healthcare
Article
Pilot and Feasibility Studies of a Lifestyle Modification
Program Based on the Health Belief Model to Prevent
the Lifestyle-Related Diseases in Patients with Mental Illness
Naomi Tsubata 1 , Akiko Kuroki 1 , Harumi Tsujimura 1 , Masako Takamasu 2 , Nariaki IIjima 1
and Takashi Okamoto 1,3,4, *
Citation: Tsubata, N.; Kuroki, A.;
Tsujimura, H.; Takamasu, M.; IIjima,
N.; Okamoto, T. Pilot and Feasibility
Studies of a Lifestyle Modification
Program Based on the Health Belief
Model to Prevent the
Lifestyle-Related Diseases in Patients
with Mental Illness. Healthcare 2023,
11, 1690. https://doi.org/10.3390/
healthcare11121690
Academic Editors: Andrea Botturi
and Andrea Tittarelli
Received: 20 January 2023
Revised: 1 June 2023
Accepted: 1 June 2023
Published: 8 June 2023
Copyright: © 2023 by the authors.
Licensee MDPI, Basel, Switzerland.
This article is an open access article
distributed under the terms and
conditions of the Creative Commons
Attribution (CC BY) license (https://
creativecommons.org/licenses/by/
4.0/).
Healthcare 2023, 11, 1690. https://doi.org/10.3390/healthcare11121690
1 Junwakai Yahagigawa Hospital, 141 Minamiyama, Fujii-cho, Anjo 448-0023, Japan
2 Department of Home Economics, Faculty of Home Economics, Japan Women’s University, 2-8-1 Mejirodai,
Bunkyo-ku, Tokyo 112-0015, Japan
3 Department of Molecular and Cellular Biology, Nagoya City University Graduate School of Medical Sciences,
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-86-1, Japan
4 Division of Internal Medicine, Yahagigawa Hospital, Anjo 448-0023, Japan
* Correspondence: takoka221@gmail.com
Abstract: In this study we have examined the feasibility of a program based on the health belief model
(HBM), for its effectiveness in improving lifestyle-related diseases in patients with schizophrenia
(SZ) and bipolar disorder (BD), which are often complicated with physical conditions. In this model,
we attempted to enable patients to identify a “threat” and to find “balance between benefits and
disadvantages”. Subjects were carefully selected from among psychiatric patients by excluding any
bias. Thus, the enrolled patients were 30 adult men and women with lifestyle-related diseases, or
those with a body mass index (BMI) of over 24. Of these 30 subjects, 15 were randomly assigned to the
intervention group and 10 the control group, since 5 subjects in the control voluntarily left from the
study. Comparison of the intervention and control groups revealed significant improvement (p < 0.05)
in HDL cholesterol in the intervention group. However, there were no significant changes in other
variables. These findings support the usefulness and efficacy of HMB-based nutritional interventions
for preventing lifestyle-related disorders among psychiatric patients. Further evaluation is needed
with a larger sample size and a longer intervention period. This HMB-based intervention could be
useful for the general population as well.
Keywords: health belief model (HBM); lifestyle-related diseases; schizophrenia (SZ); bipolar disorder
(BD); metabolic syndrome (MetS)
1. Introduction
1.1. Background
Lifestyle-related diseases is a generic term for diseases such as diabetes and obesity,
which are strongly related to lifestyle factors such as diet, exercise, rest, smoking, and
alcohol consumption. They are leading causes of death among people throughout the
world [1]. In addition, the total number of patients with mental disorders in Japan was
approximately 5,032,000 as of 2020, according to a survey carried out in Japan by the
Ministry of Health, Labor and Human Welfare [2].
A relationship between lifestyle-related illnesses and mental disorders has long been
observed. For instance, it was suggested that patients with schizophrenia (SZ) and bipolar
disorder (BD) have a higher risk of obesity, diabetes, and dyslipidemia than the general
population [3–6]. Strassnig et al. [7] reported that 62% of SZ and 50% of BD patients
were obese 20 years after their first hospitalization for psychosis. The proportions were
significantly higher than in the general adult population, where only 27% reached the
level of obesity in 20 years. This indicates that the probability of developing obesity and
lifestyle-related diseases is high in SZ and BD patients.
https://www.mdpi.com/journal/healthcare
Healthcare 2023, 11, 1690 2 of 13

The higher prevalence of obesity in SZ and BD patients is considered ascribable to

the difficulty in self-management because of low levels of understanding and cognition,
due to impaired mental function [8,9]. In addition, these patients often experience tobacco
use, lowered physical activity, and higher caloric intake, eventually leading to obesity and
hyperlipidemia [10,11]. Moreover, it is well known that some antipsychotic medications
often contribute to lifestyle-related diseases and weight gain in patients with psychiatric
disorders [12–17]. These findings suggest that patients with SZ and BD are likely to
develop lifestyle-related diseases as described earlier, which has to be substantiated through
anthropometric and biochemical parameters [18,19]. Thus, the practical efficacy of such
educational intervention in patients with psychotic disorders is examined in this study.

