Investigating Metabolic and Psychological Adaptations in a Clinical Trial
NCT ID: NCT06800794
Last Updated: 2026-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
12 participants
INTERVENTIONAL
2025-07-16
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
SINGLE
Study Groups
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Control phase
During this phase, participants are told to maintain typical behaviors and not change any normal patterns of activity/eating.
No interventions assigned to this group
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 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.
Meal Provisioning
3 meals a day consisting of low energy dense, nutrient rich, ready to eat, low GI, foods delivered to the participants' homes.
Interventions
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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.
Meal Provisioning
3 meals a day consisting of low energy dense, nutrient rich, ready to eat, low GI, foods delivered to the participants' homes.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
45 Years
FEMALE
No
Sponsors
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National Center for Advancing Translational Sciences (NCATS)
NIH
State University of New York at Buffalo
OTHER
Responsible Party
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Leonard Epstein
Principal Investigator
Locations
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Farber Hall G56
Buffalo, New York, United States
Countries
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References
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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.
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.
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.
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.
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.
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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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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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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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.
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.
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.
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.
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.
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.
Other Identifiers
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STUDY00008988
Identifier Type: -
Identifier Source: org_study_id
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