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Pre-diabetesNCT03336411

A Personalized Diet Study to Reduce Glycemic Exposure

A study testing mHealth and Personalized mHealth in people with Pre-diabetes and Overweight and Obesity, run by NYU Langone Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Pre-diabetes, Overweight and Obesity
What is being tested?
mHealth and Personalized mHealth
Could I receive a placebo?
No, everyone receives an active treatment
How many people
269 participants
Where
1 siteUnited States
Study dates
12 Dec 2017to 27 Oct 2021
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 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • New York University School of Medicine

    New York, New York, 10016

Other trials in United States

About this study

Official title: Personalized Technology-Supported Counseling to Reduce Glycemic Response in Dietary Weight Loss: The Personal Diet Study

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.

Being tested
mHealth, Personalized mHealth
Medical subject headings
Glucose Intolerance, Overweight, Obesity

What participants receive

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

  • mHealthBehavioural

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

  • Personalized mHealthBehavioural

    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.

Study groups in NCT03336411
Study groupRoleWhat they receive
mHealthActive comparatorNot described
Receives: Behavioral: Personalized mHealth
Personalized mHealthExperimentalNot described
Receives: Behavioral: mHealth

What is being measured

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

  1. Body weight, percent change

    the primary outcome will be relative weight change as a percentage of body weight at baseline and 6-months using calibrated scale.

    Measured: 6 months

Secondary outcomes (3)

  1. Body Composition

    the secondary outcome will be absolute and relative changes in fat and lean body mass based on bioelectrical impedance analysis (BIA) from baseline to 6-months, 6-months to 12-months and baseline to 12-months

    Measured: 6 & 12 months

  2. Metabolic Adaptation

    the secondary outcome will be the change in resting metabolic rate overall, and in relation to body weight and lean body mass from baseline to 6-months, 6- to 12-months, and baseline to 12-months. Resting metabolic rate will be estimated using indirect calorimetry with the participant in a fasting state (12 hours)

    Measured: 6 & 12 months

  3. Weight regain

    Measured: 12 months

Timeline

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

  1. First posted8 Nov 2017
  2. Study start12 Dec 2017
  3. Primary completion1 Apr 2021
  4. Study completion27 Oct 2021

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
269 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03336411
Sponsor's protocol ID
17-00741
Status last verified
Mar 2022
First submitted
6 Nov 2017
Last updated
10 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Berube LT, Wang C, Curran M, Pompeii ML, Hu L, Barua S, Li H, St-Jules DE, Schoenthaler A, Segal E, Bergman M, Popp CJ. Personalized Dietary Feedback Mediates the Association of Dietary Self-Monitoring Adherence and Weight Loss: A Post Hoc Analysis of the Personal Diet Study. J Nutr. 2026 Mar;156(3):101364. doi: 10.1016/j.tjnut.2026.101364. Epub 2026 Jan 13.

    PubMed 41539436

  • Kharmats AY, Popp C, Hu L, Berube L, Curran M, Wang C, Pompeii ML, Li H, Bergman M, St-Jules DE, Segal E, Schoenthaler A, Williams N, Schmidt AM, Barua S, Sevick MA. A randomized clinical trial comparing low-fat with precision nutrition-based diets for weight loss: impact on glycemic variability and HbA1c. Am J Clin Nutr. 2023 Aug;118(2):443-451. doi: 10.1016/j.ajcnut.2023.05.026. Epub 2023 May 24.

    PubMed 37236549

  • Popp CJ, Hu L, Kharmats AY, Curran M, Berube L, Wang C, Pompeii ML, Illiano P, St-Jules DE, Mottern M, Li H, Williams N, Schoenthaler A, Segal E, Godneva A, Thomas D, Bergman M, Schmidt AM, Sevick MA. Effect of a Personalized Diet to Reduce Postprandial Glycemic Response vs a Low-fat Diet on Weight Loss in Adults With Abnormal Glucose Metabolism and Obesity: A Randomized Clinical Trial. JAMA Netw Open. 2022 Sep 1;5(9):e2233760. doi: 10.1001/jamanetworkopen.2022.33760.

    PubMed 36169954

  • Popp CJ, Zhou B, Manigrasso MB, Li H, Curran M, Hu L, St-Jules DE, Aleman JO, Vanegas SM, Jay M, Bergman M, Segal E, Sevick MA, Schmidt AM. Soluble Receptor for Advanced Glycation End Products (sRAGE) Isoforms Predict Changes in Resting Energy Expenditure in Adults with Obesity during Weight Loss. Curr Dev Nutr. 2022 Mar 29;6(5):nzac046. doi: 10.1093/cdn/nzac046. eCollection 2022 May.

    PubMed 35542387

  • Popp CJ, Butler M, Curran M, Illiano P, Sevick MA, St-Jules DE. Evaluating steady-state resting energy expenditure using indirect calorimetry in adults with overweight and obesity. Clin Nutr. 2020 Jul;39(7):2220-2226. doi: 10.1016/j.clnu.2019.10.002. Epub 2019 Oct 14.

    PubMed 31669004

  • Popp CJ, St-Jules DE, Hu L, Ganguzza L, Illiano P, Curran M, Li H, Schoenthaler A, Bergman M, Schmidt AM, Segal E, Godneva A, Sevick MA. The rationale and design of the personal diet study, a randomized clinical trial evaluating a personalized approach to weight loss in individuals with pre-diabetes and early-stage type 2 diabetes. Contemp Clin Trials. 2019 Apr;79:80-88. doi: 10.1016/j.cct.2019.03.001. Epub 2019 Mar 4.

    PubMed 30844471

Questions about this trial

What is this clinical trial studying?

A study testing mHealth and Personalized mHealth in people with Pre-diabetes and Overweight and Obesity, run by NYU Langone Health 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 4 inclusion and 17 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: finished, as of the sponsor's last update on 10 Mar 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Body weight, percent change (time frame: 6 months). 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 NCT03336411, which also lists 6 linked publications.

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 10 Mar 2022; AzTrials last refreshed its copy on 30 Oct 2026.

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