Physical Activity Clinical Trial
Official title:
Feasibility and Preliminary Efficacy of Support Figure Attendance at Bariatric Patients' Clinical Visits
Verified date | August 2019 |
Source | Ohio State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 63 |
Est. completion date | August 15, 2019 |
Est. primary completion date | August 15, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Martha Morehouse Pavillion | Columbus | Ohio |
Lead Sponsor | Collaborator |
---|---|
Ohio State University |
United States,
Bouchard C, Tremblay A, Leblanc C, Lortie G, Savard R, Thériault G. A method to assess energy expenditure in children and adults. Am J Clin Nutr. 1983 Mar;37(3):461-7. — View 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.
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. — View 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. — View Citation
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.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Relationship Attachment (Patient and Partner) | Scale Name: Relationship Structures (ECR-RS) Questionnaire. There are 9 items averaged to assess relationship attachment on a scale of 1-7, where higher scores indicate higher avoidance or anxiety in the relationship. There are two subscales: 1) avoidance (items 1-6) and 2) anxiety (items 7-9). Items 1-4 are reversed. | 6 months, 4 time points | |
Other | Family Functioning (Patient and Partner/Support Figure) | Scale Name: Family Assessment Device - General Functioning Subscale. There are 12 items assessed on a 1-4 scale, which are averaged to assess overall family functioning, where lower scores indicate healthier family functioning. There is an established clinical cut off score of 2.00, where scores at or above 2.00 indicate impaired family functioning. Odd numbered items are reverse coded. | 6 moths, 4 time points | |
Primary | 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 | Dietary Compliance (Patient) | Trained dieticians will conduct oral 24-hour recalls with patients and rate as (0) not compliant or (1) compliant. Ratings are based on the American Society of Metabolic Bariatric Surgery (ASMBS) surgery guidelines. | 6 months, 4 time points | |
Secondary | Physical Activity (Patient) | Scale Name: Bouchard's Physical Activity Record. Items 1-9 are totaled to assess physical activity intensity, ranging from 24-96, where higher scores indicate higher intensity of activity throughout the day. | 6 months, 4 time points | |
Secondary | Relationship Quality (Patient and Partner) | Scale Name: Abbreviated Dyadic Assessment Scale (ADAS). There are 7 items to assess relationship quality on a continuous scale from 0-35, where higher scores indicate higher relationship quality. Items are scored on a 0-5 scale for items 1-6, and 0-6 scale for item 7. | 6 months, 4 time points | |
Secondary | Perceived Social Support for Behavior Change (Patient and Partner/Support Figure) | Scale Name: Social Support for Eating Habits and Exercise. There are 23 items scored on a continuous scale ranging from 23-115 to assess perceived social support for behavior change, where higher scores indicate higher perceived support. Each item is scored on a scale ranging from 1-5. There are four subscales 1) encouragement of eating habits (items: 1-5); 2) discouragement of eating habits (6-10); and 3) family participation in exercise (items 11-16, 20-23); and 4) punishment for exercise (items: 17-19). | 6 months, 4 time points |
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