1.2. Objective
The main objective of this pilot study is to implement a lifestyle modification program
based on the health belief model (HBM), for patients with SZ or BD and lifestyle-related
diseases or a BMI of 24 or higher, and to verify the efficacy of the program based on BMI
values and relevant biochemical data.
The HBM is a social model developed by Becker et al. [20], which attempts to change
behavior by informing subjects of the personal threat of disease and also developing confidence
in the effectiveness of recommended health behaviors, and eventually leading to meaningful
action toward such health-promoting behaviors. The HBM has also been used in nutrition
education to promote healthy eating behaviors [21,22], as well as in a wide range of other areas
such as exercise, diabetes management, and health-promoting behaviors [23–25]. Previous
studies have reported that diet and exercise programs for patients with schizophrenia can
lead to significant improvements in BMI, exercise habits, HbA1c levels, blood pressure, and
nutritional knowledge [26–30]. However, to our knowledge, no studies on patients with mental
illnesses have been attempted that have implemented an intervention program based on the
health belief model.
This study has attempted to examine the efficacy of an HBM-based intervention
program for reducing the risk of lifestyle-related illness in psychiatric patients.

2. Methods
2.1. Subjects
Adult male and female patients with psychiatric disorders such as SZ and BD, who
were hospitalized at the Yahagigawa Hospital, Anjo, Japan or attending its outpatient
rehabilitation care center, were selected. Subjects were either experiencing lifestyle-related
diseases (diabetes, dyslipidemia, hypertension, or hyperuricemia) or had a BMI of 24 or
higher, and gave consent to this study. Patients in acute care wards who were likely to
be discharged from the hospital during the study period, and those who attended the
outpatient rehabilitation irregularly, were excluded. These subjects were not assigned to
the study. They did not take part in other clinical studies.

2.2. Study Design

Subjects were randomly assigned to the intervention or the control groups. The
eventual sizes were different because some patients left this study due to the lack of
nutritional intervention. For the intervention group, a total of eight sessions of a lifestyle
improvement program (henceforth referred to as the “program”) was conducted, consisting
of a lecture, group work, review of goal setting, and individual consultation time. Before
this study had begun (before program implementation) and after program completion
(or after 4 months), both of these subject groups were surveyed with regard to their lifestyle
and knowledge of appropriate lifestyle habits.
Program implementation and the survey were conducted at Yahagigawa Hospital
from September 2018 to January 2019. Lifestyle surveillance and knowledge of appropriate
lifestyle habits were investigated using a self-administered questionnaire (in accordance
with that proposed by the Ministry of Health, Labor and Human Welfare, Japan, with some
Healthcare 2023, 11, 1690 3 of 13

modifications). Medical information on age, gender, height, current medical history, and
medication status were obtained from clinical records, while weight, body fat percentage
(BFP), BMI, and blood pressure (BP) were measured at the time of this study. Biochemical
data on triglycerides, total cholesterol, high-density lipoprotein (HDL) cholesterol, low
density lipoprotein (LDL) cholesterol, blood glucose, and HbA1c (as defined by the national
glycohemoglobin standardization program of the USA) for suspected diabetes or diabetic
patients were obtained from clinical blood laboratory tests. Biochemical tests were analyzed
at the Nagoya Clinical Laboratory (Nagoya, Japan). Body weight (kg) and BFP (%BF) were
measured using a health meter with a body fat scale (BF-046, Tanita, Tokyo, Japan), and
BP was measured using a digital automatic blood pressure monitor (HEM-7071, Omron,
Kyoto, Japan).
The self-administered questionnaire was based on the HBM [20] and included the
following three major concepts: (i) “Knowledge“ including “Perceived susceptibility,”
“Perceived severity” and “Perceived benefits”, (ii) “Perceived barriers”, (iii) “Cue to action”,
(iv) “Self-efficacy”, (v) “Environment”, and finally (vi) “Satisfaction”. Our program was
thus designed to incorporate these independent concepts. Participants were asked to
choose the most applicable answer among the two to six grades for each questionnaire. For
patients who were unable to answer these questionnaires by themselves, the conductor of
the interview helped them to complete the form. These questionnaires were then scored.

