Trial Outcomes & Findings for Intensive Lifestyle Interventions to Overweight and Obese Patients in Primary Care (NCT NCT06321809)
NCT ID: NCT06321809
Last Updated: 2025-02-04
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
165 participants
Primary outcome timeframe
3 months
Results posted on
2025-02-04
Participant Flow
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.
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.
Participant milestones
| Measure |
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
|
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
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
55
|
56
|
54
|
|
Overall Study
COMPLETED
|
51
|
51
|
51
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Intervention Group
n=51 Participants
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
|
Control-1 Group
n=51 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
|
Control-2 Group
n=51 Participants
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.
|
Total
n=153 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=51 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=153 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
51 Participants
n=51 Participants
|
51 Participants
n=51 Participants
|
51 Participants
n=51 Participants
|
153 Participants
n=153 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=51 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=153 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=51 Participants
|
34 Participants
n=51 Participants
|
35 Participants
n=51 Participants
|
107 Participants
n=153 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=51 Participants
|
17 Participants
n=51 Participants
|
16 Participants
n=51 Participants
|
46 Participants
n=153 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Body Mass Index (kg/m2)
Overweight (BMI greater than or equal to 25)
|
13 Participants
n=51 Participants
|
23 Participants
n=51 Participants
|
27 Participants
n=51 Participants
|
63 Participants
n=153 Participants
|
|
Body Mass Index (kg/m2)
Obese (BMI greater than or equal to 30)
|
38 Participants
n=51 Participants
|
28 Participants
n=51 Participants
|
24 Participants
n=51 Participants
|
90 Participants
n=153 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: All participants were analysed.
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.
Outcome measures
| Measure |
Intervention Group
n=51 Participants
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
|
Control-1 Group
n=51 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
|
Control-2 Group
n=51 Participants
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.
|
|---|---|---|---|
|
Primary Outcome
Self-esteem (baseline)
|
50 score on a scale
Interval 0.0 to 100.0
|
57.14 score on a scale
Interval 0.0 to 96.43
|
50 score on a scale
Interval 0.0 to 100.0
|
|
Primary Outcome
Sexual life (baseline)
|
75 score on a scale
Interval 0.0 to 100.0
|
87.50 score on a scale
Interval 0.0 to 100.0
|
81.25 score on a scale
Interval 0.0 to 100.0
|
|
Primary Outcome
Physical function (baseline)
|
68.18 score on a scale
Interval 0.0 to 93.18
|
68.18 score on a scale
Interval 4.55 to 97.73
|
70.45 score on a scale
Interval 9.09 to 100.0
|
|
Primary Outcome
Public distress (baseline)
|
90 score on a scale
Interval 15.0 to 100.0
|
85 score on a scale
Interval 10.0 to 100.0
|
85 score on a scale
Interval 0.0 to 100.0
|
|
Primary Outcome
Work (baseline)
|
75 score on a scale
Interval 0.0 to 100.0
|
87.50 score on a scale
Interval 0.0 to 100.0
|
87.50 score on a scale
Interval 0.0 to 100.0
|
|
Primary Outcome
Total Score (baseline)
|
63.79 score on a scale
Interval 16.38 to 95.69
|
73.28 score on a scale
Interval 28.45 to 93.97
|
69.83 score on a scale
Interval 18.97 to 99.14
|
|
Primary Outcome
Physical function (3 months)
|
79.54 score on a scale
Interval 0.0 to 100.0
|
77.27 score on a scale
Interval 22.73 to 100.0
|
84.09 score on a scale
Interval 0.0 to 100.0
|
|
Primary Outcome
Self-esteem (3 months)
|
75 score on a scale
Interval 0.0 to 100.0
|
82.14 score on a scale
Interval 0.0 to 100.0
|
60.71 score on a scale
Interval 3.57 to 100.0
|
|
Primary Outcome
Sexual life (3 months)
|
87.50 score on a scale
Interval 0.0 to 100.0
|
93.75 score on a scale
Interval 25.0 to 100.0
|
93.75 score on a scale
Interval 0.0 to 100.0
|
|
Primary Outcome
Public distress (3 months)
|
90 score on a scale
Interval 0.0 to 100.0
|
95 score on a scale
Interval 30.0 to 100.0
|
90 score on a scale
Interval 0.0 to 100.0
|
|
Primary Outcome
Work (3 months)
|
87.50 score on a scale
Interval 0.0 to 100.0
|
87.50 score on a scale
Interval 12.5 to 100.0
|
87.50 score on a scale
Interval 0.0 to 100.0
|
|
Primary Outcome
Total Score (3 months)
|
81.90 score on a scale
Interval 0.0 to 100.0
|
82.76 score on a scale
Interval 33.62 to 100.0
|
81.03 score on a scale
Interval 24.14 to 100.0
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: All participants were analysed.
Comparing the anthropometric measurements of the three groups at baseline and week 12.
