Document text
Principal Investigator: Tiffany LaShaun Carson
Organization: H. LEE MOFFITT CANCER CTR & RES INST
Fiscal Year: 2024
Award: $596,832
Funding agency: National Institute of Diabetes and Digestive and Kidney Diseases
Black females have the highest prevalence of overweight and obesity than any other racial-gender
group in the United States with 4 out of 5 adult black females being overweight or obese. Furthermore, adult
black females tend to lose less weight than whites undergoing the same obesity intervention regardless of
treatment modality. Reasons for racial differences in weight loss outcomes are not fully understood, but
suggest opportunities to further optimize obesity treatment approaches to reduce disparities. Behavioral weight
loss (BWL) interventions offer one approach that has demonstrated effectiveness in promoting modest weight
loss among some participants with obesity, but black females tend to lose less weight than their white
counterparts in the same BWL program. We hypothesize that the higher prevalence of chronic psychological
stress, which has been linked to weight gain over time and poorer weight loss in BWL programs, reported by
black females contributes to the disproportionate prevalence of obesity and suboptimal weight loss observed
among this group. Thus, stress management offers a novel approach to weight management for black females.
Our preliminary work suggests that incorporating a strong stress management component into an evidence-
based BWL program can potentially lead to better outcomes than an evidence-based BWL program alone. For
this proposal, we will test the effectiveness of a 12-month culturally-targeted, stress management-enhanced
BWL intervention on weight loss and stress reduction in a fully powered randomized, controlled trial (n=340).
Adult black females with obesity will be randomized to either a stress-management enhanced BWL
intervention (BWL-Stress) or the same BWL intervention alone (BWL-alone). The specific aims are to 1)
conduct a randomized, controlled trial to determine the effects on body weight of BWL-Stress compared to
BWL-Alone among adult black females with obesity and elevated stress, 2) evaluate intervention effects on
psychological stress as measured by a validated survey instrument and a stress biomarker, and 3) using a
multiple mediation model, test whether the relationship between the intervention and weight change is
mediated by perceived stress, energy intake, and physical activity. The primary outcome is weight change at
month 6. Secondary outcomes will include changes in stress measures (e.g., survey measures, cortisol), blood
glucose, energy intake, and physical activity at month 6. We will also assess process measures (e.g, treatment
adherence, treatment burden). We will also evaluate each outcome at month 12. This novel approach for
enhancing an evidence-based BWL program with culturally-targeted stress management strategies for black
females targets an understudied contributor to weight management among a population at high risk for obesity
and obesity-related chronic diseases (e.g. type 2 diabetes, cancer). This study will also elucidate behavioral
mechanisms linking our novel intervention to study outcomes. If proven effective, it would have significant
clinical and public health implications for weight management among black females.
Terms: <2 arm RCT><2 arm randomized control trial><2 arm randomized controlled trial><21+ years old><Active Follow-up><Address><Adult><Adult Human><Adult-Onset Diabetes Mellitus><Aeroseb-HC><Affect><Behavioral><Behavioral Mechanisms><Biological Markers><Black Populations><Black group><Black individual><Black people><Blacks><Blood Glucose><Blood Sugar><Body Weight><Body Weight Changes><Body Weight decreased><Caloric Intake><Cancers><Caucasian Females><Caucasian Women><Cetacort><Chronic><Chronic Disease><Chronic Illness><Chronic stress><Clinical><Coping Skills><Cort-Dome><Cortef><Cortenema><Cortisol><Cortispray><Cortril><Decrease disparity><Dermacort><Disparate><Effectiveness><Eldecort><Energy Expenditure><Energy Intake><Energy Metabolism><Gender><Health><High Prevalence><Hydrocortisone><Hydrocortone><Hytone><Individual><Intervention><Intervention Strategies><Ketosis-Resistant Diabetes Mellitus><Link><Literature><Lower disparity><Malignant Neoplasms><Malignant Tumor><Maturity-Onset Diabetes Mellitus><Measures><Mechanisms of Behavior and Behavior Change><Mediating><Mediation><Modality><Modeling><NIDDM><Negotiating><Negotiation><Non-Insulin Dependent Diabetes><Non-Insulin-Dependent Diabetes Mellitus><Noninsulin Dependent Diabetes><Noninsulin Dependent Diabetes Mellitus><Nutracort><Obesity><Obesity Epidemic><Outcome><Outcome Study><Over weight><Overweight><Paper><Participant><Persons><Physical activity><Population><Prevalence><Process Assessment><Process Measure><Proctocort><Psychologic Stress><Psychological Stress><Public Health><Publishing><Race><Races><Randomized><Randomized, Controlled Trials><Reporting><Risk><Risk Factors><Role><Salivary><Site><Slow-Onset Diabetes Mellitus><Stable Diabetes Mellitus><Stress><Survey Instrument><Surveys><T2 DM><T2D><T2DM><Testing><Time><Training><Type 2 Diabetes Mellitus><Type 2 diabetes><Type II Diabetes Mellitus><Type II diabetes><United States><Weight><Weight Change><Weight Gain><Weight Increase><Weight Loss><Weight Reduction><Weight maintenance regimen><White Females><White Women><Work><active followup><adiposity><adult onset diabetes><adulthood><behavior mechanism><bio-markers><biologic marker><biomarker><black female><black women><body weight gain><body weight increase><body weight loss><caloric dietary content><chronic disorder><combat><compare intervention><comparison intervention><coping strategy><corpulence><diabetes prevention program><diabetes risk><differences due to race><differences in race><differs by race><differs in race><disparity reduction><effectiveness testing><evidence base><experience><follow up><follow-up><followed up><followup><group intervention><high BMI><high body mass index><high risk><improved><improved outcome><intersectionalities><intersectionality><intervention effect><interventional strategy><ketosis resistant diabetes><life style intervention><life-time risk><lifestyle intervention><lifetime risk><malignancy><maturity onset diabetes><member><mitigate disparity><neoplasm/cancer><new approaches><novel><novel approaches><novel strategies><novel strategy><obesity intervention><obesity risk><obesity therapy><obesity treatment><perceived stress><perception of stress><primary outcome><public health relevance><race based differences><race differences><race related differences><racial><racial background><racial difference><racial origin><racially different><randomisation><randomization><randomized control trial><randomly assigned><reduce disparity><reduction in disparity><risk for obesity><risk of obesity><secondary outcome><self-reported stress><sex><social role><stress buffering><stress management><stress perception><stress reduction><systematic review><treatment adherence><treatment compliance><treatment strategy><trend><two arm RCT><two arm randomized control trial><two arm randomized controlled trial><type 2 DM><type II DM><type two diabetes><weight control><weight loss intervention><weight loss program><weight loss programming><weight loss therapy><weight loss treatment><weight management><weights><wt gain><wt-loss>