Investigating Metabolic and Psychological Adaptations in a Clinical Trial

NCT06800794 | Active Not Recruiting DMC

• 2 other identifiers: STUDY000089881UM1TR005296-01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (6)

• Change in body weight

  measured in kgs using a weight scale.

  Through study completion, an average of 25 weeks

• change in HBA1C

  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

  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

  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

  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

  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 Outcomes (2)

• change in stress

  Through study completion, an average of 25 weeks.

• change in physical activity

  Through study completion, an average of 25 weeks.

Study Arms (2)

Control phase

NO INTERVENTION

During this phase, participants are told to maintain typical behaviors and not change any normal patterns of activity/eating.

Treatment phase

EXPERIMENTAL

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; Other: Meal Provisioning

Interventions

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.

Treatment phase

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.

Treatment phase

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• State University of New York at Buffalo: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Farber Hall G56

Buffalo, New York, 14221, United States

Location

Related Publications (26)

• Pannacciulli N, Salbe AD, Ortega E, Venti CA, Bogardus C, Krakoff J. The 24-h carbohydrate oxidation rate in a human respiratory chamber predicts ad libitum food intake. Am J Clin Nutr. 2007 Sep;86(3):625-32. doi: 10.1093/ajcn/86.3.625.

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• Raynor HA, Epstein LH. The relative-reinforcing value of food under differing levels of food deprivation and restriction. Appetite. 2003 Feb;40(1):15-24. doi: 10.1016/s0195-6663(02)00161-7.

  PMID: 12631501 BACKGROUND

• Bickel WK, Freitas-Lemos R, Tomlinson DC, Craft WH, Keith DR, Athamneh LN, Basso JC, Epstein LH. Temporal discounting as a candidate behavioral marker of obesity. Neurosci Biobehav Rev. 2021 Oct;129:307-329. doi: 10.1016/j.neubiorev.2021.07.035. Epub 2021 Aug 3.

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• Green L, Myerson J, Lichtman D, Rosen S, Fry A. Temporal discounting in choice between delayed rewards: the role of age and income. Psychol Aging. 1996 Mar;11(1):79-84. doi: 10.1037//0882-7974.11.1.79.

  PMID: 8726373 BACKGROUND

• Myers CA, Beyl RA, Martin CK, Broyles ST, Katzmarzyk PT. Psychological mechanisms associated with food security status and BMI in adults: a mixed methods study. Public Health Nutr. 2020 Oct;23(14):2501-2511. doi: 10.1017/S1368980020000889. Epub 2020 Jun 29.

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• Rodriguez LR, Rasmussen EB, Kyne-Rucker D, Wong M, Martin KS. Delay discounting and obesity in food insecure and food secure women. Health Psychol. 2021 Apr;40(4):242-251. doi: 10.1037/hea0001042.

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• Epstein LH, Truesdale R, Wojcik A, Paluch RA, Raynor HA. Effects of deprivation on hedonics and reinforcing value of food. Physiol Behav. 2003 Feb;78(2):221-7. doi: 10.1016/s0031-9384(02)00978-2.

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• Crandall AK, Temple JL. Experimental scarcity increases the relative reinforcing value of food in food insecure adults. Appetite. 2018 Sep 1;128:106-115. doi: 10.1016/j.appet.2018.05.148. Epub 2018 May 29.

  PMID: 29852205 BACKGROUND

• Myers KP, Majewski M, Schaefer D, Tierney A. Chronic experience with unpredictable food availability promotes food reward, overeating, and weight gain in a novel animal model of food insecurity. Appetite. 2022 Sep 1;176:106120. doi: 10.1016/j.appet.2022.106120. Epub 2022 Jun 6.

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• Crandall AK, Ziegler AM, Mansouri T, Matteson J, Isenhart E, Carter A, Balantekin KN, Temple JL. Having less and wanting more: an investigation of socioeconomic status and reinforcement pathology. BMC Public Health. 2021 Feb 25;21(1):402. doi: 10.1186/s12889-021-10430-7.

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• Lin H, Carr KA, Fletcher KD, Epstein LH. Food reinforcement partially mediates the effect of socioeconomic status on body mass index. Obesity (Silver Spring). 2013 Jul;21(7):1307-12. doi: 10.1002/oby.20158. Epub 2013 Jun 11.

  PMID: 23754824 BACKGROUND

• Nettle D, Bateson M. Food-Insecure Women Eat a Less Diverse Diet in a More Temporally Variable Way: Evidence from the US National Health and Nutrition Examination Survey, 2013-4. J Obes. 2019 Oct 1;2019:7174058. doi: 10.1155/2019/7174058. eCollection 2019.

  PMID: 31662904 BACKGROUND

• Chaput JP, Tremblay A. The glucostatic theory of appetite control and the risk of obesity and diabetes. Int J Obes (Lond). 2009 Jan;33(1):46-53. doi: 10.1038/ijo.2008.221. Epub 2008 Nov 11.

