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Completed

NCT Number: NCT03572218

Psychological Intervention to Reduce Weight Bias Internalization

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.

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Key information

Conditions

Stigmatization Behavior Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Social Behavior Stereotyping Weight Loss

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Pennsylvania Center for Weight and Eating Disorders

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BWL

Behavioral

The BWL sessions will be based on the Diabetes Prevention Program (DPP) manual. A diet of 1200-1499 calories per day will be prescribed for participants < 250 lb, and 1500-1800 for those ≥ 250 lb. Participants will be instructed to eat a balanced deficit diet. Session topics during the first 12 weeks will include self-monitoring, stimulus control, slowing eating, social support, cognitive restructuring, portion sizes, and goal-setting. Those during weeks 13-26 will focus on continued self-monitoring and skills required for weight loss maintenance and relapse prevention. Physical activity will be prescribed at a level consistent with data showing that >250 min/wk is associated with improved long-term weight loss. BWL sessions will last 60 minutes.

BIAS

Behavioral

Following 60 minutes of BWL treatment, the BIAS intervention will devote 30 minutes to stigma-related content. Session topics will include: psychoeducation about weight and weight stigma; challenging myths and cognitive distortions related to weight; strategies for coping with instances of stigma; and increasing empowerment and body esteem. The effects of weight stigma on health behaviors will be discussed, and sessions will focus specifically on helping participants overcome stigma-related barriers to weight management. In the every-other-week and monthly weight loss maintenance sessions from weeks 13-26, strategies for coping with weight stigma and challenging internalized beliefs will be reviewed, and participants will be encouraged to use these strategies in the context of weight management.

Primary outcomes

  1. Weight Bias Internalization

    Time frame: 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)

Secondary outcomes

  1. Weight Bias Internalization

    Time frame: Baseline to week 26

    Estimated mean change score on the Weight Bias Internalization Scale (scale scoring 1-7; higher scores indicate greater weight bias internalization)

  2. Weight Self-Stigma Questionnaire (WSSQ)

    Time frame: Baseline to week 12

    Estimated mean change score for Total score (WSSQ-Total, summed 12-60) and two subscales of Self-Devaluation (WSSQ-SD) and Fear of Enacted Stigma (WSSQ-FNE) (summed 6-30); higher scores indicate greater weight self-stigma

  3. Weight Self-Stigma Questionnaire (WSSQ)

    Time frame: Baseline to week 26

    Estimated mean change score for Total score (WSSQ-Total, summed 12-60) and two subscales of Self-Devaluation (WSSQ-SD) and Fear of Enacted Stigma (WSSQ-FNE) (summed 6-30); higher scores indicate greater weight self-stigma

  4. Weight Bias

    Time frame: Baseline to week 12

    Estimated mean change score on the Fat Phobia Scale (scale scoring 1-5; higher scores indicate greater weight bias)

  5. Weight Bias

    Time frame: Baseline to week 26

    Estimated mean change score on the Fat Phobia Scale (scale scoring 1-5; higher scores indicate greater weight bias)

  6. Weight-Related Quality of Life

    Time frame: Baseline to week 12

    Estimated mean change score on the Impact of Weight on Quality of Life Questionnaire-Lite for Total score and five subscales of Physical Function, Self Esteem, Sexual Life, Work, and Public Distress (transformed scores 0-100; higher scores indicate better quality of life)

  7. Weight-Related Quality of Life

    Time frame: Baseline to week 26

    Estimated mean change score on the Impact of Weight on Quality of Life Questionnaire-Lite for Total score and five subscales of Physical Function, Self Esteem, Sexual Life, Work, and Public Distress (transformed scores 0-100; higher scores indicate better quality of life)

  8. Perceived Stress

    Time frame: Baseline to week 12

    Estimated mean change score on the Perceived Stress Scale (summed 0-40; higher scores indicate greater perceived stress)

  9. Perceived Stress

    Time frame: Baseline to week 26

    Estimated mean change score on the Perceived Stress Scale (summed 0-40; higher scores indicate greater perceived stress)

  10. Depression

    Time frame: Baseline to week 12

    Estimated mean change score on the Patient Health Questionnaire - 9 (summed 0-27; higher scores indicate more symptoms of depression)

  11. Depression

    Time frame: Baseline to week 26

    Estimated mean change score on the Patient Health Questionnaire - 9 (summed 0-27; higher scores indicate more symptoms of depression)

  12. Exercise Self-Efficacy

    Time frame: Baseline to week 12

    Estimated mean change score on the Self-Efficacy for Exercise Scale (summed 0-90; higher scores indicate greater self-efficacy)

  13. Exercise Self-Efficacy

    Time frame: Baseline to week 26

    Estimated mean change score on the Self-Efficacy for Exercise Scale (summed 0-90; higher scores indicate greater self-efficacy)

  14. Eating Self-Efficacy

    Time frame: Baseline to week 12

    Estimated mean change score on the Weight and Lifestyle Efficacy - Short Form (summed 0-80; higher scores indicate greater self-efficacy)

  15. Eating Self-Efficacy

    Time frame: Baseline to week 26

    Estimated mean change score on the Weight and Lifestyle Efficacy - Short Form (summed 0-80; higher scores indicate greater self-efficacy)

  16. Percent Weight Change

    Time frame: Baseline to week 26

    Estimated mean change in percent weight change. Weight measured in kilograms (kg).

