Clinical trial NCT06321809: Intensive Lifestyle Interventions to Overweight and Obese Patients in Primary Care
Official title: The Effect of Intensive Lifestyle Intervention Applied to Overweight and Obese Patients in Primary Care During the Pandemic Period: a Randomised Controlled Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Life Style
Lifestyle, Sedentary
Keywords: primary care
obesity
lifestyle changes
Lead sponsor: Hacettepe University
Sponsor class: OTHER
Collaborators: name: Hacettepe University
First posted: 2024-03-20
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study\&#39;s participants comprised of overweight and obese individuals who made applications to the Department of Family Medicine at XXX University\&#39;s Faculty of Medicine. Detailed information regarding the study was provided to overweight and obese individuals who applied between the dates of 25th January 2022 and 31st October 2022 and consented to participate in said study.

Brief summary: The goal of this clinical trial is to compare in the effect of different lifestyle interventions in overweight and obese participants. The main questions it aims to answer are:

* effect on anthropometric measurements
* effect on lipid profile
* effect on weight-related quality of life
* observe the differences between interventions The study participants were stratified into three groups: intervention, control-1, and control-2.
* 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 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.

Detailed description: With this study, it is aimed to evaluate the effect of intensive lifestyle intervention to be applied to patients and follow-ups made by telephone calls in order to protect overweight and obese patients who apply to primary health care services from obesity and complications of obesity in the pandemic process in which the number of applications to secondary and tertiary care decreased due to pandemic conditions and the number of applications to primary care increased, in addition to this, the susceptibility to obesity increased due to changing lifestyle behaviours with the effect of the pandemic; The aim of this study is to evaluate the effect of intensive lifestyle intervention and telephone follow-ups on body mass index, body composition, lipid profile, obesity-related quality of life and to evaluate different forms of intervention organised as intensive lifestyle intervention and increasing the frequency of follow-up.

Eligibility criteria: Inclusion Criteria:

Age 18-40 BMI ≥ 25 kg/m 2 Agreeing to participate in the study Not having a diagnosed chronic disease To be able to ambulate To be cooperative

Exclusion Criteria:

* Receiving medical treatment
* Secondary obesity (hypothyroidism, Cushing\&#39;s disease, etc.)
* Chronic disease (cardiovascular diseases, pulmonary diseases, presence of diabetes mellitus, liver diseases, renal diseases)
* Having hyperlipidaemia under treatment
* Cancer
* Pregnancy or breastfeeding
* Psychiatric disorder
* Orthopaedic or neurological disease that may prevent walking
* Are currently taking weight loss medication or enrolled in another weight loss program
* Having previously undergone obesity surgery or having surgery planned during the study period

Primary outcomes:
measure: Primary Outcome
timeFrame: 3 months
Secondary outcomes:
measure: Secondary
timeFrame: 3 months
measure: BMI (kg/m2)
timeFrame: 3 months
measure: Waist Circumference (cm)
timeFrame: 3 months
measure: Lipid Profile
timeFrame: 3 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe University
name: Duygu Ayhan Baser, Assoc. Prof.
role: STUDY_DIRECTOR
affiliation: Hacettepe University
name: Dilara Canbay Ozdemir, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: İzzet Fidanci, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Arzu Demircioglu Karagoz
role: PRINCIPAL_INVESTIGATOR
affiliation: Afyonkarahisar Health Sciences University
name: Merve Ozdemir
role: PRINCIPAL_INVESTIGATOR
References: