Motivational Interviewing to Promote Healthy Behaviours for Obesity Prevention in Young Adults: a Pilot Randomized Controlled Trial
Phase: NA
Conditions: Obesity, Risk Factors
Sponsor: McMaster University

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 January 13th, 2022 
Anderson LN, Alvarez E, Incze T, Tarride JE, Kwan M, Mbuagbaw L. Motivational interviewing to promote healthy 
behaviors for obesity prevention in young adults (MOTIVATE): a pilot randomized controlled trial protocol. Pilot 
Feasibility Stud. 2023 Sep 7;9(1):156. doi: 10.1186/s40814-023-01385-0. 
 
Document Date: January 13th, 2022 
 
Motivational interviewing to promote healthy behaviours for obesity prevention in young adults (MOTIVATE): 
a pilot randomized controlled trial protocol  
Laura N. Anderson1,2,3, Elizabeth Alvarez1,3, Taylor Incze1, Jean-Eric Tarride1,3,4, Matthew Kwan5,6 and Lawrence 
Mbuagbaw1,7-11 
1Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, 
Canada  
2Child Health Evaluative Sciences, Hospital for Sick Children Research Institute, Toronto, Ontario, Canada 
3Center for Health Economics and Policy Analysis (CHEPA), McMaster University, Hamilton, Ontario, Canada 
4Programs for Assessment of Technology in Health (PATH), The Research Institute of St. Joe’s Hamilton, St. 
Joseph’s Healthcare Hamilton 
5Department of Child and Youth Studies, Brock University, St. Catharines, Ontario, Canada 
6Department of Family Medicine, McMaster University, Hamilton, Ontario, Canada 
7Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada 
8Biostatistics Unit, Father Sean O'Sullivan Research Centre, St Joseph's Healthcare, Hamilton, Ontario, Canada 
9Centre for Development of Best Practices in Health (CDBPH), Yaoundé Central Hospital, Yaoundé, Cameroon 
10Division of Epidemiology and Biostatistics, Department of Global Health, Stellenbosch University, Cape Town, 
South Africa 

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11Department of Anaesthesia, McMaster University, Hamilton, Ontario, Canada 
Corresponding Author and Contact for Scientific and Public Queries: Laura N. Anderson, Health Research 
Methods Evidence and Impact, McMaster University, 1280 Main Street W, Hamilton, Ontario, L8S 4L8. Phone: 
(905) 525-9140, Email: ln.anderson@mcmaster.ca         https://orcid.org/0000-0002-6106-5073  
This study has undergone external peer-review and was funded by a joint Canadian Cancer Society/Canadian 
Institutes of Health Research grant. 
 

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ABSTRACT  
Background: Obesity is a chronic disease and is an established risk factor for other chronic diseases and 
mortality. Young adulthood is a period when people may be highly amenable to healthy behaviour change, 
develop lifelong healthy behaviours, and when primary prevention of obesity may be most feasible. 
Interventions in early adulthood have the potential for primary or primordial prevention (i.e., preventing risk 
factors before disease onset). The primary objective of this study is to determine the feasibility of a 6-month 
behavioural and educational intervention to promote healthy behaviours for obesity prevention among young 
adults. 
Methods: This is the study protocol for a pilot randomized controlled trial. Young adults (age 18-29) attending 
McMaster University, Hamilton, Canada, will be recruited and randomized to either the intervention or control. 
The intervention will include individual motivational interviewing sessions (online or in-person) with a trained 
interviewer plus educational materials (based on Canada’s food guide and physical activity recommendations). 
The control group will receive educational materials only. The primary feasibility outcomes that will be 
evaluated as part of this pilot study include enrollment, retention (≥80%), data completion (≥80% of weights 
measured, and surveys completed), and participant satisfaction. Secondary clinical outcomes will include body 
mass index (BMI) change from baseline to 6-months, physical activity, nutrition risk, health-related quality of life 
mental health and economic outcomes. Outcomes will be measured remotely using ‘smart’ electronic scales, 
activity trackers, and online questionnaires at baseline and every 2 months. Risk stratification will be applied at 
baseline to identify participants at high risk of obesity (e.g., due to family or personal history). Exit 
questionnaires will collect data on how participants felt about the study and cost analysis will be conducted.  
Discussion: Our pilot randomized controlled trial will evaluate the feasibility of an obesity prevention 
intervention in early adulthood and will inform future larger studies for obesity prevention. The results of this 