  17. Waist Circumference

    Time frame: Baseline to week 26

    Estimated mean change in waist circumference (cm).

  18. Blood Pressure

    Time frame: Baseline to week 26

    Estimated mean change in blood pressure (systolic blood pressure and diastolic blood pressure; mmHg), controlling for blood pressure medication.

Other outcomes

  1. Coping Behaviors in Response to Weight Stigma

    Time frame: Baseline to week 12

    Estimated mean change score on the Coping with Weight Stigma Questionnaire for Full scale and four subscales of Negative Affect, Maladaptive Eating, Healthy Lifestyle, and Exercise Avoidance (scale scoring 0-4 for Full scale and all subscales); higher scores indicate greater endorsement of coping strategies

  2. Coping Behaviors in Response to Weight Stigma

    Time frame: Baseline to week 26

    Estimated mean change score on the Coping with Weight Stigma Questionnaire for Full scale and four subscales of Negative Affect, Maladaptive Eating, Healthy Lifestyle, and Exercise Avoidance (scale scoring 0-4 for Full scale and all subscales); higher scores indicate greater endorsement of coping strategies

  3. Body Esteem

    Time frame: Baseline to Week 12

    Estimated mean change score on the Body Appreciation Scale (scale scoring 1-5; higher scores indicate greater body appreciation)

  4. Body Esteem

    Time frame: Baseline to Week 26

    Estimated mean change score on the Body Appreciation Scale (scale scoring 1-5; higher scores indicate greater body appreciation)

  5. Body Dissatisfaction

    Time frame: Baseline to Week 12

    Estimated mean change score on the Body Areas Satisfaction Subscale of the Multidimensional Body-Self Relations Questionnaire-Appearance Scales (scale scoring 1-5; higher scores indicating greater satisfaction)

  6. Body Dissatisfaction

    Time frame: Baseline to Week 26

    Estimated mean change score on the Body Areas Satisfaction Subscale of the Multidimensional Body-Self Relations Questionnaire-Appearance Scales (scale scoring 1-5; higher scores indicating greater satisfaction)

  7. Disordered Eating

    Time frame: Baseline to Week 12

    Estimated mean change score on the Eating Disorders Examination Questionnaire for Global score and four subscales of Eating Restraint, Eating Concern, Weight Concern, and Shape Concern (scale scoring 0-6 for Global score and all subscales; higher scores indicate greater pathology)

  8. Disordered Eating

    Time frame: Baseline to Week 26

    Estimated mean change score on the Eating Disorders Examination Questionnaire for Global score and four subscales of Eating Restraint, Eating Concern, Weight Concern, and Shape Concern (scale scoring 0-6 for Global score and all subscales; higher scores indicate greater pathology)

  9. Eating Behaviors

    Time frame: Baseline to Week 12

    Estimated mean change score on the Eating Inventory Questionnaire for three subscales of Dietary Restraint (summed 0-21), Disinhibition (summed 0-16), and Hunger (summed 0-14); higher values indicate greater restraint/disinhibition/hunger

  10. Eating Behaviors

    Time frame: Baseline to Week 26

    Estimated mean change score on the Eating Inventory Questionnaire for three subscales of Dietary Restraint (summed 0-21), Disinhibition (summed 0-16), and Hunger (summed 0-14); higher values indicate greater restraint/disinhibition/hunger

  11. Anxiety

    Time frame: Baseline to Week 12

    Estimated mean change score on the Generalized Anxiety Disorder-7 Questionnaire (summed 0-21; higher scores indicate greater anxiety)

  12. Anxiety

    Time frame: Baseline to Week 26

    Estimated mean change score on the Generalized Anxiety Disorder-7 Questionnaire (summed 0-21; higher scores indicate greater anxiety)

  13. Dietary Monitoring

    Time frame: Baseline to Week 12

    Estimated mean change in number of days recording caloric intake

  14. Dietary Monitoring

    Time frame: Baseline to Week 26

    Estimated mean change in number of days recording caloric intake

  15. Self-Reported Self-Monitoring Behaviors

    Time frame: Baseline to Week 12

    Estimated mean change in self-reported frequency of tracking of: weight, food/drink, calories, and physical activity; 0-4 rating for each of the four behaviors (higher scores indicate greater self-reported frequency of self-monitoring behavior)

  16. Self-Reported Self-Monitoring Behaviors

    Time frame: Baseline to Week 26

    Estimated mean change in self-reported frequency of tracking of: weight, food/drink, calories, and physical activity; 0-4 rating for each of the four behaviors (higher scores indicate greater self-reported frequency of self-monitoring behavior)

  17. Weight Bias Internalization

    Time frame: Baseline to week 52

    Estimated mean change score on the Weight Bias Internalization Scale (scale scoring 1-7; higher scores indicate greater weight bias internalization)

