Towards Understanding the Relationship Between Meals and Blood Biomarkers

May 16, 2022 updated by: Texas A&M University
The purpose of this study is to establish the reasonableness of using food-based photo diaries and continuous glucose monitors (CGM) to engage in counterfactual thinking strategies. These strategies may improve food choices among participants diagnosed with prediabetes (intervention group).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The long-term objective of this project is to create a counterfactual-based lifestyle intervention that curtails the progression of prediabetes to T2DM through management and knowledge of food choices. This is a significant objective since 70% of prediabetes patients go on to develop T2DM. The project addresses a major objective of PATHS-UP in general and Thrust 4 in particular, by developing an innovative behavior-change intervention that will eventually make use of information from the Lab-on-your-Wrist device. To our knowledge, this is the first project to (1) propose an intervention based on counterfactual thinking for diabetes prevention and (2) combine continuous glucose monitors (CGMs) and food photography to promote a better understanding of how food choices affect blood glucose.The specific aim of this project is to establish the validity of leveraging photo-based food diaries and CGMs to engage counterfactual thinking strategies that improve food choices amongst prediabetes participants. This will be measured by changes in (1) eating attitudes and behaviors, (2) behavioral intentions to improve healthy eating behavior, (3) motivation to improve eating behavior, (4) increased self- efficacy for healthy eating, and (5) number of glucose excursions and time-in-range.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • College Station, Texas, United States, 77845
        • Center for Translational Research in Age and Longevity

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ability to walk, sit down and stand up independently
  • Family history of type 2 diabetes
  • Overweight/obese status (BMI>= 25)
  • Subject is judged to be in satisfactory health based on medical history, physical examination
  • Willingness and ability to comply with the protocol
  • HbA1C levels are within the pre-diabetic range (5.7-6.4%) or fasting plasma glucose 100-125 mg/dL
  • Access to a smartphone device and willing to use WhatsApp to communicate with research personnel

Exclusion Criteria:

  • Subject has planned elective surgery requiring 2 or more days of hospitalization during the entire study

  • Planned medical procedures that are documented to interfere with CGM readings, such as:

    • Xylose absorption testing (oral sugar testing)
    • CT
    • MRI
    • X-ray
    • Diathermy treatment (high-frequency electric current to stimulate heat generation within body tissues)
  • Established diagnosis of malignancy
  • Presence of acute illness or metabolically unstable chronic illness
  • Any other condition according to the PI, nurse, or study coordinator that was found during the screening visit, that would interfere with the study or safety of the patient
  • Failure to give informed consent or Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention Group
Participants in this group will complete the same measures as the control group, but will additionally be involved in a counterfactual intervention conducted by an advanced graduate student.
Behavioral: Counterfactual Intervention
The intervention occurs during the third study visit. This is a counterfactual intervention, which will involve asking the subjects to think of an alternative reality that "might have been" based on the concurrency of their glucose readings and the meals they ate.
No Intervention: Control Group
Participants in this group will complete the same measures as the experimental group. Instead of being involved in a counterfactual intervention, participants will be asked about their intentions to complete future study components.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in average daily glucose level
Time Frame: Data will be collected in between study visits 1-4 (at baseline, 3 weeks, 4 weeks, and 6 weeks)
Collected via the Freestyle Libre Pro continuous glucose monitor placed on the participants' upper arm.
Data will be collected in between study visits 1-4 (at baseline, 3 weeks, 4 weeks, and 6 weeks)
Change in number of glucose excursions and time in range
Time Frame: Data will be collected in between study visits 1-4 (at baseline, 3 weeks, 4 weeks, and 6 weeks)
Collected via the Freestyle Libre Pro continuous glucose monitor placed on the participants' upper arm.
Data will be collected in between study visits 1-4 (at baseline, 3 weeks, 4 weeks, and 6 weeks)
Change in HbA1C
Time Frame: A blood sample will be collected at the screening visit, and at 6 weeks (Study Visit #4), 14 weeks (Study Visit #5), and 22 weeks (Study Visit #6).
Blood will be sampled through venipuncture technique on the upper arm. A blood sample of 4 mL will be collected for each measurement of the subject's A1c.
A blood sample will be collected at the screening visit, and at 6 weeks (Study Visit #4), 14 weeks (Study Visit #5), and 22 weeks (Study Visit #6).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in the Self Regulation of Eating Behaviors Questionnaire (SREBQ) scores
Time Frame: Collected via survey measures at baseline (Study Visit #1), 4 weeks (Study Visit #3), at 6 weeks (Study Visit #4), 14 weeks (Study Visit #5), and 22 weeks (Study Visit #6).
Participants will report their ability to regulate and/or change their eating habits. Items correspond to a Likert style format ranging from 1 (never) to 5 (always), where higher scores indicate worse regulation (aside from one item that must be reverse-scored).
Collected via survey measures at baseline (Study Visit #1), 4 weeks (Study Visit #3), at 6 weeks (Study Visit #4), 14 weeks (Study Visit #5), and 22 weeks (Study Visit #6).
Change in General Health Intentions (GHI) scores
Time Frame: Self-report general health intentions data will be collected at baseline (Study Visit #1), 4 weeks (Study Visit #3), 6 weeks (Study Visit #4), 14 weeks (Study Visit #5), and 22 weeks (Study Visit #6).
Participants will self-report their intentions to engage in healthier food habits over the next six months. Participants respond using a Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree), where higher scores indicate greater intentions to eat healthy.
Self-report general health intentions data will be collected at baseline (Study Visit #1), 4 weeks (Study Visit #3), 6 weeks (Study Visit #4), 14 weeks (Study Visit #5), and 22 weeks (Study Visit #6).
Change in Regulation of Eating Behaviors Scale (REBS) scores
Time Frame: Collected via survey measures at baseline (Study Visit #1), 6 weeks (Study Visit #4), 14 weeks (Study Visit #5), and 22 weeks (Study Visit #6).
Participants will self-report their motivations for eating via the Regulation of Eating Behaviors Scale, including whether they eat to cope with negative affect, to be social, to comply with others' expectations, and to enhance pleasure. Scores are measured on a Likert scale from 1 (does not correspond at all) to 7 (corresponds exactly), where higher scores indicate greater regulation of eating behaviors (with the exception of a few items that must be reverse-scored).
Collected via survey measures at baseline (Study Visit #1), 6 weeks (Study Visit #4), 14 weeks (Study Visit #5), and 22 weeks (Study Visit #6).
Change in the Eating Self-Efficacy Scale (ESES) scores
Time Frame: Data will be collected at baseline (Study Visit #1), 6 weeks (Study Visit #4), 14 weeks (Study Visit #5), and 22 weeks (Study Visit #6).
Participants respond to a survey (ESES) intended to measure self-efficacy and self-regulation of healthy eating. Items are answered using a Likert scale ranging from 1 (not difficult at all) to 7 (extremely difficult), where higher scores indicate greater use of excessive food intake in social and emotional situations.
Data will be collected at baseline (Study Visit #1), 6 weeks (Study Visit #4), 14 weeks (Study Visit #5), and 22 weeks (Study Visit #6).
Change in the Behavioral Strategies - Engagement and Intentions score
Time Frame: Collected once per week over the first 6 weeks.
Collected via questions developed through this study (Behavioral Strategies - Engagement and Intentions) by lead investigators asking about participant's (experimental group only) use of counterfactual strategies developed during Study Visit #3 (3 weeks) (e.g., "Reduce rice intake"). Responses are answered using a Likert scale ranging from 1 (none of the time) to 7 (most of the time), where higher scores indicate greater engagement and intentions to use behavioral strategies.
Collected once per week over the first 6 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Texas A&M University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
U.S. National Science Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 25, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 20, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB2020-0005F

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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