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.

Abstract

Weight loss reduces the risk of type 2 diabetes mellitus (T2D) in overweight and obese individuals. Although the physiological response to food varies among individuals, standard dietary interventions use a "one-size-fits-all" approach. The Personal Diet Study aims to evaluate two dietary interventions targeting weight loss in people with prediabetes and T2D: (1) a low-fat diet, and (2) a personalized diet using a machine-learning algorithm that predicts glycemic response to meals. Changes in body weight, body composition, and resting energy expenditure will be compared over a 6-month intervention period and a subsequent 6-month observation period intended to assess maintenance effects. The behavioral intervention is delivered via mobile health technology using the Social Cognitive Theory. Here, we describe the design, interventions, and methods used.

Trial registration: ClinicalTrials.gov NCT03336411.

Publication types

  • Clinical Trial Protocol
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Blood Glucose
  • Body Mass Index
  • Body Weights and Measures
  • Diabetes Mellitus, Type 2 / therapy*
  • Diet / methods*
  • Diet, Fat-Restricted
  • Energy Metabolism / physiology
  • Female
  • Glycated Hemoglobin
  • Glycemic Load
  • Humans
  • Maschinelles Lernen
  • Male
  • Middle Aged
  • Prediabetic State / therapy*
  • Randomized Controlled Trials as Topic
  • Research Design
  • Weight Loss / physiology
  • Weight Reduction Programs / methods*
  • Young Adult

Substances

  • Blood Glucose
  • Glycated Hemoglobin A

Associated data

  • ClinicalTrials.gov/NCT03336411