Intensive Lifestyle Interventions to Overweight and Obese Patients in Primary Care

NCT ID: NCT06321809

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 165 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-25
• Study Completion Date: 2022-12-01

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.

Conditions

Obesity; Life Style; Lifestyle, Sedentary

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

intensive lifestyle

Intervention Type: BEHAVIORAL

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.

intensive lifestyle

Intervention Type: BEHAVIORAL

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.

No interventions assigned to this group

Interventions

intensive lifestyle

INTENSIVE LIFESTYLE INTERVENTIONS

Intervention Type: BEHAVIORAL

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'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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hacettepe University

OTHER

Sponsor Role: collaborator

Duygu Ayhan Baser

OTHER

Sponsor Role: lead

Responsible Party

Duygu Ayhan Baser

Assoc Prof

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Duygu Ayhan Baser, Assoc. Prof.

Role: STUDY_DIRECTOR

Hacettepe University

Dilara Canbay Ozdemir, M.D.

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

İzzet Fidanci, Assoc. Prof.

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Arzu Demircioglu Karagoz

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Merve Ozdemir

Role: PRINCIPAL_INVESTIGATOR

Afyonkarahisar Health Sciences University

Locations

Hacettepe University

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

HUTF-FM-DABDCO-01

Identifier Type: -

Identifier Source: org_study_id