Personalized Technology-Supported Counseling to Reduce Glycemic Response in Dietary Weight Loss: The Personal Diet Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 269
- 试验地点
- 1
- 主要终点
- Body weight, percent change
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Body weight, percent change
时间窗: 6 months
the primary outcome will be relative weight change as a percentage of body weight at baseline and 6-months using calibrated scale.
次要结局
- Metabolic Adaptation(6 & 12 months)
- Weight regain(12 months)
- Body Composition(6 & 12 months)