Obesity and Type 2 DiabetesROC Teens!NCT06723028
Mobile Regulation of Craving Training (mROC-T) to Improve Dietary Intake in Rural Adolescent Girls
A study testing Regulation of craving training in people with Obesity and Type 2 Diabetes and Diet Modification, run by University of Wyoming at 1 site in United States.
Trial summary
The goal of this clinical trial is to test if a regulation of craving training intervention in the form of a mobile phone app can increase fruit and vegetable intake in adolescent girls ages 14-18 years of age. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 15 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity and Type 2 Diabetes, Diet Modification
- What is being tested?
- Regulation of craving training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2025to 1 Nov 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 15 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Biologically female
- Female gender
- Between the ages of 15y and 18y
Who cannot join
- Biologically male
- Self-identify as male
- BMI percentile (for age and sex) < 5th%
- Diagnosis from a medical profession of any of the following conditions, syndromes, diseases that may affect growth, glucose metabolism, blood clotting, cognitive development*:
- Any form of or history of cancer
- Any form of diabetes (type I, II, insipidus)
Show all 61Show fewer
- Precocious puberty
- Crohn's disease
- Congenital heart defect
- Cystic fibrosis
- Cerebral palsy
- Anorexia nervosa
- Bulimia nervosa
- Active infection
- Fever
- Hemophilia
- Hydrocephalus
- intestinal atresia
- Jeune syndrome
- Klippel-Trénaunay syndrome
- Legg-Calvé-Perthes
- Long QT syndrome
- Muenke syndrome
- Myelomeningocele
- Necrotizing Enterocolitis
- Neutropenia
- Non-alcholoic fatty liver diease
- Pfeiffer Syndrome
- Saethre-Chotzen syndrome
- Shwachman-Diamond syndrome
- Spinal muscular atrophy
- Sturge-Weber syndrome
- Ulcerative Colitis
- von Willebrand disease
- Pancreatitis
- Hurler syndrome
- Niemann-Pick disease
- Tay-Sachs disease
- Gaucher disease
- Krabbe disease
- Zellweger syndrome
- Wilson disease
- Brachial Plexus Palsy
- Brain Abscess or Spinal Abscess
- Coarctation of the Aorta
- Aortic stenosis
- Ventricular septal defect
- Patent ductus arteriosus or mitral valve abnormalities
- Congenital Adrenal Hyperplasia
- Craniofacial Microsomia
- Duchenne Muscular Dystrophy
- Dyskeratosis Congenita
- Galactosemia
- Maple syrup urine disease
- Phenylketonuria
- Turner syndrome
- Prader-Wili disease
- History of polycystic ovary syndrome
- History of thyroid disease (either hyper or hypo)
- History of adrenal disease (including Cushing's syndrome, Addison's disease)
- Use of medications related to metabolism/weight such as insulin, corticosteroids, growth hormone, sulfonylurea, thiazolidinediones, beta blockers, calcium channel blockers, bupropion, reboxetine, molindone, clozapine, olanzapine, topiramate, zonisamide, valproate, carbamazepine, lithium, hypolipidemic drugs, highly-active antiretroviral therapies
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to test if a regulation of craving training intervention in the form of a mobile phone app can increase fruit and vegetable intake in adolescent girls ages 14-18 years of age. The main questions it aims to answer are:
- What is the effect of a mobile app version of the regulation of craving training intervention on healthy eating index scores over one year?
- What is the effect of a mobile app version of the regulation of craving training intervention on body mass index, waist circumference, and blood glucose over one year? Researchers will compare the active regulation of craving training arm to a control fun food fact arm to see if the regulation of craving training improves HEI scores, BMI, and blood glucose over a year. Participants will be asked to play the regulation of craving training mobile app twice a week for a year.
Read the detailed description
Randomization: Participants will be randomized to either an active mROC-T group (mROC-T+ or mROC-Tc) or a craving rating only (CRO) control group stratified by race/ethnicity and BMI%. We will use urn randomization for participant assignment.
Baseline and 1-year follow up in-person visit measures Oral glucose tolerance test (OGTT): We will use a standard NHANES oral glucose tolerance test (OGTT) to assess the participants' glucose disposal. Participants will be fasted for at least eight hours. A fasted blood draw will be performed via finger stick. We will analyze glucose concentration using the HemoCue Glucose 201 analyzer and HbA1c using Abbott Afinion™ HbA1c analyzer. The participants will then drink a glucose bolus dosed at 1.75g glucose/kg body weight. Subsequent samples will be taken at 30, 60, 90, and 120-minutes. During which time the participant will play the mROC-T game and record their diet recall of the previous day. Participants will complete the puberty development scale (PDS), which has shown good epidemiological validity and is a suitable control variable. We will also measure height, weight, waist circumference using NHANES protocols. We will measure trait food craving using the Food Craving Questionnaire (trait).
Overall model for aims 1 and 2: For both aims we will use mixed-effect models (MEM, allows us to model random intercepts for participants by location and random slopes for the intervention by time) and estimated marginal means (EMM, corrects for potential imbalanced data). Covariates (COV) are baseline PDS, FCQT, race/ethnicity, and age. Intervention is a categorical variable representing intervention group.
Aim1 assesses the effect of the intervention over 1 year compared to baseline in the mROC-T and CRO groups on HEI calculated monthly. Fixed effects will be considered significant at p≤ 0.02. HEI1-year ~ Intervention*x(time) + HEIbaseline + COV; where x() is the time function (see note below)
Time note: we plan on modeling time using linear, power polynomials (square and cubic), and logistic functions. We will compare the different time powered models using ANOVAs and consider p ≤ 0.05 a significant difference between models, and Akaike information criterion (AIC) to assess model parsimony.
Aim 1 expected results: Based on a 6% increase in HEI after a similar 3-month intervention, we hypothesize a clinically meaningful 10% increase in HEI after 1 year in the mROC-T groups regardless of valance, and thus a 6% reduction in T2D risk. Dr. Kober has not seen a difference between the positive or negative mROC-T conditions on eating behavior, therefore we do not expect a difference.
Aim2 assesses the effect of the mROC-T and CRO intervention over 1 year on change in anthropometric (BMI%, BMIz, WC) and HbA1c measures in participants (n=40) with overweight or obesity (BMI% > 85th) and compares them to recommended weight participants matched for age, race/ethnicity, and PDS (n=40).
Absolute change in Outcome1-year ~ Intervention* BMI group(baseline) + Outcomebaseline + COV; where Outcome is BMI%, BMIz, WC, or HbA1c; COV includes baseline BMI%, WC, and/or HbA1c if not the outcome
Aim 2 Expected Results: We hypothesize a 0.25 reduction in BMIz (about a 2% decrease in BMI%) and a 3% decrease in WC in the intervention group only. A decrease of 0.25 BMIz is related to improved insulin sensitivity in adolescents. Given the expected improvement in HEI and BMIz associated with improved insulin sensitivity/lower T2D risk we hypothesize a clinically meaningful reduction in HbA1c of 0.5%.
Exploratory analysis: We will also use the model from aim 2 to explore glucose AUC and 1-hr glucose value. We will test the effect of the intervention on glucose curves using binary logistic regression.
- Conditions
- Obesity and Type 2 Diabetes, Diet Modification
- Being tested
- Regulation of craving training
- Keywords
- mobile app, cognitive behavioral therapy, fruit and vegetable intake, type 2 diabetes prevention, rural, adolescents
- 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.
Regulation of craving trainingBehavioural
Participants randomized into the active mROC-T intervention (mROC-T+ or mROC-Tc) will: 1. Read a brief essay about either the social justice benefits of eating healthy foods (POSITIVE, mROCT+) or critical of social justice aspects of unhealthy foods (CRITICAL, mROC-Tc). 2. Participants complete six free-response questions to ensure that they understood the essays.
- Participants are instructed to use the information from the essay. They are shown a cue matching the essay they read either: "Think Positive" or "Think Critically".
- They are shown an image of a healthy food (no added sugar and < 2g/serving saturated fat) OR an image of an unhealthy food (contain added sugar and/or >4.5g/serving saturated fat). 5. Finally, the participant is asked to rate how strong their craving is for the pictured food. The participant indicates their craving on a VAS from 1 (No craving at all) to 5 (Very high craving)
| Study group | Role | What they receive |
|---|---|---|
| Positive regulation of craving training | Experimental | Participants randomized into the active mROC-T intervention (mROC-T+) will:
1. Read a brief essay about the social justice benefits of eating healthy foods
2. Participants complete six free-response questions to ensure that they understood the essays.
3. Participants are instructed to use the information from the essay. They are shown a cue matching the essay: "Think Positive"
4. They are shown an image of a healthy food (no added sugar and < 2g/serving saturated fat) OR an image of an unhealthy food (contain added sugar and/or >4.5g/serving saturated fat).
5. The participant is asked to rate how strong their craving is for the pictured food. The participant indicates their craving on a VAS from 1 (No craving at all) to 5 (Very high craving) Receives: Behavioral: Regulation of craving training |
| Critical regulation of craving training | Experimental | Participants randomized into the active mROC-T intervention (mROC-Tc) will:
1. Read a brief essay about the social justice consequences of eating unhealthy foods (CIRITCAL, mROCTc)
2. Participants complete six free-response questions to ensure that they understood the essays.
3. Participants are instructed to use the information from the essay. They are shown a cue matching the essay: "Think Critical"
4. They are shown an image of a healthy food (no added sugar and < 2g/serving saturated fat) OR an image of an unhealthy food (contain added sugar and/or >4.5g/serving saturated fat).
5. The participant is asked to rate how strong their craving is for the pictured food. The participant indicates their craving on a VAS from 1 (No craving at all) to 5 (Very high craving) Receives: Behavioral: Regulation of craving training |
| Control | Sham comparator | Participants randomized to the control (CRO) group will:
1. Read a brief essay about fun food trivia (unrelated to any aspects of perceived healthiness). The essays are matched on structure/word count to the mROC-T essays.
2. Participants complete six free-response questions to ensure that they understood the essays.
3. Participants are instructed to use the information from the essay. They are shown a cue matching the essay, either: "Think Relaxed" or "Think Serene".
4. They are shown an image of a healthy food (no added sugar and < 2g/serving saturated fat) OR an image of an unhealthy food (contain added sugar and/or >4.5g/serving saturated fat).
5. The participant is asked to rate how strong their craving is for the pictured food. The participant indicates their craving on a VAS from 1 (No craving at all) to 5 (Very high craving) Receives: Behavioral: Regulation of craving training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healthy eating index (HEI)
Participants will provide diet recalls twice per month. The participants will complete the diet recalls using the Automated Self Administered 24 hour recall (ASA-24) platform. The ASA-24 computes the necessary variables to calculate the healthy eating index (HEI). HEI is a measure of overall diet quality according to the Dietary Guidelines for Americans and is scored from 0-100 (100 being the best possible diet). HEI scores will be calculated per month (mean of diet recalls per person) using the most recent HEI scoring algorithm as recommended for intervention studies.
Measured: 1 year
Secondary outcomes (2)
Body mass index
We will measure height (cm) and weight (kg) in triplicate to the nearest 0.1. Using the height and weight measurement we will calculate body mass index (BMI). We will then use the participants' age and biological sex to derive BMI percentile (BMI%) for age and sex and BMI z-score (BMIz) for age and sex.
Measured: 1 year
Blood sugar
We will measure blood sugar using hemoglobin A1c (HbA1c). HbA1c reflects an individual's average blood sugar over the past 2-3 months.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start1 Feb 2025
- Primary completion1 Feb 2026
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Obesity and Type 2 DiabetesStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wyoming
- Sponsor type
- University, hospital or other
- Collaborators
- American Diabetes Association
- Responsible party
- Principal investigator, Grace Elisabeth Shearrer, University of Wyoming
- Investigators
- Grace Shearrer, PhD, Principal investigator, University of Wyoming
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06723028
- Sponsor's protocol ID
- 23-1420-P0002
- Other IDs
- 11-22-JDFN-03
- Acronym
- ROC Teens!
- Status last verified
- Apr 2026
- First submitted
- 3 Dec 2024
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share our data 6-months after the publication of our main effects paper. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). Requests can be made to Dr. Shearrer.
Publications
Jensen CD, Duraccio KM, Barnett KA, Stevens KS. Appropriateness of the food-pics image database for experimental eating and appetite research with adolescents. Eat Behav. 2016 Dec;23:195-199. doi: 10.1016/j.eatbeh.2016.10.007. Epub 2016 Oct 27.