2.3. Program Contents

The program content and objectives are listed in Table 1. The program utilized in
this study is consisted of four steps: lecture (30 min), group work (10 min), goal setting
and review (10 min), and questions and consultation (10 min). Eight lectures were held
twice a month for 4 months, each consisting of basic principles such as “what is health?”,
“how to control eating habits for snacks”, “the healthy lifestyle habits of thin people,”,
“what is well-balanced diet?”, “the shopping knack to maintain good health”, “benefits of
physical exercise”, “exercise practice” and the “review of these lectures”. Three of these
eight sessions were conducted in a practical format, combining lectures with buffet meals
and exercise. In the group work session following the lectures, questions related to what
participants had learned in the lecture were asked in order to check their comprehension
and to further participants’ understanding. Participants were encouraged to speak up
in their own words. In the “Goal Setting” session that followed, participants discussed
the changes in their lifestyle habits in relation to their previous goals, reviewed their
goals, and set new goals. Finally, there was a “Question and Consultation time,” during
which participants had time to ask questions of the instructor and discuss their individual
problems and additional goals. The program consisted of eight sessions as described above,
and for those who were unable to attend, a professional dietitian gave further lectures
individually.
The HBM consisted of six components: “Perceived susceptibility”, “Perceived sever-
ity”, “Perceived benefits”, “Perceived barriers”, “Cue to action” and “Self-efficacy”. The
first three components, “Perceived susceptibility”, “perceived severity” and “perceived
benefits”, were made to understand the risks of getting lifestyle-related diseases. Addi-
tionally, the disadvantages of getting lifestyle-related diseases, and the benefits of being
healthy through lectures and group work were consolidated through these activities.
The participants were encouraged to continue their progress and given advice on
how to achieve their individual goals. In addition, in order to increase self-efficacy, each
participant was asked to set a small goal at each meeting and to monitor their progress. The
purpose of this goal-setting was to focus on the progress of each participant and to give
each participant confidence in implementing the plan. If the program was perceived as
difficult to complete, any participant could use the question/consultation time to overcome
“perceived barriers” and resolve individual problems.
Healthcare 2023, 11, 1690
Table 1. Lifestyle improvement program content and aims.
Title
What is health?
How to control eating habits for snacks
Healthy lifestyle habits of the healthy
people
What is the well-balanced diet?
Shopping knacks to maintain good
health
Benefits of physical exercise
Exercise practice
Review of these lectures/exercises
Aim of the Program
Knowing what good health consists of
and how to live a healthier life.
Developing the ability to set goals.
Understanding the advantages and
disadvantages of snacking.
Understanding what constitutes
appropriate snacking.
Developing the ability to change goals
and continue.
Understanding healthy lifestyle habits
and the benefits of living a healthy
lifestyle.
Developing the ability to change goals
and continue.
Understanding the dietary balance and
benefits of eating a balanced diet.
Understanding what is an appropriate
amount of food.
Developing the ability to change and
maintain the goal.
Knowing how to choose healthy
products.
Developing the ability to change and
maintain the goal.
Understanding the benefits of exercise.
Knowing that exercise is easy to do.
Developing the ability to change and
maintain goals.
Knowing simple exercises.
Developing the ability to change and
maintain goals
Recalling the previous content.
Lecture Content
and Methods
The importance of health.
(lecture)
The proper amount and selection of
snacks.
(lecture and practice)
Healthy lifestyle habits.
(lecture)
Eating a well-balanced diet
(lecture and practice)
How to choose food for improved health.
(lecture)
The Benefits of exercise
(lecture)
Exercises that can be done at home
(lecture and practice)
Review of the previous topics
(lecture)
Lecture Details
Relationship between disease and
lifestyle, showing pictures of diabetic
gangrene.
Advantages and disadvantages of eating
snacks (using actual snacks to
demonstrate the proper amount.)
Healthy lifestyle habits and their
advantages.
Well-balanced diet, followed by a buffet
lunch.
Choosing foods for health, correcting
eating/shopping habits.
Advantages of exercising and
disadvantages of not exercising, simple
ways to exercise.
Review of the six sessions above.
Practicing simple exercises that can be
done at home.
Review of the first seven sessions.
4 of 13
Group Work Questions
What is a healthy lifestyle? What do you
care about and what do you want to take
care of regarding your health?
What are the advantages and
disadvantages of eating sweets. What
are the precautions in choosing snacks?
What do you need to pay attention to in
your lifestyle?
What do you pay attention to regarding
a well-balanced diet?
What do you buy when you are
shopping? What do you need to pay
attention to when you are shopping?
What are some good/bad consequences
of exercising or not exercising? What are
some practical approaches to exercise?
What are your impressions after doing
the exercise?
How well do participants comprehend
the program after the 7th session? What
has been learned, changed, or enabled
through the program?
Healthcare 2023, 11, 1690 5 of 13

2.4. Control Group

Individuals enrolled in the control group were not given any program or other inter-
vention. After the completion of the study, the same program was implemented for those
who wished to participate.

2.5. Statistical Methods

The comparison between the intervention group and the control group was analyzed
by a Mann–Whitney U test. Statistical analysis was performed using IBM SPSS statistics 26
(IBM Japan, Ltd., Tokyo, Japan) with a significance level of 5% (two-tailed test).

