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Principal Investigator: Collin Jeffrey Popp
Organization: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
Fiscal Year: 2024
Award: $148,540
Funding agency: National Heart Lung and Blood Institute
Project Summary/Abstract
Despite great strides in achieving short-term weight loss success, long-term weight loss maintenance (WLM)
remains a challenge. Time-restricted eating (TRE), a form of intermittent fasting, is an untested bio-behavioral
strategy for WLM. The goal of this Pathway to Independence Award (K99/R00) is to accelerate the candidate's
transition to an independent investigator with focused expertise in the development and evaluation of weight
management strategies during WLM. In the K99 phase of this award, the candidate will obtain training in
expertise in behavior maintenance theories and methods, mixed methods and qualitative analyses and appetite
physiology, and conduct pilot studies to develop and test the intervention approach. The candidate will conduct
a pilot randomized controlled trial (n=40 total; 20/arm) to test the feasibility, acceptability, and adherence of two
TRE interventions (≤6 h and ≤10h eating windows). Participants will include adults (25–65y, BMI>20.5 kg/m2)
recruited from 2 nonsurgical weight loss programs who successfully attained a weight loss of ≥5% initial body
weight. Prior to randomization, participants will undergo a run-in phase that includes a 4-week weight stabilization
period. The candidate will evaluate the feasibility and acceptability in terms of recruitment, retention, and
adherence to the eating window using a mixed-methods design (Aim 1). The candidate will perform qualitative
interviews (n=12/arm) following completion of the TRE to capture participants' experience with TRE and
determine individual-, family-, and neighborhood/community-level barriers and facilitators to each TRE
intervention, such as motivation, cultural factors, occupation, and family structure (Sub-aim 1) that will be used
to strengthen the intervention. In the R00 phase, the candidate will use acquired skills and training to test the
optimum TRE intervention identified from the K99 phase. In a randomized controlled trial, the candidate will
assess the efficacy of the selected TRE on body weight regain (Aim 2a), and fat mass regain (Aim 2b) at 12
months. The candidate will recruit adults with recent non-surgical weight loss and weight stabilization (similar to
K99 phase). Participants will be randomized to one of 2 arms (n=72 total; n=36/arm): 1) TRE (selected from the
K99 phase) or 2) baseline advice control (CON). Both the TRE and CON groups will be provided with baseline
written materials and strategies that promote successful WLM. Participants in the TRE group will be instructed
to self-monitor dietary intake and body weight in a smartphone application and receive behavioral counseling.
Measurements will be obtained at baseline (0), 3, 6, and 12 months. The primary outcome is body weight regain
at 12 months. The candidate will explore the effects of randomization assignment and WLM on appetite
biomarkers and subjective appetite via a visual analog scale at 6 mos and 12 mos (Exploratory Aim). Ultimately,
this will establish the candidate as an independent investigator conducting interdisciplinary bio-behavioral
research using lifestyle interventions to become a leader in WLM.
Terms: <21+ years old><Acceleration><Acylation><Address><Adherence><Adult><Adult Human><Adult-Onset Diabetes Mellitus><Android App><Android Application><Appetite><Award><BMI><BMI percentile><BMI z-score><Behavior><Behavioral><Biological><Biological Markers><Body Composition><Body Weight><Body Weight decreased><Body mass index><Caloric Restriction><Cell Phone Application><Cell phone App><Cellular Phone App><Cellular Phone Application><Chronic Disease><Chronic Illness><Clinic><Conduct Clinical Trials><Control Groups><Counseling><Data><Desire for food><Development><Diet Monitoring><Dietary intake><Eating><Energy Expenditure><Energy Metabolism><Enrollment><Environment><Evaluation><Exclusion><Failure><Family><Fats><Fatty acid glycerol esters><Feedback><Food Intake><Foundations><GLP-1><Gastric Inhibitory Polypeptide><Glucose-Dependent Insulin-Releasing Peptide><Glucose-Dependent Insulinotropic Peptide><Goals><Guidelines><Health><Hour><Humulin R><Hunger><Individual><Insulin><Intermittent fasting><Intervention><Intervention Strategies><Interview><Investigators><Islam><Jobs><Ketosis-Resistant Diabetes Mellitus><Leptin><Maintenance><Maturity-Onset Diabetes Mellitus><Measurement><Measures><Mentors><Mentorship><Methods><Mohammedanism><Motivation><Muslim religion><NIDDM><NIH><National Institutes of Health><Neighborhoods><Non-Insulin Dependent Diabetes><Non-Insulin-Dependent Diabetes Mellitus><Noninsulin Dependent Diabetes><Noninsulin Dependent Diabetes Mellitus><Novolin R><Nutrition Research><Nutritional Study><Ob Gene Product><Ob Protein><Obese Gene Product><Obese Protein><Obesity><Occupations><Participant><Pathway interactions><Phase><Physiologic><Physiological><Physiology><Pilot Projects><Policies><Professional Positions><Provider><Public Health><Publications><Quetelet index><Randomized><Randomized, Controlled Trials><Recommendation><Regular Insulin><Research><Research Personnel><Researchers><Rest><Role><Running><Satiation><Scientific Publication><Slow-Onset Diabetes Mellitus><Smart Phone App><Smart Phone Application><Smartphone App><Stable Diabetes Mellitus><Strategic Planning><T2 DM><T2D><T2DM><Testing><Time><Time-restricted eating><Time-restricted feeding><Training><Type 2 Diabetes Mellitus><Type 2 diabetes><Type II Diabetes Mellitus><Type II diabetes><United States National Institutes of Health><Visual><Weight><Weight Loss><Weight Reduction><Weight maintenance regimen><Writing><acceptability and feasibility><adiposity><adult onset diabetes><adulthood><analog><arm><behavior change><bio-markers><biobehavior><biobehavioral><biologic><biologic marker><biomarker><body weight loss><caloric restricted><calorically restricted><calorie restricted><calorie restriction><cell phone based app><chronic disorder><community barrier><community-level barrier><corpulence><design><designing><determine efficacy><developmental><dietary monitoring><direct application><eat less><efficacy analysis><efficacy assessment><efficacy determination><efficacy evaluation><efficacy examination><efficacy testing><energy balance><enroll><evaluate efficacy><examine efficacy><experience><family structure><feasibility testing><gastric inhibitory peptide><ghrelin><glucagon-like peptide 1><iOS app><iOS application><iPhone App><iPhone Application><improved><innovate><innovation><innovative><interventional strategy><ketosis resistant diabetes><life style intervention><lifestyle intervention><maturity onset diabetes><mobile phone app><oxidation><pathway><pilot study><prevent><preventing><primary outcome><programs><randomisation><randomization><randomized control trial><randomly assigned><recruit><reduced eating><reduced food intake><response><satiety><skill acquisition><skill development><smartphone application><smartphone based app><smartphone based application><social role><success><theories><tool><trend><type 2 DM><type II DM><type two diabetes><weight control><weight loss program><weight loss programming><weight management><weights><wt-loss>