ObesityNCT06273163
Identifying Strategies to Curtail Weight Regain After GLP-1 Receptor Agonist Treatment Cessation
A study testing Medically tailored meals and Noom® in people with Obesity, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
Longitudinal studies show there is a steep increase in weight regain in the first 3-4 months after stopping GLP-1 receptor agonist medications (GLP-1s) and most patients regain most of their weight within a year. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Medically tailored meals and Noom®
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2024to 5 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older;
- ability to read, write, and speak English;
- ability to provide informed consent;
- greater than 10% GLP-1 Receptor Agonist induced weight loss
- less than 30-days since GLP-1 Receptor Agonist cessation;
- willing to participate.
Who cannot join
- major psychiatric illness or substance misuse that could impair ability to participate;
- presence of a medical condition or dietary restriction precluding eating study meals or weight loss (e.g., medical condition requiring liquid diet, pregnancy, eating disorder);
- participation in a study or program involving medically tailored meals or Noom® within the past 12-months.
Trial locations and contacts
1 site in 1 country.
About this study
Longitudinal studies show there is a steep increase in weight regain in the first 3-4 months after stopping GLP-1 receptor agonist medications (GLP-1s) and most patients regain most of their weight within a year. Insurers now question the utility of GLP-1s for weight loss as they are hesitant to cover these costs long-term (~$833 per person per month). Some patients would also prefer not to take these medications in perpetuity and are likely to struggle with lifelong adherence. These challenges present an opportunity to test alternative interventions, such as meal replacements and behavioral treatments, to support weight maintenance after successful weight loss with GLP-1s. This regimen would allow patients to benefit from significant weight loss in the first year of taking GLP-1s and use more cost effective and sustainable strategies for long-term maintenance.
Read the detailed description
In the proposed study the investigators will execute a pilot randomized controlled trial to identify whether medically tailored meals (MTM, Group 1, N=20) and/or Noom®, a mobile application (Group 2, N=20) are associated with greater treatment adherence and satisfaction than usual care (Group 3, N=20) after GLP-1 Receptor Agonist cessation. The investigators will enroll adults 18 and older that have lost more than 10% of their bodyweight taking GLP-1 Receptor Agonist and ceased treatment within the past 30-days. For four-months, Group 1 will receive 40 MTM per month, Group 2 will receive a Noom® subscription, and Group 3 will receive lifestyle counseling per standard of care.
- Conditions
- Obesity
- Being tested
- Medically tailored meals, Noom®, Usual care
- Keywords
- Glucagon-Like Peptide-1 Receptor Agonists, Body Weight Maintenance
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medically tailored mealsOther
Medically tailored meals are nutritious meals formulated for weight wellness.
Noom®Behavioural
Noom® is a subscription-based mobile application used to support healthy eating and exercise behavior change.
Usual careOther
Care is provided at the discretion of the individual provider (e.g., usual care).
| Study group | Role | What they receive |
|---|---|---|
| Medically tailored meals | Experimental | Participants will receive 10 medically tailored meals per week (40 meals per month) for four-months. Receives: Other: Medically tailored meals; Other: Usual care |
| Noom® | Experimental | Participants will receive a paid Noom® subscription for four-months. Noom® is a subscription-based mobile application that provides food intake and exercise tracking and uses principles from psychology to motivate behavior change. Receives: Behavioral: Noom®; Other: Usual care |
| Usual care | Placebo comparator | Participants will receive usual care from their provider. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Adherence
Adherence will be measured using the Perceived Behavior subscale (6-items) from the validated Treatment Adherence Perception Questionnaire (TAPQ).
Measured: 4-months
Intervention Satisfaction
The Abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9) will be used to measure satisfaction, and be adapted for the interventions understudy. Responses are provided on a 7-point Likert scale ranging from extremely satisfied to extremely dissatisfied. Scores are then transformed to a 0-100 scale with a higher score indicating greater treatment satisfaction.
Measured: 4-months
Secondary outcomes (2)
Percent weight loss maintained
The electronic health record will be used to determine the participants' weight prior to and at the end of GLP-1 Receptor Agonist treatment to determine the percent of bodyweight lost on GLP-1 Receptor Agonist. Weight will be measured using a Bluetooth scale pre- and post-intervention to calculate the percent of weight loss maintained at the end of the study.
Measured: 4-months
Diet quality
Healthy eating index-2015 (HEI-2015), scored according to National Cancer Institute (NCI) guidelines from 0-100, with 0 indicating no intake of nutritious foods and 100 indicating higher intake of nutritious food.
Measured: 4-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start5 Mar 2024
- Primary completion5 Aug 2025
- Study completion5 Aug 2025
Why it stopped: Funding ended, unable to reach recruitment goal.
