Investigating Metabolic and Psychological Adaptations in a Clinical Trial (IMPACT)

January 13, 2026 updated by: Leonard Epstein, State University of New York at Buffalo

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Women who experience food insecurity have unpredictable access to food and often miss meals and go hungry, but paradoxically are at a 50% greater risk for developing obesity than women who are food secure. This is due in part to metabolic and behavioral factors involved in food insecurity. Research suggests unpredictable access to food is associated with: 1) a high respiratory quotient (RQ) indicative of substrate oxidation that favors storage of fat and burning of carbohydrates; 2) an increase in fuel efficiency and a reduced thermic effect of food (TEF); 3) higher relative reinforcing efficacy of food (RREFOOD), due in part to periodic food deprivation that results from unpredictable access to food and being hungry, and 4) a short temporal window that involves making decisions that focus on meeting immediate versus long-term goals, as assessed by delay discounting (DD). While people with food insecurity and obesity should modify their diet, an RQ that favors storage of fat coupled with a reduced TEF, high RREFOOD and high DD may compromise the effects of traditional dietary approaches to weight loss. The goal of this pilot study is to examine the effects of providing a personalized, stable, predictable, low carbohydrate, low glycemic index, high protein, low energy dense diet on changes in metabolic and behavioral factors that characterize low-income women with food insecurity who have obesity, using a novel stepped wedge design. This work extends our research on behavioral and metabolic factors involved in food insecurity, and will provide strong pilot data for a randomized, controlled trial of a novel dietary approach that target factors involved in food insecurity and obesity that can improve weight control and reduce cardiometabolic risk factors. The investigators expect to screen at least 60 women, with an estimated screen failure rate of 80%. A goal for this pilot project is to provide effect sizes for future studies. The sample size was determined based on feasibility constraints, with the understanding that these results will serve as pilot data for a larger, fully powered randomized controlled trial.

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14221
        • Farber Hall G56

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control phase
During this phase, participants are told to maintain typical behaviors and not change any normal patterns of activity/eating.
Experimental: Treatment phase

There are two components to the treatment:

Food provisioning: The food provisioning component will consist of bi-weekly home deliveries of three meals a day. The number of calories in the provided meals for each day will be personalized based on each participant's resting metabolic rate. Caloric targets for each participant will be 20% of TDEE as this translates to ~1-2 pounds of weight loss per week. Diets composition will also be tailored to help improve TEF and RQ.

Behavioral Skills Training: This will be based on an evidence-based behavioral weight-loss program developed in our lab. This treatment has shown clinically significant weight loss with positive effects sustained over 10-years. The specific includes lessons on self-monitoring, developing alternatives to foods, meal-planning, goal setting, episodic future thinking, physical activity, and self-reinforcement.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in body weight
Time Frame: Through study completion, an average of 25 weeks
measured in kgs using a weight scale.
Through study completion, an average of 25 weeks
change in HBA1C
Time Frame: Through study completion, an average of 25 weeks.
measured via a finger-prick blood sample analyzed using a point-of-care device
Through study completion, an average of 25 weeks.
Change in respiratory quotient
Time Frame: Through 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
Through study completion, an average of 25 weeks.
change in TEF
Time Frame: Through 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
Through study completion, an average of 25 weeks.
Change in delay discounting
Time Frame: Through 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).
Through study completion, an average of 25 weeks.
Change in RRE
Time Frame: Through 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.
Through study completion, an average of 25 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in stress
Time Frame: Through study completion, an average of 25 weeks.
measured using the Perceived Stress Scale. The Perceived Stress Scale is a validated 10-item questionnaire that measures the perception of stress over the past month. Scores range from 0 to 40, where higher scores indicate greater perceived stress and worse outcomes.
Through study completion, an average of 25 weeks.
change in physical activity
Time Frame: Through study completion, an average of 25 weeks.
measured using a Fitbit activity monitor
Through study completion, an average of 25 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

State University of New York at Buffalo

Collaborators

National Center for Advancing Translational Sciences (NCATS)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

July 16, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

January 17, 2025

First Submitted That Met QC Criteria

January 23, 2025

First Posted (Actual)

January 30, 2025

Study Record Updates

Last Update Posted (Estimated)

January 14, 2026

Last Update Submitted That Met QC Criteria

January 13, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00008988
  • 1UM1TR005296-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The investigators plan to share de-identified individual participant data (IPD) with other researchers to promote transparency, reproducibility, and the advancement of scientific knowledge.

IPD Sharing Time Frame

The IPD and supporting information (Study Protocol, SAP, ICF, and Analytic Code) will be made available no later than 12 months after the publication of the primary study results or 12 months after the final study completion date (November 1, 2025), whichever comes first. Therefore, the anticipated start date for data availability is November 1, 2026. The IPD and supporting information will remain available for a period of 5 years from the start date, allowing sufficient time for secondary analyses and collaborative research. The anticipated end date is November 1, 2031.

IPD Sharing Access Criteria

Qualified Researchers: Access will be granted to researchers affiliated with academic, non-profit, or governmental institutions conducting non-commercial research. Researchers must demonstrate a legitimate scientific purpose for using the data.

Individual Participant Data (IPD):

De-identified data for all primary and secondary outcome measures (e.g., respiratory quotient, thermic effect of food, body weight, relative reinforcing value of food, and delay discounting).

Accompanying metadata and codebooks for proper interpretation of the data.

Supporting Information:

Study Protocol: Detailed description of the study design and methodology. Statistical Analysis Plan (SAP): Comprehensive explanation of the planned statistical analyses for all outcomes.

Informed Consent Form (ICF): Template of the consent form used during the study.

Analytic Code: Scripts used for data cleaning and statistical analyses, enabling reproducibility of results.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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