TARGETing Healthy Weight Loss in the Context of Food Inse... | NCT05601804

Studies
TARGETing Healthy Weight Loss in the Context of Food Insecurity

NCT05601804

Sponsor

Pennington Biomedical Research Center

Status

Active, not recruiting

Last Update Posted

Feb 4, 2025Actual

Enrollment

45Actual

Phase

Not provided

Conditions

Obesity
Food Insecurity
Food Security
Body Weight

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2022Actual

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Oct 21, 2022

First Submission Date that Met QC Criteria

Oct 26, 2022

First Posted Date

Nov 1, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 3, 2025

Last Update Posted Date

Feb 4, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Candice A. Myers, Ph.D., Assistant Professor, Pennington Biomedical Research CenterPrincipal Investigator

Lead Sponsor

Pennington Biomedical Research CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

45Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Willing to provide written informed consent
Female
18 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

Exclusion Criteria:

Male
Currently pregnant
BMI <30 kg/m2

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Candice A. Myers, PhD	Pennington Biomedical Research Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pennington Biomedical Research Center		Baton Rouge	Louisiana	70808	United States

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity
D001835	Body Weight
D015431	Weight Loss

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided