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Keep this study
Lead
University of Pennsylvania
With
National Heart, Lung, and Blood Institute (NHLBI)
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Eligible participants will be men and women ages 18 years and older.
Participants must have obesity, defined as a BMI ≥ 30 kg/m2 or ≥ 27 kg/m2 with an obesity-related comorbidity.
o Obesity-related comorbidities (which confer added CVD risk) will include:
coronary heart disease;
other atherosclerotic disease;
sleep apnea;
hypercholesteremia (i.e., high cholesterol, as diagnosed by doctor and/or if taking medication to lower cholesterol);
and components of the metabolic syndrome, including hypertension (SBP ≥130, DBP ≥80 mm Hg, diagnosed by doctor and/or if taking anti-hypertensive medication); fasting blood glucose of 100-125 mg/dL (or prediabetes, diagnosed by doctor),; low HDL cholesterol (\<40 mg/dL in men, \<50 mg/dL in women), elevated triglycerides (\>150 mg/dL, i.e., dyslipidemia diagnosed by doctor or taking medication to treat dyslipidemia), or elevated waist circumference (≥40 in for men, ≥35 in for women),.
Eligible participants must also report a history of experiencing weight bias as assessed by self-report questionnaire and in-person interview, and have elevated levels of WBI as indicated by an average score of 4 (midpoint) or above on the Weight Bias Internalization Scale (WBIS) and by in-person interview.
Participants must be seeking weight loss.
If currently taking medications, dosages must be stable for at least 3 months.
Participants will be eligible to participate if they exhibit mild to moderate severity of depression, anxiety, or binge eating disorder, as determined by the behavioral evaluation and the screening measures (Beck Depression Inventory-II and Questionnaire for Eating and Weight Patterns; see below for details). Elevated WBIS scores are often associated with these variables.
Eligible female patients will be:
non-pregnant and non-lactating
surgically sterile or postmenopausal, or they will agree to continue to use a method of birth control during the study
Participants must:
have a PCP who is responsible for providing routine care
have reliable telephone service and/or email access with which to be in contact with the study team
understand and be willing to comply with all study-related procedures and agree to participate in the study by giving written informed consent
Applicants with severe symptoms of mood (BDI-II score ≥ 29), anxiety, or binge eating disorder, and any severity of thought or substance use disorders will not be accepted into the study, as these symptoms may interfere with individuals' ability to adhere to a weight loss program.
o Clinician judgment will be used to determine severity of mood disorder symptoms independent from obesity-related concerns and complications (e.g., fatigue), and decisions about applicants' eligibility based on psychiatric symptoms will fall within the Principal Investigator's discretion.
Individuals with bulimia nervosa will not be eligible to participate, because weight loss may be contraindicated.
Applicants with current, active suicidal ideation, and/or a suicide attempt within the past year will be excluded from the study and referred to psychiatric treatment facilities in the greater Philadelphia area.
You may not be if
Applicants will be excluded if they have:
a diagnosis of type I or II diabetes (for type II diabetes, blood glucose ≥126 mg/dL or A1C ≥6.5);
uncontrolled hypertension (blood pressure ≥ 160/100 mm Hg);
experienced a cardiovascular event (e.g., stroke, myocardial infarction) in the last 12 months;
lost and maintained ≥ 5% of their initial weight in the last 3 months or ≥ 10% in the past 2 years;
or have participated in individual or group psychotherapy related to weight in the last 3 months (due to the potentially confounding effects of receiving a simultaneous cognitive-behavioral intervention).
Applicants who report obtaining 150 minutes or more of structured physical activity per week (e.g., 30 minutes 5 days per week) will not be eligible, as they will already be obtaining the recommended amount of physical activity and may not be able to further increase their activity as part of the study.
Clareo Health | Behavioral Weight Loss and Stigma Reduction
