Feasibility and Preliminary Efficacy of Support Figure Attendance at Bariatric Patients' Clinical Visits

NCT03642197 | Completed

• 1 other identifier: 2018H0264
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Bariatric Surgery; Obesity; Social Support; Health Behavior

Outcome Measures

Primary Outcomes (1)

• Percent Excess Weight Loss (%EWL, Patient)

  \[(T1 weight in lbs) - (Follow up (T2-T4) Weight)\] / \[(TI Weight) - (Ideal Weight)\]

  6 months, 4 time points

Secondary Outcomes (4)

• Dietary Compliance (Patient)

  6 months, 4 time points

• 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

Other Outcomes (2)

• Relationship Attachment (Patient and Partner)

  6 months, 4 time points

• Family Functioning (Patient and Partner/Support Figure)

  6 moths, 4 time points

Study Arms (4)

Support Figure Attended (SFA)

EXPERIMENTAL

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).

Behavioral: Attendance

SFA - Treatment as Usual (SFA-TAU)

NO INTERVENTION

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)

EXPERIMENTAL

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).

Behavioral: Attendance

PA - Treatment as Usual (PA-TAU)

NO INTERVENTION

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).

Interventions

Attendance BEHAVIORAL

The SFA and PA arms will be instructed to attend pre-surgery classes and clinical visits with the patients.

Partner Attended (PA); Support Figure Attended (SFA)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: In the PA and PA-TAU arms, female patients will be recruited, partners can identify as male or female. In the SFA and SFA-TU arms patients identifying as male or female will be recruited, support figures can identify as male or female.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

Martha Morehouse Pavillion

Columbus, Ohio, 43210, United States

Location

Related Publications (5)

• Sharpley, C. F., & Rogers, H. J. (1984). Preliminary validation of the Abbreviated Spanier Dyadic Adjustment Scale: Some psychometric data regarding a screening test of marital adjustment. Educational and Psychological Measurement, 44(4), 1045-1049.

  BACKGROUND

• Fraley RC, Heffernan ME, Vicary AM, Brumbaugh CC. The Experiences in Close Relationships-Relationship Structures questionnaire: a method for assessing attachment orientations across relationships. Psychol Assess. 2011 Sep;23(3):615-25. doi: 10.1037/a0022898.

  PMID: 21443364 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 3432232 BACKGROUND

• Bouchard C, Tremblay A, Leblanc C, Lortie G, Savard R, Theriault G. A method to assess energy expenditure in children and adults. Am J Clin Nutr. 1983 Mar;37(3):461-7. doi: 10.1093/ajcn/37.3.461.

  PMID: 6829488 BACKGROUND

MeSH Terms

Conditions

Obesity, Morbid; Feeding Behavior; Social Behavior; Motor Activity; Obesity; Health Behavior

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior

Study Officials

• Keeley J Pratt, Ph.D.

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 20, 2018
• First Posted: August 22, 2018
• Study Start: August 1, 2018
• Primary Completion: August 15, 2019
• Study Completion: August 15, 2019
• Last Updated: September 30, 2025

Record last verified: 2025-09

Locations

US (1)