New York University School of Medicine
New York, 10016, United States
NCT Number: NCT03336411
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.
Looking for future studies?
Notify Me18 year–80 year
All sexes
Interventional
Not applicable
New York, 10016, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Behavioral weight loss intervention using behavioral counseling focusing on physical activity and a one-size-fits-all, calorie-restricted, diet.
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.
Time frame: 6 months
the primary outcome will be relative weight change as a percentage of body weight at baseline and 6-months using calibrated scale.
Time frame: 6 & 12 months
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
Time frame: 6 & 12 months
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)
Time frame: 12 months
Time frame: 6 months
GV will be obtained from continuous glucose monitoring (CGM) tracings collected with the Abbott FreeStyle Libre Pro.
Time frame: 6 & 12 MONTHS
In the first 30 participants randomized to the study (15 in each group) having BMI ≥35 kg/m2, at each measurement time point we will examine activation of the RAGE/AGE/S100A8/A9 pathway using measurements of sRAGE, AGE level by ELISA, levels of S100A8/A9 by ELISA, circulating TNF-alpha, IL1-beta, IL4, IL10, and IL-17
Time frame: 6 & 12 months
Leptin and high molecular weight adiponectin each measurement time point in the subsample of participants having BMI ≥35 kg/m2
Time frame: 3,6, 12-months
Self-efficacy for weight loss will be assessed using the well-validated Weight Efficacy Lifestyle Questionnaire (WEL)
NYU Langone Health
Other
Personalized Technology-Supported Counseling to Reduce Glycemic Response in Dietary Weight Loss: The Personal Diet Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06014684
Body Weight, Glucose Intolerance
Maastricht, Limburg, Netherlands
View Trial DetailsNCT05114018
Body Weight, Glucose Intolerance
Kiel, Germany
View Trial DetailsNCT06245369
Body Weight, Glucose Intolerance
Columbia, South Carolina, United States
View Trial DetailsNCT06607341
Body Weight, Cardiovascular Diseases
Washington D.C., District of Columbia, United States
View Trial Details