The Effect of Intensive Lifestyle Intervention Applied to Overweight and Obese Patients in Primary Care During the Pandemic Period: a Randomised Controlled Trial
Conditions: Obesity, Life Style, Lifestyle, Sedentary
Sponsor: Duygu Ayhan Baser

25.01.2022 
The Effect of Intensive Lifestyle Intervention Applied to Overweight and Obese Patients in Primary 
Care During the Pandemic Period: A Randomised Controlled Trial  
NCT06321809 
 
The Effect of Intensive Lifestyle Intervention Applied to Overweight and Obese Patients in Primary 
Care During the Pandemic Period: A Randomised Controlled Trial  
Study Protocol  
Objectives 
During the Covid-19 pandemic, it is recommended that numerous interventions and 
management strategies, such as implementing nutritional changes, promoting physical activity, 
modifying behaviours, administering pharmacological treatment and, if necessary, utilizing surgical 
treatment for overweight or obese individuals, should be conducted by multidisciplinary teams, as in 
non-pandemic periods [1,3,7]. Lifestyle modifications, encompassing a decrease in calorie 
consumption, enhanced physical activity, and behavioural adjustments, assume a pivotal function in 
aiding overweight and obese individuals in managing their condition for the purpose of disease 
prevention, management, and treatment [3,7]. When creating a medical nutrition therapy program, it 
is advised to decrease the total calorie intake by 500 to 1000 kilocalories (kcal) to guarantee a weight 
loss of 0.5-1.0 kg each week [1,3,8]. Personalized interventions to increase physical activity should 
consider individuals' abilities and preferences, including engagement in daily activities such as 
walking and cycling [7,9]. To significantly change the total energy loss and reduce obesity-related risk 
factors, both resistance and aerobic exercise should be performed [1,3]. For the treatment to be 
deemed successful, a weight loss of over 5% needs to be attained following the 3-month treatment 
programme [1,10]. Increasing body mass index (BMI) is also associated with worsening people's 
quality of life; because these people are more likely to experience pain, functional disability, and 
decreased muscle strength [11]. Therefore, one of the aims of creating a management plan ought to 
be to enhance the quality of life. 

25.01.2022 
The Effect of Intensive Lifestyle Intervention Applied to Overweight and Obese Patients in Primary 
Care During the Pandemic Period: A Randomised Controlled Trial  
NCT06321809 
 
The literature review revealed studies on the impact of intensive lifestyle interventions 
among overweight and obese individuals [12,13]. However, no research has yet examined the effect 
of these interventions on such individuals in primary healthcare settings during the pandemic period. 
Upon examining the studies, it was observed that they were mainly assessed in two groups: the 
intervention group and the control group [12,14,15]. In contrast, this study assessed the participants 
in three distinct groups. While interventions in many studies involved physicians and dietitians or 
physicians and physiotherapists, this study incorporated three distinct professionals: a physician, a 
dietitian, and a physiotherapist [12,13,15]. 
In this study, lifestyle interventions applied at different intensities and telephone follow-ups 
applied at different frequencies to overweight and obese individuals applying to primary health care 
during the pandemic period; It is aimed to evaluate the effect on anthropometric measurements, 
lipid profile, weight-related quality of life and to observe the differences between interventions. 
Design 
The study's design is that of a randomized controlled trial, with a single-blind 
method. It is a clinical intervention study that was conducted between 25.01.2022 and 
31.10.2022. 
The study's participants comprised of individuals with overweight and obese who 
made applications between the dates of 25th January 2022 and 31st October 2022 to the 
Department of Family Medicine at XXX University's Faculty of Medicine. After reading and 
signing the informed consent form, participants underwent evaluation based on the study's 
inclusion and exclusion criterias. 

25.01.2022 
The Effect of Intensive Lifestyle Intervention Applied to Overweight and Obese Patients in Primary 
Care During the Pandemic Period: A Randomised Controlled Trial  
NCT06321809 
 
Body mass index (BMI) was computed by the body composition analyser. The 
classification of overweight and obesity followed World Health Organization (WHO) 
definitions [10,11]. 
Intervention group: They were given a calorie-restricted diet and exercise plan by a 
dietician or physiotherapist at their first visit, and were followed up by telephone calls at 
weeks 2, 4, 6, 8 and 10 over 12 weeks. 
Control-1 group: During the initial medical interview, the participants were given a 
calorie-restricted diet programme by a dietician and an exercise programme by a 
physiotherapist; they were followed up over 12 weeks with telephone calls at week 4. 
Control-2 group: The participants were not provided with any programme, and the 
importance of weight loss was emphasised by the family physicians. Dietary and physical 
activity advice was given according to the recommendations in the Turkish Endocrine and 
Metabolism Association's 2019 Obesity Diagnosis and Treatment Guide, and was followed 
up with phone calls at weeks 2, 4, 6, 8 and 10 over a 12-weeks. 
Method 
i. Assessment of Individual Factors: An assessment of participants' features 
associated with the sociodemographic and Covid-19 pandemic was conducted through a 
24-question survey. 
ii. Assessment of Quality of Life: Turkish version of the Impact of Weight on Quality 
of Life-Lite Version (IWQOL) scale was used. Detailed information about the scale is provided 
in the supplementary data. 

