A Personalized Diet Study to Reduce Glycemic Exposure

Not Applicable

Completed

• Conditions: Pre-diabetes; Overweight and Obesity
• Interventions: Behavioral: Personalized mHealth; Behavioral: mHealth

• Registration Number: NCT03336411
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-06
• Study First Submitted QC: 2017-11-06
• Study First Posted: 2017-11-08
• Study Start: 2017-12-12
• Primary Completion: 2021-04-01
• Study Completion: 2021-10-27
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-08
• Last Update Posted: 2022-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 269

Inclusion Criteria

• 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

Read More

Exclusion Criteria

• 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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mHealth	Personalized mHealth	-
Personalized mHealth	mHealth	-

Primary Outcome Measures

Name	Time	Method
Body weight, percent change	6 months	the primary outcome will be relative weight change as a percentage of body weight at baseline and 6-months using calibrated scale.

Secondary Outcome Measures

Name	Time	Method
Metabolic Adaptation	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)
Weight regain	12 months
Body Composition	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

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States