ACTIVE_NOT_RECRUITING

Investigating Metabolic and Psychological Adaptations in a Clinical Trial

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Effect of Meal Timing and Dietary Changes on Metabolic and Behavioral Factors Involved in the Food Insecurity-Obesity Paradox

Quick Facts

Study Start:2025-07-16
Study Completion:2026-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06800794

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Woman between the ages of 18-45.
  2. * Premenopausal.
  3. * Obese (BMI ≥ 30).
  4. * Diagnosed with prediabetes (HbA1c: 5.7%-6.4%).
  5. * Experiencing food insecurity (score of 2-6 on the six-item food insecurity questionnaire).
  6. * Income below 300% of the household federal poverty threshold.
  7. * Lives alone.
  1. * Actively planning to become pregnant (e.g., individuals trying to conceive or undergoing fertility treatment, based on self-report).
  2. * Delivered a baby within the past 6 months (self-report).
  3. * Non-ambulatory (e.g., individuals unable to walk independently or requiring a wheelchair for mobility).
  4. * Intellectual impairment that would impact treatment adherence.
  5. * Unmanaged mood disorders, substance use disorders, personality disorders, or a history of eating disorders, including:
  6. * Generalized anxiety disorder.
  7. * Depression.
  8. * Alcohol dependence.
  9. * Schizophrenia.
  10. * Anorexia nervosa, bulimia, or binge eating disorder within the past 6 months.
  11. * Recent weight loss exceeding 5% of body weight within the past 6 months (self-report).
  12. * Food allergies to study-related foods, including dairy, soy, nuts, or gluten.
  13. * History of bariatric surgery or GLP-1 agonist use (self-report).
  14. * Inability to read or write in English (self-report).
  15. * Planned relocation out of the study area during the study timeframe (self-report).
  16. * Uncontrolled diabetes (HbA1c \> 9%) or hypertension (blood pressure \> 160/100 mmHg), based on self-report or screening visit measurements.

Contacts and Locations

Study Locations (Sites)

Farber Hall G56
Buffalo, New York, 14221
United States

Collaborators and Investigators

Sponsor: State University of New York at Buffalo

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-16
Study Completion Date2026-09-30

Study Record Updates

Study Start Date2025-07-16
Study Completion Date2026-09-30

Terms related to this study

Additional Relevant MeSH Terms

  • Obesity and Type 2 Diabetes