PubMed 27842263Boswell RG, Kober H. Food cue reactivity and craving predict eating and weight gain: a meta-analytic review. Obes Rev. 2016 Feb;17(2):159-77. doi: 10.1111/obr.12354. Epub 2015 Dec 8.
PubMed 26644270Miri SF, Javadi M, Lin CY, Griffiths MD, Bjork M, Pakpour AH. Effectiveness of cognitive-behavioral therapy on nutrition improvement and weight of overweight and obese adolescents: A randomized controlled trial. Diabetes Metab Syndr. 2019 May-Jun;13(3):2190-2197. doi: 10.1016/j.dsx.2019.05.010. Epub 2019 May 22.
PubMed 31235156Boswell RG, Sun W, Suzuki S, Kober H. Training in cognitive strategies reduces eating and improves food choice. Proc Natl Acad Sci U S A. 2018 Nov 27;115(48):E11238-E11247. doi: 10.1073/pnas.1717092115. Epub 2018 Nov 12.
PubMed 30420496Bryan CJ, Yeager DS, Hinojosa CP, Chabot A, Bergen H, Kawamura M, Steubing F. Harnessing adolescent values to motivate healthier eating. Proc Natl Acad Sci U S A. 2016 Sep 27;113(39):10830-5. doi: 10.1073/pnas.1604586113. Epub 2016 Sep 12.
PubMed 27621440
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Regulation of Craving Training (mROC-T) to Improve Dietary Intake in Rural Adolescent Girls
- ClinicalTrials.gov ID
- NCT06723028
- Acronym / sponsor ID
- ROC Teens! / 23-1420-P0002
- Conditions
- Obesity and Type 2 Diabetes, Diet Modification
- Keywords
- mobile app, cognitive behavioral therapy, fruit and vegetable intake, type 2 diabetes prevention, rural, adolescents
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of WyomingUniversity, hospital or other
- Collaborators
- American Diabetes Association
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 9 Dec 2024 (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.
The goal of this clinical trial is to test if a regulation of craving training intervention in the form of a mobile phone app can increase fruit and vegetable intake in adolescent girls ages 14-18 years of age. The main questions it aims to answer are:
- What is the effect of a mobile app version of the regulation of craving training intervention on healthy eating index scores over one year?
- What is the effect of a mobile app version of the regulation of craving training intervention on body mass index, waist circumference, and blood glucose over one year? Researchers will compare the active regulation of craving training arm to a control fun food fact arm to see if the regulation of craving training improves HEI scores, BMI, and blood glucose over a year. Participants will be asked to play the regulation of craving training mobile app twice a week for a year.
Detailed description
Randomization: Participants will be randomized to either an active mROC-T group (mROC-T+ or mROC-Tc) or a craving rating only (CRO) control group stratified by race/ethnicity and BMI%. We will use urn randomization for participant assignment.
Baseline and 1-year follow up in-person visit measures Oral glucose tolerance test (OGTT): We will use a standard NHANES oral glucose tolerance test (OGTT) to assess the participants' glucose disposal. Participants will be fasted for at least eight hours. A fasted blood draw will be performed via finger stick. We will analyze glucose concentration using the HemoCue Glucose 201 analyzer and HbA1c using Abbott Afinion™ HbA1c analyzer. The participants will then drink a glucose bolus dosed at 1.75g glucose/kg body weight. Subsequent samples will be taken at 30, 60, 90, and 120-minutes. During which time the participant will play the mROC-T game and record their diet recall of the previous day. Participants will complete the puberty development scale (PDS), which has shown good epidemiological validity and is a suitable control variable. We will also measure height, weight, waist circumference using NHANES protocols. We will measure trait food craving using the Food Craving Questionnaire (trait).
Overall model for aims 1 and 2: For both aims we will use mixed-effect models (MEM, allows us to model random intercepts for participants by location and random slopes for the intervention by time) and estimated marginal means (EMM, corrects for potential imbalanced data). Covariates (COV) are baseline PDS, FCQT, race/ethnicity, and age. Intervention is a categorical variable representing intervention group.