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study have the potential to directly contribute to the primary prevention of several types of cancer by testing an 
intervention that could be scalable to public health, post-secondary education, or primary care settings.  
Trial Registration: ClinicalTrials.gov Identifier: NCT05264740. Registered March 3, 2022, 
https://clinicaltrials.gov/ct2/show/NCT05264740 
 
Keywords: Obesity; prevention; young adults; health behaviours; intervention; motivational interviewing 
 
 

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BACKGROUND 
Obesity is a chronic disease, and it is also a risk factor for other chronic diseases. In Canada, the 
prevalence of obesity among adults was 28% in 2018.(1,2) It has been estimated that the direct costs of 
overweight and obesity in Canada were $6 billion annually in 2006.(3) By 2025 approximately 20% of adults 
worldwide will have obesity.(4) Obesity is defined as a body mass index (BMI) >30 with classes of obesity 
severity defined as Class 1 (30-34), Class 2 (35-39) and Class 3 (≥40).(5) Although there are limitations in the use 
of BMI cut points to define obesity, BMI is strongly correlated with body fat and remains the most practical 
measure for population-based studies.(6,7) Obesity severity is important, with more severe obesity conferring a 
substantially greater risk of cancer, other chronic conditions, and poor mental health.(8–10) Obesity is a 
complex disease with a broad range of socio-ecological risk factors. Obesity treatment is challenging, and 
primary and secondary prevention interventions are urgently needed to reduce the incidence of obesity and 
decrease or maintain obesity severity.(11) 
The COVID-19 pandemic had a profound impact on activities of daily life, and many causes of weight 
gain, including chronic stress and physical inactivity, increased during the pandemic. Early indications suggest 
that 20-48% of people reported weight gain during the pandemic.(12–19) Some reasons include changes in food 
intake (increased food insecurity, and consumption of “comfort” foods), decreased physical activity, increased 
sedentary time, and increased alcohol. There is some evidence of sex differences (greater weight gain in 
women) and increased weight gain among people with higher BMI pre-pandemic.(12,13) One small U.S. study 
found that pandemic shelter-in-place orders were associated with an average weight gain of 1.5 lbs per 
month.(20) It is established that obesity can develop slowly over time or as a result of a rapid weight gain.(11) 
Thus, it is important to investigate interventions that may contribute to modifying health behaviours for obesity 
prevention. 

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Young adulthood is a period when people may be highly amenable to healthy behaviour change, 
develop lifelong healthy behaviours, and when the primary or secondary prevention of obesity may be feasible. 
Interventions in young adults have the potential for primary cancer prevention (i.e., stopping cancer risk factors 
before they develop). Young adulthood is a time when weight gain may occur rapidly(21) and developing 
healthy behaviours is critical to maintaining a healthy weight throughout adulthood. On average, Canadian 
adults gain 0.5 to 1 kg every two years and this is greater among young adults and those with higher BMI.(22) 
Systematic reviews suggest that students attending post-secondary education may experience greater weight 
gain.(23,24)  
Narrowly defined lifestyle interventions for obesity prevention, such as those addressing only physical 
activity, have had limited success.(25) The 2020 Obesity Clinical Practice Guidelines recommend moving “beyond 
simplistic approaches of “eat less, move more,” and address the root drivers of obesity”.(11) Yet, there have 
been relatively few attempts to implement tailored, population-based obesity prevention interventions in young 
adults. Obesity interventions must be flexible to address the complex causes of obesity and motivational 
interviewing may be a successful strategy.(25) Motivational interviewing (MI) is defined as “a collaborative 
conversation style for strengthening a person’s own motivation and commitment to change”.(26) Health care 
professionals have successfully used motivational interviewing for patients to set personalized goals for 
successful healthy life changes.(27) Motivational interviewing has shown some success for weight loss 
interventions in young adults,(25) but it has not been widely implemented for obesity prevention. It is unknown 
whether obesity prevention interventions are more successful among people at highest risk. Several obesity risk 
stratification tools have been developed and validated that identify young adults who are at greatest risk of 
obesity later in adulthood.(28–30) The use of these risk prediction tools to identify young adults who may 
benefit the most from an obesity prevention intervention may improve success and support broader population-
level, precision public health or clinical interventions.   
The primary study objective is: 