2.6. Study Registration and Ethical Approval

All subjects gave their informed consent for inclusion before they participated in the
study. The study was conducted in accordance with the Declaration of Helsinki. This
study was conducted after obtaining approval from the Ethical Review Committee for
Human Subjects of Japan Women’s University (approval date: 8 August 2018, No. 337) and
the Ethical Review Committee of Yahagigawa Hospital (approval date: 14 August 2018,
No. 2018-005). In addition, the study was registered with the Japan Medical Association
Center for Clinical Trial Promotion [JMACCT] (ID: JMA-IIA00365).

3. Results
3.1. Selection of Subjects
Of the 215 eligible participants, 185 were deemed ineligible through screening because
they did not meet the requirements for enrollment, such as acute illness or lack of evaluation
(180 cases), or because they refused to participate (5 cases). Thus, 30 cases were chosen as
Healthcare 2023, 11, x appropriate for the present study. These subjects were divided into two groups,
6 of the
15 intervention
and control groups, excluding any bias but matched for sex, age, and BMI (Figure 1).

Inpatients and psychiatric day-care attendees in this study

(n =215)
Excluded (−180)
Refused to participate (−5)
Patients with mental illness and BMI over 24
or lifestyle-related diseases (n =30)

Consented (n =30)

Allocated (n =30)

Intervention group (n =15) Control group (n =10)*

Pre-implementation survey

Program intervention Discharged en

(4 month) route (−1)

Post-implementation survey
Intervention group (n =15) Control group (n =9)
Figure 1. Flowchart of this study. * From the control group, 5 subjects voluntarily left the study
Figure 1. Flowchart of this study. * From the control group, 5 subjects voluntarily left the study
knowing that they could not access the program.
knowing that they could not access the program.
3.2. Analysis of the Study Subjects
Demographic data on the participants are shown in Table 2. The control group
consisted of 10 subjects (6 males and 4 females) and the intervention group consisted of
15 subjects (9 males and 6 females) with a mean age (standard deviation) of 60.4 (12.7) and
56.8 (12.1) years, respectively. These diagnoses of the patients in the control group were
uniformly SZ, whereas the intervention group consisted of 12 patients (80%) with SZ and
3 with (20%) mood disorders. All were Japanese (100%).
Healthcare 2023, 11, 1690 6 of 13

3.2. Analysis of the Study Subjects

Demographic data on the participants are shown in Table 2. The control group
consisted of 10 subjects (6 males and 4 females) and the intervention group consisted of 15
subjects (9 males and 6 females) with a mean age (standard deviation) of 60.4 (12.7) and
56.8 (12.1) years, respectively. These diagnoses of the patients in the control group were
uniformly SZ, whereas the intervention group consisted of 12 patients (80%) with SZ and 3
with (20%) mood disorders. All were Japanese (100%).

Table 2. Participant characteristics and the number of program completers.

Intervention Group Control Group

(n = 15) (n = 10)
Psychiatric day care 6 (40%) 5 (50%)
Medical conditions
In the hospital 9 (60%) 5 (50%)
Male 9 (60%) 6 (60%)
Gender
Female 6 (40%) 4 (40%)
Schizophrenia 12 (80%) 10 (100%)
Disease
Mood disorder 3 (20%) 0
Mean Age (years) 56.8 (12.1) 60.4 (12.7)
(Standard deviation) BMI (kg/m2 ) 27.7 (3.7) 25.1 (3.4)
Program completers 14 (93.3%) -

In the intervention group, 14 (93.3%) completed all eight sessions of the program,
and one person who could not complete the program withdrew from participation in
the program immediately before the first session, but participated in a survey using a
self-administered questionnaire administered after the completion of the eight sessions. In
addition, one participant in the intervention group had polydipsia as a symptom of their
condition, but completed the eight sessions of the program and participated in the two
surveys. One person in the midway discharge (control group: n = 1) did not complete the
final evaluation. Finally, 24 participants (24/25: 15 in the intervention group and 9 in the
control group) completed the final evaluation.

3.3. Pre-Intervention Comparisons

Categorical variables were analyzed using Fisher’s exact test, while continuous vari-
ables were analyzed using Student’s t-test. There was a significant difference in the self-
administered questionnaire items such as “Sweaty exercise for at least 30 min at least 2 days
a week”, “Don’t you have any financial barrier?”, “Walking faster than others of the same
age” (Tables 3 and 4). However, these results appeared as not significant; thus, we did not
pursue them any further.

Table 3. Pre-intervention comparisons (physical status, blood biochemistry).

