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| ID | Type | Description | Link |
|---|---|---|---|
| 1K12TR004413 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Condition | Experimental | Participants will receive 8 weeks of ReConnect followed by 8 weeks check-in surveys/follow-ups, as well as 3 assessments (baseline, 8 weeks, 16 weeks) in this waitlist-control design. |
|
| Waitlist Control Condition | Other | Participants will receive 8 weeks of check-in surveys/follow-ups followed by 8 weeks of ReConnect, as well as 3 assessments (baseline, 8 weeks, 16 weeks) in this waitlist-control design. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reimagining Us in the Context of Bariatric Surgery (ReConnect) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Depressive Symptoms | Patient Health Questionnaire-9 (PHQ-9) Measured Scale 0 - 27 (0 = minimum - 27 = maximum), the higher the score the worse depressive symptoms. | Baseline |
| Depressive Symptoms | Patient Health Questionnaire-9 (PHQ-9) Measured Scale 0 - 27 (0 = minimum - 27 = maximum), the higher the score the worse depressive symptoms. | Week # 8 |
| Depressive Symptoms | Patient Health Questionnaire-9 (PHQ-9) Measured Scale 0 - 27 (0 = minimum - 27 maximum), the higher the score the worse depressive symptoms. | Week #16 |
| Measure | Description | Time Frame |
|---|---|---|
| Resilience | Connor-Davidson Resilience Scale (CD-RISC) Measured Scale 0 -100 (0 = minimum - 100 = maximum), the higher the score the better outcome. | Baseline |
| Resilience | Connor-Davidson Resilience Scale (CD-RISC) Measured Scale 0 -100 (0 = minimum - 100 = maximum), the higher the score the better outcome. |
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Inclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Larissa McGarrity, PhD | University of Utah Craig Neilsen H. Rehabilitation Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah | Salt Lake City | Utah | 84132 | United States |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Condition | This study aims to pilot test an 8 week, self-administered dyadic (couples-based) positive psychology intervention for couples using a randomized, waitlist control design. Participants will receive 8 weeks of ReConnect followed by 8 weeks check-in surveys/follow-ups, as well as 3 assessments (baseline, 8 weeks, 16 weeks) in this waitlist-control design project. Reimagining Us in the Context of Bariatric Surgery (ReConnect): 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. |
| FG001 | Waitlist Control Condition | This study aims to pilot test an 8 week, self-administered dyadic (couples-based) positive psychology intervention for couples using a randomized, waitlist control design. Participants will receive 8 weeks of check-in surveys/follow-ups followed by 8 weeks of ReConnect, as well as 3 assessments (baseline, 8 weeks, 16 weeks) in this waitlist-control design. Reimagining Us in the Context of Bariatric Surgery (ReConnect): 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline Characteristics data was collected from bariatric surgery patients and their romantic partners. 82 individual participants enrolled (41 Intervention dyad couples) and 80 individual participant enrolled (40 Waitlist dyad couples) completed all study interventions. 2 individual participants (1 dyad intervention couple) voluntarily withdrew due to time constraints.
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Condition | Participants will receive 8 weeks of ReConnect followed by 8 weeks check-in surveys/follow-ups, as well as 3 assessments (baseline, 8 weeks, 16 weeks).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. Reimagining Us in the Context of Bariatric Surgery (ReConnect): 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Baseline characteristics reported separately for each part of the dyad. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Depressive Symptoms | Patient Health Questionnaire-9 (PHQ-9) Measured Scale 0 - 27 (0 = minimum - 27 = maximum), the higher the score the worse depressive symptoms. | This analysis includes all randomized participants (patients and partners) with complete item data to contribute to scales at each assessment time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
Adverse and serious events were monitored from baseline through end of study participation for each of the 82 bariatric surgery patients and their romantic partners(16 weeks total). One couple withdrew following baseline intervention.
All participants (intervention and waitlisted) received intervention and non-intervention during the two different study periods. Adverse events are reported by intervention and waitlist combining data across both periods.
