Feasibility and Preliminary Efficacy of Support Figure Attendance at Bariatric Patients' Clinical Visits
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Percent Excess Weight Loss (%EWL, Patient)
研究概览
简要总结
The purpose of this study is to examine the feasibility, acceptability, and preliminary efficacy for the inclusion of support figures and romantic partners throughout the bariatric surgery process, from pre-surgery to two months post-surgery. This will be done using a four-arm randomized controlled trial (RCT). Using simple randomization, female patients in romantic relationships will be randomized into partner attended (PA) groups and treatment as usual (PA-TU) groups; patients (female or male) not in romantic relationships will be randomized into support figure attended (SFA) and SFA-TU groups.
The goals of this study are to provide preliminary evidence for including support figures/partners in patients' routine BS healthcare visits, including the subsequent impact on post-surgery patient and support figure/partner behavior change and weight loss, relationship outcomes, and exploration of barriers to support figure/partner involvement.
Aim 1: To assess the feasibility and acceptability of support figure/partner involvement for BS patients. Feasibility will be assessed throughout the study by attendance at the four pre-surgery classes and the clinic visit assessment time points. Perceived fiscal and time involved in the study will be assessed. Acceptability will be assessed from patient and support figure/partner interviews regarding the barriers and benefits to attendance, and alternative mediums to engage support figures/partners.
Aim 2: To evaluate the effect of support figure/partner attendance (SFA, PA arms) on patient weight loss, behavior change, and relationship outcomes from T1-T4. Estimates of effect size and variance in patient weight loss and behavior change will be collected from T1-T4 for comparison of the SFA/PA and SFA-TU/PA-TU arms.
详细描述
The purpose of this study is to examine the feasibility, acceptability, and preliminary efficacy for the inclusion of support figures and romantic partners throughout the bariatric surgery process, from pre-surgery to two months post-surgery. This will be done using a four-arm randomized controlled trial (RCT). Using simple randomization, female patients in romantic relationships will be randomized into partner attended (PA) groups and treatment as usual (PA-TU) groups; patients (female or male) not in romantic relationships will be randomized into support figure attended (SFA) and SFA-TU groups.
The goals of this study are to provide preliminary evidence for including support figures/partners in patients' routine BS healthcare visits, including the subsequent impact on post-surgery patient and support figure/partner behavior change and weight loss, relationship outcomes, and exploration of barriers to support figure/partner involvement.
Inclusion criteria for the PA arm requires patients be pre-surgery and registered for pre-surgery classes, identify as female, and in a romantic relationship with a cohabitating partner/spouse for at least 6 months. Inclusion criteria for the SFA arm requires patients be pre-surgery and registered for pre-surgery classes, and not be in a cohabitating romantic relationships. Known terminal illness diagnosis excludes patients and support figure/partner participation. The recruitment goal is 110 dyads in all four arms of the study (SFA, SFA-TU, PA, PA-TU).
Patients in all arms will receive routine care, which includes four pre-surgery classes and routine clinical visits. Support figures/partners of patients in the SFA and PA arms will be requested to attend the four pre-surgery classes with the patient and the three clinical visits; patients in the SFA-TU and PA-TU arms will attend individually. Assessments will be completed by patients and support figures/partners (all four arms) at the first pre-surgery class (T1) and routine clinical visits: the pre-surgery appointment (T2), two-weeks post-surgery appointment (T3), and at the two-months post-surgery appointment (T4).
Aim 1: To assess the feasibility and acceptability of support figure/partner involvement for BS patients. Feasibility will be assessed throughout the study by attendance at the four pre-surgery classes and the clinic visit assessment time points. Perceived fiscal and time involved in the study will be assessed. Acceptability will be assessed from patient and support figure/partner interviews regarding the barriers and benefits to attendance, and alternative mediums to engage support figures/partners.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients in all arms must be ≥18 years-old, seeking bariatric surgery, speak and read/write English
- •Partners and support figures must be ≥18 years old, speak and read/write English, and have no prior history of BS
- •Partners in the PA and PA-TAU arms must be in a romantic relationship and cohabitate with the patient for at least 6 months
排除标准
- •No known terminal health diagnosis (i.e., Cancer)
- •In the PA and PA-TAU arms, no known domestic violence or abuse between partners
研究组 & 干预措施
Support Figure Attended (SFA)
Using simple randomization patients (female or male) not in romantic relationships will be randomized into support figure attended (SFA) and SFA-TU groups. Patients in all arms will receive routine care, which includes four pre-surgery classes and routine clinical visits. Support figures in the SFA arm will be requested to attend the four pre-surgery classes with the patient and the three clinical visits. The intervention is support figure attendance. Assessments will be completed by patients and support figures at the first pre-surgery class (T1) and routine clinical visits: the pre-surgery appointment (T2), two-weeks post-surgery appointment (T3), and at the two-months post-surgery appointment (T4).
干预措施: Attendance (Behavioral)
SFA - Treatment as Usual (SFA-TAU)
Using simple randomization patients (female or male) not in romantic relationships will be randomized into support figure attended (SFA) and SFA-TU groups. Patients in all arms will receive routine care, which includes four pre-surgery classes and routine clinical visits. Support figures in the SFA-TU arm will not be requested to attend the four pre-surgery classes with the patient and the three clinical visits- patients will attend alone. Assessments will be completed by patients and support figures at the first pre-surgery class (T1) and routine clinical visits: the pre-surgery appointment (T2), two-weeks post-surgery appointment (T3), and at the two-months post-surgery appointment (T4).
Partner Attended (PA)
Using simple randomization female patients in cohabiting romantic relationships for at least 6 months will be randomized into partner attended (PA) and PA-TU groups. Patients in all arms will receive routine care, which includes four pre-surgery classes and routine clinical visits. Partners in the PA arm will be requested to attend the four pre-surgery classes with the patient and the three clinical visits. The intervention is partner attendance. Assessments will be completed by patients and partners at the first pre-surgery class (T1) and routine clinical visits: the pre-surgery appointment (T2), two-weeks post-surgery appointment (T3), and at the two-months post-surgery appointment (T4).
干预措施: Attendance (Behavioral)
PA - Treatment as Usual (PA-TAU)
Using simple randomization female patients in cohabiting romantic relationships for at least 6 months will be randomized into partner attended (PA) and PA-TU groups. Patients in all arms will receive routine care, which includes four pre-surgery classes and routine clinical visits. Partners in the PA-TU arm will not be requested to attend the four pre-surgery classes with the patient and the three clinical visits- patients will attend alone. Assessments will be completed by patients and partners at the first pre-surgery class (T1) and routine clinical visits: the pre-surgery appointment (T2), two-weeks post-surgery appointment (T3), and at the two-months post-surgery appointment (T4).
结局指标
主要结局
Percent Excess Weight Loss (%EWL, Patient)
时间窗: 6 months, 4 time points
\[(T1 weight in lbs) - (Follow up (T2-T4) Weight)\] / \[(TI Weight) - (Ideal Weight)\]
次要结局
- Physical Activity (Patient)(6 months, 4 time points)
- Relationship Quality (Patient and Partner)(6 months, 4 time points)
- Perceived Social Support for Behavior Change (Patient and Partner/Support Figure)(6 months, 4 time points)
- Dietary Compliance (Patient)(6 months, 4 time points)
研究者
Keeley Pratt
Associate Professor
Ohio State University