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Principal Investigator: Stephanie Manasse
Organization: DREXEL UNIVERSITY
Fiscal Year: 2024
Award: $664,491
Funding agency: National Heart Lung and Blood Institute
ABSTRACT
Overweight/obesity (OW/OB) affects 14 million adolescents in the United States, disproportionately affecting
girls and racial/ethnic minorities, increasing their risk of cardiovascular disease and type 2 diabetes. Behavioral
weight loss interventions are the foundation of obesity treatment modalities, yet many have led to limited
weight loss and weight regain is common. Limited success in adolescent weight loss interventions may be
attributed primarily to adolescents’ lack of self-regulation skills, which are essential for adhering to diet and
physical activity goals. There is a critical need for development of interventions that teach self-regulation skills
to adolescents in order to adapt to pervasive biological and environmental cues that are often experienced
during weight loss. An innovative behavioral treatment, acceptance-based therapy (ABT), focuses on self-
regulation skills and increasing mindfulness and tolerance of negative or uncomfortable emotions. ABT has
demonstrated strong evidence as an effective weight loss strategy in adults. Our group utilized an adolescent-
engaged approach to develop, implement, and test the feasibility and acceptability of an ABT weight loss
intervention for adolescent girls with OW/OB. The feasibility study was a 6-month ABT behavioral weight loss
intervention comprised of 15 in-person group sessions (90-minutes each) over a 6-month period led by an
instructor trained in ABT. The feasibility study demonstrated strong acceptability among adolescent girls with
OW/OB. The objective of this study, called the Wellness Achieved Through Changing Habits (WATCH) trial, is
to test the efficacy of an ABT intervention versus an enhanced care (EC) intervention on markers of
cardiometabolic health, health related behaviors, and psychological factors. During the R61 phase (year one),
we will finalize all WATCH policies and procedures including clinical trials registration, manual of operations,
IRB approvals, convening the DSMB board, and begin recruitment. We will also submit a NIH progress report
on participant recruitment, demographics, and intervention fidelity. During the R33 phase (years 2-5), we
propose a randomized controlled trial of 148 adolescent girls (≥40% racial/ethnic minorities) with OW/OB to
test the hypothesis that those randomized to ABT (vs. EC) will have significantly decreased BMI z-score
(primary outcome) and body fat, and improved blood pressure and blood lipids at post-treatment, 6-month
follow-up, and 12-month follow-up. We also hypothesize that relative to EC intervention, ABT will significantly
improve health-related behaviors and psychological factors. As an exploratory aim, we will examine the extent
to which ABT’s effects on weight and body composition are mediated by improvements in behavioral and
psychological factors, and identify key moderators of ABT intervention effects including baseline demographic
and psychological factors. This study will yield a novel, obesity intervention tailored to the needs of adolescents
with OW/OB by developing self-regulation skills and providing tools to promote cardiometabolic health.