Adverse and serious events were monitored throughout the entire study periods for both the bariatric surgery patients and their romantic partners via participant self-report during study activities.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Condition | Participants will receive 8 weeks of ReConnect followed by 8 weeks check-in surveys/follow-ups, as well as 3 assessments (baseline, 8 weeks, 16 weeks). Reimagining Us in the Context of Bariatric Surgery (ReConnect): 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Larissa McGarrity | University of Utah | 8016469210 | larissa.mcgarrity@hsc.utah.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 27, 2025 | Apr 1, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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Waitlist Control Design
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|
| Week # 8 |
| Resilience | Connor-Davidson Resilience Scale (CD-RISC) Measured Scale 0 -100 (0 = minimum - 100 = maximum), the higher the score the better outcome. | Week # 16 |
| Relationship Satisfaction | Dyadic Adjustment Scale (DAS) Measured Scale 0-151 ((0 = minimum - 151 = maximum), the higher the score the better outcome. | Baseline |
| Relationship Satisfaction | Dyadic Adjustment Scale (DAS) Measured Scale 0-151 (0 = minimum - 151 = maximum), the higher the score the better outcome. | Week #8 |
| Relationship Satisfaction | Dyadic Adjustment Scale (DAS) Measured Scale 0-151 ((0 = minimum - 151 = maximum), the higher the score the better outcome. | Week #16 |
| Physical Activity | 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. | Baseline |
| Physical Activity | 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. | Week #8 |
| Physical Activity | 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. | Week #16 |
| Eating Behaviors | Short Healthy Eating Index Survey Measured Scale 0 -100 (0 = minimum - 100 = maximum), the higher the score the better outcome. | Baseline |
| Eating Behaviors | Short Healthy Eating Index Survey Measured Scale 0 -100 (0 = minimum - 100 = maximum), the higher the score the better outcome. | Week # 8 |
| Eating Behaviors | Short Healthy Eating Index Survey Measured Scale 0 -100 (0 = minimum - 100 = maximum), the higher the score the better outcome. | Week # 16 |
| Weight Maintenance | Body Mass Index = measure of weight relative to height, calculated as weight in kilograms divided by height in meters squared. | Baseline |
| Weight Maintenance | Body Mass Index = measure of weight relative to height, calculated as weight in kilograms divided by height in meters squared, (kg/m²). | Week #8 |
| Weight Maintenance | Body Mass Index = measure of weight relative to height, calculated as weight in kilograms divided by height in meters squared. | Week #16 |
| Anxiety | GAD-7 Measure Scaled 0-21 (0= minimum - 27 = maximum), The higher the score indicates worse anxiety. | Baseline |
| Anxiety | GAD-7 Measure Scaled 0-21 (0= minimum - 27 = maximum), The higher the score indicates worse anxiety. | 8 Weeks |
| Anxiety | GAD-7 Measure Scaled 0-21 (0= minimum - 27 = maximum), The higher the score indicates worse anxiety. | Week #16 |
| BG001 | Waitlist Control Condition | Participants will receive 8 weeks of check-in surveys/follow-ups followed by 8 weeks of ReConnect, as well as 3 assessments (baseline, 8 weeks, 16 weeks). 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. Reimagining Us in the Context of Bariatric Surgery (ReConnect): 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. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Mesure Title: Sex Description: Self Reported Sex of Participants Units: Participants | Dyad, characteristics are reported separately for each part of the dyad. | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Dyad, characteristics are reported separately for each part of the dyad | Count of Participants | Participants |
|
| OG001 | Waitlist Control Condition | Participants will receive 8 weeks of check-in surveys/follow-ups followed by 8 weeks of ReConnect, as well as 3 assessments (baseline, 8 weeks, 16 weeks). Reimagining Us in the Context of Bariatric Surgery (ReConnect): 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. |
|
|
| Primary | Depressive Symptoms | Patient Health Questionnaire-9 (PHQ-9) Measured Scale 0 - 27 (0 = minimum - 27 = maximum), the higher the score the worse depressive symptoms. | This analysis includes all randomized participants (patients and partners) with complete item data to contribute to scales at each assessment time point. | Posted | Mean | Standard Deviation | score on a scale | Week # 8 |
|
|
|
| Primary | Depressive Symptoms | Patient Health Questionnaire-9 (PHQ-9) Measured Scale 0 - 27 (0 = minimum - 27 maximum), the higher the score the worse depressive symptoms. | This analysis includes all randomized participants (patients and partners) with complete item data to contribute to scales at each assessment time point. | Posted | Mean | Standard Deviation | score on a scale | Week #16 |
|
|
|
| Secondary | Resilience | Connor-Davidson Resilience Scale (CD-RISC) Measured Scale 0 -100 (0 = minimum - 100 = maximum), the higher the score the better outcome. | This analysis includes all randomized participants (patients and partners) with complete item data to contribute to scales at each assessment time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| Secondary | Resilience | Connor-Davidson Resilience Scale (CD-RISC) Measured Scale 0 -100 (0 = minimum - 100 = maximum), the higher the score the better outcome. | This analysis includes all randomized participants (patients and partners) with complete item data to contribute to scales at each assessment time point. | Posted | Mean | Standard Deviation | score on a scale | Week # 8 |
|
|
|
| Secondary | Resilience | Connor-Davidson Resilience Scale (CD-RISC) Measured Scale 0 -100 (0 = minimum - 100 = maximum), the higher the score the better outcome. | This analysis includes all randomized participants (patients and partners) with complete item data to contribute to scales at each assessment time point. | Posted | Mean | Standard Deviation | score on a scale | Week # 16 |
|
|
|
