A Personalized Diet Study to Reduce Glycemic Exposure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

269 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-12

Study Completion Date

2021-10-27

Brief Summary

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The aim of this 2-phase, randomized clinical trial will be to examine the effects of two behavioral weight loss interventions on weight loss. This study will be conducted in 200 overweight or obese prediabetic individuals recruited from community-based settings.. Phase 1 will include 6-months of active intervention. Phase 2 will consist of 6-months of maintenance and observation. Measurements will occur at screening, baseline, 3, 6, and 12 months. Participants will be randomized with equal allocation to 2 groups: (1) a standardized behavioral weight loss intervention with a one-size-fits-all regimen that includes counseling about restriction of calories and calories from fat, and physical activity, delivered using mHealth technology, or (2) all of the elements of mHealth, plus personalized dietary recommendations to minimize glycemic response to meals. Participants will be required to attend 6 separate visits over both phases of the study.

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Detailed Description

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Conditions

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Pre-diabetes Overweight and Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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mHealth

Group Type ACTIVE_COMPARATOR

Personalized mHealth

Intervention Type BEHAVIORAL

Behavioral weight loss intervention with personalized dietary recommendations based on machine learning algorithm that integrates gut microbiota, dietary intake, physical activity and various blood parameters to predict postprandial glycemic response.

Personalized mHealth

Group Type EXPERIMENTAL

mHealth

Intervention Type BEHAVIORAL

Behavioral weight loss intervention using behavioral counseling focusing on physical activity and a one-size-fits-all, calorie-restricted, diet.

Interventions

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mHealth

Behavioral weight loss intervention using behavioral counseling focusing on physical activity and a one-size-fits-all, calorie-restricted, diet.

Intervention Type BEHAVIORAL

Personalized mHealth

Behavioral weight loss intervention with personalized dietary recommendations based on machine learning algorithm that integrates gut microbiota, dietary intake, physical activity and various blood parameters to predict postprandial glycemic response.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Healthy overweight or obese prediabetic (HbA1c \<8.0%)
* BMI ≥27 kg/m2
* Oral medications with metformin, sulfonylureas, DPP4 inhibitors
* Posses smartphone or use study loaner smartphone

Exclusion Criteria

* unable or unwilling to provide informed consent
* unable to participate meaningfully in an intervention that involves self-monitoring using software available in English (e.g., due to uncorrected sight impairment, illiterate, non-English-speaking, dementia)
* unwilling to accept randomization assignment
* women who pregnant, or plan to become pregnant in the next 13 months, or who become pregnant during the study
* institutionalized (e.g., in a nursing home or personal care facility, or those who are incarcerated and have limited control over diet)
* unwilling to delay bariatric surgery for the next 12 months
* diagnosed with heart disease, kidney disease, or retinopathy, (to rule-out those with long-standing T2D)
* chronically active inflammatory or neoplastic disease in the past 3 years
* diagnosed with a chronic gastrointestinal disorder (e.g. inflammatory bowel disease or celiac disease)
* diagnosed with active infection requiring antibiotics in the last 3 months or who develop an active infection requiring antibiotics during the study
* taking medications containing acetaminophen and are unwilling or unable to discontinue its use during the study (acetaminophen affects the accuracy of the continuous glucose monitoring \[CGM\] device)
* taking chronic immunosuppressive medications or used them in the 3 months prior to participation, or during the study
* managing glycemia with insulin, GLP-I agonists (exenatide, liraglutide, lixisenatide, albiglutide, dulaglutide), insulin secretagogues (Glimepiride, Glipizide, Glyburide, Repaglinide, Nateglinide), or SGLT2 inhibitors (canagliflozin, dapagliflozin, empagliflozin, empagliflozin/metformin, dapagliflozin/metformin)
* prescribed medications expected to result in weight loss such as Orlistat, Naltrexone, Bupropion, Lorcaserin, Phentermine, Topiramate, or Liraglutide, and who are unwilling to delay treatment with these medications for the next 12 months
* +/- 5% weight change within last month at screening
* a eGFR \<60 mL/min/1.73m2
* younger than 18 or older than 80 years old.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes