ObesityTARGET P&F INCT05601804
TARGETing Healthy Weight Loss in the Context of Food Insecurity
An observational study of Obesity and Food Insecurity, run by Pennington Biomedical Research Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Food Insecurity, Food Security
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2022to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women aged 18 to 65 years with a BMI of 30.0 kg/m2 or greater.
Who may be able to join
- 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
Who cannot join
- Male
- Currently pregnant
- BMI <30 kg/m2
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: TARGETing Healthy Weight Loss in the Context of Food Insecurity Pilot and Feasibility Trial I
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.
- Conditions
- Obesity, Food Insecurity, Food Security, Body Weight
- Keywords
- Food Insecurity, Obesity, Weight Loss
- Medical subject headings
- Obesity, Body Weight, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2022
- Study start1 Sep 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
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.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Candice A. Myers, Ph.D., Pennington Biomedical Research Center
- Investigators
- Candice A. Myers, PhD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05601804
- Sponsor's protocol ID
- PBRC 2022-039
- Acronym
- TARGET P&F I
- Status last verified
- Feb 2025
- First submitted
- 21 Oct 2022
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TARGETing Healthy Weight Loss in the Context of Food Insecurity Pilot and Feasibility Trial I
- ClinicalTrials.gov ID
- NCT05601804
- Acronym / sponsor ID
- TARGET P&F I / PBRC 2022-039
- Conditions
- Obesity, Food Insecurity, Food Security, Body Weight
- Keywords
- Food Insecurity, Obesity, Weight Loss
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 1 Nov 2022 (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.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women aged 18 to 65 years with a BMI of 30.0 kg/m2 or greater.
Key inclusion criteria (7 listed)
- Willing to provide written informed consent
- Female
- 18 to 65 years of age
- BMI ≥ 30 kg/m2
- Ability to read and write using English
Key exclusion criteria (3 listed)
- Male
- Currently pregnant
- BMI <30 kg/m2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Desires and needs for weight loss
Time frame: Through study completion, up to 1 year
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
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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.
Candice A. Myers, PhD principal investigator
Pennington Biomedical Research Center
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 and Food Insecurity, run by Pennington Biomedical Research Center at 1 site in United States.
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 7 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: under way, not looking for participants, as of the sponsor's last update on 4 Feb 2025. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Desires and needs for weight loss (time frame: Through study completion, up to 1 year). 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 4 Feb 2025.