An observational study in Obesity, Life Style and Lifestyle, Sedentary, sponsored by Duygu Ayhan Baser. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2025-02-04.
Sponsored by Duygu Ayhan Baser · Observational
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.
6,570 studies on the registry are indexed under Obesity; 1,718 are open to participants now.
This study's enrollment of 165 is above the median of 132 across 1,338 observational studies indexed under Obesity.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
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.
Behavioral: intensive lifestyle
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.
Behavioral: intensive lifestyle
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.
INTENSIVE LIFESTYLE INTERVENTIONS
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.
Time frame: 3 months
Secondary
Comparing the anthropometric measurements of the three groups at baseline and week 12.
Time frame: 3 months
BMI (kg/m2)
Comparing the BMI of the three groups at baseline and week 12.
Time frame: 3 months
Waist Circumference (cm)
Comparing the Waist Circumference measurements of the three groups at baseline and week 12.
Time frame: 3 months
Lipid Profile
Lipid profile of the three groups at baseline and week 12.
Time frame: 3 months
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.
| Milestone | Intervention Group | Control-1 Group | Control-2 Group |
|---|---|---|---|
| Started | 55 | 56 | 54 |
| Completed | 51 | 51 | 51 |
| Not completed | 4 | 5 | 3 |
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.
| score on a scale | Intervention Group | Control-1 Group | Control-2 Group |
|---|---|---|---|
| Physical function (baseline) | 68.18 (0 to 93.18) | 68.18 (4.55 to 97.73) | 70.45 (9.09 to 100) |
| Self-esteem (baseline) | 50 (0 to 100) | 57.14 (0 to 96.43) | 50 (0 to 100) |
| Sexual life (baseline) | 75 (0 to 100) | 87.50 (0 to 100) | 81.25 (0 to 100) |
| Public distress (baseline) | 90 (15 to 100) | 85 (10 to 100) | 85 (0 to 100) |
| Work (baseline) | 75 (0 to 100) | 87.50 (0 to 100) | 87.50 (0 to 100) |
| Total Score (baseline) | 63.79 (16.38 to 95.69) | 73.28 (28.45 to 93.97) | 69.83 (18.97 to 99.14) |
| Physical function (3 months) | 79.54 (0 to 100) | 77.27 (22.73 to 100) | 84.09 (0 to 100) |
| Self-esteem (3 months) | 75 (0 to 100) | 82.14 (0 to 100) | 60.71 (3.57 to 100) |
| Sexual life (3 months) | 87.50 (0 to 100) | 93.75 (25 to 100) | 93.75 (0 to 100) |
| Public distress (3 months) | 90 (0 to 100) | 95 (30 to 100) | 90 (0 to 100) |
| Work (3 months) | 87.50 (0 to 100) | 87.50 (12.50 to 100) | 87.50 (0 to 100) |
| Total Score (3 months) | 81.90 (0 to 100) | 82.76 (33.62 to 100) | 81.03 (24.14 to 100) |
Comparing the anthropometric measurements of the three groups at baseline and week 12.
| kg | Intervention Group | Control-1 Group | Control-2 Group |
|---|---|---|---|
| Weight (kg) (Baseline) | 89.50 (66.10 to 125.80) | 84.50 (61.90 to 135) | 85.10 (64.20 to 108.40) |
| Fat mass (kg) (Baseline) | 33.50 (13 to 63.60) | 28.70 (17.20 to 48.80) | 26.80 (11.30 to 51.50) |
| Fat free mass (kg) (Baseline) | 52.80 (43.10 to 83.30) | 50 (41.70 to 89.20) | 53.40 (40.70 to 78.60) |
| Weight (kg) (3 months) | 88 (65.60 to 128.60) | 79.90 (58.80 to 135) | 84 (62.30 to 108.40) |
| Fat mass (kg) (3 months) | 31.10 (13 to 64.20) | 28.80 (11.40 to 47.50) | 25.20 (5 to 51.50) |
| Fat free mass (kg)(3 months) | 51.90 (43.40 to 82) | 48.50 (37.10 to 89.20) | 53.80 (41.90 to 75.30) |
Comparing the BMI of the three groups at baseline and week 12.
| kg/m2 | Intervention Group | Control-1 Group | Control-2 Group |
|---|---|---|---|
| BMI (kg/m2) (Baseline) | 31.50 (25 to 47.30) | 30.50 (25.30 to 43.20) | 29.70 (25 to 42.30) |
| BMI (kg/m2) (3 months) | 30.60 (24.30 to 48.40) | 29.50 (23 to 42.80) | 29.20 (24.80 to 42.30) |
Comparing the Waist Circumference measurements of the three groups at baseline and week 12.
| cm | Intervention Group | Control-1 Group | Control-2 Group |
|---|---|---|---|
| Waist circumference (cm) (Baseline) | 106 (85.50 to 140) | 101.50 (77 to 158) | 101 (86 to 132) |
| Waist circumference (cm) (3 months) | 102 (80 to 141) | 100 (70 to 158) | 100 (80.80 to 132) |
Lipid profile of the three groups at baseline and week 12.
| mg/dL | Intervention Group | Control-1 Group | Control-2 Group |
|---|---|---|---|
| Triglyceride (Baseline) | 105 (35 to 375) | 110 (39 to 231) | 94 (50 to 335) |
| Total cholesterol (Baseline) | 188 (141 to 266) | 193 (131 to 284) | 181 (99 to 315) |
| LDL cholesterol (Baseline) | 121 (68 to 180) | 120 (71 to 181) | 126 (74 to 231) |
| HDL cholesterol (Baseline) | 45 (30 to 84) | 50 (31 to 90) | 46 (28 to 69) |
| Triglyceride (3 months) | 100 (36 to 503) | 98 (45 to 230) | 96 (49 to 657) |
| Total cholesterol (3 months) | 189 (120 to 282) | 189 (111 to 256) | 173 (105 to 324) |
| LDL cholesterol (3 months) | 128 (70 to 193) | 125 (81 to 174) | 129 (88 to 258) |
| HDL cholesterol (3 months) | 50 (33 to 87) | 48 (31 to 88) | 48 (27 to 67) |
Collected over All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention Group | — | — | — |
| Control-1 Group | — | — | — |
| Control-2 Group | — | — | — |
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.
| Age, Categorical(Participants) | Intervention Group | Control-1 Group | Control-2 Group | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 51 | 51 | 51 | 153 |
| >=65 years | 0 | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Intervention Group | Control-1 Group | Control-2 Group | Total |
|---|---|---|---|---|
| Female | 38 | 34 | 35 | 107 |
| Male | 13 | 17 | 16 | 46 |
| Race and Ethnicity Not Collected(Participants) | Intervention Group | Control-1 Group | Control-2 Group | Total |
|---|---|---|---|---|
| Count of participants | — | — | — | 0 |
| Body Mass Index (kg/m2)(Participants) | Intervention Group | Control-1 Group | Control-2 Group | Total |
|---|---|---|---|---|
| Overweight (BMI greater than or equal to 25) | 13 | 23 | 27 | 63 |
| Obese (BMI greater than or equal to 30) | 38 | 28 | 24 | 90 |
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