Intervention Group Control Group

Items (Average, SD) p-Value
(n = 15) (n = 10)
body weight (kg) 71.9 (13.9) 61.6 (9.4) ns *
BMI (kg/m2 ) 27.7 (3.8) 25.1 (3.6) ns
Physical status body fat percentage (%) 31.8 (7.3) 27.9 (7.8) ns
systolic BP (mm Hg) 123 (21.3) 112 (21.1) ns
diastolic BP (mm Hg) 79.6 (10.3) 73.2 (10.1) ns
blood sugar (g/dL) 96 (33.5) 116 (48.5) ns
total cholesterol (mg/dL) 183 (36.9) 172 (25.8) ns
Blood biochemistry triglyceride (mg/dL) 182 (106) 134 (71.5) ns
HDL cholesterol (mg/dL) 44.7 (10.4) 52.1 (13.3) ns
LDL cholesterol ** (mg/dL) 106 (30.4) 101 (35.7) ns
* ns, not significant ** LDL cholesterol was calculated by formula F.
Healthcare 2023, 11, 1690 7 of 13

Table 4. Pre-intervention comparisons (self-administered questionnaire).

Intervention Group Control Group

Questions (n, %) Options p-Value
(n = 15) (n = 10)
Not at all 2 (13.3) 2 (20) ns
I don’t think so. 3 (20) 0 (0)
Do you know what “health” Somewhat agree 0 (0) 2 (20)
is? Slightly agree. 6 (40) 2 (20)
I agree. 1 (6.7) 2 (20)
I agree very much. 3 (20) 2 (20)
Not at all 3 (20) 1 (10) ns
I don’t think so. 1 (6.7) 0 (0)
Are you taking “healthy Somewhat agree 2 (13.3) 1 (10)
lifestyle” Slightly agree. 2 (13.3) 5(50)
I agree. 4 (26.7) 1(10)
I agree very much. 3 (20) 2(20)
Not at all 3 (20) 1(10) ns
I don’t think so. 0 (0) 0(0)
Is your daily Diet well Somewhat agree 0 (0) 3 (30)
balanced? Slightly agree. 7 (46.7) 3 (30)
I agree. 2 (13.3) 1 (10)
Knowledge about I agree very much. 3 (20) 2 (20)
Not at all 5 (33.3) 3 (30) ns
I don’t think so. 2 (13.3) 1 (10)
Do you know how to choose Somewhat agree 3 (20) 0 (0)
healthy Snacks? Slightly agree. 2 (13.3) 4 (40)
I agree. 2 (13.3) 1 (10)
I agree very much. 1 (6.7) 1 (10)
Not at all 3 (20) 2 (20) ns
I don’t think so. 3 (20) 1 (10)
Do you go out for Shopping
Somewhat agree 3 (20) 2 (20)
to buy healthy promoting
Slightly agree. 3 (20) 4 (40)
goods?
I agree. 1 (6.7) 1 (10)
I agree very much. 2 (13.3) 0 (0)
Not at all 3 (20) 2(20) ns
I don’t think so. 1 (6.7) 1 (10)
Do you know why Exercise is Somewhat agree 1 (6.7) 2 (20)
important? Slightly agree. 5 (33.3) 5 (50)
I agree. 2 (13.3) 0 (0)
I agree very much. 3 (20) 0 (0)
Not at all 3 (20) 4 (40) ns
I don’t think so. 0 (0) 0 (0)
Somewhat agree 3 (20) 0 (0)
Do you Exercise regularly?
Slightly agree. 1 (6.7) 3 (30)
I agree. 3 (20) 2 (20)
I agree very much. 5 (33.3) 1 (10)
Not at all 1 (6.7) 4 (40) ns
I don’t think so. 2 (13.3) 0 (0)
Do you know the appropriate Somewhat agree 3 (20) 1 (10)
Food intake? Slightly agree. 3 (20) 3 (30)
I agree. 3 (20) 1 (10)
I agree very much. 3 (20) 1 (10)
Not at all 4 (26.7) 2 (20) ns
I don’t think so. 2 (13.3) 1 (10)
Can you achieve the goals Somewhat agree 3 (20) 3 (30)
you expected? Slightly agree. 2 (13.3) 1 (10)
I agree. 1 (6.7) 2 (20)
I agree very much. 3 (20) 1 (10)
Self-efficacy
Not at all 4 (26.7) 3 (30) ns
I don’t think so. 3 (20) 1 (10)
Can you achieve goals even Somewhat agree 2 (13.3) 3 (30)
when you are exhausted? Slightly agree. 2 (13.3) 2 (20)
I agree. 1 (6.7) 0 (0)
I agree very much. 3 (20) 1 (10)
I agree very much. 1 (6.7) 2 (20) ns
I agree. 0 (0) 2 (20)
Do you feel difficulty in Slightly agree. 8 (53.3) 2 (20)
Perceived barriers feeling healthy? (%) Somewhat agree 0 (0) 1 (10)
I don’t think so. 2 (13.3) 1 (10)
Not at all 4 (26.7) 2 (20)
Healthcare 2023, 11, 1690 8 of 13

Table 4. Cont.