Aim1 assesses the effect of the intervention over 1 year compared to baseline in the mROC-T and CRO groups on HEI calculated monthly. Fixed effects will be considered significant at p≤ 0.02. HEI1-year ~ Intervention*x(time) + HEIbaseline + COV; where x() is the time function (see note below)
Time note: we plan on modeling time using linear, power polynomials (square and cubic), and logistic functions. We will compare the different time powered models using ANOVAs and consider p ≤ 0.05 a significant difference between models, and Akaike information criterion (AIC) to assess model parsimony.
Aim 1 expected results: Based on a 6% increase in HEI after a similar 3-month intervention, we hypothesize a clinically meaningful 10% increase in HEI after 1 year in the mROC-T groups regardless of valance, and thus a 6% reduction in T2D risk. Dr. Kober has not seen a difference between the positive or negative mROC-T conditions on eating behavior, therefore we do not expect a difference.
Aim2 assesses the effect of the mROC-T and CRO intervention over 1 year on change in anthropometric (BMI%, BMIz, WC) and HbA1c measures in participants (n=40) with overweight or obesity (BMI% > 85th) and compares them to recommended weight participants matched for age, race/ethnicity, and PDS (n=40).
Absolute change in Outcome1-year ~ Intervention* BMI group(baseline) + Outcomebaseline + COV; where Outcome is BMI%, BMIz, WC, or HbA1c; COV includes baseline BMI%, WC, and/or HbA1c if not the outcome
Aim 2 Expected Results: We hypothesize a 0.25 reduction in BMIz (about a 2% decrease in BMI%) and a 3% decrease in WC in the intervention group only. A decrease of 0.25 BMIz is related to improved insulin sensitivity in adolescents. Given the expected improvement in HEI and BMIz associated with improved insulin sensitivity/lower T2D risk we hypothesize a clinically meaningful reduction in HbA1c of 0.5%.
Exploratory analysis: We will also use the model from aim 2 to explore glucose AUC and 1-hr glucose value. We will test the effect of the intervention on glucose curves using binary logistic regression.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Positive regulation of craving training | Experimental | Behavioral: Regulation of craving trainingParticipants randomized into the active mROC-T intervention (mROC-T+) will: 1. Read a brief essay about the social justice benefits of eating healthy foods 2. Participants complete six free-response questions to ensure that they understood the essays. 3. Participants are instructed to use the information from the essay. They are shown a cue matching the essay: "Think Positive" 4. They are shown an image of a healthy food (no added sugar and < 2g/serving saturated fat) OR an image of an unhealthy food (contain added sugar and/or >4.5g/serving saturated fat). 5. The participant is asked to rate how strong their craving is for the pictured food. The participant indicates their craving on a VAS from 1 (No craving at all) to 5 (Very high craving) |
| Critical regulation of craving training | Experimental | Behavioral: Regulation of craving trainingParticipants randomized into the active mROC-T intervention (mROC-Tc) will: 1. Read a brief essay about the social justice consequences of eating unhealthy foods (CIRITCAL, mROCTc) 2. Participants complete six free-response questions to ensure that they understood the essays. 3. Participants are instructed to use the information from the essay. They are shown a cue matching the essay: "Think Critical" 4. They are shown an image of a healthy food (no added sugar and < 2g/serving saturated fat) OR an image of an unhealthy food (contain added sugar and/or >4.5g/serving saturated fat). 5. The participant is asked to rate how strong their craving is for the pictured food. The participant indicates their craving on a VAS from 1 (No craving at all) to 5 (Very high craving) |
| Control | Sham comparator | Behavioral: Regulation of craving trainingParticipants randomized to the control (CRO) group will: 1. Read a brief essay about fun food trivia (unrelated to any aspects of perceived healthiness). The essays are matched on structure/word count to the mROC-T essays. 2. Participants complete six free-response questions to ensure that they understood the essays. 3. Participants are instructed to use the information from the essay. They are shown a cue matching the essay, either: "Think Relaxed" or "Think Serene". 4. They are shown an image of a healthy food (no added sugar and < 2g/serving saturated fat) OR an image of an unhealthy food (contain added sugar and/or >4.5g/serving saturated fat). 5. The participant is asked to rate how strong their craving is for the pictured food. The participant indicates their craving on a VAS from 1 (No craving at all) to 5 (Very high craving) |
Who may qualify
- Ages
- 15 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Biologically female
- Female gender
- Between the ages of 15y and 18y
Key exclusion criteria (61 listed)
- Biologically male
- Self-identify as male
- BMI percentile (for age and sex) < 5th%
- Diagnosis from a medical profession of any of the following conditions, syndromes, diseases that may affect growth, glucose metabolism, blood clotting, cognitive development*:
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 |
|---|---|---|
| Regulation of craving trainingParticipants randomized into the active mROC-T intervention (mROC-T+ or mROC-Tc) will: 1. Read a brief essay about either the social justice benefits of eating healthy foods (POSITIVE, mROCT+) or critical of social justice aspects of unhealthy foods (CRITICAL, mROC-Tc). 2. Participants complete six free-response questions to ensure that they understood the essays. 3. Participants are instructed to use the information from the essay. They are shown a cue matching the essay they read either: "Think Positive" or "Think Critically". 4. They are shown an image of a healthy food (no added sugar and < 2g/serving saturated fat) OR an image of an unhealthy food (contain added sugar and/or >4.5g/serving saturated fat). 5. Finally, the participant is asked to rate how strong their craving is for the pictured food. The participant indicates their craving on a VAS from 1 (No craving at all) to 5 (Very high craving) | Behavioural | Control, Critical regulation of craving training, Positive regulation of craving training |
Primary outcome
Healthy eating index (HEI)
Time frame: 1 year
Participants will provide diet recalls twice per month. The participants will complete the diet recalls using the Automated Self Administered 24 hour recall (ASA-24) platform. The ASA-24 computes the necessary variables to calculate the healthy eating index (HEI). HEI is a measure of overall diet quality according to the Dietary Guidelines for Americans and is scored from 0-100 (100 being the best possible diet). HEI scores will be calculated per month (mean of diet recalls per person) using the most recent HEI scoring algorithm as recommended for intervention studies.
2 secondary outcomes
Body mass index
Time frame: 1 year
Blood sugar
Time frame: 1 year
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 5 May 2026.
- Background: PubMed 27842263Jensen CD, Duraccio KM, Barnett KA, Stevens KS. Appropriateness of the food-pics image database for experimental eating and appetite research with adolescents. Eat Behav. 2016 Dec;23:195-199. doi: 10.1016/j.eatbeh.2016.10.007. Epub 2016 Oct 27.
- Background: PubMed 26644270Boswell RG, Kober H. Food cue reactivity and craving predict eating and weight gain: a meta-analytic review. Obes Rev. 2016 Feb;17(2):159-77. doi: 10.1111/obr.12354. Epub 2015 Dec 8.
- Background: PubMed 31235156Miri SF, Javadi M, Lin CY, Griffiths MD, Bjork M, Pakpour AH. Effectiveness of cognitive-behavioral therapy on nutrition improvement and weight of overweight and obese adolescents: A randomized controlled trial. Diabetes Metab Syndr. 2019 May-Jun;13(3):2190-2197. doi: 10.1016/j.dsx.2019.05.010. Epub 2019 May 22.
- Background: PubMed 30420496Boswell RG, Sun W, Suzuki S, Kober H. Training in cognitive strategies reduces eating and improves food choice. Proc Natl Acad Sci U S A. 2018 Nov 27;115(48):E11238-E11247. doi: 10.1073/pnas.1717092115. Epub 2018 Nov 12.
- Background: PubMed 27621440Bryan CJ, Yeager DS, Hinojosa CP, Chabot A, Bergen H, Kawamura M, Steubing F. Harnessing adolescent values to motivate healthier eating. Proc Natl Acad Sci U S A. 2016 Sep 27;113(39):10830-5. doi: 10.1073/pnas.1604586113. Epub 2016 Sep 12.
- PreregistrationLink provided by the sponsor.
- Data safety monitoring planLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. We will share our data 6-months after the publication of our main effects paper. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). Requests can be made to Dr. Shearrer.
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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.
Grace Shearrer, PhD principal investigator
University of Wyoming
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regulation of craving training in people with Obesity and Type 2 Diabetes and Diet Modification, run by University of Wyoming 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 3 inclusion and 61 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 5 May 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. Some participants in this study may receive a placebo. 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?
Healthy eating index (HEI) (time frame: 1 year). 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 NCT06723028, which also lists 5 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 5 May 2026.