Mobile Regulation of Craving Training (mROC-T) to Improve Dietary Intake in Rural Adolescent Girls

NCT06723028 | Active Not Recruiting

• 2 other identifiers: 23-1420-P000211-22-JDFN-03
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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. 1.What is the effect of a mobile app version of the regulation of craving training intervention on healthy eating index scores over one year?
2. 2.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.

Conditions

Obesity and Type 2 Diabetes; Diet Modification

Keywords

mobile app; cognitive behavioral therapy; fruit and vegetable intake; type 2 diabetes prevention; rural; adolescents

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (2)

• Body mass index

  1 year

• Blood sugar

  1 year

Other Outcomes (2)

• Blood sugar dynamics

  1 year

• Insulin sensitivity

  1 year

Study Arms (3)

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)

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)

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)

Behavioral: Regulation of craving training

Interventions

Regulation of craving training BEHAVIORAL

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. 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)

Control; Critical regulation of craving training; Positive regulation of craving training

Eligibility Criteria

• Age: 15 Years - 18 Years
• Gender Eligibility Details: Currently we are studying participants who are biologically female and who consider themselves female.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Biologically female
• Female gender
• Between the ages of 15y and 18y

You may not qualify if:

• 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)
• Precocious puberty
• Crohn's disease
• Congenital heart defect
• Cystic fibrosis
• Cerebral palsy
• Anorexia nervosa
• Bulimia nervosa
• Active infection
• Fever

Sponsors & Collaborators

• American Diabetes Association: collaborator
• University of Wyoming: lead

Study Sites (1)

University of Wyoming

Laramie, Wyoming, 80270, United States

Location

Related Publications (5)

• 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.

  PMID: 27842263 BACKGROUND

• Boswell 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.

  PMID: 26644270 BACKGROUND

• Miri 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.

  PMID: 31235156 BACKGROUND

• Boswell 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.

  PMID: 30420496 BACKGROUND

• Bryan 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.

  PMID: 27621440 BACKGROUND

Related Links

• Preregistration
• Data safety monitoring plan

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 Officials

• Grace Shearrer, PhD

  University of Wyoming

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 9, 2024
• Study Start: February 1, 2025
• Primary Completion: February 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: We will share our data 6-months after the publication of our main effects paper for up to 24 months
• Access Criteria: Data that will be shared: All of the individual participant data collected during the trial, after de-identification. Other documents that will be available: Study Protocol, Statistical Analysis Plan, Informed Consent Form, Clinical Study Report, Analytic Code Timeframe: Beginning 6 months and ending 24 months following article publication Who is able to access the data: Researchers who provide a methodologically sound proposal with delineation of publication expectations and authorship outlined. Types of analysis: To achieve aims in the approved proposal. Mechanism data will be made available: Proposals should be directed to Dr. Shearrer. To gain access, data requestors will need to sign a data access agreement and submit a proposal.

Locations

US (1)