  PMID: 19002144 BACKGROUND

• Flatt JP. The difference in the storage capacities for carbohydrate and for fat, and its implications in the regulation of body weight. Ann N Y Acad Sci. 1987;499:104-23. doi: 10.1111/j.1749-6632.1987.tb36202.x.

  PMID: 3300476 BACKGROUND

• Ellis AC, Hyatt TC, Hunter GR, Gower BA. Respiratory quotient predicts fat mass gain in premenopausal women. Obesity (Silver Spring). 2010 Dec;18(12):2255-9. doi: 10.1038/oby.2010.96. Epub 2010 May 6.

  PMID: 20448540 BACKGROUND

• Booker JM, Chang DC, Stinson EJ, Mitchell CM, Votruba SB, Krakoff J, Gluck ME, Cabeza de Baca T. Food insecurity is associated with higher respiratory quotient and lower glucagon-like peptide 1. Obesity (Silver Spring). 2022 Jun;30(6):1248-1256. doi: 10.1002/oby.23437.

  PMID: 35674698 BACKGROUND

• Bateson M, Andrews C, Dunn J, Egger CBCM, Gray F, Mchugh M, Nettle D. Food insecurity increases energetic efficiency, not food consumption: an exploratory study in European starlings. PeerJ. 2021 May 28;9:e11541. doi: 10.7717/peerj.11541. eCollection 2021.

  PMID: 34123601 BACKGROUND

• Farshchi HR, Taylor MA, Macdonald IA. Regular meal frequency creates more appropriate insulin sensitivity and lipid profiles compared with irregular meal frequency in healthy lean women. Eur J Clin Nutr. 2004 Jul;58(7):1071-7. doi: 10.1038/sj.ejcn.1601935.

  PMID: 15220950 BACKGROUND

• Farshchi HR, Taylor MA, Macdonald IA. Decreased thermic effect of food after an irregular compared with a regular meal pattern in healthy lean women. Int J Obes Relat Metab Disord. 2004 May;28(5):653-60. doi: 10.1038/sj.ijo.0802616.

  PMID: 15085170 BACKGROUND

• Calcagno M, Kahleova H, Alwarith J, Burgess NN, Flores RA, Busta ML, Barnard ND. The Thermic Effect of Food: A Review. J Am Coll Nutr. 2019 Aug;38(6):547-551. doi: 10.1080/07315724.2018.1552544. Epub 2019 Apr 25.

  PMID: 31021710 BACKGROUND

• Morales ME, Berkowitz SA. The Relationship between Food Insecurity, Dietary Patterns, and Obesity. Curr Nutr Rep. 2016 Mar;5(1):54-60. doi: 10.1007/s13668-016-0153-y. Epub 2016 Jan 25.

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• Franklin B, Jones A, Love D, Puckett S, Macklin J, White-Means S. Exploring mediators of food insecurity and obesity: a review of recent literature. J Community Health. 2012 Feb;37(1):253-64. doi: 10.1007/s10900-011-9420-4.

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• Nettle D, Andrews C, Bateson M. Food insecurity as a driver of obesity in humans: The insurance hypothesis. Behav Brain Sci. 2017 Jan;40:e105. doi: 10.1017/S0140525X16000947. Epub 2016 Jul 28.

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• Bateson M, Pepper GV. Food insecurity as a cause of adiposity: evolutionary and mechanistic hypotheses. Philos Trans R Soc Lond B Biol Sci. 2023 Oct 23;378(1888):20220228. doi: 10.1098/rstb.2022.0228. Epub 2023 Sep 4.

  PMID: 37661744 BACKGROUND

• Epstein LH, Rizwan A, Paluch RA, Temple JL. Delay Discounting and the Income-Food Insecurity-Obesity Paradox in Mothers. J Obes. 2023 Sep 19;2023:8898498. doi: 10.1155/2023/8898498. eCollection 2023.

  PMID: 37766882 BACKGROUND

• Epstein LH, Jankowiak N, Lin H, Paluch R, Koffarnus MN, Bickel WK. No food for thought: moderating effects of delay discounting and future time perspective on the relation between income and food insecurity. Am J Clin Nutr. 2014 Sep;100(3):884-90. doi: 10.3945/ajcn.113.079772. Epub 2014 Jul 9.

  PMID: 25008855 BACKGROUND

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: The research assistants who are performing data collection will be blind to what stage of the experiment participants are in. However, the counselor who performs behavioral skills training will not be blind.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study uses a stepped-wedge cluster randomized trial design. Participants are grouped into clusters, which sequentially transition from the control condition to the intervention condition. Each cluster acts as its own control during the baseline period. Data are collected repeatedly over time to evaluate the intervention's effects.

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: January 30, 2025
• Study Start: July 16, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• 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.
• 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.

Locations

US (1)