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Wellness Education Intervention

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: NCT04962321
Recruitment Status : Recruiting
First Posted : July 14, 2021
Last Update Posted : October 27, 2021
Sponsor:
Information provided by (Responsible Party):
Carrie McAdams, University of Texas Southwestern Medical Center

Brief Summary:
Individuals suffering from depression and anxiety have an increased risk of obesity due to multiple factors such as side effects to psychotropic medications, associated appetite dysregulation, disruption of sleep, anergia leading to psychomotor retardation or inactivity, and increased stress hormones through the disruption in the hypothalamic-pituitary-adrenal (HPA) axis. Though not a causal relationship, an intimate bidirectional connection exists between the two conditions, which subsequently impacts the journey of weight loss. The impact mental health can have on weight loss is evident as concurrent depression and anxiety in individuals with obesity predicts poorer outcomes like decreased adherence and less success with weight loss interventions. Here, we will determine if delivery of psychoeducation regarding the primitive brain and model of safety in a group setting to those with obesity seeking weight loss intervention has an impact on not only psychiatric symptoms of depression and anxiety but also weight loss, eating behaviors, sleeping patterns, activity level, and health-related quality of life. This project will improve our understanding of the role of mental health and the stress response in obesity.

Condition or disease Intervention/treatment Phase
Overweight and Obesity Eating Disorders Depression, Anxiety Behavioral: Wellness Education Not Applicable

Detailed Description:
This project will recruit subjects seeking weight loss in the Dallas Fort Worth area. A screen consisting of patient's weight and height to calculate a patient's BMI will be completed. Pre-assessment measures of anxiety, depression, eating disorder symptoms, sleep, self-efficacy, quality of life, and weight-wellness related behaviors (sleeping patterns, exercise patterns, eating patterns) will be completed before the intervention using a secure online link to RedCap. Participants will then attend eight weekly sessions of a group psychoeducational intervention. The intervention includes eight modules of various topics including the psychoeducation on the primitive brain model, motivation, goal-setting, affirmations, rewards, promoting autonomy, reducing guilt, and relapse prevention. Participants will complete homework assignments, share their work with the group to elicit feedback, and participate in guided discussions. Post-assessments will be completed 1-4 weeks and 3-5 months after the interventions is completed. These measures will determine (1) if psychological symptoms are responsive to the intervention, and (2) if clinical symptom changes related to weight and quality of life are affected.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Pilot study to examine acceptability, feasibility, and explore clinical responses related to wellness behaviors and quality of life.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Wellness Education Intervention
Actual Study Start Date : July 19, 2021
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: PsychoEd
These participants are enrolled to participate in the 8-session education sessions.
Behavioral: Wellness Education
Psychoeducation on relationships between mood, anxiety, eating, and exercise behaviors. One one-hour session each week for 8 weeks.




Primary Outcome Measures :
  1. Change in Physical Health Summary Scores from Pre-assessment to Post-assessment 1 [ Time Frame: Baseline, 1-4 weeks after intervention ends ]
    Patient-Reported Outcomes Measurement Information System® (PROMIS) 29 Profile, v. 2.0 Adult Profile measures the patient's perceived quality of life over the past week using various criteria. For our primary measure, we will use the physical health to examine pain interference and intensity. PROMIS raw scores range from 9-50; the PROMIS T-scores have a mean of 50 with a standard deviation of 10 and where higher scores indicate more symptoms and less functioning. Scores up to 55 are considered to be within normal range, scores of 55-60 are indicative of mild symptoms or minor impairment, scores of 61-70 are indicative of moderate symptoms or moderate impairment, and scores greater than 71 are indicative of severe symptoms or severe impairment.

  2. Change in Mental Health Summary Scores from Pre-assessment to Post-assessment 1 [ Time Frame: Baseline, 1-4 weeks after intervention ends ]
    Patient-Reported Outcomes Measurement Information System® (PROMIS) 29 Profile, v. 2.0 Adult Profile measures the patient's perceived quality of life over the past week using various criteria. For our primary measure, we will use the mental health summary score to examine anxiety, depression, and ability to participate in social roles. PROMIS raw scores range from 12-60; the PROMIS T-scores have a mean of 50 with a standard deviation of 10 where higher scores indicate more symptoms and less functioning. Scores up to 55 are considered to be within normal range, scores of 55-60 are indicative of mild symptoms or minor impairment, scores of 61-70 are indicative of moderate symptoms or moderate impairment, and scores greater than 71 are indicative of severe symptoms or severe impairment.

