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Behavioral Weight Loss and Stigma Reduction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03704064
Recruitment Status : Recruiting
First Posted : October 12, 2018
Last Update Posted : October 4, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Rebecca L. Pearl, Ph.D., University of Pennsylvania

Brief Summary:
This is a randomized controlled trial to test the effects on long-term weight loss of a novel stigma-reduction intervention combined with standard BWL treatment, as compared to BWL alone. Participants will be a total of 104 men and women seeking weight loss, ages 18 years and older, with a body mass index (BMI) of 30 kg/m2 or above (or 27 kg/m2 or above with an obesity-related comorbidity), 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 = 52) or the stigma + BWL intervention (n = 52). All participants will attend weekly, 90-minute group meetings for 20 weeks (20 visits). In the stigma + BWL treatment group, 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 20 weeks of weight loss treatment, participants will attend group meetings focused on weight loss maintenance, monthly from weeks 21-46 (6 visits), and every-other-month from weeks 47-72 (3 visits). Maintenance sessions in the stigma + BWL group will continue to incorporate discussion of WBI and stigma-related barriers to physical activity. Assessments - which include questionnaires, blood draws, and measurements of body weight and physical activity - will occur at baseline and weeks 20, 46 (no blood draw this week), and 72. Weight will be measured at every group meeting for clinical purposes.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Stigma-Reduction Intervention Behavioral: Behavioral Weight Loss (BWL) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Behavioral Weight Loss and Stigma Reduction for Long-Term Weight Loss
Actual Study Start Date : October 16, 2018
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Stigma + BWL Intervention
Participants in this group will receive the standard behavioral weight loss (BWL) program, which will be combined with a stigma-reduction intervention (more details provided in the Intervention section). All group meetings will be 90 minutes. Beginning at week 5, the 60-minute BWL sessions will be followed by 30 minutes devoted to stigma-related content. In the monthly and every-other-month weight loss maintenance sessions from weeks 21-72, strategies for coping with weight stigma and challenging internalized beliefs will be reviewed, and participants will be encouraged to use these strategies specifically with physical activity.
Behavioral: Stigma-Reduction Intervention
Session topics will be based on those tested in a previous pilot study, including: 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 physical activity. For example, they will be given strategies to cope with anticipated stigma while exercising in public spaces (e.g., while walking), as well as to challenge self-critical beliefs (e.g., that they are lazy) which may otherwise lead them to avoid exercising. These concrete strategies, along with reducing WBI and improving self-confidence, are intended to increase participants' self-efficacy for and engagement in physical activity.

Behavioral: Behavioral Weight Loss (BWL)
This intervention will be based on the Diabetes Prevention Program. 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 20 weeks will include self-monitoring, stimulus control, social support, portion sizes, and goal-setting. Those during weeks 21-72 will focus on skills required for weight loss maintenance and relapse prevention. Physical activity will be begin with a prescription of 60 min/wk, and will gradually progress by 10 minutes over 2-4 week intervals until achieving 150 min/wk by week 20, 200 min/wk by week 46, and 250 min/wk by week 72. Participants will be instructed to spread the activity equally across at least 5 days in bouts that are >10 minutes in duration. Moderate intensity will be prescribed with an emphasis on walking; the vast majority of our research participants self-select this form of activity.

Active Comparator: Standard BWL Intervention
Participants in this group will be provided with 20 weekly behavioral weight loss (BWL) session (described in more detail in the Intervention section), followed by 6 monthly weight loss maintenance sessions and 3 every-other-month sessions (for a total of 29 visits over 72 weeks). All group meetings will be 90 minutes. Beginning at week 5, BWL content in these sessions will last 60 minutes, with an additional 30 minutes devoted to discussing recipes and food preparation.
Behavioral: Behavioral Weight Loss (BWL)
This intervention will be based on the Diabetes Prevention Program. 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 20 weeks will include self-monitoring, stimulus control, social support, portion sizes, and goal-setting. Those during weeks 21-72 will focus on skills required for weight loss maintenance and relapse prevention. Physical activity will be begin with a prescription of 60 min/wk, and will gradually progress by 10 minutes over 2-4 week intervals until achieving 150 min/wk by week 20, 200 min/wk by week 46, and 250 min/wk by week 72. Participants will be instructed to spread the activity equally across at least 5 days in bouts that are >10 minutes in duration. Moderate intensity will be prescribed with an emphasis on walking; the vast majority of our research participants self-select this form of activity.