25.01.2022 
The Effect of Intensive Lifestyle Intervention Applied to Overweight and Obese Patients in Primary 
Care During the Pandemic Period: A Randomised Controlled Trial  
NCT06321809 
 
iii. Body Composition: Height, waist circumference, and body composition 
measurements (weight, BMI, fat mass, and fat-free mass) were measured for all participants 
by family physicians using the same body composition analyser. 
iv. Lipid profile: Triglyceride, Total Cholesterol, LDL-Cholesterol and HDL-Cholesterol 
levels were measured. 
v. Telemedicine applications: During phone interviews, participants were assessed 
on their adherence to the diet and exercise programme and encouraged to recognise the 
significance of leading a healthy lifestyle and losing weight. During the telephone 
interviews, the family physician discussed the obstacles to improving participants' 
compliance with diet and exercise, and proposed potential solutions. The participants 
received motivational speeches from family physician during the phone calls. At the 12-
week interview, participants were asked to rate their diet and exercise adherence from 1 
(very poor adherence) to 10 (very good adherence). Telemedicine were preferred in order 
to minimise the risk of transmission of Covid-19 infection. 
vi. Diet program: The dietary program for intensive lifestyle intervention was 
individually calculated as energy restriction and administered to both the study and control-
1 group by the dietician during the initial interview. To achieve weight loss through dietary 
intervention, the energy of the diets to be applied to individuals was calculated by reducing 
the daily energy requirement by 30%, or 500-750 kcal, to achieve a weight loss of 
approximately 500 g per week, taking into account individual energy requirements and 
physical activity levels. 
vii. Exercise program: The physiotherapist conducted an individualized exercise 
program for both the intervention group and control-1 group participants during the initial 
interview. During the initial interview, participants underwent a 6-minute walk test (6MWT) 

25.01.2022 
The Effect of Intensive Lifestyle Intervention Applied to Overweight and Obese Patients in Primary 
Care During the Pandemic Period: A Randomised Controlled Trial  
NCT06321809 
 
and an assessment of muscle strength. The test outcomes provide valuable insights on the 
physical condition of the participants. The 6MWT was utilised to gauge aerobic capacity and 
endurance. For hand grip strength, the Jamar Hydraulic Hand Dynamometer (Jamar, 
Sammons Preston, Bolingbrook, Illionis, USA) was used for the Quadriceps Femoris muscle 
group (J-TECH, Medical Commander Powetrack II, USA). Considering the results of the 
applied tests, the exercise program was determined by the physiotherapist to suit the 
individual, with 3 sessions per week and each session lasting 70 minutes for 12 weeks. The 
exercise programme was designed as 5 minutes warm-up, 30 minutes aerobic, 30 minutes 
strengthening and 5 minutes cool-down. Within the aerobic exercise programme, a walking 
regime was established at 65-75% (moderate intensity) of the maximum heart rate (220-
age). For strengthening, exercises were applied to large muscle groups with an elastic 
resistance band. 
Statistical Analysis Plan  
SPSS 20.0 statistical package software will be used to analyse all data (IBM Corp. Released 
2015. IBM SPSS Statistics for Windows, Version 23.0. Armonk, NY: IBM Corp.). Means and standard 
deviations will be used for continuous variables and frequency tables for qualitative data. Chi-square 
test will be used to examine the relationship between qualitative data. Differences between 
continuous variables will be analysed using t-test, ANOVA test or their non-parametric equivalents. 
A=0.05 will be accepted as the level of error.  