| Secondary | Relationship Satisfaction | Dyadic Adjustment Scale (DAS) Measured Scale 0-151 ((0 = minimum - 151 = maximum), the higher the score the better outcome. | This analysis includes all randomized participants (patients and partners) with complete item data to contribute to scales at each assessment time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| Secondary | Relationship Satisfaction | Dyadic Adjustment Scale (DAS) Measured Scale 0-151 (0 = minimum - 151 = maximum), the higher the score the better outcome. | This analysis includes all randomized participants (patients and partners) with complete item data to contribute to scales at each assessment time point. | Posted | Mean | Standard Deviation | score on a scale | Week #8 |
|
|
|
| Secondary | Relationship Satisfaction | Dyadic Adjustment Scale (DAS) Measured Scale 0-151 ((0 = minimum - 151 = maximum), the higher the score the better outcome. | This analysis includes all randomized participants (patients and partners) with complete item data to contribute to scales at each assessment time point. | Posted | Mean | Standard Deviation | score on a scale | Week #16 |
|
|
|
| Secondary | Physical Activity | 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. | This analysis includes all randomized participants (patients and partners) with complete item data to contribute to scales at each assessment time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| Secondary | Physical Activity | 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. | This analysis includes all randomized participants (patients and partners) with complete item data to contribute to scales at each assessment time point. | Posted | Mean | Standard Deviation | score on a scale | Week #8 |
|
|
|
| Secondary | Physical Activity | 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. | This analysis includes all randomized participants (patients and partners) with complete item data to contribute to scales at each assessment time point. | Posted | Mean | Standard Deviation | score on a scale | Week #16 |
|
|
|
| Secondary | Eating Behaviors | Short Healthy Eating Index Survey Measured Scale 0 -100 (0 = minimum - 100 = maximum), the higher the score the better outcome. | This analysis includes all randomized participants (patients and partners) with complete item data to contribute to scales at each assessment time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| Secondary | Eating Behaviors | Short Healthy Eating Index Survey Measured Scale 0 -100 (0 = minimum - 100 = maximum), the higher the score the better outcome. | This analysis includes all randomized participants (patients and partners) with complete item data to contribute to scales at each assessment time point. | Posted | Mean | Standard Deviation | score on a scale | Week # 8 |
|
|
|
| Secondary | Eating Behaviors | Short Healthy Eating Index Survey Measured Scale 0 -100 (0 = minimum - 100 = maximum), the higher the score the better outcome. | This analysis includes all randomized participants (patients and partners) with complete item data to contribute to scales at each assessment time point. | Posted | Mean | Standard Deviation | score on a scale | Week # 16 |
|
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|
| Secondary | Weight Maintenance | Body Mass Index = measure of weight relative to height, calculated as weight in kilograms divided by height in meters squared. | This analysis includes all randomized participants (patients and partners) with complete item data to contribute to scales at each assessment time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
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|
| Secondary | Weight Maintenance | Body Mass Index = measure of weight relative to height, calculated as weight in kilograms divided by height in meters squared, (kg/m²). | This analysis includes all randomized participants (patients and partners) with complete item data to contribute to scales at each assessment time point. | Posted | Mean | Standard Deviation | score on a scale | Week #8 |
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|
| Secondary | Weight Maintenance | Body Mass Index = measure of weight relative to height, calculated as weight in kilograms divided by height in meters squared. | This analysis includes all randomized participants (patients and partners) with complete item data to contribute to scales at each assessment time point. | Posted | Mean | Standard Deviation | score on a scale | Week #16 |
|
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| Secondary | Anxiety | GAD-7 Measure Scaled 0-21 (0= minimum - 27 = maximum), The higher the score indicates worse anxiety. | This analysis includes all randomized participants (patients and partners) with complete item data to contribute to scales at each assessment time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| Secondary | Anxiety | GAD-7 Measure Scaled 0-21 (0= minimum - 27 = maximum), The higher the score indicates worse anxiety. | This analysis includes all randomized participants (patients and partners) with complete item data to contribute to scales at each assessment time point. | Posted | Mean | Standard Deviation | score on a scale | 8 Weeks |
|
|
|
| Secondary | Anxiety | GAD-7 Measure Scaled 0-21 (0= minimum - 27 = maximum), The higher the score indicates worse anxiety. | This analysis includes all randomized participants (patients and partners) with complete item data to contribute to scales at each assessment time point. | Posted | Mean | Standard Deviation | score on a scale | Week #16 |
|
|
|
| 0 |
| 42 |
| 0 |
| 42 |
| 0 |
| 42 |
| EG001 | Waitlist Control Condition | Participants will receive 8 weeks of check-in surveys/follow-ups followed by 8 weeks of ReConnect, as well as 3 assessments (baseline, 8 weeks, 16 weeks). Reimagining Us in the Context of Bariatric Surgery (ReConnect): 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. | 0 | 40 | 0 | 40 | 0 | 40 |
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Not provided
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Male |
|
| Black/African American |
|
| American Indian/Alaska Native |
|
| Chose Not to Answer |
|
| Native Hawaiian or Pacific Islander |
|
| Asian |
|
| Mixed Race |
|
| Hispanic/Latino/X |
|
| Black/African American |
|
| American Indian/Alaska Native |
|
| Chose Not to Answer |
|
| Native Hawaiian or Pacific Islander |
|
| Asian |
|
| Mixed Race |
|