Primary Outcome Measures :
  1. Percent weight change at week 72 [ Time Frame: Baseline to week 72 ]

Secondary Outcome Measures :
  1. Loss of 5% or greater of initial body weight at week 72 [ Time Frame: Baseline to week 72 ]
    Categorical weight loss (yes/no)

  2. Loss of 10% or greater of initial body weight at week 72 [ Time Frame: Baseline to week 72 ]
    Categorical weight loss (yes/no)

  3. Percent weight change at week 46 [ Time Frame: Baseline to week 46 ]
  4. Percent weight change at week 20 [ Time Frame: Baseline to week 20 ]
  5. Loss of 5% or greater of initial body weight at week 46 [ Time Frame: Baseline to week 46 ]
    Categorical weight loss (yes/no)

  6. Loss of 10% or greater of initial body weight at week 46 [ Time Frame: Baseline to week 46 ]
    Categorical weight loss (yes/no)

  7. Loss of 5% or greater of initial body weight at week 20 [ Time Frame: Baseline to week 20 ]
    Categorical weight loss (yes/no)

  8. Loss of 10% or greater of initial body weight at week 20 [ Time Frame: Baseline to week 20 ]
    Categorical weight loss (yes/no)

  9. Change in minutes of physical activity (accelerometer) at week 72 [ Time Frame: Baseline to week 72 ]
    Activity measured by accelerometer

  10. Change in minutes of physical activity (accelerometer) at week 46 [ Time Frame: Baseline to week 46 ]
    Activity measured by accelerometer

  11. Change in minutes of physical activity (accelerometer) at week 20 [ Time Frame: Baseline to week 20 ]
    Activity measured by accelerometer

  12. Change in energy expenditure at week 72 [ Time Frame: Baseline to week 72 ]
    Measured by Paffenbarger Physical Activity Questionnaire

  13. Change in energy expenditure at week 46 [ Time Frame: Baseline to week 46 ]
    Measured by Paffenbarger Physical Activity Questionnaire

  14. Change in energy expenditure at week 20 [ Time Frame: Baseline to week 20 ]
    Measured by Paffenbarger Physical Activity Questionnaire

  15. Change in exercise self-efficacy at week 72 [ Time Frame: Baseline to week 72 ]
    Self-Efficacy to Exercise Scale (total score 0-90; higher scores = greater self-efficacy)

  16. Change in exercise self-efficacy at week 46 [ Time Frame: Baseline to week 46 ]
    Self-Efficacy to Exercise Scale (total score 0-90; higher scores = greater self-efficacy)

  17. Change in exercise self-efficacy at week 20 [ Time Frame: Baseline to week 20 ]
    Self-Efficacy to Exercise Scale (total score 0-90; higher scores = greater self-efficacy)

  18. Change in eating self-efficacy at week 72 [ Time Frame: Baseline to week 72 ]
    Weight Efficacy Lifestyle Questionnaire - Short Form (total score 0-72; higher scores = greater self-efficacy)

  19. Change in eating self-efficacy at week 46 [ Time Frame: Baseline to week 46 ]
    Weight Efficacy Lifestyle Questionnaire - Short Form (total score 0-72; higher scores = greater self-efficacy)

  20. Change in eating self-efficacy at week 20 [ Time Frame: Baseline to week 20 ]
    Weight Efficacy Lifestyle Questionnaire - Short Form (total score 0-72; higher scores = greater self-efficacy)

  21. Change in triglycerides at week 72 [ Time Frame: Baseline to week 72 ]
    Concentration in blood, controlling for medication use

  22. Change in triglycerides at week 20 [ Time Frame: Baseline to week 20 ]
    Concentration in blood, controlling for medication use

  23. Change in blood pressure at week 72 [ Time Frame: Baseline to week 72 ]
    Systolic and diastolic, controlling for medication use

  24. Change in blood pressure week 20 [ Time Frame: Baseline to week 20 ]
    Systolic and diastolic, controlling for medication use

  25. Change in Weight Bias Internalization Scale score at week 72 [ Time Frame: Baseline to week 72 ]
    Scale scoring 1-7; higher scores = higher weight bias internalization

  26. Change in Weight Bias Internalization Scale score at week 46 [ Time Frame: Baseline to week 46 ]
    Scale scoring 1-7; higher scores = higher weight bias internalization

  27. Change in Weight Bias Internalization Scale score at week 20 [ Time Frame: Baseline to week 20 ]
    Scale scoring 1-7; higher scores = higher weight bias internalization

