Psychological Intervention to Reduce Weight Bias Internalization
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 3/10/2019 |
| Start Date: | April 10, 2018 |
| End Date: | October 2019 |
A Randomized Controlled Trial of a Psychological Intervention to Reduce Weight Bias Internalization in the Context of Behavioral Weight Loss
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.
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
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.
We found this trial at
1
site
Philadelphia, Pennsylvania 19104
Principal Investigator: Rebecca L Pearl, PhD
Phone: 215-746-5129
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