Weight LossNCT05276544
The Effect of Telephone and Video Counseling on Weight Loss and Quality of Life
A study testing Dietary intervention in people with Weight Loss and Obesity, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
Individuals with obesity are at higher risk for severe disease, hospitalizations, and death from the SARS-CoV-2 virus. Social distancing guidelines intended to prevent viral spread during the COVID-19 pandemic resulted in major changes to daily routines . Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Loss, Obesity
- What is being tested?
- Dietary intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2022to 18 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being between the ages of 20-65
- Being obese (BMI≥30 kg/m2)
- Having a smartphone with internet access and being competent to use it
- Volunteering to participate in research
Who cannot join
- Being pregnant/lactating
- Having a hearing problem
- Being on a followed diet program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Telephone and Video Counseling Given to Obese Individuals on Weight Loss and Quality of Life in the COVID-19 Pandemic: an RCT
Individuals with obesity are at higher risk for severe disease, hospitalizations, and death from the SARS-CoV-2 virus. Social distancing guidelines intended to prevent viral spread during the COVID-19 pandemic resulted in major changes to daily routines . Several studies have demonstrated that individuals with overweight/obesity reported worsening mental health, poor eating habits , less physical activity (PA) since the onset of the COVID-19 pandemic. Because of these pandemic rules, the use of phone/video consultancy applications and online classes for body weight control and diet monitoring is increasing. Therefore, in this study it is aimed to determine the effect of diet counseling via phone or video on weight loss and to compare it with the traditional follow-up method in the COVID-19 pandemic.
Read the detailed description
The use of phone/video consultancy applications for body weight control and diet monitoring is increasing. One of the main reasons for this situation is that individuals care more about the social distance rule as a result of the increase in health concerns after the COVID-19 (SARS-CoV-2) pandemic. In addition, due to the uncertainty of how long the pandemic will last, many people are adapting to online applications and programs quicly. However, it's unclear which method of phone/video-based diet counseling is more successful or preferable to traditional diet follow-up. Based on the above-mentioned information; in this study, it is aimed to determine the effect of diet counseling via phone or video on weight loss and to compare it with the traditional follow-up method in the COVID-19 pandemic.
Individuals who meet the research criteria will randomize according to their file numbers (with the ramdomizer program) and divide into 3 groups: telephone counseling (15), video counseling (15) and traditional follow-up group (Figure 1.). Food consumption records, anthropometric measurements and quality of life scale scores of all individuals will record at the beginning and end of the study (Figure 2.). In order to prevent interaction between individuals, all diet programs will prepare at different times and individually.
- Conditions
- Weight Loss, Obesity
- Being tested
- Dietary intervention
- Keywords
- Obesity, Weight Loss, COVID-19 pandemic
- Medical subject headings
- Weight Loss, Obesity, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary interventionBehavioural
Dietary intervention: Preparation and follow-up of diet program.
| Study group | Role | What they receive |
|---|---|---|
| phone counseling | Experimental | dietary intervention via phone counseling Receives: Behavioral: Dietary intervention |
| video counseling | Experimental | dietary intervention via video counseling Receives: Behavioral: Dietary intervention |
| Traditional follow up | Experimental | dietary intervention via traditional follow up Receives: Behavioral: Dietary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight chance
BMI (kilogram/ metre2 (kg/m2))
Measured: At the end of the 3 months
Secondary outcomes (1)
Quality of Life Score
The score ranges from 0 to 100 points, with an increased score reflecting improved quality of life
Measured: At the end of the 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start15 Apr 2022
- Primary completion15 Jul 2022
- Study completion18 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Collaborators
- Amasya University
- Responsible party
- Principal investigator, ümüş özbey yücel, Ankara University
- Investigators
- ümüş Ö yücel, Dr, Principal investigator, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05276544
- Sponsor's protocol ID
- AmasyaUniv
- Status last verified
- Jul 2022
- First submitted
- 3 Mar 2022
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Telephone and Video Counseling Given to Obese Individuals on Weight Loss and Quality of Life in the COVID-19 Pandemic: an RCT
- ClinicalTrials.gov ID
- NCT05276544
- Acronym / sponsor ID
- AmasyaUniv
- Conditions
- Weight Loss, Obesity
- Keywords
- Obesity, Weight Loss, COVID-19 pandemic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Collaborators
- Amasya University
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 18 Jul 2022 (actual)
- First posted
- 11 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Individuals with obesity are at higher risk for severe disease, hospitalizations, and death from the SARS-CoV-2 virus. Social distancing guidelines intended to prevent viral spread during the COVID-19 pandemic resulted in major changes to daily routines . Several studies have demonstrated that individuals with overweight/obesity reported worsening mental health, poor eating habits , less physical activity (PA) since the onset of the COVID-19 pandemic. Because of these pandemic rules, the use of phone/video consultancy applications and online classes for body weight control and diet monitoring is increasing. Therefore, in this study it is aimed to determine the effect of diet counseling via phone or video on weight loss and to compare it with the traditional follow-up method in the COVID-19 pandemic.
Detailed description
The use of phone/video consultancy applications for body weight control and diet monitoring is increasing. One of the main reasons for this situation is that individuals care more about the social distance rule as a result of the increase in health concerns after the COVID-19 (SARS-CoV-2) pandemic. In addition, due to the uncertainty of how long the pandemic will last, many people are adapting to online applications and programs quicly. However, it's unclear which method of phone/video-based diet counseling is more successful or preferable to traditional diet follow-up. Based on the above-mentioned information; in this study, it is aimed to determine the effect of diet counseling via phone or video on weight loss and to compare it with the traditional follow-up method in the COVID-19 pandemic.
Individuals who meet the research criteria will randomize according to their file numbers (with the ramdomizer program) and divide into 3 groups: telephone counseling (15), video counseling (15) and traditional follow-up group (Figure 1.). Food consumption records, anthropometric measurements and quality of life scale scores of all individuals will record at the beginning and end of the study (Figure 2.). In order to prevent interaction between individuals, all diet programs will prepare at different times and individually.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| phone counseling | Experimental | Behavioral: Dietary interventiondietary intervention via phone counseling |
| video counseling | Experimental | Behavioral: Dietary interventiondietary intervention via video counseling |
| Traditional follow up | Experimental | Behavioral: Dietary interventiondietary intervention via traditional follow up |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being between the ages of 20-65
- Being obese (BMI≥30 kg/m2)
- Having a smartphone with internet access and being competent to use it
- Volunteering to participate in research
Key exclusion criteria (3 listed)
- Being pregnant/lactating
- Having a hearing problem
- Being on a followed diet program
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 |
|---|---|---|
| Dietary interventionDietary intervention: Preparation and follow-up of diet program. | Behavioural | Traditional follow up, phone counseling, video counseling |
Primary outcome
Weight chance
Time frame: At the end of the 3 months
BMI (kilogram/ metre2 (kg/m2))
1 secondary outcome
Quality of Life Score
Time frame: At the end of the 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- 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.
ümüş Ö yücel, Dr principal investigator
Ankara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary intervention in people with Weight Loss and Obesity, run by Ankara University 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 4 inclusion and 3 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 20 Jul 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Weight chance (time frame: At the end of the 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jul 2022.