This pilot study aims to recruit 30 adults with abdominal obesity, without major chronic disease, and test whether clinical dietary advice that is solely focused on the timing of eating (time restricted eating), has an effect on cardiometabolic health compared to standard dietary advice for cardiometabolic health, which is focused on content. The goal of this pilot study is to develop and hone dietary counseling approaches for time restricted eating for RD's in a clinical practice paradigm, and collect data on testing this intervention compared to standard dietary counseling approaches for cardiometabolic health.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
30
The intervention is delivered in a paradigm in which an individual with abdominal obesity would be referred by their physician to receive dietary counseling from a Registered Dietitian (RD). The aim of the intervention is to improve cardiometabolic health and assist with weight management via 4, individualized counseling sessions over the course of 8 weeks. Participants are educated on basic concepts related to circadian rhythms, metabolism and TRE; and the evidence demonstrating benefit of TRE in animal models and humans. The goal is provide rationale for the potential benefits of a TRE approach. In addition, the RD sessions focus on developing a plan for successfully implementing a TRE approach, identifying challenges for adherence, and a plan for dealing with real or potential challenges. The counseling is focused the TRE concept, with no specific direction or counseling related to modifying the content of the participant's diet or any prescription to reduce energy intake.
The intervention is delivered in a paradigm in which an individual with abdominal obesity would be referred by their physician to receive dietary counseling from a Registered Dietitian (RD). The aim of the intervention is to improve cardiometabolic health and assist with weight management via 4, individualized counseling sessions over the course of 8 weeks. Participants are educated on basic concepts and known benefits related to eating a diet for cardiometabolic health and weight management recommended by the American Heart Association and the Academy of Nutrition and Dietetics as a standard of practice for dietitians in healthcare settings. The RD sessions focus on adopting a dietary pattern aligned with this approach, identifying challenges to adopting this dietary pattern, and education and plans for dealing with real or potential challenges. The counseling gives no direction related to modifying the timing of dietary intake or any prescription to reduce energy intake.
Institute for Clinical and Translational Science
Irvine, California, United States
Triglyceride : HDL cholesterol ratio
Ratio of fasting triglycerides to HDL cholesterol
Time frame: 8 weeks
HOMA-IR
Estimation of HOMA-IR from fasting glucose and insulin
Time frame: 8 weeks
Glucose
Fasting glucose
Time frame: 8 weeks
Insulin
Fasting insulin
Time frame: 8 weeks
LDL cholesterol
LDL cholesterol
Time frame: 8 weeks
Weight
Body weight measured on calibrated scale
Time frame: 8 weeks
Waist Circumference
Measured by standard approach utilized in NHANES
Time frame: 8 weeks
Diet Quality
Assessed by 2 unannounced recalls during run-in period and 3 during intervention
Time frame: Run-in (up to 2 weeks), Intervention (8 weeks)
Post-hoc estimated energy intake
Estimated by utilizing NIDDK Body weight planner with weights measured over 8 weeks
Time frame: 8 weeks
Objective sleep and physical activity habits
Measured with fitbit
Time frame: Run-in (up to 2 weeks), Intervention (8 weeks)
Blood pressure
Resting systolic and diastolic blood pressure
Time frame: 8 weeks
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