Intervention
Control Group
Questions (n, %) Options Group p-Value
(n = 10)
(n = 15)
Not at all 4 (26.7) 3 (30) ns
I don’t think so. 1 (6.7) 0 (0)
Can you control your own Somewhat agree 2 (13.3) 2 (20)
diet? Slightly agree. 6 (40) 3 (30)
I agree. 0 (0) 1 (10)
I agree very much. 2 (13.3) 1 (10)
Not at all 2 (13.3) 5 (50) ns
I don’t think so. 1 (6.7) 1 (10)
Can you control your Somewhat agree 4 (26.7) 1 (10)
lifestyle? Slightly agree. 3 (20) 2 (20)
I agree. 1 (6.7) 0 (0)
I agree very much. 4 (26.7) 1 (10)
Frequency of taking ≥3/week 6 (40) 3 (30) ns
snacks <3/week 9 (60) 7 (70)
Times of meals per day ≥3 times/week 2 (13.3) 1 (10) ns
(within 2 h of bedtime) <3/week 13 (86.7) 9 (90)
Cue to action
Frequency of taking <4 times/week 1 (6.7) 1 (10) ns
breakfast ≥4/week 14 (93.3) 9 (90)
Slow 5 (33.3) 2 (20) ns
Eating fast as compared to
Normal 5 (33.3) 5 (50)
others
fast 5 (33.3) 3 (30)
no 7 (46.7) 6 (60) ns
1~2 times/week 1 (6.7) 0 (0)
Exercise
3~4 times/week 6 (40) 2 (20)
every day 1 (6.7) 2 (20)
Slow 4 (26.7) 5 (50) p < 0.05
Walking faster than others
Normal 4 (26.7) 5 (50)
of the same age
fast 7 (46.7) 0 (0)
Sweaty exercise for at least no 8 (53.3) 10 (100) p < 0.05
30 min at least 2 days a
week yes 7 (46.7) 0 (0)
no 9 (60) 10 (100) ns
Exercise for 1 h per day
yes 6 (40) 0 (0)
I agree very much. 1 (6.7) 1 (10) p < 0.05
I agree. 0 (0) 2 (20)
Don’t you have any Slightly agree. 1 (6.7) 4 (40)
financial barrier? Somewhat agree 3 (20) 1 (10)
I don’t think so. 0 (0) 1 (10)
Not at all 10 (66.7) 1 (10)
Not at all 3 (20) 5 (50) ns
I don’t think so. 1 (6.7) 0 (0)
Do you have family
Somewhat agree 4 (26.7) 0 (0)
Environment support for health
Slightly agree. 1 (6.7) 3 (30)
promotion?
I agree. 2 (13.3) 0 (0)
I agree very much. 4 (26.7) 2 (20)
Not at all 5 (33.3) 1 (10) ns
I don’t think so. 1 (6.7) 2 (20)
Do you have supportive
Somewhat agree 3 (20) 1 (10)
environments for your
Slightly agree. 0 (0) 2 (20)
health promotion?
I agree. 3 (20) 2 (20)
I agree very much. 3 (20) 2 (20)

3.4. Post-Intervention Comparison (Physical Status and Biochemical Tests)

As shown in Table 5, the test group who received the lifestyle modification program
intervention showed a significant improvement in HDL cholesterol compared to the control
Healthcare 2023, 11, 1690 9 of 13

group (p < 0.05) as analyzed via the Mann–Whitney U test. There was no significant
difference in “body weight,” “BMI,” “BFP,” “BP,” “triglycerides,” “LDL cholesterol,” “blood
glucose,”, and “HbA1c” values. The post power of analysis was 0.72 based on the results
for HDL cholesterol, which was significantly different.
The values of the self-administered questionnaire were tested with the Mann–Whitney
U test and found to be not significantly different. However, the number of those who
understood the program content actually increased, though not statistically significantly
(Table 6).

Table 5. Post-intervention comparisons (physical status, blood biochemistry).

Difference
Before After
Items before and after p-Value
Average, (SD) Average, (SD) Average, (SD)
Systolic BP (mm Hg) Intervention group (n = 15) 79.6 (10.3) 80.6 (9.5) 1 (9.7) ns
Control group (n = 9) 73.7 (10.5) 67 (7.6) −6.7 (11.2)
Diastolic BP (mm Hg) Intervention group (n = 15) 123 (21.3) 128 (23.0) 5.9 (16.4) ns
Control group (n = 9) 114 (21.2) 116 (16.8) 1.7 (24.2)
BMI (kg/m2 ) Intervention group (n = 15) 27.7 (3.8) 27.3 (4.1) −0.4 (0.6) ns
Control group (n = 9) 25.4 (3.7) 25.2 (3.8) −0.1 (0.7)
Body weight (kg) Intervention group (n = 15) 71.9 (13.8) 70.8 (14.0) −1.0 (1.8) ns
Control group (n = 9) 62.3 (9.7) 61.9 (10.7) −0.3 (1.9)
Blood sugar (g/dL) Intervention group (n = 15) 96 (33.5) 104 (53.1) 8.9 (32.5) ns
Control group (n = 8) 122 (48.5) 99.7 (36.7) −22.2 (56.3)
(mg/dL) Intervention group (n = 15) 183 (36.9) 193 (30.2) 10.4 (23.5) ns
Total cholesterol Control group (n = 8) 171 (27.4) 168 (22.1) −3.3 (19.2)
Triglyceride (mg/dL) Intervention group (n = 15) 182 (106) 175 (153) −6.8 (95.5) ns
Control group (n = 8) 142 (71.4) 133 (57.6) −9.2 (62.7)
Intervention group (n = 15) 44.7 (10.4) 51.5 (11.7) 6.8 (7.6) p < 0.05
HDL cholesterol (mg/dL)
Control group (n = 8) 51.2 (13.9) 48.3 (12.2) −2.9 (6.9)
Intervention group (n = 14) 106 (30.4) 112 (28.5) 5.9 (16.9) ns
LDL cholesterol * (mg/dL)
Control group (n = 8) 100 (38.1) 93.2 (21.9) −7.7 (21.3)
* LDL cholesterol was calculated by formula F.3.5. Post-Intervention Comparison (Self-Administered Questionnaire).

Table 6. Changes in score post-intervention comparisons (self-administered questionnaire).

Difference
Before After before and
Items p-Value
after
Average Average Average
Do you know what “health” Intervention group (n = 15) 4 5 0 ns
is? Control group (n = 9) 4 3 0
Are you taking “healthy Intervention group (n = 15) 4 4 0
lifestyle” Control group (n = 9) 4 5 1
Is your daily Diet well Intervention group (n = 15) 4 5 0 ns
Knowledge balanced? Control group (n = 9) 4 4 0
about Do you know how to choose Intervention group (n = 15) 3 6 2
healthy Snacks?
Control group (n = 9) 4 4 1 ns
Do you go out for Shopping to Intervention group (n = 15) 3 5 1
buy healthy promoting goods? Control group (n = 9) 3 4 1
Do you know why Exercise is Intervention group (n = 15) 4 5 1 ns
important? Control group (n = 9) 3 3 0
Intervention group (n = 15) 5 5 1 ns
Do you Exercise regularly?
Control group (n = 9) 4 4 1
Do you know the appropriate Intervention group (n = 15) 4 5 1 ns
Food intake? Control group (n = 9) 3 4 2
Can you achieve the goals you Intervention group (n = 15) 3 5 1 ns
expected? Control group (n = 9) 3 3 0
Self-efficacy
Can you achieve goals even Intervention group (n = 15) 3 3 −1 ns
when you are exhausted? Control group (n = 9) 3 3 0
Healthcare 2023, 11, 1690 10 of 13

Table 6. Cont.

Difference
Before After before and
Items p-Value
after
Perceived Do you feel difficulty in Intervention group (n = 15) 3 3 0 ns
barriers feeling healthy? Control group (n = 9) 3 2 0
Can you control your own Intervention group (n = 15) 4 4 1 ns
diet? Control group (n = 9) 3 4 1
Intervention group (n = 15) 4 5 1 ns
Can you control your lifestyle?
Control group (n = 9) 1 4 1
Intervention group (n = 15) 2 2 0 ns
Frequency of taking snacks
Control group (n = 9) 2 2 0
Times of meals per day (within Intervention group (n = 15) 2 2 0 ns
2 h of bedtime) Control group (n = 9) 2 2 0
Intervention group (n = 15) 2 2 0 ns
Frequency of taking breakfast
Control group (n = 9) 2 2 0
Cue to action
Eating fast as compared to Intervention group (n = 15) 2 2 0 ns
others Control group (n = 9) 2 2 0
Intervention group (n = 15) 2 2 0 ns
Exercise
Control group (n = 9) 1 1 0
Walking faster than others of Intervention group (n = 15) 2 2 0 ns
the same age Control group (n = 9) 1 2 0
Sweaty exercise for at least 30 Intervention group (n = 15) 1 1 0 ns
min at least 2 days a week Control group (n = 9) 1 1 0
Intervention group (n = 15) 1 1 0 ns
Exercise for 1 h per day
Control group (n = 9) 1 1 0
Don’t you have any financial Intervention group (n = 15) 6 3 −1 ns
barrier? Control group (n = 9) 3 3 0
Do you have family support Intervention group (n = 15) 3 5 0 ns
Environment
for health promotion? Control group (n = 9) 1 1 0
Do you have supportive Intervention group (n = 15) 3 5 1 ns
environments for your health Control group (n = 9) 4 5 0
promotion?

