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Type 2 DiabetesNCT05295706

Towards Understanding the Relationship Between Meals and Blood Biomarkers

A study testing Counterfactual Intervention in people with Type 2 Diabetes, run by Texas A&M University at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes
What is being tested?
Counterfactual Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
1 Jun 2022to Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • Center for Translational Research in Age and Longevity

    College Station, Texas, 77845

Other trials in United States

About this study

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).

Read the 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
Being tested
Counterfactual Intervention
Keywords
Continuous glucose monitoring, Dietary habits, Counterfactual thinking
Medical subject headings
Diabetes Mellitus, Type 2, Feeding Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Counterfactual InterventionBehavioural

    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.

Study groups in NCT05295706
Study groupRoleWhat they receive
Intervention GroupExperimentalParticipants 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.
Receives: Behavioral: Counterfactual Intervention
Control GroupNo interventionParticipants 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in average daily glucose level

    Collected via the Freestyle Libre Pro continuous glucose monitor placed on the participants' upper arm.

    Measured: Data will be collected in between study visits 1-4 (at baseline, 3 weeks, 4 weeks, and 6 weeks)

  2. Change in number of glucose excursions and time in range

    Collected via the Freestyle Libre Pro continuous glucose monitor placed on the participants' upper arm.

    Measured: Data will be collected in between study visits 1-4 (at baseline, 3 weeks, 4 weeks, and 6 weeks)

  3. Change in HbA1C

    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.

    Measured: 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 (5)

  1. Change in the Self Regulation of Eating Behaviors Questionnaire (SREBQ) scores

    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).

    Measured: 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).

  2. Change in General Health Intentions (GHI) scores

    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.

    Measured: 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).

  3. Change in Regulation of Eating Behaviors Scale (REBS) scores

    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).

    Measured: 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).

  4. Change in the Eating Self-Efficacy Scale (ESES) scores

    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.

    Measured: 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).

  5. Change in the Behavioral Strategies - Engagement and Intentions score

    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.

    Measured: Collected once per week over the first 6 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2022
  2. Study start1 Jun 2022 (estimated)
  3. Primary completionDec 2022 (estimated)
  4. Study completionDec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05295706
Sponsor's protocol ID
IRB2020-0005F
Status last verified
Sep 2021
First submitted
25 Feb 2022
Last updated
20 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Counterfactual Intervention in people with Type 2 Diabetes, run by Texas A&M University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05295706.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2022.

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