25.01.2022 
The Effect of Intensive Lifestyle Intervention Applied to Overweight and Obese Patients in Primary 
Care During the Pandemic Period: A Randomised Controlled Trial  
NCT06321809 
 
References: 
1. Türkiye endokrinoloji ve metabolizma derneği, Obezite tanı ve tedavi klavuzu 2019- Ankara. 
2. T.C. Sağlık Bakanlığı Halk Sağlığı ve Genel Müdürlüğü Sağlıklı Beslenme ve Hareketli Hayat 
Dairesi Başkanlığı. Obezitenin Yol Açtığı Sağlık Problemleri  [cited 2022 September 19]. 
Available 
from: 
https://hsgm.saglik.gov.tr/tr/obezite/obezitenin-yol-actigi-saglik-
problemleri.html. 
3. Tchang BG, Saunders KH, Igel LI. Best Practices in the Management of Overweight and Obesity. 
Med Clin North Am. 2021;105(1):149-74. Epub 2020/11/29. doi: 10.1016/j.mcna.2020.08.018. 
PubMed PMID: 33246516. 
4. Sanchis-Gomar F, Lavie CJ, Mehra MR, Henry BM, Lippi G. Obesity and Outcomes in COVID-19: 
When an Epidemic and Pandemic Collide. Mayo Clin Proc. 2020;95(7):1445-53. Epub 
2020/07/06. doi: 10.1016/j.mayocp.2020.05.006. PubMed PMID: 32622449; PubMed Central 
PMCID: PMCPMC7236707. 
5. Huang Y, Lu Y, Huang Y-M, Wang M, Ling W, Sui Y, et al. Obesity in patients with COVID-19: a 
systematic review and meta-analysis. Metabolism. 2020;113:154378-. Epub 2020/09/28. doi: 
10.1016/j.metabol.2020.154378. PubMed PMID: 33002478. 
6. Mattioli AV, Sciomer S, Cocchi C, Maffei S, Gallina S. Quarantine during COVID-19 outbreak: 
Changes in diet and physical activity increase the risk of cardiovascular disease. Nutr Metab 
Cardiovasc Dis. 2020;30(9):1409-17. Epub 2020/06/24. doi: 10.1016/j.numecd.2020.05.020. 
PubMed PMID: 32571612; PubMed Central PMCID: PMCPMC7260516. 
7. Semlitsch T, Stigler FL, Jeitler K, Horvath K, Siebenhofer A. Management of overweight and 
obesity in primary care-A systematic overview of international evidence-based guidelines. 
Obes Rev. 2019;20(9):1218-30. Epub 2019/07/10. doi: 10.1111/obr.12889. PubMed PMID: 
31286668; PubMed Central PMCID: PMCPMC6852048. 
8. Durrer Schutz D, Busetto L, Dicker D, Farpour-Lambert N, Pryke R, Toplak H, et al. European 
Practical and Patient-Centred Guidelines for Adult Obesity Management in Primary Care. Obes 
Facts. 2019;12(1):40-66. Epub 2019/01/24. doi: 10.1159/000496183. PubMed PMID: 
30673677; PubMed Central PMCID: PMCPMC6465693. 
9. Donini LM, Rosano A, Di Lazzaro L, Lubrano C, Carbonelli M, Pinto A, et al. Impact of Disability, 
Psychological Status, and Comorbidity on Health-Related Quality of Life Perceived by Subjects 
with Obesity. Obes Facts. 2020;13(2):191-200. Epub 2020/03/26. doi: 10.1159/000506079. 
PubMed PMID: 32208387; PubMed Central PMCID: PMCPMC7250341. 

25.01.2022 
The Effect of Intensive Lifestyle Intervention Applied to Overweight and Obese Patients in Primary 
Care During the Pandemic Period: A Randomised Controlled Trial  
NCT06321809 
 
10. World Health Organization. Body mass index - BMI  [cited 2022 May 01]. Available from: 
https://www.euro.who.int/en/health-topics/disease-prevention/nutrition/a-healthy-
lifestyle/body-mass-index-bmi. 
11. World Health Organization. Obesity and Overweight  [cited 2022 May 01]. Available from: 
https://www.who.int/news-room/fact-sheets/detail/obesity-and-overweight 
12. Türkiye endokrinoloji ve metabolizma derneği, Tıbbi beslenme ve egzersiz metabolizması 
kılavuzu 2020- Ankara. 
13. Bouzalmate Hajjaj A, Massó Guijarro P, Khan KS, Bueno-Cavanillas A, Cano-Ibáñez N. A 
systematic review and meta-analysis of weight loss in control group participants of lifestyle 
randomized trials. Scientific Reports. 2022;12(1):12252. doi: 10.1038/s41598-022-15770-x. 
14. Mistik S, Şahin H, Kütük S, Oruç S. Aile Hekimliği’nde Obezite Yönetimi ve Takip Sıklığı. Eurasian 
Journal of Family Medicine. 2017;6(1):18-24. 
15. Pearl RL, Wadden TA, Tronieri JS, Berkowitz RI, Chao AM, Alamuddin N, et al. Short- and Long-
Term Changes in Health-Related Quality of Life with Weight Loss: Results from a Randomized 
Controlled Trial. Obesity (Silver Spring, Md). 2018;26(6):985-91. Epub 2018/04/20. doi: 
10.1002/oby.22187. PubMed PMID: 29676530.