Investigating Metabolic and Psychological Adaptations in a Clinical Trial

NCT06800794 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-01-14

No results posted yet for this study

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.

Conditions

  • Obesity and Type 2 Diabetes

Interventions

BEHAVIORAL

Behavioral Skill Training

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.

OTHER

Meal Provisioning

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

Sponsors & Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

    collaborator NIH
  • State University of New York at Buffalo

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-16
Primary Completion
2026-06-30
Completion
2026-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06800794 on ClinicalTrials.gov