Obesity, Morbid
Conditions
Brief summary
The goal of this waitlist-control design, pilot randomized controlled trial is to test feasibility, acceptability, and preliminary efficacy of a remotely-delivered dyadic positive psychology intervention for patients 2 years after bariatric surgery and their romantic partners (called ReConnect). The main question it aims to answer is whether the intervention results in improvements in depressive symptoms for patients and partners. The additional questions it aims to answer are whether the intervention results in improvements in resilience, relationship satisfaction, eating and physical activity behaviors, and weight maintenance for those in the intervention versus waitlist control condition. Participant couples randomly assigned to the intervention condition will engage in ReConnect for 8 weekly modules and associated positive psychology activities, some individually and some as a couple. Participant couples randomly assigned to the waitlist control condition will wait for 8 weeks to begin the 8 week intervention. All participants will fill out assessment measures at baseline, 8 weeks, and 16 weeks.
Detailed description
Bariatric surgery is the most effective intervention for severe obesity and associated co-morbidities. However, around 2 years after surgery, a substantial proportion of patients struggle with weight regain, psychological complications (e.g., disordered eating, depression), and relationship challenges. To achieve optimal long-term outcomes, a biopsychosocial focus and treatment approach is critical. Existing interventions primarily target weight, occur at the individual patient level, use a risk-based or problem-focused lens, and are inaccessible to the average patient. In contrast, this proposed research will test feasibility, acceptability, and preliminary efficacy of an intervention to improve psychosocial health, occurring at the dyadic (patient and partner) level, using a strengths-based or positive psychology lens, and remotely-delivered for accessibility. This multi-faceted approach is needed to address the high rate of psychiatric disorders and lack of social support among bariatric surgery patients that compromises long-term surgical outcomes. Patients in relationships report inconsistency in support provision from partners, lose less weight than those not in relationships, and are at elevated risk of divorce post-surgery. The investigator(s) research has demonstrated declines in relationship satisfaction from before to after surgery, and associations with elevated levels of binge eating, anxiety, and social stress 2 years after surgery. The investigator(s) has also documented the importance of adaptive coping, social support, and resilience for improved mental health and eating behaviors in this stigmatized population. In combination, existing research supports the need for dyadic-level and strengths-focused intervention to prevent exacerbation of psychological distress and difficulties in long-term weight management. The investigator and research team have utilized pilot grant funding to adapt an evidence-based dyadic positive psychology intervention (dPPI) for post-bariatric surgery patients and their partners. This intervention was developed in a two-phase, mixed-methods study. The investigator first obtained feedback from 6 patients and partners in focus groups about relationship health following bariatric surgery and intervention needs. The investigators then asked these couples to pilot test 4 adapted intervention modules and obtained quantitative and qualitative feedback, which suggested high satisfaction with and benefit from the intervention modules. This study resulted in a finalized 8-module, remotely-delivered dPPI with content consisting of activities (expressing gratitude, practicing acts of kindness, fostering relationships, focusing on the positive, savoring, working toward goals, meaning finding/values, planning for the future) completed individually and as a couple. The dPPI is now ready for formal testing of feasibility, acceptability, and preliminary efficacy in a pilot randomized clinical trial (RCT).
Interventions
ReConnect is an intervention for bariatric surgery patients approximately 2 years after surgery and their romantic partners to participate in together with the goal of improving mental health and enhancing resilience. The intervention is entirely remotely-delivered via handouts sent by PDF and mail to participants instructing them through the 8 weekly modules, as well as associated videos. Each module features psychoeducational materials, instructions and guidance on positive psychology activities, choices of activities to complete both individually and as a couple, and additional resources relevant to that week's theme. The themes are: channeling strengths and focusing on the positive, clarifying values and finding meaning, goal setting, intimacy and fostering the relationship, open communication and gratitude, self-care and savoring the moment, fostering relationships and acts of kindness, and maintaining progress long-term.