  28. "Remission" of elevated weight bias internalization at week 72 [ Time Frame: Baseline to week 72 ]
    Score below 4 on the Weight Bias Internalization Scale

  29. "Remission" of elevated weight bias internalization at week 46 [ Time Frame: Baseline to week 46 ]
    Score below 4 on the Weight Bias Internalization Scale

  30. "Remission" of elevated weight bias internalization at week 20 [ Time Frame: Baseline to week 20 ]
    Score below 4 on the Weight Bias Internalization Scale

  31. Change in weight self-stigma scores at week 72 [ Time Frame: Baseline to week 72 ]
    Weight Self-Stigma Questionnaire (total score summed 12-60; two subscales summed 6-36; higher scores = greater self-stigma)

  32. Change in weight self-stigma scores at week 46 [ Time Frame: Baseline to week 46 ]
    Weight Self-Stigma Questionnaire (total score summed 12-60; two subscales summed 6-36; higher scores = greater self-stigma)

  33. Change in weight self-stigma scores at week 20 [ Time Frame: Baseline to week 20 ]
    Weight Self-Stigma Questionnaire (total score summed 12-60; two subscales summed 6-36; higher scores = greater self-stigma)

  34. Treatment acceptability at week 20 [ Time Frame: Week 20 ]
    Ratings (1-7) of skill acquisition/use and acceptability of the program and of each treatment component

  35. Treatment acceptability at week 72 [ Time Frame: Week 72 ]
    Ratings (1-7) of skill acquisition/use and acceptability of the program and of each treatment component


Other Outcome Measures:
  1. Change in minutes of sedentary time at week 72 [ Time Frame: Baseline to week 72 ]
    Single item from Global Physical Activity Questionnaire (minutes)

  2. Change in minutes of sedentary time at week 46 [ Time Frame: Baseline to week 46 ]
    Single item from Global Physical Activity Questionnaire (minutes)

  3. Change in minutes of sedentary time at week 20 [ Time Frame: Baseline to week 20 ]
    Single item from Global Physical Activity Questionnaire (minutes)

  4. Change in high-density lipoprotein (HDL) cholesterol at week 72 [ Time Frame: Baseline to week 72 ]
    Concentration in blood, controlling for medication use

  5. Change in high-density lipoprotein (HDL) cholesterol at week 20 [ Time Frame: Baseline to week 20 ]
    Concentration in blood, controlling for medication use

  6. Change in waist circumference at week 72 [ Time Frame: Baseline to week 72 ]
  7. Change in waist circumference at week 20 [ Time Frame: Baseline to week 20 ]
  8. Change in blood glucose at week 72 [ Time Frame: Baseline to week 72 ]
    Concentration in blood, controlling for medication use

  9. Change in blood glucose at week 20 [ Time Frame: Baseline to week 20 ]
    Concentration in blood, controlling for medication use

  10. Change in C-reactive protein at week 72 [ Time Frame: Baseline to week 72 ]
    Concentration in blood

  11. Change in C-reactive protein at week 20 [ Time Frame: Baseline to week 20 ]
    Concentration in blood

  12. Change in stereotype endorsement scores at week 72 [ Time Frame: Baseline to week 72 ]
    Fat Phobia Scale (scores averaged 1-5, with higher scores indicating greater weight bias)

  13. Change in stereotype endorsement scores at week 46 [ Time Frame: Baseline to week 46 ]
    Fat Phobia Scale (scores averaged 1-5, with higher scores indicating greater weight bias)

  14. Change in stereotype endorsement scores at week 20 [ Time Frame: Baseline to week 20 ]
    Fat Phobia Scale (scores averaged 1-5, with higher scores indicating greater weight bias)

  15. Change in weight-related quality of life at week 72 [ Time Frame: Baseline to week 72 ]
    Impact of Weight on Quality of Life Questionnaire-Lite (total score and 5 subscales; t-scores ranging from 0-100, with higher scores indicating better quality of life)

  16. Change in weight-related quality of life at week 46 [ Time Frame: Baseline to week 46 ]
    Impact of Weight on Quality of Life Questionnaire-Lite (total score and 5 subscales; t-scores ranging from 0-100, with higher scores indicating better quality of life)

  17. Change in weight-related quality of life at week 20 [ Time Frame: Baseline to week 20 ]
    Impact of Weight on Quality of Life Questionnaire-Lite (total score and 5 subscales; t-scores ranging from 0-100, with higher scores indicating better quality of life)