4. Discussion
In this pilot study we have examined the feasibility of a lifestyle modification program
and found that there were significant effects on upregulating the plasma level of HDL
cholesterol. Since we do not currently know of an effective medication to increase the
level of HDL cholesterol, although there are a number of effective reagents to LDL choles-
terol [31], our finding should give an interesting view for the treatment and prevention of
hypercholesterolemia and, thus, of atherosclerosis. Further studies are needed to scale up
this intervention program and increase the observation period. Another issue is whether
the efficacy of this program is applicable to major psychiatric disorders. If the efficacy of
this program is proved to be effective in general, it would be a significant development in
the understanding and the treatment of hypercholesterolemia and atherosclerosis.
The HBM is a social model that attempts to assist subjects in perceiving the threat of disease
and the effects of recommended health behaviors, in order to encourage them to improve their
health. Panahi et al. [32] conducted a study of behavior promotion for osteoporosis prevention
based on HBM and found significant improvements in preventive walking behaviors and
knowledge. They attributed this to educational interventions including Q&A and encouraging
messages. Differences from the current study include the fact that the study by Panahi et al. [32]
was conducted with healthy subjects rather than patients, and incorporated the use of e-learning
via the internet. Similarly, both studies included sufficient time for questions and focused on
increasing self-efficacy. It should be noted that through these efforts, knowledge of disease
prevention increased, and the time and frequency of walking exercise increased spontaneously.
In general, increased knowledge directly led to action. Moreover, in this study, there was a
significant improvement in HDL cholesterol levels, which cannot be achieved with ordinary
Healthcare 2023, 11, 1690 11 of 13

dyslipidemia medications. On the other hand, the Nooriani et al. [22] investigated the impact of
HBM-based interventions on the increase in nutritional knowledge regarding dietary intake in
hemodialysis patients, but found no significant improvement in actual dietary intake; the study
by Nooriani et al. included only outpatients, whereas the present study included inpatients.
It is possible that snacking and exercise were easier to manage due to the participation and
monitoring by medical staff involved in lifestyle and hospitalization facilitates during the
nutritional education.

Limitations
Regarding the duration of intervention, this study took place over 4 months. Con-
tinuous support should have given for a longer time in order to encourage active health
behaviors among the participants. However, such continuation might not always be
possible for patients with major psychiatric diseases.
In addition, this study was conducted in a single hospital and had a small number
of subjects. Although we performed this study by randomly assigning the intervention
and the control groups as a pilot study, future studies with a larger study group should
consider thorough random assignment to increase the statistical power.
It is worthwhile to conduct future research focusing not only on physical aspects but
also on quality of life in the long run. In addition, the effectiveness of this program is not
limited to those with mental illness, but may be effective for people in general.

5. Conclusions
This program was based on the health belief model and is considered feasible for
patients with psychiatric disorders, with obesity, and with lifestyle-related diseases. We
would like to stress the observation that the current program was effective in improving
biochemical risks for atherosclerosis to prevent lifestyle-related diseases. Future issues
include extending the period of support, expanding the target population, and structuring
program content, independent of the skills of the dietitian/practitioner. It is hoped that
this study will lead to improvements in health conditions of a wide variety of patients and
even healthy subjects.

Author Contributions: Conceptualization, N.T., M.T., H.T. and T.O.; methodology, N.T., M.T., A.K.
and T.O.; software, N.T.; validation, M.T. and T.O.; formal analysis, N.T.; investigation, N.T., A.K. and
H.T.; resources, N.T., M.T., A.K., N.I. and T.O.; data curation, N.T.; writing—original draft preparation,
N.T.; writing—review and editing, N.T., T.O. and N.I.; visualization, T.O.; supervision, T.O.; project
administration, T.O.; funding acquisition, none. All authors have read and agreed to the published
version of the manuscript.
Funding: This research received no external funding.
Institutional Review Board Statement: This study was conducted after obtaining approval from
the Ethical Review Committee for Human Subjects of Japan Women’s University (approval date:
8 August 2018, No. 337) and the Ethical Review Committee of Yahagigawa Hospital (approval
date: 14 August 2018, No. 2018-005). In addition, the study was registered with the Japan Medical
Association Center for Clinical Trial Promotion [JMACCT] (ID: JMA-IIA00365). All participants have
given consent for participation.
Informed Consent Statement: Informed consent was obtained from all subjects involved in the study.
Data Availability Statement: The data obtained will be available in an anonymized format so that
each individual cannot be identified. Data requests must be made to the author.
Acknowledgments: In conducting this study, we would like to express our deepest gratitude to all
the participants in Yahagigawa Hospital. We also acknowledge the staff of Yahagigawa Hospital,
especially T. Senga, S. Nakanishi, R. Ichie, and T. Nagasaka, for their encouragements and kind advice
throughout this study. This study has not received any public funding.
Conflicts of Interest: The authors declare no conflict of interest.
Healthcare 2023, 11, 1690 12 of 13

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