Towards Understanding the Relationship Between Meals and Blood Biomarkers

Texas A&M University

Status: Unknown

Conditions: Type 2 Diabetes

Treatments: Behavioral: Counterfactual Intervention

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05295706

IRB2020-0005F

Details and patient eligibility

About

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).

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Intervention Group

Experimental group

Description:

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.

Treatment:

Behavioral: Counterfactual Intervention

Control Group

No Intervention group

Description:

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.