Intensive Lifestyle Interventions to Overweight and Obese Patients in Primary Care

The Effect of Intensive Lifestyle Intervention Applied to Overweight and Obese Patients in Primary Care During the Pandemic Period: a Randomised Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Life Style; Lifestyle, Sedentary
• Intervention / Treatment: Behavioral: intensive lifestyle

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.

• Study Type: Observational
• Enrollment (Actual): 165

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Hacettepe University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

The study's participants comprised of overweight and obese individuals who made applications to the Department of Family Medicine at XXX University'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.

Description

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'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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Behavioral: intensive lifestyle; INTENSIVE LIFESTYLE INTERVENTIONS
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.	Behavioral: intensive lifestyle; INTENSIVE LIFESTYLE INTERVENTIONS
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Outcome	Turkish version of the Impact of Weight on Quality of Life-Lite Version (IWQOL) scale was used. The scale has a minimum score of 0 and a maximum of 100. The scoring system is valid for both the scale subgroups and the scale total score. Based on the scale scoring, quality-of-life decreases as the score decreases.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary	Comparing the anthropometric measurements of the three groups at baseline and week 12.	3 months
BMI (kg/m2)	Comparing the BMI of the three groups at baseline and week 12.	3 months
Waist Circumference (cm)	Comparing the Waist Circumference measurements of the three groups at baseline and week 12.	3 months
Lipid Profile	Lipid profile of the three groups at baseline and week 12.	3 months

Collaborators and Investigators

• Sponsor: Duygu Ayhan Baser
• Collaborators: Hacettepe University
• Investigators: Study Director: Duygu Ayhan Baser, Assoc. Prof., Hacettepe University; Principal Investigator: Dilara Canbay Ozdemir, M.D., Hacettepe University; Principal Investigator: İzzet Fidanci, Assoc. Prof., Hacettepe University; Principal Investigator: Arzu Demircioglu Karagoz, Hacettepe University; Principal Investigator: Merve Ozdemir, Afyonkarahisar Health Sciences University

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2022
• Primary Completion (Actual): October 1, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: March 4, 2024
• First Submitted That Met QC Criteria: March 14, 2024
• First Posted (Actual): March 20, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 11, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: obesity; primary care; lifestyle changes
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight
• Other Study ID Numbers: HUTF-FM-DABDCO-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No