Intensive Lifestyle Interventions to Overweight and Obese Patients in Primary Care

NCT06321809 | Completed Results

• 1 other identifier: HUTF-FM-DABDCO-01
• Study Type: observational
• Target: 165
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Life Style; Lifestyle, Sedentary

Keywords

primary care; obesity; lifestyle changes

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (4)

• Secondary

  3 months

• BMI (kg/m2)

  3 months

• Waist Circumference (cm)

  3 months

• Lipid Profile

  3 months

Study Arms (3)

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.

Behavioral: intensive lifestyle

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.

Behavioral: intensive lifestyle

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.

Interventions

intensive lifestyle BEHAVIORAL

INTENSIVE LIFESTYLE INTERVENTIONS

Control-1 group; Intervention group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duygu Ayhan Baser: lead
• Hacettepe University: collaborator

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Obesity; Sedentary Behavior

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Limitations and Caveats

Yet, the three-month follow-up might not sufficiently capture lifestyle intervention impacts. Challenges in reaching participants during telephone follow-ups led to exclusions, potentially influencing the study's completeness.

Results Point of Contact

• Title: Assoc.Prof. Duygu Ayhan Baser
• Organization: Hacettepe University

dr.duyguayhan@gmail.com

+90-505-664-5210

Study Officials

• Duygu Ayhan Baser, Assoc. Prof.

  Hacettepe University

  STUDY DIRECTOR

• Dilara Canbay Ozdemir, M.D.

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• İzzet Fidanci, Assoc. Prof.

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Arzu Demircioglu Karagoz

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Merve Ozdemir

  Afyonkarahisar Health Sciences University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assoc Prof

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 20, 2024
• Study Start: January 25, 2022
• Primary Completion: October 1, 2022
• Study Completion: December 1, 2022
• Last Updated: February 4, 2025
• Results First Posted: February 4, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)