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1) To determine the feasibility (enrollment, retention, data completion, satisfaction) of a 6-month behavioural 
and educational intervention to promote healthy behaviours for obesity prevention among young adults.  
The secondary objectives are: 
 2) To determine the effects of the 6-month behavioural and educational intervention, compared to an 
educational intervention only, on change in BMI, health behaviours (nutrition, physical activity and sedentary 
time), health-related quality of life, and mental health (depression and anxiety). 
 3) To explore whether obesity risk stratification tools identify young adults who may be more successful in an 
obesity intervention. 
METHODS  
Study Design and Population  
We will conduct a pilot randomized controlled trial (RCT). The protocol is reported following the SPIRIT 
guidelines for RCT pilot studies,(31) the Template for Intervention Description and Replication (TIDieR) checklist 
and guideline,(32) and has been pre-registered (ClinicalTrials.gov Identifier: NCT05264740). Study participants 
will be young adults (age 18-29) who are students at McMaster University, Hamilton, Ontario, Canada. 
Recruitment posters will be posted in common areas on campus, shared on social media, and through email 
lists. The study website is available at: https://motivate.healthsci.mcmaster.ca/ 
 
The study inclusion criteria are:  
• 
English speaking, and capable of providing informed consent.  
• 
McMaster University students 18-29 years of age.  
• 
BMI of at least 18.5 (BMI< 18.5 is considered underweight and will be excluded).   
• 
Access to wireless internet (WiFi) at home.  

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Exclusion criteria are:  
• 
Physical and mental health conditions that would be contraindications for a weight management 
intervention, including eating disorders, pregnancy, cancer, or medications that affect body weight.   
Randomization 
Participants will be randomized to intervention and control arms in a 1:1 allocation ratio using a computer-
generated randomization list that will be generated centrally by the Biostatistics Unit at St Joseph's Healthcare 
Hamilton. Randomization will be stratified by sex and BMI (BMI<25 vs BMI≥25) to achieve some prognostic 
balance. We will use permuted blocks of random sizes to ensure equal numbers in each group. The block sizes 
and allocation will be concealed from the participants and trial staff, and the randomization codes will only be 
revealed after the participants have been recruited and baseline data has been collected. This is an open-label 
trial. Trial staff and participants will not be blinded to the intervention, but data analysts will be blinded. 
Consent and Ethics  
Ethics approval was obtained from the Hamilton Integrated Research Ethics Board on July 25, 2022 
(HiREB Project Number: 14675). Informed consent will be obtained from all participants at the first in-person 
visit. Participants may choose to withdraw from the study at any time and when possible, we will capture the 
reasons for withdrawal. Consideration has been given to issues of equity (advertisement and recruitment 
materials, research staff and investigators) and among this population of students, we do not anticipate that the 
English-language requirement will be a barrier. 
Timing of Visits, Intervention and Control Groups 
An overview of the study design is provided in Figure 1. The first visit will occur in-person with a 
research assistant to obtain consent, collect baseline measures, provide participants with the study 
materials/equipment, and build a relationship with the study participants. For all subsequent visits, participants 
will have the option of in-person or virtual sessions.  

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The intervention will include motivational interviewing sessions with a trained research 
assistant/interviewer plus educational material. The motivational interviewing sessions will occur at baseline 
and once a month (7 visits in total). For this feasibility study, a priori criteria for the discontinuation or 
modification of the allocated intervention are not available. 
The research assistant will receive training in motivational interviewing. Intervention fidelity (adherence 
to the principles of MI) will be assessed using recorded training interviews and established rating scales with 
continuing training as needed.(33) For training purposes, mock interviews conducted between members of the 
research team will be recorded and evaluated. Interviews with study participants will not be recorded.  
The control group will receive educational material only. The same educational material will be provided 
to both the intervention and control group and will consist of evidence-based recommendations based on 
Canada’s food guide(34) and Canadian 24-hour movement guidelines.(35) The SPIRIT schedule of enrolment, 
interventions, and assessments for this study is provided in Figure 2. 
Measurement of Outcomes  
Table 1 describes all outcomes. The primary feasibility outcomes that will be measured are recruitment, 
retention, data completion, and participant satisfaction. We will consider a larger trial feasible if recruitment 
rates are ≥ 50%, retention rates are ≥ 80%, and the data completion rate for all secondary clinical outcomes is ≥ 
80%. Participant satisfaction with different aspects of the study will be measured at the exit questionnaire using 
a Likert scale and semi-structured qualitative free-text responses.  
Secondary outcomes will include BMI change from baseline to 6-months. Interventions are more 
successful if longer than 4 months in duration.(36) All study participants will have one in-person visit with the 
research assistant at the start of the study where baseline weight and height will be measured using 
standardized methods with calibrated study instruments. Participants (both intervention and control) will then 
receive a Fitbit activity tracker to wear for the duration of the study. Study participants will be asked to visit the 