  3. Change in Physical Health Summary Scores from Pre-assessment to Post-assessment 2 [ Time Frame: Baseline, 3-5 months after intervention ends ]
    Patient-Reported Outcomes Measurement Information System® (PROMIS) 29 Profile, v. 2.0 Adult Profile measures the patient's perceived quality of life over the past week using various criteria. For our primary measure, we will use the physical health to examine pain interference and intensity. PROMIS raw scores range from 9-50; the PROMIS T-scores have a mean of 50 with a standard deviation of 10 and where higher scores indicate more symptoms and less functioning. Scores up to 55 are considered to be within normal range, scores of 55-60 are indicative of mild symptoms or minor impairment, scores of 61-70 are indicative of moderate symptoms or moderate impairment, and scores greater than 71 are indicative of severe symptoms or severe impairment.

  4. Change in Mental Health Summary Scores from Pre-assessment to Post-assessment 2 [ Time Frame: Baseline, 3-5 months after intervention ends ]
    Patient-Reported Outcomes Measurement Information System® (PROMIS) 29 Profile, v. 2.0 Adult Profile measures the patient's perceived quality of life over the past week using various criteria. For our primary measure, we will use the mental health summary score to examine anxiety, depression, and ability to participate in social roles. PROMIS raw scores range from 12-60; the PROMIS T-scores have a mean of 50 with a standard deviation of 10 where higher scores indicate more symptoms and less functioning. Scores up to 55 are considered to be within normal range, scores of 55-60 are indicative of mild symptoms or minor impairment, scores of 61-70 are indicative of moderate symptoms or moderate impairment, and scores greater than 71 are indicative of severe symptoms or severe impairment.

  5. Change in self-efficacy score from Pre-assessment to Post-assessment 1 [ Time Frame: Baseline, 1-4 weeks after intervention ends ]
    Generalized Self-Efficacy Scale measures how the respondent copes with daily hassles and adapts to stressful life events. Possible scores range from 10-40, with higher scores indicative of greater self-efficacy.

  6. Change in self-efficacy score from Pre-assessment to Post-assessment 2 [ Time Frame: Baseline, 3-5 months after intervention ends ]
    Generalized Self-Efficacy Scale measures how the respondent copes with daily hassles and adapts to stressful life events. Possible scores range from 10-40, with higher scores indicative of greater self-efficacy.

  7. Change in frequency of patients with eating disorders from Pre- assessment to Post-assessment 1 [ Time Frame: Baseline, 1-4 weeks after intervention ends ]
    Eating Disorder Screener for DSM-V (EDDS-5) screens a participant for the presence of an eating disorder. Should the screen be positive, a patient may meet criteria for an eating disorder.

  8. Change in frequency of patients with eating disorders from Pre- assessment to Post-assessment 2 [ Time Frame: Baseline, 3-5 months after intervention ends ]
    Eating Disorder Screener for DSM-V (EDDS-5) screens a participant for the presence of an eating disorder. Should the screen be positive, a patient may meet criteria for an eating disorder.

  9. Study components feedback score at 4 weeks after starting intervention [ Time Frame: 4 weeks after starting intervention ]
    The Weight Wellness Intervention Evaluation addresses study component feedback using both a rating scales and free form written commentary. Possible scores range from 1 to 5 with higher scores indicating more positive values.

  10. Study components feedback score at 8 weeks after starting intervention [ Time Frame: 8 weeks after starting intervention ]
    The Weight Wellness Intervention Evaluation addresses study component feedback using both a rating scales and free form written commentary. Possible scores range from 1 to 5 with higher scores indicating more positive values.

  11. Patient satisfaction score [ Time Frame: 1-4 weeks after intervention ends ]
    The Weight Wellness Group Intervention Evaluation form measured patient satisfaction (the impact and value of study) with free-form verbal responses as well as a single rating scale. Possible scores range from 1 to 5 with higher scores indicating more satisfaction with the intervention.

