Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06321809
Status:
COMPLETED
Last Update Posted:
2024-03-21
First Post:
2024-03-04
Brief Title:
Intensive Lifestyle Interventions to Overweight and Obese Patients in Primary Care
Sponsor:
Duygu Ayhan Baser
Organization:
Hacettepe University
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None