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| Name | Class |
|---|---|
| Hacettepe University | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intensive lifestyle | Behavioral | INTENSIVE LIFESTYLE INTERVENTIONS |
|
| 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 |
| 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. |
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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:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Duygu Ayhan Baser, Assoc. Prof. | Hacettepe University | Study Director |
| Dilara Canbay Ozdemir, M.D. | Hacettepe University | Principal Investigator |
| Ä°zzet Fidanci, Assoc. Prof. | Hacettepe University | Principal Investigator |
| Arzu Demircioglu Karagoz | Hacettepe University | Principal Investigator |
| Merve Ozdemir | Afyonkarahisar Health Sciences University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hacettepe University | Ankara | Turkey (Türkiye) |
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Sixteen participants were excluded from the study. Six participants were excluded due to having a BMI of less than 25 kg/m2. Two participants were excluded due to pregnancy or breastfeeding, and five participants were excluded due to having a chronic disease.
Three participants were excluded due to their age, being either under 18 years old or over 40 years old.
The study's participants comprised of individuals with overweight and obese who made applications between the dates of 25th January 2022 and 1st October 2022 to the Department of Family Medicine.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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: INTENSIVE LIFESTYLE INTERVENTIONS |
| FG001 | 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: INTENSIVE LIFESTYLE INTERVENTIONS |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
It is identical to the assignment in Participant Flow or information about how participants contribute units.In the single-blind trial, patients were assigned to groups based on the order of admission. Randomization was performed using the blocked randomization technique with six blocks determined.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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: INTENSIVE LIFESTYLE INTERVENTIONS |
| BG001 | Control-1 Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All participants were analysed. | Posted | Median | Full Range | score on a scale | 3 months |
|
All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored.
All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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: INTENSIVE LIFESTYLE INTERVENTIONS |
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Yet, the three-month follow-up might not sufficiently capture lifestyle intervention impacts. Challenges in reaching participants during telephone follow-ups led to exclusions, potentially influencing the study's completeness.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Assoc.Prof. Duygu Ayhan Baser | Hacettepe University | +90-505-664-5210 | dr.duyguayhan@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 25, 2022 | Sep 14, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 25, 2022 | Mar 21, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D057185 | Sedentary Behavior |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| 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 |
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: INTENSIVE LIFESTYLE INTERVENTIONS |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Body Mass Index (kg/m2) | Count of Participants | Participants |
|
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: INTENSIVE LIFESTYLE INTERVENTIONS |
| OG002 | 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. |
|
|
|
| Secondary | Secondary | Comparing the anthropometric measurements of the three groups at baseline and week 12. | All participants were analysed. | Posted | Median | Full Range | kg | 3 months |
|
|
|
|
| Secondary | BMI (kg/m2) | Comparing the BMI of the three groups at baseline and week 12. | All participants were analysed. | Posted | Median | Full Range | kg/m2 | 3 months |
|
|
|
|
| Secondary | Waist Circumference (cm) | Comparing the Waist Circumference measurements of the three groups at baseline and week 12. | All participants were analysed. | Posted | Median | Full Range | cm | 3 months |
|
|
|
|
| Secondary | Lipid Profile | Lipid profile of the three groups at baseline and week 12. | All participants were analysed. | Posted | Median | Full Range | mg/dL | 3 months |
|
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|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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: INTENSIVE LIFESTYLE INTERVENTIONS | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
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| Obese (BMI greater than or equal to 30) |
|
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| Fat free mass (kg) (Baseline) |
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| Weight (kg) (3 months) |
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| Fat mass (kg) (3 months) |
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| Fat free mass (kg)(3 months) |
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| LDL cholesterol (Baseline) |
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| HDL cholesterol (Baseline) |
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| Triglyceride (3 months) |
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| Total cholesterol (3 months) |
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| LDL cholesterol (3 months) |
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| HDL cholesterol (3 months) |
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