  12. Change in Behavioral Patterns from Pre-assessment to Post-assessment 1 [ Time Frame: Baseline, 1-4 weeks after intervention ends ]
    Using the Wellness Pattern Questionnaire, consistency of eating, sleeping, and activity patterns are assessed. Possible scores range from 0 to 30, with higher scores reflecting more consistent scheduling for these daily behaviors.

  13. Change in Behavioral Patterns from Pre-assessment to Post-assessment 2 [ Time Frame: Time Frame: Baseline, 3-5 months after intervention end ]
    Using the Wellness Pattern Questionnaire, consistency of eating, sleeping, and activity patterns are assessed. Possible scores range from 0 to 30, with higher scores reflecting more consistent scheduling of daily behaviors.


Secondary Outcome Measures :
  1. Change in weight from Pre-assessment to Post-assessment 1 [ Time Frame: Baseline, 1-4 weeks after intervention ends ]
    Weight will be measured in pounds, percentage changed from baseline (loss or gain), and BMI.

  2. Change in weight from Pre-assessment to Post-assessment 2 [ Time Frame: Baseline, 3-5 months after intervention ends ]
    Weight will be measured in pounds, percentage changed from baseline (loss or gain), and BMI.

  3. Change in physical function score from Pre-assessment to Post-assessment 1 [ Time Frame: Baseline, 1-4 weeks after intervention ends ]
    Patient-Reported Outcomes Measurement Information System® (PROMIS) 29 Profile, v. 2.0 Adult Profile measures the patient's perceived quality of life over the past week using various criteria. For this secondary measure, we will examine the physical function sub-section score. PROMIS raw scores for this subscale range from 4 to 20; the PROMIS T-scores have a mean 50 and a standard deviation of 10 where higher scores indicate more symptoms and less functioning. T-scores up to 55 are considered to be within normal range, scores of 55-60 are indicative of mild symptoms or minor impairment, scores of 61-70 are indicative of moderate symptoms or moderate impairment, and scores greater than 71 are indicative of severe symptoms or severe impairment.

  4. Change in physical function score from Pre-assessment to Post-assessment 2 [ Time Frame: Baseline, 3-5 months after intervention ends ]
    Patient-Reported Outcomes Measurement Information System® (PROMIS) 29 Profile, v. 2.0 Adult Profile measures the patient's perceived quality of life over the past week using various criteria. For this secondary measure, we will examine the physical function sub-section score. PROMIS raw scores for this subscale range from 4 to 20; the PROMIS T-scores have a mean 50 and a standard deviation of 10 where higher scores indicate more symptoms and less functioning. T-scores up to 55 are considered to be within normal range, scores of 55-60 are indicative of mild symptoms or minor impairment, scores of 61-70 are indicative of moderate symptoms or moderate impairment, and scores greater than 71 are indicative of severe symptoms or severe impairment.

  5. Change in depression score from Pre-assessment to Post-assessment 1 [ Time Frame: Baseline, 1-4 weeks after intervention ends ]
    Patient-Reported Outcomes Measurement Information System® (PROMIS) 29 Profile, v. 2.0 Adult Profile measures the patient's perceived quality of life over the past week using various criteria. For this secondary measure, we will examine the physical function sub-section score. PROMIS raw scores for this subscale range from 4 to 20; the PROMIS T-scores have a mean 50 and a standard deviation of 10 where higher scores indicate more symptoms and less functioning. Scores up to 55 are considered to be within normal range, scores of 55-60 are indicative of mild symptoms or minor impairment, scores of 61-70 are indicative of moderate symptoms or moderate impairment, and scores greater than 71 are indicative of severe symptoms or severe impairment.