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.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized repeated measures between-subjects design
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- UT Southwestern Nutrition Obesity Research Center
- Responsible party
- Principal investigator, Kelseanna Hollis-Hansen, University of Texas Southwestern Medical Center
- Investigators
- Kelseanna Hollis-Hansen, PhD, MPH, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06273163
- Sponsor's protocol ID
- STU-2023-1168
- Status last verified
- Oct 2025
- First submitted
- 15 Feb 2024
- Last updated
- 15 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Strategies to Curtail Weight Regain After GLP-1 Receptor Agonist Treatment Cessation
- ClinicalTrials.gov ID
- NCT06273163
- Acronym / sponsor ID
- STU-2023-1168
- Conditions
- Obesity
- Keywords
- Glucagon-Like Peptide-1 Receptor Agonists, Body Weight Maintenance
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding ended, unable to reach recruitment goal.
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- UT Southwestern Nutrition Obesity Research Center
- Study start
- 5 Mar 2024 (actual)
- Primary completion
- 5 Aug 2025 (actual)
- Study completion
- 5 Aug 2025 (actual)
- First posted
- 22 Feb 2024 (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.
Longitudinal studies show there is a steep increase in weight regain in the first 3-4 months after stopping GLP-1 receptor agonist medications (GLP-1s) and most patients regain most of their weight within a year. Insurers now question the utility of GLP-1s for weight loss as they are hesitant to cover these costs long-term (~$833 per person per month). Some patients would also prefer not to take these medications in perpetuity and are likely to struggle with lifelong adherence. These challenges present an opportunity to test alternative interventions, such as meal replacements and behavioral treatments, to support weight maintenance after successful weight loss with GLP-1s. This regimen would allow patients to benefit from significant weight loss in the first year of taking GLP-1s and use more cost effective and sustainable strategies for long-term maintenance.
Detailed description
In the proposed study the investigators will execute a pilot randomized controlled trial to identify whether medically tailored meals (MTM, Group 1, N=20) and/or Noom®, a mobile application (Group 2, N=20) are associated with greater treatment adherence and satisfaction than usual care (Group 3, N=20) after GLP-1 Receptor Agonist cessation. The investigators will enroll adults 18 and older that have lost more than 10% of their bodyweight taking GLP-1 Receptor Agonist and ceased treatment within the past 30-days. For four-months, Group 1 will receive 40 MTM per month, Group 2 will receive a Noom® subscription, and Group 3 will receive lifestyle counseling per standard of care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized repeated measures between-subjects design
| Arm | Type | Receives |
|---|---|---|
| Medically tailored meals | Experimental | Other: Medically tailored meals, Other: Usual careParticipants will receive 10 medically tailored meals per week (40 meals per month) for four-months. |
| Noom® | Experimental | Behavioral: Noom®, Other: Usual careParticipants will receive a paid Noom® subscription for four-months. Noom® is a subscription-based mobile application that provides food intake and exercise tracking and uses principles from psychology to motivate behavior change. |
| Usual care | Placebo comparator | Other: Usual careParticipants will receive usual care from their provider. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age or older;
- ability to read, write, and speak English;
- ability to provide informed consent;
- greater than 10% GLP-1 Receptor Agonist induced weight loss
- less than 30-days since GLP-1 Receptor Agonist cessation;
Key exclusion criteria (3 listed)
- major psychiatric illness or substance misuse that could impair ability to participate;
- presence of a medical condition or dietary restriction precluding eating study meals or weight loss (e.g., medical condition requiring liquid diet, pregnancy, eating disorder);
- participation in a study or program involving medically tailored meals or Noom® within the past 12-months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medically tailored mealsMedically tailored meals are nutritious meals formulated for weight wellness. | Other | Medically tailored meals |
| Noom®Noom® is a subscription-based mobile application used to support healthy eating and exercise behavior change. | Behavioural | Noom® |
| Usual careCare is provided at the discretion of the individual provider (e.g., usual care). | Other | Medically tailored meals, Noom®, Usual care |
Primary outcome
Intervention Adherence
Time frame: 4-months
Adherence will be measured using the Perceived Behavior subscale (6-items) from the validated Treatment Adherence Perception Questionnaire (TAPQ).
Intervention Satisfaction
Time frame: 4-months
The Abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9) will be used to measure satisfaction, and be adapted for the interventions understudy. Responses are provided on a 7-point Likert scale ranging from extremely satisfied to extremely dissatisfied. Scores are then transformed to a 0-100 scale with a higher score indicating greater treatment satisfaction.
2 secondary outcomes
Percent weight loss maintained
Time frame: 4-months
Diet quality
Time frame: 4-months
Results and safety
The study was stopped early (reason given: Funding ended, unable to reach recruitment goal.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2025.
- Individual participant dataSharing planned: Undecided
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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.
Kelseanna Hollis-Hansen, PhD, MPH principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medically tailored meals and Noom® in people with Obesity, run by University of Texas Southwestern Medical 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 6 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: stopped early, as of the sponsor's last update on 15 Oct 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. Some participants in this study may receive a placebo. 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?
The study was stopped early (reason given: Funding ended, unable to reach recruitment goal.). Results are not available in the source record.
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?
Intervention Adherence (time frame: 4-months). The study lists 2 primary outcomes in all. 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 15 Oct 2025.