Obesity, Life Style, Lifestyle, Sedentary
Conditions
Keywords
primary care, obesity, lifestyle changes
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.
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.
Interventions
BEHAVIORALintensive lifestyle
INTENSIVE LIFESTYLE INTERVENTIONS
Sponsors
Hacettepe University
Duygu Ayhan Baser
Study design
Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Outcome | 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
| Measure | Time frame | Description |
|---|---|---|
| Secondary | 3 months | Comparing the anthropometric measurements of the three groups at baseline and week 12. |
| BMI (kg/m2) | 3 months | Comparing the BMI of the three groups at baseline and week 12. |
| Waist Circumference (cm) | 3 months | Comparing the Waist Circumference measurements of the three groups at baseline and week 12. |
| Lipid Profile | 3 months | Lipid profile of the three groups at baseline and week 12. |
Countries
Turkey (Türkiye)
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 51 |
| 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 | 51 |
| 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. | 51 |
| Total | 153 |
Baseline characteristics
| Characteristic | Intervention Group | Control-1 Group | Control-2 Group | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 51 Participants | 51 Participants | 51 Participants | 153 Participants |
| Body Mass Index (kg/m2) Obese (BMI greater than or equal to 30) | 38 Participants | 28 Participants | 24 Participants | 90 Participants |
| Body Mass Index (kg/m2) Overweight (BMI greater than or equal to 25) | 13 Participants | 23 Participants | 27 Participants | 63 Participants |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Sex: Female, Male Female | 38 Participants | 34 Participants | 35 Participants | 107 Participants |
| Sex: Female, Male Male | 13 Participants | 17 Participants | 16 Participants | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: 3 months
Population: All participants were analysed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention Group | Primary Outcome | Self-esteem (baseline) | 50 score on a scale |
| Intervention Group | Primary Outcome | Sexual life (3 months) | 87.50 score on a scale |
| Intervention Group | Primary Outcome | Total Score (baseline) | 63.79 score on a scale |
| Intervention Group | Primary Outcome | Work (3 months) | 87.50 score on a scale |
| Intervention Group | Primary Outcome | Self-esteem (3 months) | 75 score on a scale |
| Intervention Group | Primary Outcome | Physical function (3 months) | 79.54 score on a scale |
| Intervention Group | Primary Outcome | Total Score (3 months) | 81.90 score on a scale |
| Intervention Group | Primary Outcome | Physical function (baseline) | 68.18 score on a scale |
| Intervention Group | Primary Outcome | Public distress (baseline) | 90 score on a scale |
| Intervention Group | Primary Outcome | Sexual life (baseline) | 75 score on a scale |
| Intervention Group | Primary Outcome | Public distress (3 months) | 90 score on a scale |
| Intervention Group | Primary Outcome | Work (baseline) | 75 score on a scale |
| Control-1 Group | Primary Outcome | Physical function (3 months) | 77.27 score on a scale |
| Control-1 Group | Primary Outcome | Total Score (3 months) | 82.76 score on a scale |
| Control-1 Group | Primary Outcome | Sexual life (baseline) | 87.50 score on a scale |
| Control-1 Group | Primary Outcome | Public distress (baseline) | 85 score on a scale |
| Control-1 Group | Primary Outcome | Work (baseline) | 87.50 score on a scale |