  6. Change in depression score from Pre-assessment to Post-assessment 2 [ Time Frame: Baseline, 3-5 months after intervention ends ]
    Patient-Reported Outcomes Measurement Information System® (PROMIS) 29 Profile, v. 2.0 Adult Profile measures the patient's perceived quality of life over the past week using various criteria. For this secondary measure, we will examine the physical function sub-section score. PROMIS raw scores for this subscale range from 4 to 20; the PROMIS T-scores have a mean 50 and a standard deviation of 10 where higher scores indicate more symptoms and less functioning. Scores up to 55 are considered to be within normal range, scores of 55-60 are indicative of mild symptoms or minor impairment, scores of 61-70 are indicative of moderate symptoms or moderate impairment, and scores greater than 71 are indicative of severe symptoms or severe impairment.

  7. Change in anxiety score from Pre-assessment to Post-assessment 1 [ Time Frame: Baseline, 1-4 weeks after intervention ends ]
    Patient-Reported Outcomes Measurement Information System® (PROMIS) 29 Profile, v. 2.0 Adult Profile measures the patient's perceived quality of life over the past week using various criteria. For this secondary measure, we will examine the physical function sub-section score. PROMIS raw scores for this subscale range from 4 to 20; the PROMIS T-scores have a mean 50 and a standard deviation of 10 where higher scores indicate more symptoms and less functioning. Scores up to 55 are considered to be within normal range, scores of 55-60 are indicative of mild symptoms or minor impairment, scores of 61-70 are indicative of moderate symptoms or moderate impairment, and scores greater than 71 are indicative of severe symptoms or severe impairment.

  8. Change in anxiety score from Pre-assessment to Post-assessment 2 [ Time Frame: Baseline, 3-5 months after intervention ends ]
    Patient-Reported Outcomes Measurement Information System® (PROMIS) 29 Profile, v. 2.0 Adult Profile measures the patient's perceived quality of life over the past week using various criteria. For this secondary measure, we will examine the physical function sub-section score. PROMIS raw scores for this subscale range from 4 to 20; the PROMIS T-scores have a mean 50 and a standard deviation of 10 where higher scores indicate more symptoms and less functioning. Scores up to 55 are considered to be within normal range, scores of 55-60 are indicative of mild symptoms or minor impairment, scores of 61-70 are indicative of moderate symptoms or moderate impairment, and scores greater than 71 are indicative of severe symptoms or severe impairment.

  9. Change in fatigue score from Pre-assessment to Post-assessment 1 [ Time Frame: Baseline, 1-4 weeks after intervention ends ]
    Patient-Reported Outcomes Measurement Information System® (PROMIS) 29 Profile, v. 2.0 Adult Profile measures the patient's perceived quality of life over the past week using various criteria. For this secondary measure, we will examine the fatigue sub-section score. PROMIS raw scores for this subscale range from 4 to 20; the PROMIS T-scores have a mean 50 and a standard deviation of 10 where higher scores indicate more symptoms and less functioning. Scores up to 55 are considered to be within normal range, scores of 55-60 are indicative of mild symptoms or minor impairment, scores of 61-70 are indicative of moderate symptoms or moderate impairment, and scores greater than 71 are indicative of severe symptoms or severe impairment.

  10. Change in fatigue score from Pre-assessment to Post-assessment 2 [ Time Frame: Baseline, 3-5 months after intervention ends ]
    Patient-Reported Outcomes Measurement Information System® (PROMIS) 29 Profile, v. 2.0 Adult Profile measures the patient's perceived quality of life over the past week using various criteria. For this secondary measure, we will examine the fatigue sub-section score. PROMIS raw scores for this subscale range from 4 to 20; the PROMIS T-scores have a mean 50 and a standard deviation of 10 where higher scores indicate more symptoms and less functioning. Scores up to 55 are considered to be within normal range, scores of 55-60 are indicative of mild symptoms or minor impairment, scores of 61-70 are indicative of moderate symptoms or moderate impairment, and scores greater than 71 are indicative of severe symptoms or severe impairment.

  11. Change in sleep disturbance score from Pre-assessment to Post-assessment 1 [ Time Frame: Baseline, 1-4 weeks after intervention ends ]
    Patient-Reported Outcomes Measurement Information System® (PROMIS) 29 Profile, v. 2.0 Adult Profile measures the patient's perceived quality of life over the past week using various criteria. For this secondary measure, we will examine the physical function sub-section score. PROMIS raw scores for this subscale range from 4 to 20; the PROMIS T-scores have a mean 50 and a standard deviation of 10 where higher scores indicate more symptoms and less functioning. Scores up to 55 are considered to be within normal range, scores of 55-60 are indicative of mild symptoms or minor impairment, scores of 61-70 are indicative of moderate symptoms or moderate impairment, and scores greater than 71 are indicative of severe symptoms or severe impairment.

