Wellness Education Intervention

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Wellness Education Intervention

Conditions
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Overweight and Obesity, Eating Disorders, Depression, Anxiety

Intervention / Treatment
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* Behavioral: Wellness Education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Pilot study to examine acceptability, feasibility, and explore clinical responses related to wellness behaviors and quality of life.
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Physical Health Summary Scores from Pre-assessment to Post-assessment 1 | 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. | Baseline, 1-4 weeks after intervention ends | 
| Change in Mental Health Summary Scores from Pre-assessment to Post-assessment 1 | 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. | Baseline, 1-4 weeks after intervention ends | 
| Change in Physical Health Summary Scores from Pre-assessment to Post-assessment 2 | 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. | Baseline, 3-5 months after intervention ends | 
| Change in Mental Health Summary Scores from Pre-assessment to Post-assessment 2 | 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. | Baseline, 3-5 months after intervention ends | 
| Change in self-efficacy score from Pre-assessment to Post-assessment 1 | 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. | Baseline, 1-4 weeks after intervention ends | 
| Change in self-efficacy score from Pre-assessment to Post-assessment 2 | 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. | Baseline, 3-5 months after intervention ends | 
| Change in frequency of patients with eating disorders from Pre- assessment to Post-assessment 1 | 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. | Baseline, 1-4 weeks after intervention ends | 
| Change in frequency of patients with eating disorders from Pre- assessment to Post-assessment 2 | 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. | Baseline, 3-5 months after intervention ends | 
| Study components feedback score at 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. | 4 weeks after starting intervention | 
| Study components feedback score at 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. | 8 weeks after starting intervention | 
| Patient satisfaction score | 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. | 1-4 weeks after intervention ends | 
| Change in Behavioral Patterns from Pre-assessment to Post-assessment 1 | 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. | Baseline, 1-4 weeks after intervention ends | 
| Change in Behavioral Patterns from Pre-assessment to Post-assessment 2 | 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. | Time Frame: Baseline, 3-5 months after intervention end | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in weight from Pre-assessment to Post-assessment 1 | Weight will be measured in pounds, percentage changed from baseline (loss or gain), and BMI. | Baseline, 1-4 weeks after intervention ends | 
| Change in weight from Pre-assessment to Post-assessment 2 | Weight will be measured in pounds, percentage changed from baseline (loss or gain), and BMI. | Baseline, 3-5 months after intervention ends | 
| Change in physical function score from Pre-assessment to Post-assessment 1 | 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. | Baseline, 1-4 weeks after intervention ends | 
| Change in physical function score from Pre-assessment to Post-assessment 2 | 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. | Baseline, 3-5 months after intervention ends | 
| Change in depression score from Pre-assessment to Post-assessment 1 | 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. | Baseline, 1-4 weeks after intervention ends | 
| Change in depression score from Pre-assessment to Post-assessment 2 | 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. | Baseline, 3-5 months after intervention ends | 
| Change in anxiety score from Pre-assessment to Post-assessment 1 | 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. | Baseline, 1-4 weeks after intervention ends | 
| Change in anxiety score from Pre-assessment to Post-assessment 2 | 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. | Baseline, 3-5 months after intervention ends | 
| Change in fatigue score from Pre-assessment to Post-assessment 1 | 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. | Baseline, 1-4 weeks after intervention ends | 
| Change in fatigue score from Pre-assessment to Post-assessment 2 | 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. | Baseline, 3-5 months after intervention ends | 
| Change in sleep disturbance score from Pre-assessment to Post-assessment 1 | 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. | Baseline, 1-4 weeks after intervention ends | 
| Change in sleep disturbance score from Pre-assessment to Post-assessment 2 | 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. | Baseline, 3-5 months after intervention ends | 
| Change in ability to participate in social roles and activities score from Pre-assessment to Post-assessment 1 | 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. | Baseline, 1-4 weeks after intervention ends | 
| Change in ability to participate in social roles and activities score from Pre-assessment to Post-assessment 2 | 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. | Baseline, 3-5 months after intervention ends | 
| Change in pain interference score from Pre-assessment to Post-assessment 1 | 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. | Baseline, 1-4 weeks after intervention ends | 
| Change in pain interference score from Pre-assessment to Post-assessment 2 | 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. | Baseline, 3-5 months after intervention ends | 
| Change in ASA dietary recall data analysis of food groups from Pre-assessment to Post-assessment 1 | 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. | Baseline, 1-4 weeks after intervention ends | 
| Change in ASA dietary recall data analysis of food groups from Pre-assessment to Post-assessment 2 | 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. | Baseline, 3-5 months after intervention end | 
| Change in sleep pattern score from Pre-assessment to Post-assessment 1 | 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. | Baseline, 1-4 weeks after intervention ends | 
| Change in sleep pattern score from Pre-assessment to Post-assessment 2 | 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. | Baseline, 3-5 months after intervention end | 
| Change in eating pattern score from Pre-assessment to Post-assessment 1 | 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. | Baseline, 1-4 weeks after intervention ends | 
| Change in eating pattern score from Pre-assessment to Post-assessment 2 | 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. | Baseline, 3-5 months after intervention end | 
| Change in activity score from Pre-assessment to Post-assessment 1 | 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. | Baseline, 1-4 weeks after intervention ends | 
| Change in activity score from Pre-assessment to Post-assessment 2 | 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. | Baseline, 3-5 months after intervention end |