Wellness Education Intervention

NCT04962321 | Completed

• 1 other identifier: STU-2021-0563
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity; Eating Disorders; Depression, Anxiety

Outcome Measures

Primary Outcomes (13)

• 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 Outcomes (24)

• Change in weight from Pre-assessment to Post-assessment 1

  Baseline, 1-4 weeks after intervention ends

• Change in weight from Pre-assessment to Post-assessment 2

  Baseline, 3-5 months after intervention ends

• Change in physical function score from Pre-assessment to Post-assessment 1

  Baseline, 1-4 weeks after intervention ends

• Change in physical function score from Pre-assessment to Post-assessment 2

  Baseline, 3-5 months after intervention ends

• Change in depression score from Pre-assessment to Post-assessment 1

  Baseline, 1-4 weeks after intervention ends

Study Arms (1)

PsychoEd

EXPERIMENTAL

These participants are enrolled to participate in the 8-session education sessions.

Behavioral: Wellness Education

Interventions

Wellness Education BEHAVIORAL

Psychoeducation on relationships between mood, anxiety, eating, and exercise behaviors. One one-hour session each week for 8 weeks.

PsychoEd

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

Overweight; Obesity; Feeding and Eating Disorders; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Carrie J McAdams, MD PhD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Pilot study to examine acceptability, feasibility, and explore clinical responses related to wellness behaviors and quality of life.

Study Record Dates

• First Submitted: July 9, 2021
• First Posted: July 14, 2021
• Study Start: July 19, 2021
• Primary Completion: October 12, 2022
• Study Completion: October 12, 2022
• Last Updated: October 11, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)