Wellness Education Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Change in Physical Health Summary Scores from Pre-assessment to Post-assessment 2
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •medically unstable
- •inpatient medical
- •psychiatric inpatient
- •psychiatric residential care
结局指标
主要结局
Change in Physical Health Summary Scores from Pre-assessment to Post-assessment 2
时间窗: 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 frequency of patients with eating disorders from Pre- assessment to Post-assessment 1
时间窗: 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 Mental Health Summary Scores from Pre-assessment to Post-assessment 1
时间窗: 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 self-efficacy score from Pre-assessment to Post-assessment 1
时间窗: 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 Physical Health Summary Scores from Pre-assessment to Post-assessment 1
时间窗: 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 2
时间窗: 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 frequency of patients with eating disorders from Pre- assessment to Post-assessment 2
时间窗: 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 8 weeks after starting intervention
时间窗: 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.
Change in Behavioral Patterns from Pre-assessment to Post-assessment 1
时间窗: 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.
Patient satisfaction score
时间窗: 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 self-efficacy score from Pre-assessment to Post-assessment 2
时间窗: 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 Behavioral Patterns from Pre-assessment to Post-assessment 2
时间窗: 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.
Study components feedback score at 4 weeks after starting intervention
时间窗: 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.
次要结局
- Change in physical function score from Pre-assessment to Post-assessment 2(Baseline, 3-5 months after intervention ends)
- Change in fatigue score from Pre-assessment to Post-assessment 1(Baseline, 1-4 weeks after intervention ends)
- Change in sleep pattern score from Pre-assessment to Post-assessment 2(Baseline, 3-5 months after intervention end)
- Change in anxiety score from Pre-assessment to Post-assessment 1(Baseline, 1-4 weeks after intervention ends)
- Change in sleep disturbance score from Pre-assessment to Post-assessment 2(Baseline, 3-5 months after intervention ends)
- Change in eating pattern score from Pre-assessment to Post-assessment 2(Baseline, 3-5 months after intervention end)
- Change in weight 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)
- Change in depression score from Pre-assessment to Post-assessment 2(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(Baseline, 1-4 weeks after intervention ends)
- Change in weight from Pre-assessment to Post-assessment 1(Baseline, 1-4 weeks after intervention ends)
- Change in anxiety score from Pre-assessment to Post-assessment 2(Baseline, 3-5 months after intervention ends)
- Change in ability to participate in social roles and activities score from Pre-assessment to Post-assessment 2(Baseline, 3-5 months after intervention ends)
- Change in pain interference 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 1(Baseline, 1-4 weeks after intervention ends)
- Change in fatigue score from Pre-assessment to Post-assessment 2(Baseline, 3-5 months after intervention ends)
- Change in sleep disturbance score from Pre-assessment to Post-assessment 1(Baseline, 1-4 weeks after intervention ends)
- Change in pain interference score from Pre-assessment to Post-assessment 2(Baseline, 3-5 months after intervention ends)
- Change in activity score from Pre-assessment to Post-assessment 1(Baseline, 1-4 weeks after intervention ends)
- Change in ASA dietary recall data analysis of food groups from Pre-assessment to Post-assessment 1(Baseline, 1-4 weeks after intervention ends)
- Change in ASA dietary recall data analysis of food groups from Pre-assessment to Post-assessment 2(Baseline, 3-5 months after intervention end)
- Change in sleep pattern score from Pre-assessment to Post-assessment 1(Baseline, 1-4 weeks after intervention ends)
- Change in eating pattern score from Pre-assessment to Post-assessment 1(Baseline, 1-4 weeks after intervention ends)
- Change in activity score from Pre-assessment to Post-assessment 2(Baseline, 3-5 months after intervention end)
研究者
Carrie McAdams
Associate Professor
University of Texas Southwestern Medical Center