (IRB) of Bahir Dar University, College of Medicine and Health Sciences. Official
letters of co-operation from IRB obtained will be given to the respective offices of the
selected study sub-cities and Kebeles; the smallest administrative unit in Ethiopia.
Data collectors and counsellors will approach the potential study participants to explain the
purpose of the study and to invite them to participate in the study. Before the interview,
oral consent will be obtained for the cross-sectional studies from study participant and/or
their caregivers. For the QE study, those who are voluntary and literate will sign the
informed consent form, while those who are unable to sign will be fingerprinted before
conducting the research. Participants will give information based on voluntary and they can
stop the interview at any time if they are not comfortable. To ensure participants'
confidentiality, names or personal identifiers will not be included in the written
questionnaires. If elders found with malnutrition and other disorder during data collection
and consultation time, they will be referred to the nearest health facilities for treatment
and efforts will be tried to link them with charity organizations. Convenient spaces will be
selected within the household and office compound in conducting the interviews.
Data Dissemination Plan The findings of this research will be presented and disseminated in
print form to Bahir Dar University, College of Medicine and Health Sciences, School of Public
Health, Research and publication office. Workshop/conference presentation will be done and
efforts will be made to publish in relevant peer-reviewed journal.