Sponsors
Study design
Intervention model description
Waitlist Control Design
Eligibility
Inclusion criteria
* Adult couples (18 years and older) consisting of one partner who had bariatric surgery (Roux-en-Y gastric bypass or sleeve gastrectomy) at participating institution * Between 1 to 3 years post bariatric surgery performed at participating institution and * A cohabiting romantic partner who have been in the same relationship from before bariatric surgery to time of recruitment * Both partners are willing and able to enroll in study
Exclusion criteria
* Couples in which both members have undergone bariatric surgery * Current participation in another intervention study * Lack of access to internet for remotely delivered intervention * Absence of depressive symptoms, relationship challenges, or difficulty coping with lifestyle changes at screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depressive Symptoms | Baseline | Patient Health Questionnaire-9 (PHQ-9) Measured Scale 0 - 27 (0 = minimum - 27 = maximum), the higher the score the worse depressive symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resilience | Baseline | Connor-Davidson Resilience Scale (CD-RISC) Measured Scale 0 -100 (0 = minimum - 100 = maximum), the higher the score the better outcome. |
| Relationship Satisfaction | Baseline | Dyadic Adjustment Scale (DAS) Measured Scale 0-151 ((0 = minimum - 151 = maximum), the higher the score the better outcome. |
| Physical Activity | Baseline | Godin Leisure Time Physical Activity Questionnaire with higher score indicating more physically active on a continuous scale. Scores range from 0 to a theoretical maximum with higher scores indicating greater levels of physical activity. The Godin Leisure-Time Exercise Questionnaire assesses weekly frequency of strenuous, moderate, and light leisure-time physical activity sessions of at least 15 minutes duration. A total Leisure Score Index (LSI) is calculated as: (9 × strenuous) + (5 × moderate) + (3 × light) activity episodes per week. Scores range from 0 to a theoretical maximum with higher scores indicating greater levels of physical activity. |
| Eating Behaviors | Baseline | Short Healthy Eating Index Survey Measured Scale 0 -100 (0 = minimum - 100 = maximum), the higher the score the better outcome. |
| Weight Maintenance | Baseline | Body Mass Index = measure of weight relative to height, calculated as weight in kilograms divided by height in meters squared. |
| Anxiety | Baseline | GAD-7 Measure Scaled 0-21 (0= minimum - 27 = maximum), The higher the score indicates worse anxiety. |
Countries
United States
Contacts
University of Utah Craig Neilsen H. Rehabilitation Hospital
Participant flow
Recruitment details
Patients who had bariatric surgery approximately 2 years prior were recruited from the University of Utah Comprehensive Weight Management Program if they were in the same romantic relationship as prior to surgery. This is a waitlist-control design.
Pre-assignment details
Patients and partners who were interested in participating in the study after contact by the study coordinator completed screening questions by phone, followed by the baseline assessment if they qualified, followed by waitlist control design randomization of the dyad couples to either the intervention or waitlist control condition.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous Partner | 45.7 years STANDARD_DEVIATION 10.1 |
| Age, Continuous Patient | 43.6 years STANDARD_DEVIATION 8.9 |
| Race/Ethnicity, Customized Partner American Indian/Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Partner Asian | 0 Participants |
| Race/Ethnicity, Customized Partner Black/African American | 1 Participants |
| Race/Ethnicity, Customized Partner Chose Not to Answer | 1 Participants |
| Race/Ethnicity, Customized Partner Hispanic/Latino/X | 6 Participants |
| Race/Ethnicity, Customized Partner Mixed Race | 2 Participants |
| Race/Ethnicity, Customized Partner Native Hawaiian or Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Partner White/Caucasian | 29 Participants |
| Race/Ethnicity, Customized Patient American Indian/Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Patient Asian | 0 Participants |
| Race/Ethnicity, Customized Patient Black/African American | 1 Participants |
| Race/Ethnicity, Customized Patient Chose Not to Answer | 0 Participants |
| Race/Ethnicity, Customized Patient Hispanic/Latino/X | 7 Participants |
| Race/Ethnicity, Customized Patient Mixed Race | 1 Participants |
| Race/Ethnicity, Customized Patient Native Hawaiian or Pacific Islander | 1 Participants |
| Race/Ethnicity, Customized Patient White/Caucasian | 10 Participants |
| Sex: Female, Male Partner Female | 4 Participants |
| Sex: Female, Male Partner Male | 17 Participants |
| Sex: Female, Male Patient Female | 17 Participants |
| Sex: Female, Male Patient Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 40 |
| other Total, other adverse events | 0 / 42 | 0 / 40 |
| serious Total, serious adverse events | 0 / 42 | 0 / 40 |