Clinical trial NCT03642197: Feasibility and Preliminary Efficacy of Support Figure Attendance at Bariatric Patients' Clinical Visits
Official title: Feasibility and Preliminary Efficacy of Support Figure Attendance at Bariatric Patients' Clinical Visits
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Morbid
Bariatric Surgery Candidate
Diet Habit
Behavior, Social
Physical Activity
Keywords: Bariatric Surgery
Obesity
Social Support
Health Behavior
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2018-08-22
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A four-arm randomized controlled trial (RCT) using simple randomization will randomize female patients in romantic relationships 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.

Patients in all arms will receive routine care. 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). The study will follow all groups for roughly six months.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

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.

Hypothesis. Patients in the SFA and PA arms will experience increased weight loss, physical activity frequency, and higher compliance with post-surgery dietary recommendations compared to patients in the SFA-TU and PA-TU arms at T4.

Sub-aim 2.1. To evaluate the effect of attendance on support figure/partner weight status. Support figures and partners will complete measures of weight status at the same time points as the patient. Because it is largely unknown if support figures/partners could benefit from intervention with the patient, or if support figures/partners' weight status is similar to the patients, we will explore support figures/partners' weight status and if their weight status changes from T1 to T4.

Sub-aim 2.2. To determine the preliminary effect of attendance on relationship outcomes. Patients and support figures/partners will complete self-report measures of relationship quality (PA-only), attachment security (PA-only), family functioning, and perceived social support from T1-T4 to determine the effect of attendance on patient and support figure/partners' perspectives of relationship outcomes.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* No known terminal health diagnosis (i.e., Cancer)
* In the PA and PA-TAU arms, no known domestic violence or abuse between partners

Primary outcomes:
measure: Percent Excess Weight Loss (%EWL, Patient)
timeFrame: 6 months, 4 time points
Secondary outcomes:
measure: Dietary Compliance (Patient)
timeFrame: 6 months, 4 time points
measure: Physical Activity (Patient)
timeFrame: 6 months, 4 time points
measure: Relationship Quality (Patient and Partner)
timeFrame: 6 months, 4 time points
measure: Perceived Social Support for Behavior Change (Patient and Partner/Support Figure)
timeFrame: 6 months, 4 time points
Other outcomes:
measure: Relationship Attachment (Patient and Partner)
timeFrame: 6 months, 4 time points
measure: Family Functioning (Patient and Partner/Support Figure)
timeFrame: 6 moths, 4 time points
Locations:
city: Columbus
country: United States
facility: Martha Morehouse Pavillion
state: Ohio
Study officials:
affiliation: Ohio State University
name: Keeley J Pratt, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Epstein, N. B., Baldwin, L. M., & Bishop, D. S. (1983). The McMaster family assessment device. Journal of marital and family therapy, 9(2), 171-180.
citation: Sallis JF, Grossman RM, Pinski RB, Patterson TL, Nader PR. The development of scales to measure social support for diet and exercise behaviors. Prev Med. 1987 Nov;16(6):825-36. doi: 10.1016/0091-7435(87)90022-3.
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