ObesityNCT05736120
Persons With Obesity (PwO) Exploratory Research
An observational study of Obesity, run by Novo Nordisk A/S at 1 site in India.
Trial summary
The purpose of this study is to understand the personal flow along the weight loss management journey. A range of variables will be addressed in a survey to explore the weight loss journey, barriers and management. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- No treatment given
- How many people
- 46 participants
- Where
- 1 siteIndia
- Study dates
- 19 Feb 2023to 19 Apr 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
- Adult, Older adult
Study population: Study participants will be recruited to participate in 2 types of qualitative research. Online Bulletin Boards and Virtual Focus Groups
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.
- Current body mass index (BMI) of 25 or greater
- Not currently pregnant
- Does not participate in intense fitness or body building program
- Weight loss not through illness or injury
Show all 9Show fewer
- At least somewhat concerned about current weight
- If no plans for weight loss in the next six months, has made at least 1 weight loss effort in last 5 years
- Struggling with weight for at least 3 years
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.
About this study
Official title: Persons With Obesity (PwO) Exploratory Research - India
The purpose of this study is to understand the personal flow along the weight loss management journey. A range of variables will be addressed in a survey to explore the weight loss journey, barriers and management. Topics include weight loss strategies and challenges, HCP involvement, and perceptions towards weight loss medications.
Potential participants will be recruited using various online panels. Study participants will be recruited to participate in 2 types of qualitative research.
Phase I: Online bulletin boards (OBB) Phase II: Virtual focus groups (real-time)
- Conditions
- Obesity
- Being tested
- No treatment given
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No treatment givenOther
No treatment given
| Study group | Role | What they receive |
|---|---|---|
| Phase I | Online bulletin boards (OBB) Receives: Other: No treatment given | |
| Phase II | Virtual focus groups (real-time) Receives: Other: No treatment given |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of perceptions, behaviours and awareness related to obesity and obesity management among people living with obesity.
120-minute OBB discussion with numeric and open-ended response (Phase 1)
Measured: 5 days (Phase 1)
Description of perceptions, behaviours and awareness related to obesity and obesity management among people living with obesity.
90-minute focus group with open-ended response (Phase 2)
Measured: 1 day (Phase 2)
Assessment of triggers for people with obesity to request medical therapy and expectations for both therapy available and their weight loss journey.
120-minute OBB discussion with numeric and open-ended response (Phase 1)
Measured: 5 days (Phase 1)
Assessment of triggers for people with obesity to request medical therapy and expectations for both therapy available and their weight loss journey.
90-minute focus group with open-ended response (Phase 2)
Measured: 1 day (Phase 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start19 Feb 2023
- Primary completion19 Apr 2023
- Study completion19 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- 46 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
- NCT05736120
- Sponsor's protocol ID
- DAS-7679
- Other IDs
- U1111-1285-1486
- Status last verified
- May 2023
- First submitted
- 9 Feb 2023
- Last updated
- 12 May 2023
- 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 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Persons With Obesity (PwO) Exploratory Research - India
- ClinicalTrials.gov ID
- NCT05736120
- Acronym / sponsor ID
- DAS-7679
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 19 Feb 2023 (actual)
- Primary completion
- 19 Apr 2023 (actual)
- Study completion
- 19 Apr 2023 (actual)
- First posted
- 21 Feb 2023 (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 study is to understand the personal flow along the weight loss management journey. A range of variables will be addressed in a survey to explore the weight loss journey, barriers and management. Topics include weight loss strategies and challenges, HCP involvement, and perceptions towards weight loss medications.
Potential participants will be recruited using various online panels. Study participants will be recruited to participate in 2 types of qualitative research.
Phase I: Online bulletin boards (OBB) Phase II: Virtual focus groups (real-time)
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase I | – | Other: No treatment givenOnline bulletin boards (OBB) |
| Phase II | – | Other: No treatment givenVirtual focus groups (real-time) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Study participants will be recruited to participate in 2 types of qualitative research. Online Bulletin Boards and Virtual Focus Groups
Key inclusion criteria (9 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.
- Current body mass index (BMI) of 25 or greater
- Not currently pregnant
- Does not participate in intense fitness or body building program
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 givenNo treatment given | Other | Phase I, Phase II |
Primary outcome
Description of perceptions, behaviours and awareness related to obesity and obesity management among people living with obesity.
Time frame: 5 days (Phase 1)
120-minute OBB discussion with numeric and open-ended response (Phase 1)
Description of perceptions, behaviours and awareness related to obesity and obesity management among people living with obesity.
Time frame: 1 day (Phase 2)
90-minute focus group with open-ended response (Phase 2)
Assessment of triggers for people with obesity to request medical therapy and expectations for both therapy available and their weight loss journey.
Time frame: 5 days (Phase 1)
120-minute OBB discussion with numeric and open-ended response (Phase 1)
Assessment of triggers for people with obesity to request medical therapy and expectations for both therapy available and their weight loss journey.
Time frame: 1 day (Phase 2)
90-minute focus group with open-ended response (Phase 2)
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 12 May 2023.
- 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 Obesity, run by Novo Nordisk A/S at 1 site in India.
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 9 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 12 May 2023. 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 India. 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?
Description of perceptions, behaviours and awareness related to obesity and obesity management among people living with obesity. (time frame: 5 days (Phase 1)). The study lists 4 primary outcomes in all. 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 12 May 2023.