feasibility and preliminary efficacy of support figure attendance at bariatric patients' clinical visits

Conditions: Obesity, Morbid; Bariatric Surgery Candidate; Diet Habit; Behavior, Social; Physical Activity

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.

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

Keywords: bariatric surgery obesity social support health behavior