  12. Change in sleep disturbance score from Pre-assessment to Post-assessment 2 [ Time Frame: Baseline, 3-5 months after intervention ends ]
    Patient-Reported Outcomes Measurement Information System® (PROMIS) 29 Profile, v. 2.0 Adult Profile measures the patient's perceived quality of life over the past week using various criteria. For this secondary measure, we will examine the physical function sub-section score. PROMIS raw scores for this subscale range from 4 to 20; the PROMIS T-scores have a mean 50 and a standard deviation of 10 where higher scores indicate more symptoms and less functioning. Scores up to 55 are considered to be within normal range, scores of 55-60 are indicative of mild symptoms or minor impairment, scores of 61-70 are indicative of moderate symptoms or moderate impairment, and scores greater than 71 are indicative of severe symptoms or severe impairment.

  13. Change in ability to participate in social roles and activities score from Pre-assessment to Post-assessment 1 [ Time Frame: Baseline, 1-4 weeks after intervention ends ]
    Patient-Reported Outcomes Measurement Information System® (PROMIS) 29 Profile, v. 2.0 Adult Profile measures the patient's perceived quality of life over the past week using various criteria. For our secondary measure, we will examine the sleep disturbance sub-section score. For this secondary measure, we will examine the physical function sub-section score. PROMIS raw scores for this subscale range from 4 to 20; the PROMIS T-scores have a mean 50 and a standard deviation of 10 where higher scores indicate more symptoms and less functioning. Scores up to 55 are considered to be within normal range, scores of 55-60 are indicative of mild symptoms or minor impairment, scores of 61-70 are indicative of moderate symptoms or moderate impairment, and scores greater than 71 are indicative of severe symptoms or severe impairment.

  14. Change in ability to participate in social roles and activities score from Pre-assessment to Post-assessment 2 [ Time Frame: Baseline, 3-5 months after intervention ends ]
    Patient-Reported Outcomes Measurement Information System® (PROMIS) 29 Profile, v. 2.0 Adult Profile measures the patient's perceived quality of life over the past week using various criteria. For our secondary measure, we will examine the sleep disturbance sub-section score. For this secondary measure, we will examine the physical function sub-section score. PROMIS raw scores for this subscale range from 4 to 20; the PROMIS T-scores have a mean 50 and a standard deviation of 10 where higher scores indicate more symptoms and less functioning. Scores up to 55 are considered to be within normal range, scores of 55-60 are indicative of mild symptoms or minor impairment, scores of 61-70 are indicative of moderate symptoms or moderate impairment, and scores greater than 71 are indicative of severe symptoms or severe impairment.

  15. Change in pain interference score from Pre-assessment to Post-assessment 1 [ Time Frame: Baseline, 1-4 weeks after intervention ends ]
    Patient-Reported Outcomes Measurement Information System® (PROMIS) 29 Profile, v. 2.0 Adult Profile measures the patient's perceived quality of life over the past week using various criteria. For this secondary measure, we will examine the physical function sub-section score. PROMIS raw scores for this subscale range from 4 to 20; the PROMIS T-scores have a mean 50 and a standard deviation of 10 where higher scores indicate more symptoms and less functioning. Scores up to 55 are considered to be within normal range, scores of 55-60 are indicative of mild symptoms or minor impairment, scores of 61-70 are indicative of moderate symptoms or moderate impairment, and scores greater than 71 are indicative of severe symptoms or severe impairment.

