OverweightASPECT - APACNCT06260696
Assessing Health-Related Quality of Life and Willingness to Pay for Weight Management in Asia-Pacific by Gender
An observational study of Overweight and Obesity, run by Novo Nordisk A/S at 1 site in United Arab Emirates.
Trial summary
The purpose of this survey is to collect information for scientific research and to identify the impact of overweight and obesity on health-related quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- No treatment is given
- How many people
- 3,000 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 10 Aug 2023to 5 Oct 2023
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults recruited to complete self-administered online service
Who may be able to join
- Informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
- Male or female, age above or equal to 18 years at the time of signing informed consent.
- Not currently pregnant
- Does not participate in intense fitness or body building program
- Weight loss not through illness or injury
- Lives in South Korea, Australia, or India
- BMI above or equal to 18 and associated weight class (Normal Weight or above) will be determined by a programmed calculation based on participant-reported height and weight.
Who cannot join
- Previous participation in this study. Participation is defined as having given informed consent in this study
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
- Does not meet inclusion criteria.
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site
Novo Nordisk Investigational Site
Dubai
About this study
The purpose of this survey is to collect information for scientific research and to identify the impact of overweight and obesity on health-related quality of life.
- Conditions
- Overweight, Obesity
- Being tested
- No treatment is given
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No treatment is givenOther
No treatment is given
| Study group | Role | What they receive |
|---|---|---|
| Normal weight | Adults with normal weight, recruited to complete self-administered online service Receives: Other: No treatment is given | |
| Overweight | Adults with overweight, recruited to complete self-administered online service Receives: Other: No treatment is given | |
| Obesity Class I | Adults with obesity class I, recruited to complete self-administered online service Receives: Other: No treatment is given | |
| Obesity Class II | Adults with obesity class II, recruited to complete self-administered online service Receives: Other: No treatment is given | |
| Obesity Class III | Adults with obesity class III, recruited to complete self-administered online service Receives: Other: No treatment is given |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score on IWQOL-Lite validated
Calculated score. Likert scale; 1=Never True, 5=Always True
Measured: At time of survey response (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start10 Aug 2023
- Primary completion5 Oct 2023
- Study completion5 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06260696
- Sponsor's protocol ID
- DAS-7626
- Other IDs
- U1111-1282-5512
- Acronym
- ASPECT - APAC
- Status last verified
- Feb 2024
- First submitted
- 7 Feb 2024
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Health-Related Quality of Life and Willingness to Pay for Weight Management in Asia-Pacific by Gender
- ClinicalTrials.gov ID
- NCT06260696
- Acronym / sponsor ID
- ASPECT - APAC / DAS-7626
- Conditions
- Overweight, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 10 Aug 2023 (actual)
- Primary completion
- 5 Oct 2023 (actual)
- Study completion
- 5 Oct 2023 (actual)
- First posted
- 15 Feb 2024 (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.
The purpose of this survey is to collect information for scientific research and to identify the impact of overweight and obesity on health-related quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Normal weight | – | Other: No treatment is givenAdults with normal weight, recruited to complete self-administered online service |
| Overweight | – | Other: No treatment is givenAdults with overweight, recruited to complete self-administered online service |
| Obesity Class I | – | Other: No treatment is givenAdults with obesity class I, recruited to complete self-administered online service |
| Obesity Class II | – | Other: No treatment is givenAdults with obesity class II, recruited to complete self-administered online service |
| Obesity Class III | – | Other: No treatment is givenAdults with obesity class III, recruited to complete self-administered online service |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults recruited to complete self-administered online service
Key inclusion criteria (7 listed)
- Informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
- Male or female, age above or equal to 18 years at the time of signing informed consent.
- Not currently pregnant
- Does not participate in intense fitness or body building program
- Weight loss not through illness or injury
Key exclusion criteria (3 listed)
- Previous participation in this study. Participation is defined as having given informed consent in this study
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
- Does not meet inclusion criteria.
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 |
|---|---|---|
| No treatment is givenNo treatment is given | Other | Normal weight, Obesity Class I, Obesity Class II, Obesity Class III, Overweight |
Primary outcome
Score on IWQOL-Lite validated
Time frame: At time of survey response (Day 1)
Calculated score. Likert scale; 1=Never True, 5=Always True
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 15 Feb 2024.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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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.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
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 Overweight and Obesity, run by Novo Nordisk A/S at 1 site in United Arab Emirates.
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 7 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 15 Feb 2024. 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 United Arab Emirates. 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?
Score on IWQOL-Lite validated (time frame: At time of survey response (Day 1)). 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 15 Feb 2024.