Terms: <19 year old><19 years of age><21+ years old><Accelerometer><Active Follow-up><Adherence><Adolescent><Adolescent Youth><Adult><Adult Human><Adult-Onset Diabetes Mellitus><Affect><After Care><After-Treatment><Aftercare><Anorexia><BMI><BMI percentile><BMI z-score><BP reduction><Behavior Conditioning Therapy><Behavior Modification><Behavior Therapy><Behavior Treatment><Behavioral><Behavioral Conditioning Therapy><Behavioral Modification><Behavioral Therapy><Behavioral Treatment><Biological><Blood Pressure><Body Composition><Body Weight decreased><Body fat><Body mass index><Cardiometabolic Disease><Cardiometabolic Disorder><Clinical Trials><Conditioning Therapy><Cues><Demographic Factors><Development><Devices><Diet><Dietary intake><Disinhibition><Eating Behavior><Eating Disorders><Educational process of instructing><Effectiveness><Emotions><Ethnic Origin><Ethnicity><Exhibits><Faculty Education><Faculty Training><Feasibility Studies><Female Adolescents><Foundations><Goals><Habits><Health><Health behavior><Hour><Hybrids><Hyperphagia><IRB><IRBs><Informal Social Control><Institutional Review Boards><Intervention><Intervention Strategies><Ketosis-Resistant Diabetes Mellitus><Maintenance><Manuals><Maturity-Onset Diabetes Mellitus><Measures><Mediating><Mental Depression><Meta-Analysis><Modality><NIDDM><NIH><National Institutes of Health><Non-Insulin Dependent Diabetes><Non-Insulin-Dependent Diabetes Mellitus><Noninsulin Dependent Diabetes><Noninsulin Dependent Diabetes Mellitus><Obesity><Out-patients><Outcome><Outpatients><Over weight><Overeating><Overweight><Participant><Patient Recruitments><Perceived quality of life><Persons><Phase><Physical activity><Physiologic><Physiological><Policies><Population Heterogeneity><Prevention><Procedures><Progress Reports><Psychological Factors><QOL><Quality of life><Quetelet index><Race><Races><Randomized><Randomized, Controlled Trials><Remote session><Risk Factors><Sedentary behavior><Sedentary life-style><Self Regulation><Sleep><Slow-Onset Diabetes Mellitus><Socio-economic status><Socioeconomic Status><Stable Diabetes Mellitus><T2 DM><T2D><T2DM><Teacher Education><Teacher Educator><Teacher Preparation><Teacher Professional Development><Teacher Training><Teaching><Testing><Therapeutic Intervention><Time><Time Study><Type 2 Diabetes Mellitus><Type 2 diabetes><Type II Diabetes Mellitus><Type II diabetes><United States><United States National Institutes of Health><Weight><Weight Loss><Weight Reduction><Work><accelerometry><acceptability and feasibility><active followup><activity monitor><activity tracker><adiposity><adolescent girl><adult onset diabetes><adulthood><age 19 years><anxiety sensitivity><behavior intervention><behavior outcome><behavioral intervention><behavioral outcome><biologic><blood lipid><blood pressure reduction><body weight loss><cardiometabolic><cardiometabolism><cardiovascular disease risk><cardiovascular disorder risk><chronic pain><community clinic><compare treatment><corpulence><craving><customized therapy><customized treatment><demographics><depression><develop therapy><developmental><dietary><diets><diverse populations><efficacy testing><enhanced care><ethnic minority><experience><faculty development><faculty professional development><feasibility testing><flexibility><flexible><follow up><follow-up><followed up><followup><girls><health related behavior><healthy life-style><healthy lifestyle><heterogeneous population><high risk><high risk sex activity><high risk sex behavior><high risk sexual activity><high risk sexual behavior><improved><individualized medicine><individualized patient treatment><individualized therapeutic strategy><individualized therapy><individualized treatment><innovate><innovation><innovative><instructor training><intervention development><intervention effect><intervention therapy><interventional strategy><juvenile><juvenile human><ketosis resistant diabetes><life style intervention><lifestyle intervention><lower BP><lower blood pressure><lowers blood pressure><maturity onset diabetes><mindfulness><nineteen year old><nineteen years old><novel><obesity intervention><obesity therapy><obesity treatment><operation><operations><participant recruitment><patient specific therapies><patient specific treatment><polyphagia><population diversity><post treatment><primary outcome><psychologic><psychological><psychological outcomes><racial><racial background><racial diversity><racial minority><racial origin><racially diverse><randomisation><randomization><randomized control trial><randomly assigned><recruit><reduce BP><reduce blood pressure><reduction in BP><reduction in blood pressure><restraint><risky sexual behavior><secondary outcome><sedentary lifestyle><skills><socio-economic position><socioeconomic position><standard care><standard treatment><success><tailored medical treatment><tailored therapy><tailored treatment><teacher development><therapy development><tool><treatment comparison><treatment development><trial comparing><type 2 DM><type II DM><type two diabetes><unique treatment><weight loss intervention><weight loss therapy><weight loss treatment><weights><wt-loss>