NCT05601804

Brief Summary

This pilot and feasibility study will collect information from food insecure, as well as food secure, women with obesity to detail their desires and needs for healthy weight reduction. Up to 60 women with obesity will be enrolled. Pennington Biomedical Research Center will coordinate this qualitative study and use focus groups discussion to collect formative data.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 1, 2022

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

February 4, 2025

Status Verified

February 1, 2025

Enrollment Period

3.3 years

First QC Date

October 21, 2022

Last Update Submit

February 3, 2025

Conditions

ObesityFood InsecurityFood SecurityBody Weight

Keywords

Food InsecurityObesityWeight Loss

Outcome Measures

Primary Outcomes (1)

  • Desires and needs for weight loss

    Via focus group discussions, we will elicit in-depth information from women with food insecurity and obesity to detail their desires and needs for weight loss.

    Through study completion, up to 1 year

Study Arms (2)

Food Insecure Women with Obesity

4 focus groups with 6-8 participants each

Food Secure Women with Obesity

3 focus groups with 6-8 participants each

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women aged 18 to 65 years with a BMI of 30.0 kg/m2 or greater.

You may qualify if:

  • Willing to provide written informed consent
  • Female
  • to 65 years of age
  • BMI ≥ 30 kg/m2
  • Ability to read and write using English
  • Willing to participate in focus group discussions
  • Willing to be audio/video recorded

You may not qualify if:

  • Male
  • Currently pregnant
  • BMI \<30 kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

MeSH Terms

Conditions

ObesityBody WeightWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Candice A. Myers, PhD

    Pennington Biomedical Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 21, 2022

First Posted

November 1, 2022

Study Start

September 1, 2022

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

February 4, 2025

Record last verified: 2025-02

Locations

US(1)