  18. Change in perceived stress at week 72 [ Time Frame: Baseline to week 72 ]
    Perceived Stress Scale (total score 0-40; higher scores = greater perceived stress)

  19. Change in perceived stress at week 46 [ Time Frame: Baseline to week 46 ]
    Perceived Stress Scale (total score 0-40; higher scores = greater perceived stress)

  20. Change in perceived stress at week 20 [ Time Frame: Baseline to week 20 ]
    Perceived Stress Scale (total score 0-40; higher scores = greater perceived stress)

  21. Change in depression symptoms at week 72 [ Time Frame: Baseline to week 72 ]
    Patient Health Questionnaire-9 (scores summed 0-27; higher scores = more symptoms of depression)

  22. Change in depression symptoms at week 46 [ Time Frame: Baseline to week 46 ]
    Patient Health Questionnaire-9 (scores summed 0-27; higher scores = more symptoms of depression)

  23. Change in depression symptoms at week 20 [ Time Frame: Baseline to week 20 ]
    Patient Health Questionnaire-9 (scores summed 0-27; higher scores = more symptoms of depression)

  24. Change in body image scores at week 72 [ Time Frame: Baseline to week 72 ]
    Body Appreciation Scale (scores averaged 1-5; higher scores = greater body appreciation)

  25. Change in body image scores at week 46 [ Time Frame: Baseline to week 46 ]
    Body Appreciation Scale (scores averaged 1-5; higher scores = greater body appreciation)

  26. Change in body image scores at week 20 [ Time Frame: Baseline to week 20 ]
    Body Appreciation Scale (scores averaged 1-5; higher scores = greater body appreciation)

  27. Change in presence and frequency of binge eating at week 72 [ Time Frame: Baseline to week 72 ]
    Questionnaire on Eating and Weight Patterns (yes/no and episodes per week)

  28. Change in presence and frequency of binge eating at week 46 [ Time Frame: Baseline to week 46 ]
    Questionnaire on Eating and Weight Patterns (yes/no and episodes per week)

  29. Change in presence and frequency of binge eating at week 20 [ Time Frame: Baseline to week 20 ]
    Questionnaire on Eating and Weight Patterns (yes/no and episodes per week)

  30. Change in self-monitoring behaviors at week 72 [ Time Frame: Baseline to week 72 ]
    Food records and self-report recording of food intake and physical activity

  31. Change in self-monitoring behaviors at week 46 [ Time Frame: Baseline to week 46 ]
    Food records and self-report recording of food intake and physical activity

  32. Change in self-monitoring behaviors at week 20 [ Time Frame: Baseline to week 20 ]
    Food records and self-report recording of food intake and physical activity



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.
  • 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 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

Exclusion Criteria:

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).

    o Participants who have recently received or are currently receiving therapy for a pre-existing mental health issue unrelated to weight (e.g., psychotherapy for depression or anxiety, or marriage, grief, or career counseling) may be eligible if the therapy is deemed by the Principal Investigator to be unlikely to affect weight, eating habits, or physical activity.

  • 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.
  • 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 16 months are not eligible to participate.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03704064


Contacts
Layout table for location contacts
Contact: Caroline Bach 215-746-7191 caroline.bach@pennmedicine.upenn.edu
Contact: Rebecca L Pearl, PhD 215-746-5129 rpearl@pennmedicine.upenn.edu

Locations
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United States, Pennsylvania
The University of Pennsylvania Center for Weight and Eating Disorders Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Caroline Bach    215-746-7191    caroline.bach@pennmedicine.upenn.edu   
Contact: Rebecca L Pearl, PhD    215-746-5129    rpearl@pennmedicine.upenn.edu   
Principal Investigator: Rebecca L Pearl, PhD         
Sponsors and Collaborators
University of Pennsylvania
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Rebecca L Pearl, PhD University of Pennsylvania
  Study Documents (Full-Text)

Documents provided by Rebecca L. Pearl, Ph.D., University of Pennsylvania:

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Responsible Party: Rebecca L. Pearl, Ph.D., Assistant Professor, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03704064     History of Changes
Other Study ID Numbers: 828274
K23HL140176 ( U.S. NIH Grant/Contract )
First Posted: October 12, 2018    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rebecca L. Pearl, Ph.D., University of Pennsylvania:
Weight Loss
Weight Stigma
Physical Activity
Cardiovascular Risk Factor
Additional relevant MeSH terms:
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Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms