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Completed

NCT Number: NCT06321809

Intensive Lifestyle Interventions to Overweight and Obese Patients in Primary Care

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.

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Key information

Conditions

Obesity Behavior Body Weight Life Style Lifestyle, Sedentary Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Sedentary Behavior Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hacettepe University

Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intensive lifestyle

Behavioral

INTENSIVE LIFESTYLE INTERVENTIONS

Primary outcomes

  1. Primary Outcome

    Time frame: 3 months

    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.

Secondary outcomes

  1. Secondary

    Time frame: 3 months

    Comparing the anthropometric measurements of the three groups at baseline and week 12.

  2. BMI (kg/m2)

    Time frame: 3 months

    Comparing the BMI of the three groups at baseline and week 12.

  3. Waist Circumference (cm)

    Time frame: 3 months

    Comparing the Waist Circumference measurements of the three groups at baseline and week 12.

  4. Lipid Profile

    Time frame: 3 months

    Lipid profile of the three groups at baseline and week 12.

Sponsors and collaborators

Lead sponsor

Duygu Ayhan Baser

Other

Collaborators

  • Hacettepe University

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 20, 2024
Registry last updated
Feb 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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