NCT06321809

Intensive Lifestyle Interventions to Overweight and Obese Patients in Primary Care

Completed Results posted Last updated 4 February 2025

What this trial tests

trial testing intensive lifestyle in Obesity in 165 participants. Completed in 1 December 2022.

Timeline

25 January 2022

Primary endpoint
1 October 2022

1 December 2022

Quick facts

Lead sponsor	Duygu Ayhan Baser
Status	Completed
Study type	OBSERVATIONAL
Enrollment	165
Start date	25 January 2022
Primary completion	1 October 2022
Estimated completion	1 December 2022
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• intensive lifestyle

Conditions studied

• Obesity — all drugs for Obesity →
• Life Style — all drugs for Life Style →
• Lifestyle, Sedentary — all drugs for Lifestyle, Sedentary →

Sponsor

Duygu Ayhan Baser

Who can join

Adults 18 to 40, any sex, with Obesity or Life Style. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Primary Outcome Primary · 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.

Physical function (baseline)

Group	Value	95% CI
Intervention Group	68.18	0 – 93.18
Control-1 Group	68.18	4.55 – 97.73
Control-2 Group	70.45	9.09 – 100

Self-esteem (baseline)

Group	Value	95% CI
Intervention Group	50	0 – 100
Control-1 Group	57.14	0 – 96.43
Control-2 Group	50	0 – 100

Sexual life (baseline)

Group	Value	95% CI
Intervention Group	75	0 – 100
Control-1 Group	87.50	0 – 100
Control-2 Group	81.25	0 – 100

Public distress (baseline)

Group	Value	95% CI
Intervention Group	90	15 – 100
Control-1 Group	85	10 – 100
Control-2 Group	85	0 – 100

Work (baseline)

Group	Value	95% CI
Intervention Group	75	0 – 100
Control-1 Group	87.50	0 – 100
Control-2 Group	87.50	0 – 100

Total Score (baseline)

Group	Value	95% CI
Intervention Group	63.79	16.38 – 95.69
Control-1 Group	73.28	28.45 – 93.97
Control-2 Group	69.83	18.97 – 99.14

Physical function (3 months)

Group	Value	95% CI
Intervention Group	79.54	0 – 100
Control-1 Group	77.27	22.73 – 100
Control-2 Group	84.09	0 – 100

Self-esteem (3 months)

Group	Value	95% CI
Intervention Group	75	0 – 100
Control-1 Group	82.14	0 – 100
Control-2 Group	60.71	3.57 – 100

Secondary Secondary · 3 months

Comparing the anthropometric measurements of the three groups at baseline and week 12.

Weight (kg) (Baseline)

Group	Value	95% CI
Intervention Group	89.50	66.10 – 125.80
Control-1 Group	84.50	61.90 – 135
Control-2 Group	85.10	64.20 – 108.40

Fat mass (kg) (Baseline)

Group	Value	95% CI
Intervention Group	33.50	13 – 63.60
Control-1 Group	28.70	17.20 – 48.80
Control-2 Group	26.80	11.30 – 51.50

Fat free mass (kg) (Baseline)

Group	Value	95% CI
Intervention Group	52.80	43.10 – 83.30
Control-1 Group	50	41.70 – 89.20
Control-2 Group	53.40	40.70 – 78.60

Weight (kg) (3 months)

Group	Value	95% CI
Intervention Group	88	65.60 – 128.60
Control-1 Group	79.90	58.80 – 135
Control-2 Group	84	62.30 – 108.40

Fat mass (kg) (3 months)

Group	Value	95% CI
Intervention Group	31.10	13 – 64.20
Control-1 Group	28.80	11.40 – 47.50
Control-2 Group	25.20	5 – 51.50

Fat free mass (kg)(3 months)

Group	Value	95% CI
Intervention Group	51.90	43.40 – 82
Control-1 Group	48.50	37.10 – 89.20
Control-2 Group	53.80	41.90 – 75.30

BMI (kg/m2) Secondary · 3 months

Comparing the BMI of the three groups at baseline and week 12.

BMI (kg/m2) (Baseline)

Group	Value	95% CI
Intervention Group	31.50	25 – 47.30
Control-1 Group	30.50	25.30 – 43.20
Control-2 Group	29.70	25 – 42.30

BMI (kg/m2) (3 months)

Group	Value	95% CI
Intervention Group	30.60	24.30 – 48.40
Control-1 Group	29.50	23 – 42.80
Control-2 Group	29.20	24.80 – 42.30

Waist Circumference (cm) Secondary · 3 months

Comparing the Waist Circumference measurements of the three groups at baseline and week 12.

Waist circumference (cm) (Baseline)

Group	Value	95% CI
Intervention Group	106	85.50 – 140
Control-1 Group	101.50	77 – 158
Control-2 Group	101	86 – 132

Waist circumference (cm) (3 months)

Group	Value	95% CI
Intervention Group	102	80 – 141
Control-1 Group	100	70 – 158
Control-2 Group	100	80.80 – 132

Lipid Profile Secondary · 3 months

Lipid profile of the three groups at baseline and week 12.

Triglyceride (Baseline)

Group	Value	95% CI
Intervention Group	105	35 – 375
Control-1 Group	110	39 – 231
Control-2 Group	94	50 – 335

Total cholesterol (Baseline)

Group	Value	95% CI
Intervention Group	188	141 – 266
Control-1 Group	193	131 – 284
Control-2 Group	181	99 – 315

LDL cholesterol (Baseline)

Group	Value	95% CI
Intervention Group	121	68 – 180
Control-1 Group	120	71 – 181
Control-2 Group	126	74 – 231

HDL cholesterol (Baseline)

Group	Value	95% CI
Intervention Group	45	30 – 84
Control-1 Group	50	31 – 90
Control-2 Group	46	28 – 69

Triglyceride (3 months)

Group	Value	95% CI
Intervention Group	100	36 – 503
Control-1 Group	98	45 – 230
Control-2 Group	96	49 – 657

Total cholesterol (3 months)

Group	Value	95% CI
Intervention Group	189	120 – 282
Control-1 Group	189	111 – 256
Control-2 Group	173	105 – 324

LDL cholesterol (3 months)

Group	Value	95% CI
Intervention Group	128	70 – 193
Control-1 Group	125	81 – 174
Control-2 Group	129	88 – 258

HDL cholesterol (3 months)

Group	Value	95% CI
Intervention Group	50	33 – 87
Control-1 Group	48	31 – 88
Control-2 Group	48	27 – 67

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The Effects of Different Intervention Protocols on Anthropometric Measures, Lipid Profile, and Quality of Life: Insights from a Pandemic-Era Randomized Controlled Trial.
   Ozdemir DC, Baser DA, Fidanci I, Karagoz AD, et al · · 2025 · PMID 41277922 · DOI 10.18502/ijph.v54i9.19860