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A Personalized Diet Study to Reduce Glycemic Exposure 269 Randomisiert Ernährung Personalisiert

Abgeschlossen
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Die klinische Studie NCT03336411 untersuchte Prädiabetes, Übergewicht und Adipositas als interventionsstudie und hat den Status abgeschlossen. Die Studie begann am 12. Dezember 2017 mit 269 Teilnehmern. Sie wurde durchgeführt von NYU Langone Health und am 27. Oktober 2021 abgeschlossen. Die Daten von ClinicalTrials.gov wurden zuletzt am 10. März 2022 aktualisiert.
Kurzbeschreibung
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,...Mehr anzeigen
Offizieller Titel

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

Erkrankungen
PrädiabetesÜbergewicht und Adipositas
Publikationen
Wissenschaftliche Artikel und Forschungspapiere zu dieser klinischen Studie:
Weitere Studien-IDs
  • 17-00741
NCT-Nummer
NCT03336411
Studienbeginn (tatsächlich)
2017-12-12
Zuletzt aktualisiert
2022-03-10
Studienende (vorauss.)
2021-10-27
Geplante Rekrutierung
269
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Abgeschlossen
Primäres Ziel
Behandlung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Doppelt verblindet
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
Aktives VergleichspräparatmHealth
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.
ExperimentellPersonalized mHealth
mGesundheit
Behavioral weight loss intervention using behavioral counseling focusing on physical activity and a one-size-fits-all, calorie-restricted, diet.
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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
6 & 12 months
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)
6 & 12 months
Weight regain
12 months
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
Akzeptiert gesunde Freiwillige
Ja
  • 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

  • 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.
NYU Langone Health logoNYU Langone Health
  • American Heart Association logoAmerican Heart Association
  • Weizmann Institute of Science logoWeizmann Institute of Science
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1 Studienstandorte in 1 Ländern

New York

New York University School of Medicine, New York, New York, 10016, United States