Active — Not RecruitingNot Applicable

Investigating Metabolic and Psychological Adaptations in a Clinical Trial

United States12 participantsStarted 2025-07-16

Plain-language summary

This study aims to explore how food insecurity, a lack of consistent access to enough food, may lead to changes in the body that make it harder to lose weight. The investigators are testing whether providing women experiencing food insecurity with a stable, healthy, and personalized meal plan can improve their metabolism and reduce their motivation to eat unhealthy foods. The hypothesis is that addressing food insecurity with a predictable diet can lower a person's respiratory quotient (a measure of how the body uses energy), promote fat burning, and improve overall health. This research will improve the understanding for how food insecurity contributes to obesity and may lead to better solutions for managing weight in individuals facing these challenges.

Who can participate

Age range

18 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Woman between the ages of 18-45. * Premenopausal. * Obese (BMI ≥ 30). * Diagnosed with prediabetes (HbA1c: 5.7%-6.4%). * Experiencing food insecurity (score of 2-6 on the six-item food insecurity questionnaire). * Income below 300% of the household federal poverty threshold. * Lives alone. Exclusion Criteria: * Actively planning to become pregnant (e.g., individuals trying to conceive or undergoing fertility treatment, based on self-report). * Delivered a baby within the past 6 months (self-report). * Non-ambulatory (e.g., individuals unable to walk independently or requiring a wheelchair for mobility). * Intellectual impairment that would impact treatment adherence. * Unmanaged mood disorders, substance use disorders, personality disorders, or a history of eating disorders, including: * Generalized anxiety disorder. * Depression. * Alcohol dependence. * Schizophrenia. * Anorexia nervosa, bulimia, or binge eating disorder within the past 6 months. * Recent weight loss exceeding 5% of body weight within the past 6 months (self-report). * Food allergies to study-related foods, including dairy, soy, nuts, or gluten. * History of bariatric surgery or GLP-1 agonist use (self-report). * Inability to read or write in English (self-report). * Planned relocation out of the study area during the study timeframe (self-report). * Uncontrolled diabetes (HbA1c \> 9%) or hypertension (blood pressure \> 160/100 mmHg), based on self-report or screening visi…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in body weight

Timeframe: Through study completion, an average of 25 weeks

change in HBA1C

Timeframe: Through study completion, an average of 25 weeks.

Change in respiratory quotient

Timeframe: Through study completion, an average of 25 weeks.

change in TEF

Timeframe: Through study completion, an average of 25 weeks.

Change in delay discounting

Timeframe: Through study completion, an average of 25 weeks.

Change in RRE

Timeframe: Through study completion, an average of 25 weeks.

Trial details

NCT IDNCT06800794

SponsorState University of New York at Buffalo

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-30

View on ClinicalTrials.gov More Obesity and Type 2 Diabetes trials

Plain-language summary

Who can participate

Age range

18 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in body weight

Timeframe: Through study completion, an average of 25 weeks

change in HBA1C

Timeframe: Through study completion, an average of 25 weeks.

Change in respiratory quotient

Timeframe: Through study completion, an average of 25 weeks.

change in TEF

Timeframe: Through study completion, an average of 25 weeks.

Change in delay discounting

Timeframe: Through study completion, an average of 25 weeks.

Change in RRE

Timeframe: Through study completion, an average of 25 weeks.