Clinical trial NCT04962321: Wellness Education Intervention
Official title: Wellness Education Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Eating Disorders
Depression, Anxiety
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2021-07-14
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot study to examine acceptability, feasibility, and explore clinical responses related to wellness behaviors and quality of life.
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in Physical Health Summary Scores from Pre-assessment to Post-assessment 1
timeFrame: Baseline, 1-4 weeks after intervention ends
measure: Change in Mental Health Summary Scores from Pre-assessment to Post-assessment 1
timeFrame: Baseline, 1-4 weeks after intervention ends
measure: Change in Physical Health Summary Scores from Pre-assessment to Post-assessment 2
timeFrame: Baseline, 3-5 months after intervention ends
measure: Change in Mental Health Summary Scores from Pre-assessment to Post-assessment 2
timeFrame: Baseline, 3-5 months after intervention ends
measure: Change in self-efficacy score from Pre-assessment to Post-assessment 1
timeFrame: Baseline, 1-4 weeks after intervention ends
measure: Change in self-efficacy score from Pre-assessment to Post-assessment 2
timeFrame: Baseline, 3-5 months after intervention ends
measure: Change in frequency of patients with eating disorders from Pre- assessment to Post-assessment 1
timeFrame: Baseline, 1-4 weeks after intervention ends
measure: Change in frequency of patients with eating disorders from Pre- assessment to Post-assessment 2
timeFrame: Baseline, 3-5 months after intervention ends
measure: Study components feedback score at 4 weeks after starting intervention
timeFrame: 4 weeks after starting intervention
measure: Study components feedback score at 8 weeks after starting intervention
timeFrame: 8 weeks after starting intervention
measure: Patient satisfaction score
timeFrame: 1-4 weeks after intervention ends
measure: Change in Behavioral Patterns from Pre-assessment to Post-assessment 1
timeFrame: Baseline, 1-4 weeks after intervention ends
measure: Change in Behavioral Patterns from Pre-assessment to Post-assessment 2
timeFrame: Time Frame: Baseline, 3-5 months after intervention end
Secondary outcomes:
measure: Change in weight from Pre-assessment to Post-assessment 1
timeFrame: Baseline, 1-4 weeks after intervention ends
measure: Change in weight from Pre-assessment to Post-assessment 2
timeFrame: Baseline, 3-5 months after intervention ends
measure: Change in physical function score from Pre-assessment to Post-assessment 1
timeFrame: Baseline, 1-4 weeks after intervention ends
measure: Change in physical function score from Pre-assessment to Post-assessment 2
timeFrame: Baseline, 3-5 months after intervention ends
measure: Change in depression score from Pre-assessment to Post-assessment 1
timeFrame: Baseline, 1-4 weeks after intervention ends
measure: Change in depression score from Pre-assessment to Post-assessment 2
timeFrame: Baseline, 3-5 months after intervention ends
measure: Change in anxiety score from Pre-assessment to Post-assessment 1
timeFrame: Baseline, 1-4 weeks after intervention ends
measure: Change in anxiety score from Pre-assessment to Post-assessment 2
timeFrame: Baseline, 3-5 months after intervention ends
measure: Change in fatigue score from Pre-assessment to Post-assessment 1
timeFrame: Baseline, 1-4 weeks after intervention ends
measure: Change in fatigue score from Pre-assessment to Post-assessment 2
timeFrame: Baseline, 3-5 months after intervention ends
measure: Change in sleep disturbance score from Pre-assessment to Post-assessment 1
timeFrame: Baseline, 1-4 weeks after intervention ends
measure: Change in sleep disturbance score from Pre-assessment to Post-assessment 2
timeFrame: Baseline, 3-5 months after intervention ends
measure: Change in ability to participate in social roles and activities score from Pre-assessment to Post-assessment 1
timeFrame: Baseline, 1-4 weeks after intervention ends
measure: Change in ability to participate in social roles and activities score from Pre-assessment to Post-assessment 2
timeFrame: Baseline, 3-5 months after intervention ends
measure: Change in pain interference score from Pre-assessment to Post-assessment 1
timeFrame: Baseline, 1-4 weeks after intervention ends
measure: Change in pain interference score from Pre-assessment to Post-assessment 2
timeFrame: Baseline, 3-5 months after intervention ends
measure: Change in ASA dietary recall data analysis of food groups from Pre-assessment to Post-assessment 1
timeFrame: Baseline, 1-4 weeks after intervention ends
measure: Change in ASA dietary recall data analysis of food groups from Pre-assessment to Post-assessment 2
timeFrame: Baseline, 3-5 months after intervention end
measure: Change in sleep pattern score from Pre-assessment to Post-assessment 1
timeFrame: Baseline, 1-4 weeks after intervention ends
measure: Change in sleep pattern score from Pre-assessment to Post-assessment 2
timeFrame: Baseline, 3-5 months after intervention end
measure: Change in eating pattern score from Pre-assessment to Post-assessment 1
timeFrame: Baseline, 1-4 weeks after intervention ends
measure: Change in eating pattern score from Pre-assessment to Post-assessment 2
timeFrame: Baseline, 3-5 months after intervention end
measure: Change in activity score from Pre-assessment to Post-assessment 1
timeFrame: Baseline, 1-4 weeks after intervention ends
measure: Change in activity score from Pre-assessment to Post-assessment 2
timeFrame: Baseline, 3-5 months after intervention end
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Carrie J McAdams, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: