Persons With Obesity (PwO) Exploratory Research

Obesity Clinical Trial

Official title:

Persons With Obesity (PwO) Exploratory Research - India

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05736120
• Other study ID #: DAS-7679
• Secondary ID: U1111-1285-1486
• Status: Completed
• Start date: February 19, 2023
• Est. completion date: April 19, 2023

Study information

• Verified date: May 2023
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: April 19, 2023
• Est. primary completion date: April 19, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).

2. Male or female, age above or equal to 18 years at the time of signing informed consent.

3. Current body mass index (BMI) of 25 or greater

4. Not currently pregnant

5. Does not participate in intense fitness or body building program

6. Weight loss not through illness or injury

7. At least somewhat concerned about current weight

8. If no plans for weight loss in the next six months, has made at least 1 weight loss effort in last 5 years

9. Struggling with weight for at least 3 years

Exclusion Criteria:

1. Previous participation in this study. Participation is defined as having given informed consent in this study

2. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation

3. Does not meet inclusion criteria.

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• No treatment given
No treatment given

Locations

Country	Name	City	State
India	Novo Nordisk Investigational Site	Bengaluru

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	5 days (Phase 1)
Primary	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)	1 day (Phase 2)
Primary	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)	5 days (Phase 1)
Primary	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)	1 day (Phase 2)