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study office once a month to conduct a self weigh-in using a Fitbit electronic ‘smart’ scale (e-scale). They will be 
asked to weigh themselves monthly and reminders will be sent by email or text message. E-scales are feasible 
and valid for research conducted remotely and participant adherence to home weigh-ins is high(37–39), as part 
of this feasibility study we will assess the adherence to self weigh-ins when the scale is located in a private study 
office.  Other secondary outcomes will include nutrition risk, physical activity (measured as 24-hour movement, 
including sedentary time and sleep), and mental health collected using online questionnaires at baseline and 
every 2 months. Nutrition risk will be measured using the National Cancer Institute's Dietary Screener 
Questionnaire (DSQ). The DSQ measures the frequency of intake of selected foods that are known to affect risk 
of cancer and obesity, including fruits, vegetables, whole grains, and sugary drinks. The DSQ has good validity 
compared to 24-hour recalls.(40) Self-reported physical activity, sedentary time, recreational screen time and 
sleep will be measured to describe adherence to recommended 24-hour movement guidelines using 
questionnaires previously used in young adults(41), including the International Physical Activity Questionnaire 
(IPAQ)(42), and International Sedentary Assessment Tool (ISAT).(43) The Insomnia Severity Index will also be 
included as a measure of perceived sleep quality.(44)  Mental health is an important upstream determinant of 
health behaviours and is highly associated with obesity risk. We will measure depressive symptoms, anxiety and 
health-related quality of Life using the following validated tools: Centre for Epidemiologic Studies Depression 
Measure -10 (CESD-10)(45), Generalized Anxiety Disorder -7 (GAD-7)(46), and Euroqol-5D-5L (EQ-5D-5L).(47) We 
anticipate that some youth may also raise issues related to alcohol or substance use in the interviews, thus we 
have included questions that ask about alcohol, smoking, cannabis and medication use in the questionnaires. A 
single-item measure of body satisfaction is included in the study to evaluate any changes over the course of the 
study.(48) A validated two-item food insecurity screen is also included.(49)  
For objective 3, we will evaluate whether feasibility and other secondary outcomes differed for 
participants who were identified as high versus low risk using existing obesity risk stratification tools. Three 
validated risk stratification tools will be applied to the data to explore these differences.(28–30) The Edmonton 

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Obesity Staging System will also be used.(50) The required variables for each of the risk tools will be collected 
from the baseline questionnaire (e.g., parent obesity, history of child obesity, alcohol, smoking, medical history). 
Feasibility data to inform costing and economic analyses for a larger scale trial will be collected. In addition to 
the EQ-5D-5L,  self-reported healthcare use, and time missed from school/work will be collected on the surveys. 
For this pilot study a descriptive cost analysis will be conducted. 
Data collection and management  
All data will be stored in a secure REDCap database.  Surveys will be collected online using secure 
electronic data capture in REDcap. The final trial dataset will only be available to select members of the research 
team (LA, LM, TI). The final dataset will not be made publicly available to protect the confidentiality of 
participants, but de-identified data could be made available upon request. Baseline surveys will collect detailed 
data on socioeconomic variables, including age, sex, gender identity, income, and food security, medical history, 
and the secondary outcomes described above (nutrition, physical activity, sedentary time, mental health). 
Follow-up surveys administered every 2 months (at 2, 4 and 6 months) will collect updated data on secondary 
outcomes. Participants in both the control and intervention groups will receive a $30 gift card at the time of 
each survey completion. We will continue to collect data from participants if they deviate from protocol unless 
there is withdrawal from the study.  To ensure confidentiality, a unique study id number will be used for the 
weight and activity data and linked at McMaster by the research team to the main study database.  
Safety protocols and unanticipated outcomes 
  