Outcome measures
| Measure |
Intervention Group
n=51 Participants
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
|
Control-1 Group
n=51 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
|
Control-2 Group
n=51 Participants
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
Weight (kg) (Baseline)
|
89.50 kg
Interval 66.1 to 125.8
|
84.50 kg
Interval 61.9 to 135.0
|
85.10 kg
Interval 64.2 to 108.4
|
|
Secondary
Fat mass (kg) (Baseline)
|
33.50 kg
Interval 13.0 to 63.6
|
28.70 kg
Interval 17.2 to 48.8
|
26.80 kg
Interval 11.3 to 51.5
|
|
Secondary
Fat free mass (kg) (Baseline)
|
52.80 kg
Interval 43.1 to 83.3
|
50 kg
Interval 41.7 to 89.2
|
53.40 kg
Interval 40.7 to 78.6
|
|
Secondary
Weight (kg) (3 months)
|
88 kg
Interval 65.6 to 128.6
|
79.90 kg
Interval 58.8 to 135.0
|
84 kg
Interval 62.3 to 108.4
|
|
Secondary
Fat mass (kg) (3 months)
|
31.10 kg
Interval 13.0 to 64.2
|
28.80 kg
Interval 11.4 to 47.5
|
25.20 kg
Interval 5.0 to 51.5
|
|
Secondary
Fat free mass (kg)(3 months)
|
51.90 kg
Interval 43.4 to 82.0
|
48.50 kg
Interval 37.1 to 89.2
|
53.80 kg
Interval 41.9 to 75.3
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: All participants were analysed.
Comparing the BMI of the three groups at baseline and week 12.
Outcome measures
| Measure |
Intervention Group
n=51 Participants
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
|
Control-1 Group
n=51 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
|
Control-2 Group
n=51 Participants
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.
|
|---|---|---|---|
|
BMI (kg/m2)
BMI (kg/m2) (3 months)
|
30.60 kg/m2
Interval 24.3 to 48.4
|
29.50 kg/m2
Interval 23.0 to 42.8
|
29.20 kg/m2
Interval 24.8 to 42.3
|
|
BMI (kg/m2)
BMI (kg/m2) (Baseline)
|
31.50 kg/m2
Interval 25.0 to 47.3
|
30.50 kg/m2
Interval 25.3 to 43.2
|
29.70 kg/m2
Interval 25.0 to 42.3
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: All participants were analysed.
Comparing the Waist Circumference measurements of the three groups at baseline and week 12.
Outcome measures
| Measure |
Intervention Group
n=51 Participants
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
|
Control-1 Group
n=51 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
|
Control-2 Group
n=51 Participants
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.
|
|---|---|---|---|
|
Waist Circumference (cm)
Waist circumference (cm) (Baseline)
|
106 cm
Interval 85.5 to 140.0
|
101.50 cm
Interval 77.0 to 158.0
|
101 cm
Interval 86.0 to 132.0
|
|
Waist Circumference (cm)
Waist circumference (cm) (3 months)
|
102 cm
Interval 80.0 to 141.0
|
100 cm
Interval 70.0 to 158.0
|
100 cm
Interval 80.8 to 132.0
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: All participants were analysed.
Lipid profile of the three groups at baseline and week 12.
Outcome measures
| Measure |
Intervention Group
n=51 Participants
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
|
Control-1 Group
n=51 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
|
Control-2 Group
n=51 Participants
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.
|
|---|---|---|---|
|
Lipid Profile
Triglyceride (Baseline)
|
105 mg/dL
Interval 35.0 to 375.0
|
110 mg/dL
Interval 39.0 to 231.0
|
94 mg/dL
Interval 50.0 to 335.0
|
|
Lipid Profile
Total cholesterol (Baseline)
|
188 mg/dL
Interval 141.0 to 266.0
|
193 mg/dL
Interval 131.0 to 284.0
|
181 mg/dL
Interval 99.0 to 315.0
|
|
Lipid Profile
LDL cholesterol (Baseline)
|
121 mg/dL
Interval 68.0 to 180.0
|
120 mg/dL
Interval 71.0 to 181.0
|
126 mg/dL
Interval 74.0 to 231.0
|
|
Lipid Profile
HDL cholesterol (Baseline)
|
45 mg/dL
Interval 30.0 to 84.0
|
50 mg/dL
Interval 31.0 to 90.0
|
46 mg/dL
Interval 28.0 to 69.0
|
|
Lipid Profile
Triglyceride (3 months)
|
100 mg/dL
Interval 36.0 to 503.0
|
98 mg/dL
Interval 45.0 to 230.0
|
96 mg/dL
Interval 49.0 to 657.0
|
|
Lipid Profile
Total cholesterol (3 months)
|
189 mg/dL
Interval 120.0 to 282.0
|
189 mg/dL
Interval 111.0 to 256.0
|
173 mg/dL
Interval 105.0 to 324.0
|
|
Lipid Profile
LDL cholesterol (3 months)
|
128 mg/dL
Interval 70.0 to 193.0
|
125 mg/dL
Interval 81.0 to 174.0
|
129 mg/dL
Interval 88.0 to 258.0
|
|
Lipid Profile
HDL cholesterol (3 months)
|
50 mg/dL
Interval 33.0 to 87.0
|
48 mg/dL
Interval 31.0 to 88.0
|
48 mg/dL
Interval 27.0 to 67.0
|
Adverse Events
Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control-1 Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control-2 Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place