| Control-1 Group | Primary Outcome | Total Score (baseline) | 73.28 score on a scale |
| Control-1 Group | Primary Outcome | Work (3 months) | 87.50 score on a scale |
| Control-1 Group | Primary Outcome | Self-esteem (3 months) | 82.14 score on a scale |
| Control-1 Group | Primary Outcome | Sexual life (3 months) | 93.75 score on a scale |
| Control-1 Group | Primary Outcome | Public distress (3 months) | 95 score on a scale |
| Control-1 Group | Primary Outcome | Physical function (baseline) | 68.18 score on a scale |
| Control-1 Group | Primary Outcome | Self-esteem (baseline) | 57.14 score on a scale |
| Control-2 Group | Primary Outcome | Total Score (3 months) | 81.03 score on a scale |
| Control-2 Group | Primary Outcome | Sexual life (3 months) | 93.75 score on a scale |
| Control-2 Group | Primary Outcome | Public distress (baseline) | 85 score on a scale |
| Control-2 Group | Primary Outcome | Work (3 months) | 87.50 score on a scale |
| Control-2 Group | Primary Outcome | Public distress (3 months) | 90 score on a scale |
| Control-2 Group | Primary Outcome | Sexual life (baseline) | 81.25 score on a scale |
| Control-2 Group | Primary Outcome | Self-esteem (baseline) | 50 score on a scale |
| Control-2 Group | Primary Outcome | Physical function (3 months) | 84.09 score on a scale |
| Control-2 Group | Primary Outcome | Total Score (baseline) | 69.83 score on a scale |
| Control-2 Group | Primary Outcome | Physical function (baseline) | 70.45 score on a scale |
| Control-2 Group | Primary Outcome | Self-esteem (3 months) | 60.71 score on a scale |
| Control-2 Group | Primary Outcome | Work (baseline) | 87.50 score on a scale |
Comparison: total scale score comparisonp-value: 0.24Wilcoxon (Mann-Whitney)
Comparison: total scale score comparisonp-value: 0.001Wilcoxon (Mann-Whitney)
Comparison: total scale score comparisonp-value: 0.03Wilcoxon (Mann-Whitney)
Comparison: total scale score comparisonp-value: 0.003Kruskal-Wallis
Secondary
BMI (kg/m2)
Comparing the BMI of the three groups at baseline and week 12.
Time frame: 3 months
Population: All participants were analysed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention Group | BMI (kg/m2) | BMI (kg/m2) (Baseline) | 31.50 kg/m2 |
| Intervention Group | BMI (kg/m2) | BMI (kg/m2) (3 months) | 30.60 kg/m2 |
| Control-1 Group | BMI (kg/m2) | BMI (kg/m2) (Baseline) | 30.50 kg/m2 |
| Control-1 Group | BMI (kg/m2) | BMI (kg/m2) (3 months) | 29.50 kg/m2 |
| Control-2 Group | BMI (kg/m2) | BMI (kg/m2) (Baseline) | 29.70 kg/m2 |
| Control-2 Group | BMI (kg/m2) | BMI (kg/m2) (3 months) | 29.20 kg/m2 |
Comparison: BMI Comparisonp-value: 0.13Kruskal-Wallis
Secondary
Lipid Profile
Lipid profile of the three groups at baseline and week 12.
Time frame: 3 months
Population: All participants were analysed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention Group | Lipid Profile | Triglyceride (Baseline) | 105 mg/dL |
| Intervention Group | Lipid Profile | Total cholesterol (Baseline) | 188 mg/dL |
| Intervention Group | Lipid Profile | LDL cholesterol (Baseline) | 121 mg/dL |
| Intervention Group | Lipid Profile | HDL cholesterol (Baseline) | 45 mg/dL |
| Intervention Group | Lipid Profile | Triglyceride (3 months) | 100 mg/dL |
| Intervention Group | Lipid Profile | Total cholesterol (3 months) | 189 mg/dL |
| Intervention Group | Lipid Profile | LDL cholesterol (3 months) | 128 mg/dL |
| Intervention Group | Lipid Profile | HDL cholesterol (3 months) | 50 mg/dL |
| Control-1 Group | Lipid Profile | LDL cholesterol (Baseline) | 120 mg/dL |
| Control-1 Group | Lipid Profile | LDL cholesterol (3 months) | 125 mg/dL |
