Overweight and ObesityNCT04962321
Wellness Education Intervention
A study testing Wellness Education in people with Overweight and Obesity and Eating Disorders, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Overweight and Obesity, Eating Disorders, Depression, Anxiety
- What is being tested?
- Wellness Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jul 2021to 12 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- medically unstable
- inpatient medical
- psychiatric inpatient
- psychiatric residential care
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Wellness Education
- Medical subject headings
- Overweight, Obesity, Feeding and Eating Disorders, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wellness EducationBehavioural
Psychoeducation on relationships between mood, anxiety, eating, and exercise behaviors. One one-hour session each week for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| PsychoEd | Experimental | These participants are enrolled to participate in the 8-session education sessions. Receives: Behavioral: Wellness Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Time Frame: Baseline, 3-5 months after intervention end
Secondary outcomes (24)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3-5 months after intervention end
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start19 Jul 2021
- Primary completion12 Oct 2022
- Study completion12 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot study to examine acceptability, feasibility, and explore clinical responses related to wellness behaviors and quality of life.
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carrie McAdams, University of Texas Southwestern Medical Center
- Investigators
- Carrie J McAdams, MD PhD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04962321
- Sponsor's protocol ID
- STU-2021-0563
- Status last verified
- Oct 2023
- First submitted
- 9 Jul 2021
- Last updated
- 11 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wellness Education Intervention
- ClinicalTrials.gov ID
- NCT04962321
- Acronym / sponsor ID
- STU-2021-0563
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 19 Jul 2021 (actual)
- Primary completion
- 12 Oct 2022 (actual)
- Study completion
- 12 Oct 2022 (actual)
- First posted
- 14 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot study to examine acceptability, feasibility, and explore clinical responses related to wellness behaviors and quality of life.
| Arm | Type | Receives |
|---|---|---|
| PsychoEd | Experimental | Behavioral: Wellness EducationThese participants are enrolled to participate in the 8-session education sessions. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- medically unstable
- inpatient medical
- psychiatric inpatient
- psychiatric residential care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wellness EducationPsychoeducation on relationships between mood, anxiety, eating, and exercise behaviors. One one-hour session each week for 8 weeks. | Behavioural | PsychoEd |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
24 secondary outcomes
Change in weight from Pre-assessment to Post-assessment 1
Time frame: Baseline, 1-4 weeks after intervention ends
Change in weight from Pre-assessment to Post-assessment 2
Time frame: Baseline, 3-5 months after intervention ends
Change in physical function score from Pre-assessment to Post-assessment 1
Time frame: Baseline, 1-4 weeks after intervention ends
Change in physical function score from Pre-assessment to Post-assessment 2
Time frame: Baseline, 3-5 months after intervention ends
Change in depression score from Pre-assessment to Post-assessment 1
Time frame: Baseline, 1-4 weeks after intervention ends
Change in depression score from Pre-assessment to Post-assessment 2
Time frame: Baseline, 3-5 months after intervention ends
Change in anxiety score from Pre-assessment to Post-assessment 1
Time frame: Baseline, 1-4 weeks after intervention ends
Change in anxiety score from Pre-assessment to Post-assessment 2
Time frame: Baseline, 3-5 months after intervention ends
Change in fatigue score from Pre-assessment to Post-assessment 1
Time frame: Baseline, 1-4 weeks after intervention ends
Change in fatigue score from Pre-assessment to Post-assessment 2
Time frame: Baseline, 3-5 months after intervention ends
Change in sleep disturbance score from Pre-assessment to Post-assessment 1
Time frame: Baseline, 1-4 weeks after intervention ends
Change in sleep disturbance score from Pre-assessment to Post-assessment 2
Time frame: 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
Time frame: 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
Time frame: Baseline, 3-5 months after intervention ends
Change in pain interference score from Pre-assessment to Post-assessment 1
Time frame: Baseline, 1-4 weeks after intervention ends
Change in pain interference score from Pre-assessment to Post-assessment 2
Time frame: Baseline, 3-5 months after intervention ends
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
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
Change in sleep pattern score from Pre-assessment to Post-assessment 1
Time frame: Baseline, 1-4 weeks after intervention ends
Change in sleep pattern score from Pre-assessment to Post-assessment 2
Time frame: Baseline, 3-5 months after intervention end
Change in eating pattern score from Pre-assessment to Post-assessment 1
Time frame: Baseline, 1-4 weeks after intervention ends
Change in eating pattern score from Pre-assessment to Post-assessment 2
Time frame: Baseline, 3-5 months after intervention end
Change in activity score from Pre-assessment to Post-assessment 1
Time frame: Baseline, 1-4 weeks after intervention ends
Change in activity score from Pre-assessment to Post-assessment 2
Time frame: Baseline, 3-5 months after intervention end
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carrie J McAdams, MD PhD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wellness Education in people with Overweight and Obesity and Eating Disorders, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Physical Health Summary Scores from Pre-assessment to Post-assessment 1 (time frame: Baseline, 1-4 weeks after intervention ends). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2023.