Obesity and Type 2 DiabetesIMPACTNCT06800794
Investigating Metabolic and Psychological Adaptations in a Clinical Trial
A study testing Behavioral Skill Training and Meal Provisioning in people with Obesity and Type 2 Diabetes, run by State University of New York at Buffalo at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Obesity and Type 2 Diabetes
- What is being tested?
- Behavioral Skill Training and Meal Provisioning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2025to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity and Type 2 Diabetes
- Being tested
- Behavioral Skill Training, Meal Provisioning
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Skill TrainingBehavioural
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 ProvisioningOther
3 meals a day consisting of low energy dense, nutrient rich, ready to eat, low GI, foods delivered to the participants' homes.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Behavioral Skill Training; Other: Meal Provisioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight
measured in kgs using a weight scale.
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: 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.
Measured: Through study completion, an average of 25 weeks.
Secondary outcomes (2)
change in stress
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.
Measured: Through study completion, an average of 25 weeks.
change in physical activity
measured using a Fitbit activity monitor
Measured: Through study completion, an average of 25 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start16 Jul 2025
- Primary completion30 Jun 2026
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Obesity and Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Leonard Epstein, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06800794
- Sponsor's protocol ID
- STUDY00008988
- Acronym
- IMPACT
- Status last verified
- Jan 2026
- First submitted
- 17 Jan 2025
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators plan to share de-identified individual participant data (IPD) with other researchers to promote transparency, reproducibility, and the advancement of scientific knowledge.
Publications
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.
PubMed 17823426Raynor 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.
PubMed 12631501Bickel 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.
PubMed 34358579Green 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.
PubMed 8726373Myers 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.
PubMed 32597739Rodriguez 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.
PubMed 33856831Epstein 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.
PubMed 12576119Crandall 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.
PubMed 29852205Myers 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.
PubMed 35671918Crandall 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.
PubMed 33632174Lin 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.
PubMed 23754824Nettle 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.
PubMed 31662904Chaput 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.
PubMed 19002144Flatt 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.
PubMed 3300476Ellis 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.
PubMed 20448540
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Meal Timing and Dietary Changes on Metabolic and Behavioral Factors Involved in the Food Insecurity-Obesity Paradox
- ClinicalTrials.gov ID
- NCT06800794
- Acronym / sponsor ID
- IMPACT / STUDY00008988
- Conditions
- Obesity and Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 16 Jul 2025 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 30 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Behavioral Skill Training, Other: Meal ProvisioningThere 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (16 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral Skill Training7 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. | Behavioural | Treatment phase |
| Meal Provisioning3 meals a day consisting of low energy dense, nutrient rich, ready to eat, low GI, foods delivered to the participants' homes. | Other | Treatment phase |
Primary outcome
Change in body weight
Time frame: Through study completion, an average of 25 weeks
measured in kgs using a weight scale.
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
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
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
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).
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.
2 secondary outcomes
change in stress
Time frame: Through study completion, an average of 25 weeks.
change in physical activity
Time frame: Through study completion, an average of 25 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Background: PubMed 17823426Pannacciulli 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.
- Background: PubMed 12631501Raynor 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.
- Background: PubMed 34358579Bickel 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.
- Background: PubMed 8726373Green 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.
- Background: PubMed 32597739Myers 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.
- Background: PubMed 33856831Rodriguez 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.
- Background: PubMed 12576119Epstein 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.
- Background: PubMed 29852205Crandall 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.
- Background: PubMed 35671918Myers 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.
- Background: PubMed 33632174Crandall 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.
- Background: PubMed 23754824Lin 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.
- Background: PubMed 31662904Nettle 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.
- Individual participant dataSharing planned: Yes. The investigators plan to share de-identified individual participant data (IPD) with other researchers to promote transparency, reproducibility, and the advancement of scientific knowledge.
Related trials for Obesity and Type 2 Diabetes
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Active, not recruitingPhase 3
AMAZE 2: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Type 2 Diabetes Lose Weight
Diabetes Mellitus, Overweight
Not yet recruiting
Use and Acceptability of an AI-Assisted Health Application for Individuals Living With a Chronic Condition
Hypertension, Diabetes Mellitus, Type 2
Not yet recruitingObservational study
Obesity-Related Indices and Albuminuria in Type 2 Diabetes
Obesity and Diabetes Mellitus, Type 2, Albuminuria
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Skill Training and Meal Provisioning in people with Obesity and Type 2 Diabetes, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight (time frame: Through study completion, an average of 25 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06800794, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.