Intensive Lifestyle Interventions to Overweight and Obese Patients in Primary Care

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06321809
• Other study ID #: HUTF-FM-DABDCO-01
• Status: Completed
• Start date: January 25, 2022
• Est. completion date: December 1, 2022

Study information

• Verified date: March 2024
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: December 1, 2022
• Est. primary completion date: October 1, 2022
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Life Style
• Lifestyle, Sedentary
• Obesity
• Overweight

Intervention

Behavioral:
• intensive lifestyle
INTENSIVE LIFESTYLE INTERVENTIONS

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara

Sponsors (2)

Lead Sponsor	Collaborator
Duygu Ayhan Baser	Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	primary outcome	The research does not involve a treatment study, but rather diagnostic methods. The aim of the lifestyle intervention is to improve quality of life and reduce body composition and lipid profiles.; The sample size calculation determined a standard effect size of 0.57 with a margin of error of 5%, an 80% power, and plans to include 49 cases in each group. Considering situations such as loss of follow-up, it was planned to reach 159 people.; An assessment of participants' features associated with the sociodemographic and Covid-19 pandemic was conducted through a 24-question survey. Turkish version of the Impact of Weight on Quality of Life-Lite Version (IWQOL) scale was used. Height, waist circumference and body composition measurements (weight, BMI, fat mass and fat-free mass) were measured using a body composition analyser.	3 months