| Control-1 Group | Lipid Profile | HDL cholesterol (Baseline) | 50 mg/dL |
| Control-1 Group | Lipid Profile | Triglyceride (3 months) | 98 mg/dL |
| Control-1 Group | Lipid Profile | Total cholesterol (3 months) | 189 mg/dL |
| Control-1 Group | Lipid Profile | Triglyceride (Baseline) | 110 mg/dL |
| Control-1 Group | Lipid Profile | Total cholesterol (Baseline) | 193 mg/dL |
| Control-1 Group | Lipid Profile | HDL cholesterol (3 months) | 48 mg/dL |
| Control-2 Group | Lipid Profile | LDL cholesterol (Baseline) | 126 mg/dL |
| Control-2 Group | Lipid Profile | Total cholesterol (Baseline) | 181 mg/dL |
| Control-2 Group | Lipid Profile | Triglyceride (Baseline) | 94 mg/dL |
| Control-2 Group | Lipid Profile | HDL cholesterol (Baseline) | 46 mg/dL |
| Control-2 Group | Lipid Profile | LDL cholesterol (3 months) | 129 mg/dL |
| Control-2 Group | Lipid Profile | Total cholesterol (3 months) | 173 mg/dL |
| Control-2 Group | Lipid Profile | Triglyceride (3 months) | 96 mg/dL |
| Control-2 Group | Lipid Profile | HDL cholesterol (3 months) | 48 mg/dL |
Comparison: LDL Cholesterol Comparisonp-value: 0.89Kruskal-Wallis
Secondary
Secondary
Comparing the anthropometric measurements of the three groups at baseline and week 12.
Time frame: 3 months
Population: All participants were analysed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention Group | Secondary | Weight (kg) (Baseline) | 89.50 kg |
| Intervention Group | Secondary | Fat mass (kg) (Baseline) | 33.50 kg |
| Intervention Group | Secondary | Fat free mass (kg) (Baseline) | 52.80 kg |
| Intervention Group | Secondary | Weight (kg) (3 months) | 88 kg |
| Intervention Group | Secondary | Fat mass (kg) (3 months) | 31.10 kg |
| Intervention Group | Secondary | Fat free mass (kg)(3 months) | 51.90 kg |
| Control-1 Group | Secondary | Fat free mass (kg)(3 months) | 48.50 kg |
| Control-1 Group | Secondary | Weight (kg) (Baseline) | 84.50 kg |
| Control-1 Group | Secondary | Weight (kg) (3 months) | 79.90 kg |
| Control-1 Group | Secondary | Fat mass (kg) (3 months) | 28.80 kg |
| Control-1 Group | Secondary | Fat mass (kg) (Baseline) | 28.70 kg |
| Control-1 Group | Secondary | Fat free mass (kg) (Baseline) | 50 kg |
| Control-2 Group | Secondary | Fat mass (kg) (Baseline) | 26.80 kg |
| Control-2 Group | Secondary | Fat free mass (kg) (Baseline) | 53.40 kg |
| Control-2 Group | Secondary | Fat free mass (kg)(3 months) | 53.80 kg |
| Control-2 Group | Secondary | Weight (kg) (3 months) | 84 kg |
| Control-2 Group | Secondary | Weight (kg) (Baseline) | 85.10 kg |
| Control-2 Group | Secondary | Fat mass (kg) (3 months) | 25.20 kg |
Comparison: Weight comparisonp-value: 0.08Kruskal-Wallis
Secondary
Waist Circumference (cm)
Comparing the Waist Circumference measurements of the three groups at baseline and week 12.
Time frame: 3 months
Population: All participants were analysed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention Group | Waist Circumference (cm) | Waist circumference (cm) (Baseline) | 106 cm |
| Intervention Group | Waist Circumference (cm) | Waist circumference (cm) (3 months) | 102 cm |
| Control-1 Group | Waist Circumference (cm) | Waist circumference (cm) (Baseline) | 101.50 cm |
| Control-1 Group | Waist Circumference (cm) | Waist circumference (cm) (3 months) | 100 cm |
| Control-2 Group | Waist Circumference (cm) | Waist circumference (cm) (Baseline) | 101 cm |
| Control-2 Group | Waist Circumference (cm) | Waist circumference (cm) (3 months) | 100 cm |
Comparison: Waist Circumference Comparisonp-value: 0.63Kruskal-Wallis