Clinical trial

Investigating Metabolic and Psychological Adaptations in a Clinical Trial

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT06800794

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 45 Years

SexFemale

Healthy volunteersNot accepted

ConditionObesity and Type 2 Diabetes

Full registry 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.

Treatments and study arms

Behavioral Skill Training

Behavioral

7 sessions including: Hunger and fullness, eating on a budget, traffic light eating plan, menu planning, creating alternatives to food, financial planning, and changing the environment.

Meal Provisioning

Other

3 meals a day consisting of low energy dense, nutrient rich, ready to eat, low GI, foods delivered to the participants' homes.

Primary outcomes

Change in body weightThrough study completion, an average of 25 weeks

measured in kgs using a weight scale.

change in HBA1CThrough study completion, an average of 25 weeks.

measured via a finger-prick blood sample analyzed using a point-of-care device

Change in respiratory quotientThrough study completion, an average of 25 weeks.

will be measured in morning fasting state using the Breezing Pro, an FDA approved device for portable metabolic measures

change in TEFThrough study completion, an average of 25 weeks.

will be measured in morning fasting state using the Breezing Pro, an FDA approved device for portable metabolic measures

Change in delay discountingThrough study completion, an average of 25 weeks.

will be measured using the adjusting amount delay discounting task that presents participants with choices between a fraction of the total delayed amount of money now or the full amount ($100 \&/ $1000) at a future delayed time for five different periods from 30 days, 180 days, 365 days (1 year), 1095 days (3 years), 1825 days (5 years) (order randomized).

Change in RREThrough study completion, an average of 25 weeks.

RRE will be assessed through a survey that will use participants' preferred snack foods that are classified as either hyperpalatable or healthy. Scores have no fixed minimum or maximum, as they are determined by the highest ratio completed before the participant stops working for the food reward. Higher scores indicate greater reinforcing efficacy and a stronger motivational drive for the food reward, which is considered a worse outcome in this context.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Farber Hall G56🇺🇸 Buffalo, New York, United States

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