Clinical trial NCT05295706: Towards Understanding the Relationship Between Meals and Blood Biomarkers
Official title: Towards Understanding the Relationship Between Meals and Blood Biomarkers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Continuous glucose monitoring
Dietary habits
Counterfactual thinking
Lead sponsor: Texas A&M University
Sponsor class: OTHER
Collaborators: name: U.S. National Science Foundation
First posted: 2022-03-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Change in average daily glucose level
timeFrame: Data will be collected in between study visits 1-4 (at baseline, 3 weeks, 4 weeks, and 6 weeks)
measure: Change in number of glucose excursions and time in range
timeFrame: Data will be collected in between study visits 1-4 (at baseline, 3 weeks, 4 weeks, and 6 weeks)
measure: Change in HbA1C
timeFrame: 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 outcomes:
measure: Change in the Self Regulation of Eating Behaviors Questionnaire (SREBQ) scores
timeFrame: 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).
measure: Change in General Health Intentions (GHI) scores
timeFrame: 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).
measure: Change in Regulation of Eating Behaviors Scale (REBS) scores
timeFrame: 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).
measure: Change in the Eating Self-Efficacy Scale (ESES) scores
timeFrame: 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).
measure: Change in the Behavioral Strategies - Engagement and Intentions score
timeFrame: Collected once per week over the first 6 weeks.
Other outcomes:
Locations:
city: College Station
country: United States
facility: Center for Translational Research in Age and Longevity
state: Texas
Study officials:
References: