Persons With Obesity (PwO) Exploratory Research

May 11, 2023 updated by: Novo Nordisk A/S

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

46

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Bengaluru, India
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Study participants will be recruited to participate in 2 types of qualitative research. Online Bulletin Boards and Virtual Focus Groups

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Phase I
Online bulletin boards (OBB)
Other: No treatment given
No treatment given
Phase II
Virtual focus groups (real-time)
Other: No treatment given
No treatment given

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
5 days (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)
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.
Time Frame: 5 days (Phase 1)
120-minute OBB discussion with numeric and open-ended response (Phase 1)
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.
Time Frame: 1 day (Phase 2)
90-minute focus group with open-ended response (Phase 2)
1 day (Phase 2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Investigators

  • Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 19, 2023

Primary Completion (Actual)

April 19, 2023

Study Completion (Actual)

April 19, 2023

Study Registration Dates

First Submitted

February 9, 2023

First Submitted That Met QC Criteria

February 9, 2023

First Posted (Actual)

February 21, 2023

Study Record Updates

Last Update Posted (Actual)

May 12, 2023

Last Update Submitted That Met QC Criteria

May 11, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DAS-7679
  • U1111-1285-1486 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

"According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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