Personalized Dietary Management in Type 2 Diabetes

ACTIVE NOT RECRUITING

NCT05046886

NA

Sponsor: NYU Langone Health

Summary

In a randomized trial of 255 participants with early-stage T2D, participants will be randomized to 1 of 3 groups: Standardized, Personalized, or a Usual Care Control (UCC). In the first phase, participants will be randomized with equal allocation to these 3 groups. In the second phase (current phase), the remaining participants will be randomized with equal allocation to the Standardized and UCC groups.

Key Details

Gender

All

Age Range

21 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

294

Start Date

2021-12-14

Completion Date

2025-11-30

Last Updated

2025-09-18

Healthy Volunteers

No

Conditions

Type 2 Diabetes

Interventions

BEHAVIORAL

Standardized

Participants are instructed to follow a Mediterranean-style diet. Dietary counseling is paired with SCT-based behavioral counseling, which focuses on the role played by self-referent thought in the maintenance of behavior change. Self-efficacy (e.g., the participant's confidence in their ability to engage in healthier behavior) is derived from four major sources of information: mastery experiences, social modeling, verbal persuasion, and physiological states. Participants self-monitor their diet using a mobile app and receive real-time feedback from the app on macronutrient distribution.

BEHAVIORAL

Usual Care Control (UCC)

Participants are instructed to follow a Mediterranean-style diet,

BEHAVIORAL

Personalized Guidance to Minimize Postprandial Glycemic Response (PPGR)

Participants are instructed to follow a Mediterranean-style diet. Dietary counseling is paired with SCT-based behavioral counseling, which focuses on the role played by self-referent thought in the maintenance of behavior change. Self-efficacy (e.g., the participant's confidence in their ability to engage in healthier behavior) is derived from four major sources of information: mastery experiences, social modeling, verbal persuasion, and physiological states. Participants self-monitor their diet using a mobile app and receive real-time feedback from the app on their predicted PPGR to meals and snacks at the time they enter them into their smart phone. PPGR predictions will be generated from a gut microbiome-based machine learning algorithm.

Inclusion Criteria: * must be an adult 21-80 years of age * must be diagnosed with early-stage T2D defined as HbA1c\<8% and managed for the past 3 months on a diabetes regimen that included lifestyle plus metformin. * those who are willing and able to use a smart phone to self monitor their diet and to attend WebEx sessions Exclusion Criteria: * those who have conditions or treatments likely to alter the underlying function of the microbiome, an insulin response that is driven by factors other than glycemic response to food, conditions/treatments that make it difficult to isolate the true nature of the relationship between randomization assignment and weight loss, characteristics or preferences that would preclude meaningful participation in the study * those who are unable or unwilling to adhere to an intervention that requires dietary self-monitoring * those who have been prescribed: (1) antibiotics or antifungals in the past 3 months, (2) diabetic medications other than metformin, (3) weight loss medications, (4) chronic use of steroids or immunosuppressants, (5) atypical antipsychotics, and (6) chemotherapy. * those who are pregnant, planning to become pregnant during the study period, or become pregnant during the study * those who have a chronic disease that affects energy/glucose metabolism (e.g., Cushing's syndrome, acromegaly, hyperthyroidism) * those who require special dietary management (end-stage kidney disease, cirrhosis, HIV) * those who are unable or unwilling to provide informed consent * those who are unable to participate meaningfully in an intervention that involves self-monitoring using software available in English (e.g., uncorrected sight impairment, illiterate, non-English-speaking, dementia) * those who are unwilling to accept randomization assignment * those who have limited control over diet (e.g., are homeless or institutionalized, in a nursing home or personal care facility, or incarcerated) * those who have previously had bariatric surgery, or are unwilling to delay bariatric surgery for the next 7 months * those who are unable to walk without a walker or cane for 2 city blocks * those who have been diagnosed with a chronic active inflammatory or neoplastic disease in the past 3 years * those who have been diagnosed with a chronic gastrointestinal disorder (e.g., inflammatory bowel disease or celiac disease) * those who have an active substance use disorder

Locations (1)

NYU Langone Health

New York, New York, United States

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