  18. Weight Self-Stigma Questionnaire (WSSQ)

    Time frame: Baseline to week 52

    Estimated mean change score for Total score (WSSQ-Total, summed 12-60) and two subscales of Self-Devaluation (WSSQ-SD) and Fear of Enacted Stigma (WSSQ-FNE) (summed 6-30); higher scores indicate greater weight self-stigma

  19. Weight Bias

    Time frame: Baseline to week 52

    Estimated mean change score on the Fat Phobia Scale (scale scoring 1-5; higher scores indicate greater weight bias)

  20. Depression

    Time frame: Baseline to week 52

    Estimated mean change score on the Patient Health Questionnaire - 9 (summed 0-27; higher scores indicate more symptoms of depression)

  21. Perceived Stress

    Time frame: Baseline to week 52

    Estimated mean change score on the Perceived Stress Scale (summed 0-40; higher scores indicate greater perceived stress)

  22. Exercise Self-Efficacy

    Time frame: Baseline to week 52

    Estimated mean change score on the Self-Efficacy for Exercise Scale (summed 0-90; higher scores indicate greater self-efficacy)

  23. Weight-Related Quality of Life

    Time frame: Baseline to week 52

    Estimated mean change score on the Impact of Weight on Quality of Life Questionnaire-Lite for Total score and five subscales of Physical Function, Self Esteem, Sexual Life, Work, and Public Distress (transformed scores 0-100; higher scores indicate better quality of life)

  24. Eating Self-Efficacy

    Time frame: Baseline to week 52

    Estimated mean change score on the Weight and Lifestyle Efficacy - Short Form (summed 0-80; higher scores indicate greater self-efficacy)

  25. Percent Weight Change

    Time frame: Baseline to week 52

    Estimated mean change in percent weight change. Weight measured in kilograms (kg)

  26. Waist Circumference

    Time frame: Baseline to week 52

    Estimated mean change in waist circumference (cm)

  27. Blood Pressure

    Time frame: Baseline to week 52

    Estimated mean change in blood pressure (systolic blood pressure and diastolic blood pressure; mmHg), controlling for blood pressure medication.

  28. Body Esteem

    Time frame: Baseline to Week 52

    Estimated mean change score on the Body Appreciation Scale (scale scoring 1-5; higher scores indicate greater body appreciation)

  29. Coping Behaviors in Response to Weight Stigma

    Time frame: Baseline to Week 52

    Estimated mean change score on the Coping with Weight Stigma Questionnaire for Full scale and four subscales of Negative Affect, Maladaptive Eating, Healthy Lifestyle, and Exercise Avoidance (scale scoring 0-4 for Full scale and all subscales); higher scores indicate greater endorsement of coping strategies

  30. Body Dissatisfaction

    Time frame: Baseline to Week 52

    Estimated mean change score on the Body Areas Satisfaction Subscale of the Multidimensional Body-Self Relations Questionnaire-Appearance Scales (scale scoring 1-5; higher scores indicating greater satisfaction)

  31. Anxiety

    Time frame: Baseline to Week 52

    Estimated mean change score on the Generalized Anxiety Disorder-7 Questionnaire (summed 0-21; higher scores indicate greater anxiety)

  32. Disordered Eating

    Time frame: Baseline to Week 52

    Estimated mean change score on the Eating Disorders Examination Questionnaire for Global score and four subscales of Eating Restraint, Eating Concern, Weight Concern, and Shape Concern (scale scoring 0-6 for Global score and all subscales; higher scores indicate greater pathology)

  33. Eating Behaviors

    Time frame: Baseline to Week 52

    Estimated mean change score on the Eating Inventory Questionnaire for three subscales of Dietary Restraint (summed 0-21), Disinhibition (summed 0-16), and Hunger (summed 0-14); higher values indicate greater restraint/disinhibition/hunger

  34. Self-Reported Self-Monitoring Behaviors

    Time frame: Baseline to Week 52

    Estimated mean change in self-reported frequency of tracking of: weight, food/drink, calories, and physical activity; 0-4 rating for each of the four behaviors (higher scores indicate greater self-reported frequency of self-monitoring behavior)

  35. Treatment Acceptability Ratings

    Time frame: Week 26

    To assess treatment acceptability, participants in both groups rated (1-7) the BWL treatment, as well as the stigma intervention (i.e., BIAS component) or recipe exchange, on how helpful they found each component of the program, how much they liked the components, and how much they learned new skills or information from each component. Scores for these three items were averaged (1-7) separately for the BWL treatment, BIAS component, and recipe exchange. Higher scores indicate greater treatment acceptability.

  36. Treatment Acceptability Ratings

    Time frame: Week 52

    To assess treatment acceptability, participants rated (1-7) 5 items to indicate the extent to which they found the program (as a whole) to be helpful and acceptable, and how much they liked, were satisfied with, and would recommend the program to others. Scores are averaged 1-7, with higher scores indicating greater treatment acceptability.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • WW International Inc

Registry information

Official study title

A Randomized Controlled Trial of a Psychological Intervention to Reduce Weight Bias Internalization in the Context of Behavioral Weight Loss

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 28, 2018
Registry last updated
Oct 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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