Overweight and Obesity, Pre-diabetes
Conditions
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.
Interventions
BEHAVIORALmHealth
Behavioral weight loss intervention using behavioral counseling focusing on physical activity and a one-size-fits-all, calorie-restricted, diet.
BEHAVIORALPersonalized 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.
Sponsors
American Heart Association
Weizmann Institute of Science
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Glycemic variability (GV ) | 6 months | GV will be obtained from continuous glucose monitoring (CGM) tracings collected with the Abbott FreeStyle Libre Pro. |
| RAGE/AGE/S100/A8/A9 | 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 |
| Adipokines | 6 & 12 months | Leptin and high molecular weight adiponectin each measurement time point in the subsample of participants having BMI ≥35 kg/m2 |
| Self-efficacy | 3,6, 12-months | Self-efficacy for weight loss will be assessed using the well-validated Weight Efficacy Lifestyle Questionnaire (WEL) |
Countries
United States
Outcome results
None listed