Possible adverse outcomes may include concerns related to mental health, including eating disorders, or 
frustration due to weight gain/no change. Expectations of the research will be laid out before enrollment and 
feelings such as these can be addressed as part of the motivational interviewing process. Our research team 
including the research assistants/interviewers and physician co-investigator (EA) are equipped to assess the 
situation and provide necessary referrals. Medical and counselling services are available on campus for all 

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students. If participants raise any concerns of self-harm or harm to others, then safety protocols will be 
followed. 
Data Analysis  
The analysis and reporting of our results will be done according to the CONSORT guidelines.(51) The 
data analyst will be blinded. Patient screening, randomization, allocation, and follow-up numbers will be 
illustrated in a flow diagram. Baseline data will be reported in a table for both groups (Intervention and Control) 
and summarised as means (standard deviation) or median (first quartile, third quartile) for continuous variables 
and counts (percent) for categorical variables. Data on feasibility outcomes will be measured and compared to 
pre-determined thresholds for interpretation. The primary analysis will be by intention-to-treat (data from 
participants will be analyzed according to their allocation irrespective of whether they received that 
intervention). For these purposes, a complete data set is required. Multiple imputation techniques will be used 
to manage missing data points. Comparison of groups for secondary outcomes will be reported descriptively for 
this pilot study. No formal significance testing for comparisons of the secondary clinical outcomes will be made 
because this is a pilot study with a priori sample size determined based on feasibility outcomes only.  It is well 
established that there are sex and gender differences in obesity.(52) Disaggregated data on sex and gender will 
be reported. 
Sample size  
Our sample size estimation was based on feasibility considerations and calculated using WINPEPI.(53) 
Using a 95% confidence level, assuming that 80% of the participants will complete the study with a 7.5% margin 
of error, 110 participants are needed (55 intervention and 55 control). This sample size is not sufficiently 
powered to make between-group comparisons but will provide accurate data on feasibility and estimates of 
effect size variability that will inform the sample size calculation of a larger definitive trial.  
Reporting and interpretation  

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Study results will be reported following the CONSORT extension for randomized pilot and feasibility 
trials guideline(54) For each feasibility outcome, we will report whether the feasibility threshold was met and 
use a traffic light system to inform progression to a larger trial. Green: proceed to larger trial; yellow: proceed 
with some modifications; red: larger trial not feasible. At least one feasibility outcome must be green. Any 
deviations to the protocol will be recorded and reported in the final manuscript. Study results will be shared 
with participants through a final report and published in a peer-reviewed manuscript.  
CONCLUSIONS 
Although it is well recognized that the causes of obesity are complex, many obesity trials have evaluated 
a narrowly defined “one size fits all” intervention. We will evaluate the feasibility of a tailored intervention 
delivered through motivational interviewing sessions with a trained research assistant interviewer. This 
approach will allow participants to set their own behavioural change goals. Further, we are evaluating the 
feasibility of a targeted or risk stratification approach to an obesity intervention to determine if higher-risk 
young adults benefit more from the intervention.    
This intervention is designed to be flexible to focus on a broad range of health behaviours so study 
participants can set behavioural change goals related to the behaviours that they think are most important to 
them. While for some participants, this may focus on traditional, obesity-related risk factors such as diet or 
physical activity, for other participants this may include behaviours related to sleep, mental health, substance 
use, or time management. All these behaviours have the potential to either directly or indirectly impact obesity 
prevention.  
Our feasibility trial will inform future larger RCTs for obesity prevention. The results of this study have 
the potential to directly contribute to the primary prevention of several types of cancer by testing an 
intervention that could be scalable to public health, post-secondary education, or primary care settings. This 
study is pragmatic with the option of remote visits for MI. Unlike traditional MI, this format with a trained 

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interviewer is feasible and the results of the risk stratification objective may inform who would benefit the most 
from a larger-scale program. This pilot study will provide proof of concept for an intervention that could be 
expanded to other settings such as public health, post-secondary education, or primary care. If successful, this 
program could be implemented in university wellness services and may have a profound impact on the primary 
prevention of an established and highly prevalent chronic disease risk factor. 
 
