NCT03336411

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
269

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 8, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

December 12, 2017

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 27, 2021

Completed
Last Updated

March 10, 2022

Status Verified

March 1, 2022

Enrollment Period

3.3 years

First QC Date

November 6, 2017

Last Update Submit

March 8, 2022

Conditions

Pre-diabetesOverweight and Obesity

Outcome Measures

Primary Outcomes (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.

    6 months

Secondary Outcomes (3)

  • Body Composition

    6 & 12 months

  • Metabolic Adaptation

    6 & 12 months

  • Weight regain

    12 months

Other Outcomes (4)

  • Glycemic variability (GV )

    6 months

  • RAGE/AGE/S100/A8/A9

    6 & 12 MONTHS

  • Adipokines

    6 & 12 months

  • +1 more other outcomes

Study Arms (2)

mHealth

ACTIVE COMPARATOR
Behavioral: Personalized mHealth

Personalized mHealth

EXPERIMENTAL
Behavioral: mHealth

Interventions

mHealthBEHAVIORAL

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

Personalized mHealth
Personalized mHealthBEHAVIORAL

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.

mHealth

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

Related Publications (6)

  • 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 Jan 13:101364. doi: 10.1016/j.tjnut.2026.101364. Online ahead of print.

    PMID: 41539436DERIVED

  • 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.

    PMID: 37236549DERIVED

  • 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.

    PMID: 36169954DERIVED

  • 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.

    PMID: 35542387DERIVED

  • 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.

    PMID: 31669004DERIVED

  • 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.

    PMID: 30844471DERIVED

MeSH Terms

Conditions

Glucose IntoleranceOverweightObesity

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Mary Ann Sevick, ScD

    NYU Langone Medical Center, Department of Population Health

    PRINCIPAL INVESTIGATOR

  • Eran Segal, PhD

    Weizmann Institute of Science, Department of Computer Science and Applied Mathematics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2017

First Posted

November 8, 2017

Study Start

December 12, 2017

Primary Completion

April 1, 2021

Study Completion

October 27, 2021

Last Updated

March 10, 2022

Record last verified: 2022-03

Locations

US(1)