Towards Understanding the Relationship Between Meals and Blood Biomarkers

NCT ID: NCT05295706

Last Updated: 2022-05-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2022-12-31

Brief Summary

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).

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Counterfactual Intervention

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

U.S. National Science Foundation

FED

Sponsor Role: collaborator

Texas A&M University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Center for Translational Research in Age and Longevity

College Station, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

IRB2020-0005F

Identifier Type: -

Identifier Source: org_study_id