A Randomized Controlled Trial of a Psychological Intervention to Reduce Weight Bias Internalization in the Context of Behavioral Weight Loss
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Weight Bias Internalization
研究概览
简要总结
This is a randomized controlled trial to test the effects on WBI of a novel psychological intervention combined with standard behavioral weight loss (BWL) treatment, as compared to BWL alone. Participants will be a total of 72 men and women seeking weight loss, ages 18-65 years, with a body mass index (BMI) of 30 kg/m2 or above, a history of experiencing weight bias, and elevated levels of WBI. Participants will attend a screening visit in which they will complete a behavioral evaluation with a psychologist and a medical history that will be reviewed by a nurse practitioner or physician. Questionnaires assessing experiences and internalization of weight bias, with confirmation by interviewer assessment during the behavioral evaluation, will be used to determine whether participants meet criteria for having high levels of WBI. Eligible consenting participants will be randomly assigned to the standard BWL intervention (n = 36) or the BWL + BIAS program (n = 36). All participants will attend weekly, 90-minute group meetings for 12 weeks (12 visits). In the BWL + stigma intervention, 60 minutes will be devoted to BWL and 30 minutes to weight stigma. In the standard BWL treatment group, the additional 30 minutes will be devoted to sharing recipes and food preparation tips. Following 12 weeks of weight loss treatment, participants will attend group meetings focused on weight loss maintenance, every-other-week from weeks 13-16 (2 visits), and monthly from weeks 17-26 (2 visits). Maintenance sessions in the BWL + stigma group will continue to incorporate discussion of WBI. Assessments - which include questionnaires and measurements of body weight - will occur at baseline and weeks 12 and 26. Weight will be measured at every group meeting for clinical purposes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible participants will be men and women ages 18-65 years.
- •Participants must have obesity (defined as a BMI ≥ 30 kg/m2); 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.
- •Participants taking anti-depressant medication will be eligible if their dose has been stable for a minimum of 3 months.
- •Eligible female patients will be:
- •non-pregnant, evidenced by a negative urine dipstick pregnancy test
- •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 with which to participate in conference calls
- •understand and be willing to comply with all study-related procedures and agree to participate in the study by giving written informed consent
排除标准
- •Applicants will be excluded if they have:
- •a diagnosis of type I or II diabetes;
- •uncontrolled hypertension (blood pressure ≥ 160/100 mm Hg);
- •experienced a cardiovascular event (e.g., stroke, myocardial infarction) in the last 12 months;
- •lost ≥ 5% of their initial weight in the last 6 months;
- •or have participated in individual or group psychotherapy in the last 3 months (due to the potentially confounding effects of receiving a simultaneous cognitive-behavioral intervention). Applicants who have recently participated in or are currently receiving counseling for concerns unrelated to mood, self-esteem, or weight (e.g. career, marriage, or grief counseling; caregiver support) may be eligible per Principal Investigator's discretion.
- •Applicants with severe symptoms of mood (for example, 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. 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.
- •Applicants will not be eligible if they have a history of bariatric surgery.
- •Women who are nursing, pregnant, or planning to become pregnant in the next 12 months are not eligible to participate.
结局指标
主要结局
Weight Bias Internalization
时间窗: Baseline to week 12
Estimated mean change score on the Weight Bias Internalization Scale (scale scoring 1-7; higher scores indicate greater weight bias internalization)
次要结局
- Weight Bias(Baseline to week 26)
- Weight-Related Quality of Life(Baseline to week 26)
- Waist Circumference(Baseline to week 26)
- Exercise Self-Efficacy(Baseline to week 26)
- Blood Pressure(Baseline to week 26)
- Weight Bias Internalization(Baseline to week 26)
- Weight Self-Stigma Questionnaire (WSSQ)(Baseline to week 26)
- Perceived Stress(Baseline to week 26)
- Eating Self-Efficacy(Baseline to week 26)
- Depression(Baseline to week 26)
- Percent Weight Change(Baseline to week 26)
研究者
Rebecca L. Pearl, Ph.D.
Assistant Professor
University of Pennsylvania