  16. Change in pain interference score from Pre-assessment to Post-assessment 2 [ Time Frame: Baseline, 3-5 months after intervention ends ]
    Patient-Reported Outcomes Measurement Information System® (PROMIS) 29 Profile, v. 2.0 Adult Profile measures the patient's perceived quality of life over the past week using various criteria. For this secondary measure, we will examine the physical function sub-section score. PROMIS raw scores for this subscale range from 4 to 20; the PROMIS T-scores have a mean 50 and a standard deviation of 10 where higher scores indicate more symptoms and less functioning. Scores up to 55 are considered to be within normal range, scores of 55-60 are indicative of mild symptoms or minor impairment, scores of 61-70 are indicative of moderate symptoms or moderate impairment, and scores greater than 71 are indicative of severe symptoms or severe impairment.

  17. Change in ASA dietary recall data analysis of food groups from Pre-assessment to Post-assessment 1 [ Time Frame: Baseline, 1-4 weeks after intervention ends ]
    Automated Self-administered (ASA) Dietary Recall measures the foods and beverages consumed throughout the previous day. We will compare the dietary analysis (nutrients and food groups) reported by participant on the ASA Dietary Recall.

  18. Change in ASA dietary recall data analysis of food groups from Pre-assessment to Post-assessment 2 [ Time Frame: Baseline, 3-5 months after intervention end ]
    Automated Self-administered (ASA) Dietary Recall measures the foods and beverages consumed throughout the previous day. We will compare the dietary analysis (nutrients and food groups) reported by participant on the ASA Dietary Recall.

  19. Change in sleep pattern score from Pre-assessment to Post-assessment 1 [ Time Frame: Baseline, 1-4 weeks after intervention ends ]
    Using the Wellness Patterns Questionnaire, effort and ability to keep a regular sleep schedule are assessed. Possible scores range from 0 to 7, with higher scores indicating a more regular sleep pattern.

  20. Change in sleep pattern score from Pre-assessment to Post-assessment 2 [ Time Frame: Baseline, 3-5 months after intervention end ]
    Using the Wellness Patterns Questionnaire, effort and ability to keep a regular sleep schedule are assessed. Possible scores range from 0 to 7, with higher scores indicating a more regular sleep pattern.

  21. Change in eating pattern score from Pre-assessment to Post-assessment 1 [ Time Frame: Baseline, 1-4 weeks after intervention ends ]
    Using the Wellness Patterns Questionnaire, eating effort and ability to keep a regular eating pattern are assessed. Possible scores range from 0 to 16, with higher scores suggesting more consistent eating patterns.

  22. Change in eating pattern score from Pre-assessment to Post-assessment 2 [ Time Frame: Baseline, 3-5 months after intervention end ]
    Using the Wellness Patterns Questionnaire, effort and ability to keep a regular eating pattern are assessed. Possible scores range from 0 to 16, with higher scores suggesting more consistent eating patterns.

  23. Change in activity score from Pre-assessment to Post-assessment 1 [ Time Frame: Baseline, 1-4 weeks after intervention ends ]
    Using the Wellness Patterns Questionnaire, consistency of exercise and activity patterns is assessed. Possible scores range from 0 to 7, with higher scores reflecting more consistent engagement in exercise.

  24. Change in activity score from Pre-assessment to Post-assessment 2 [ Time Frame: Baseline, 3-5 months after intervention end ]
    Using the Wellness Patterns Questionnaire, consistency of exercise and activity patterns is assessed. Possible scores range from 0 to 7, with higher scores reflecting more consistent engagement in exercise.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • able to give informed consent
  • able to speak English sufficiently to understand study procedures, provide written informed consent for study participation, and complete questionnaires
  • BMI > 25
  • appropriate for outpatient care

Exclusion Criteria:

  • medically unstable
  • inpatient medical
  • psychiatric inpatient
  • psychiatric residential care

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): NCT04962321


Contacts
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Contact: Carrie J McAdams, MD PhD 214-648-4617 edresearch@utsouthwestern.edu

Locations
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United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75235
Contact: Mohita Patel    214-648-4617    mohita1.patel@utsouthwestern.edu   
Principal Investigator: Carrie McAdams         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Carrie J McAdams, MD PhD University of Texas Southwestern Medical Center
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Responsible Party: Carrie McAdams, Associate Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT04962321    
Other Study ID Numbers: STU-2021-0563
First Posted: July 14, 2021    Key Record Dates
Last Update Posted: October 27, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Overweight
Feeding and Eating Disorders
Body Weight
Mental Disorders