ObesityNCT06321809

Intensive Lifestyle Interventions to Overweight and Obese Patients in Primary Care

An observational study of Obesity and Life Style, run by Duygu Ayhan Baser at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Ages 18 to 40 years
Conditions the study is for: Obesity, Life Style, Lifestyle, Sedentary
What is being tested?: intensive lifestyle
Type of treatment: Lifestyle or therapy programme
How many people: 165 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 25 Jan 2022to 1 Dec 2022
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 40 years
All sexes
Adult

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.

Who may be able to join

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

Who cannot join

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

Show all 10Show fewer

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Hacettepe University
Ankara

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Intensive Lifestyle Intervention Applied to Overweight and Obese Patients in Primary Care During the Pandemic Period: a Randomised Controlled Trial

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.

Read the 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.

Conditions: Obesity, Life Style, Lifestyle, Sedentary
Being tested: intensive lifestyle
Keywords: primary care, obesity, lifestyle changes
Medical subject headings: Obesity, Sedentary Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

intensive lifestyleBehavioural
INTENSIVE LIFESTYLE INTERVENTIONS

Study groups in NCT06321809
Study group	Role	What they receive
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. Receives: 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. Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 3 months

Secondary outcomes (4)

Secondary
Comparing the anthropometric measurements of the three groups at baseline and week 12.
Measured: 3 months
BMI (kg/m2)
Comparing the BMI of the three groups at baseline and week 12.
Measured: 3 months
Waist Circumference (cm)
Comparing the Waist Circumference measurements of the three groups at baseline and week 12.
Measured: 3 months
Lipid Profile
Lipid profile of the three groups at baseline and week 12.
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Jan 20221 Dec 2022

First posted20 Mar 2024
Study start25 Jan 2022
Primary completion1 Oct 2022
Study completion1 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for ObesityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case crossover
Time perspective: Prospective
Enrolment: 165 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06321809
Sponsor's protocol ID: HUTF-FM-DABDCO-01
Status last verified: Jan 2025
First submitted: 4 Mar 2024
Last updated: 4 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Obesity trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Intensive Lifestyle Intervention Applied to Overweight and Obese Patients in Primary Care During the Pandemic Period: a Randomised Controlled Trial
ClinicalTrials.gov ID: NCT06321809
Acronym / sponsor ID: HUTF-FM-DABDCO-01
Conditions: Obesity, Life Style, Lifestyle, Sedentary
Keywords: primary care, obesity, lifestyle changes
Study type: Observational
Recruitment status: Completed
Enrolment: 165 participants (actual)
Lead sponsor: Duygu Ayhan BaserUniversity, hospital or other
Collaborators: Hacettepe University
Study start: 25 Jan 2022 (actual)
Primary completion: 1 Oct 2022 (actual)
Study completion: 1 Dec 2022 (actual)
First posted: 20 Mar 2024 (actual)
Results: Posted 4 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Case crossover
Time perspective: Prospective
Number of arms: 3

Arm	Type	Receives
Intervention group	–	Behavioral: intensive lifestyleThey 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	–	Behavioral: intensive lifestyleDuring 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.

Who may qualify

Ages: 18 to 40 years
Sex: All
Age groups: Adult
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.

Key inclusion criteria (1 listed)

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

Key exclusion criteria (10 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
intensive lifestyleINTENSIVE LIFESTYLE INTERVENTIONS	Behavioural	Control-1 group, Intervention group

Primary outcome

Primary Outcome
Time frame: 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.

4 secondary outcomes

Secondary
Time frame: 3 months
BMI (kg/m2)
Time frame: 3 months
Waist Circumference (cm)
Time frame: 3 months
Lipid Profile
Time frame: 3 months

Results and safety

Results posted to the registry on 4 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention Group	55	51
Control-1 Group	56	51
Control-2 Group	54	51

Primary outcome: Primary Outcome

Time frame: 3 months. Median (Full Range). Unit: score on a scale

Measure	Intervention Group n = 51	Control-1 Group n = 51	Control-2 Group n = 51
Physical function (baseline)	68.18 (0 to 93.18)	68.18 (4.55 to 97.73)	70.45 (9.09 to 100)
Self-esteem (baseline)	50 (0 to 100)	57.14 (0 to 96.43)	50 (0 to 100)
Sexual life (baseline)	75 (0 to 100)	87.50 (0 to 100)	81.25 (0 to 100)
Public distress (baseline)	90 (15 to 100)	85 (10 to 100)	85 (0 to 100)
Work (baseline)	75 (0 to 100)	87.50 (0 to 100)	87.50 (0 to 100)
Total Score (baseline)	63.79 (16.38 to 95.69)	73.28 (28.45 to 93.97)	69.83 (18.97 to 99.14)
Physical function (3 months)	79.54 (0 to 100)	77.27 (22.73 to 100)	84.09 (0 to 100)
Self-esteem (3 months)	75 (0 to 100)	82.14 (0 to 100)	60.71 (3.57 to 100)

Intervention Group vs Control-1 Group: p = 0.24, Wilcoxon (Mann-Whitney)
Intervention Group vs Control-2 Group: p = 0.001, Wilcoxon (Mann-Whitney)
Control-1 Group vs Control-2 Group: p = 0.03, Wilcoxon (Mann-Whitney)

Population analysed: All participants were analysed.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events
Intervention Group	0 of 0	0 of 0
Control-1 Group	0 of 0	0 of 0
Control-2 Group	0 of 0	0 of 0

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Duygu Ayhan Baser, Assoc. Prof. study director

Hacettepe University

Dilara Canbay Ozdemir, M.D. principal investigator

Hacettepe University

İzzet Fidanci, Assoc. Prof. principal investigator

Hacettepe University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity and Life Style, run by Duygu Ayhan Baser at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Outcome (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06321809.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025.