List of Abbreviations 
BMI 
 
Body Mass Index 
CESD-10 
Centre for Epidemiologic Studies Depression Measure-10 
DSQ  
 
Dietary Screener Questionnaire  
EQ-5D-5L 
Euroqol -5D 
GAD-7  
Generalized Anxiety Disorder -7 
HiREB  
Hamilton Integrated Research Ethics Board 
IPAQ 
 
International Physical Activity Questionnaire 
ISAT 
 
International Sedentary Assessment Tool 
MI 
 
Motivational Interviewing 
RCT 
 
Randomized Controlled Trial 
 
 
DECLARATIONS 

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Ethics approval and consent to participate: Study participants will provide written consent and this study has 
been approved by the Hamilton Integrated Research Ethics Board (HiREB Project Number: 14675). 
Consent for publication: Not applicable. 
Availability of data and materials: Not applicable. 
Competing interests: The authors declare that they have no competing interests. 
Funding:  This research is funded by a Proof of Concept Intervention Grant in Primary Prevention of Cancer 
(Action Grant) of the Canadian Cancer Society and the Canadian Institutes of Health Research-Institute for 
Cancer Research (CCS grant #707228/CIHR-ICR grant # POC-181032). 
Authors' contributions: All authors contributed to the development of the study design and contributed to 
writing the manuscript. All authors read and approved the final manuscript. 
 
 
 
 
 
 

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Figure 1.  Overview of the Study Design 
 
 
 
 

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Figure 2. SPIRIT schedule of enrolment, interventions, and assessments. 
 
 
 
 
STUDY PERIOD 
 
Enrolment 
Allocation 
Post-allocation 
Close-out 
TIMEPOINT 
-t1 
0 
Baseli-
ne 
Month 
1 
Month 
2 
Month 
3 
Month 
4 
Month 
5 
Month 6 
ENROLMENT: 
 
 
 
 
 
 
 
 
 
Eligibility screening 
X 
 
 
 
 
 
 
 
 
Informed consent  
X 
 
 
 
 
 
 
 
 
Measurement of 
BMI and Sex 
 
 
X 
 
 
 
 
 
 
Allocation 
 
X 
 
 
 
 
 
 
 
INTERVENTIONS: 
 
 
 
 
 
 
 
 
 
Intervention Group: 
Motivational 
Interviewing 
sessions + 
educational 
materials 
 
 
 
 
 
 
 
 
 
 
 

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Table 1. Summary of all outcome measures and method of analysis 
Outcome measure 
Variable Type 
Measurement 
Method of analysis 
Primary Feasibility Outcomes 
     Recruitment rate 
Binary 
% of eligible participants who are 
recruited from all those who contact 
the research team to learn about the 
study 
Feasibility threshold of 
≥50% 
Control Group: 
Educational 
materials 
 
 
 
 
 
 
 
 
 
 
ASSESSMENTS: 
Height 
Measurement 
 
 
 
X 
 
 
 
 
 
 
Weight 
measurement 
 
 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
Study 
questionnaires 
 
 
 
X 
 
 
X 
 
 
X 
 
 
X 

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     Retention rate 
Binary 
% of participants who complete 6-
month follow-up 
Feasibility threshold of 
≥80%.  
     Data completion 
Binary 
% of secondary outcomes with no 
missing data 
Feasibility threshold of 
≥80%.  
     Satisfaction 
Continuous 
Mean score on a 7-point Likert scale 
Mean satisfaction score 
≥4 
Secondary Outcomes 
     BMI change 
Continuous 
Change in BMI from baseline to 6-
month follow-up, weight measures 
using wifi enabled smart scales 
Mean, SD 
     Physical activity 
Binary 
 International Physical Activity 
Questionnaire (IPAQ) 
Mean, SD 
 
Continuous 
Minutes per day from activity trackers 
Mean, SD 
     Sedentary time 
Binary 
International Sedentary Assessment 
Tool (ISAT) 
Mean, SD 
     Nutrition 
Continuous 
National Cancer Institute's Dietary 
Screener Questionnaire (DSQ) 
Mean, SD 
     Mental health  
Binary 
Depressive symptoms (CESD-10) score 
>10, Anxiety (GAD-7) score >10,  
N, % 
     Health-related quality    
    of life 
Continuous 
Quality of Life (EQ-5D-5L) 
Median, IQR 
 
 
 

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