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Investigating Metabolic and Psychological Adaptations in a Clinical Trial

Active Not RecruitingNA

Sponsor: State University of New York at Buffalo

Conditions: Obesity and Type 2 Diabetes

Interventions: Behavioral Skill Training, Meal Provisioning

Countries: United States

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.

Eligibility overview

Sex: FEMALE

Age: 18 Years to 45 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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 visit measurements.

Locations (1)

Buffalo, New York, United States