N/A
N=165
Intensive Lifestyle Interventions to Overweight and Obese Patients in Primary Care
Obesity · Life Style · Lifestyle, Sedentary
Bottom Line
View on ClinicalTrials.gov: NCT06321809 ↗Enrolled (actual)
165
Serious AEs
—
Results posted
Feb 2025
Primary outcome: Primary: Primary Outcome — 68.18; 68.18; 70.45; 50 score on a scale — p=0.24
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- intensive lifestyle (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duygu Ayhan Baser
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Outcome |
68.18; 68.18; 70.45; 50; 57.14; 50 | 0.24 |
| SECONDARY Secondary |
89.50; 84.50; 85.10; 33.50; 28.70; 26.80 | 0.08 |
| SECONDARY BMI (kg/m2) |
31.50; 30.50; 29.70; 30.60; 29.50; 29.20 | 0.13 |
| SECONDARY Waist Circumference (cm) |
106; 101.50; 101; 102; 100; 100 | 0.63 |
| SECONDARY Lipid Profile |
105; 110; 94; 188; 193; 181 | 0.89 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT06321809). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.