Obesity, MorbidNCT05958615
Positive Psychology Intervention for Patients Post-bariatric Surgery and Their Partners
A study testing Reimagining Us in the Context of Bariatric Surgery (ReConnect) in people with Obesity, Morbid, run by Larissa McGarrity, Ph.D. at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Morbid
- What is being tested?
- Reimagining Us in the Context of Bariatric Surgery (ReConnect)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2024to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Feasibility, Acceptability, and Preliminary Efficacy of a Dyadic Positive Psychology Intervention for Patients Post-bariatric Surgery and Their Partners: A Pilot Randomized Controlled Trial
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.
Read the 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).
- Conditions
- Obesity, Morbid
- Being tested
- Reimagining Us in the Context of Bariatric Surgery (ReConnect)
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reimagining Us in the Context of Bariatric Surgery (ReConnect)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Reimagining Us in the Context of Bariatric Surgery (ReConnect) |
| 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. Receives: Behavioral: Reimagining Us in the Context of Bariatric Surgery (ReConnect) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive Symptoms
Patient Health Questionnaire-9 (PHQ-9) Measured Scale 0 - 27 (0 = minimum - 27 = maximum), the higher the score the worse depressive symptoms.
Measured: 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.
Measured: 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.
Measured: Week #16
Secondary outcomes (18)
Resilience
Connor-Davidson Resilience Scale (CD-RISC) Measured Scale 0 -100 (0 = minimum - 100 = maximum), the higher the score the better outcome.
Measured: Baseline
Resilience
Connor-Davidson Resilience Scale (CD-RISC) Measured Scale 0 -100 (0 = minimum - 100 = maximum), the higher the score the better outcome.
Measured: Week # 8
Resilience
Connor-Davidson Resilience Scale (CD-RISC) Measured Scale 0 -100 (0 = minimum - 100 = maximum), the higher the score the better outcome.
Measured: Week # 16
Relationship Satisfaction
Dyadic Adjustment Scale (DAS) Measured Scale 0-151 ((0 = minimum - 151 = maximum), the higher the score the better outcome.
Measured: Baseline
Relationship Satisfaction
Dyadic Adjustment Scale (DAS) Measured Scale 0-151 (0 = minimum - 151 = maximum), the higher the score the better outcome.
Measured: Week #8
Relationship Satisfaction
Dyadic Adjustment Scale (DAS) Measured Scale 0-151 ((0 = minimum - 151 = maximum), the higher the score the better outcome.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week #16
Eating Behaviors
Short Healthy Eating Index Survey Measured Scale 0 -100 (0 = minimum - 100 = maximum), the higher the score the better outcome.
Measured: Baseline
Eating Behaviors
Short Healthy Eating Index Survey Measured Scale 0 -100 (0 = minimum - 100 = maximum), the higher the score the better outcome.
Measured: Week # 8
Eating Behaviors
Short Healthy Eating Index Survey Measured Scale 0 -100 (0 = minimum - 100 = maximum), the higher the score the better outcome.
Measured: Week # 16
Weight Maintenance
Body Mass Index = measure of weight relative to height, calculated as weight in kilograms divided by height in meters squared.
Measured: 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).
Measured: Week #8
Weight Maintenance
Body Mass Index = measure of weight relative to height, calculated as weight in kilograms divided by height in meters squared.
Measured: Week #16
Anxiety
GAD-7 Measure Scaled 0-21 (0= minimum - 27 = maximum), The higher the score indicates worse anxiety.
Measured: Baseline
Anxiety
GAD-7 Measure Scaled 0-21 (0= minimum - 27 = maximum), The higher the score indicates worse anxiety.
Measured: 8 Weeks
Anxiety
GAD-7 Measure Scaled 0-21 (0= minimum - 27 = maximum), The higher the score indicates worse anxiety.
Measured: Week #16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start12 Feb 2024
- Primary completion19 Mar 2025
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Waitlist Control Design
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Larissa McGarrity, Ph.D.
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor-investigator, Larissa McGarrity, Ph.D., University of Utah
- Investigators
- Larissa McGarrity, PhD, Principal investigator, University of Utah Craig Neilsen H. Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05958615
- Sponsor's protocol ID
- IRB_00165737
- Other IDs
- 1K12TR004413
- Status last verified
- Jun 2026
- First submitted
- 11 Jul 2023
- Last updated
- 8 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Feasibility, Acceptability, and Preliminary Efficacy of a Dyadic Positive Psychology Intervention for Patients Post-bariatric Surgery and Their Partners: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05958615
- Acronym / sponsor ID
- IRB_00165737
- Conditions
- Obesity, Morbid
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Larissa McGarrity, Ph.D.University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 12 Feb 2024 (actual)
- Primary completion
- 19 Mar 2025 (actual)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 24 Jul 2023 (actual)
- Results
- Posted 8 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Waitlist Control Design
| Arm | Type | Receives |
|---|---|---|
| Intervention Condition | Experimental | Behavioral: Reimagining Us in the Context of Bariatric Surgery (ReConnect)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 | Behavioral: Reimagining Us in the Context of Bariatric Surgery (ReConnect)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Couples in which both members have undergone bariatric surgery
- Current participation in another intervention study
- Lack of access to internet for remotely delivered intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Intervention Condition, Waitlist Control Condition |
Primary outcome
Depressive Symptoms
Time frame: Baseline
Patient Health Questionnaire-9 (PHQ-9) Measured Scale 0 - 27 (0 = minimum - 27 = maximum), the higher the score the worse depressive symptoms.
Depressive Symptoms
Time frame: Week # 8
Patient Health Questionnaire-9 (PHQ-9) Measured Scale 0 - 27 (0 = minimum - 27 = maximum), the higher the score the worse depressive symptoms.
Depressive Symptoms
Time frame: Week #16
Patient Health Questionnaire-9 (PHQ-9) Measured Scale 0 - 27 (0 = minimum - 27 maximum), the higher the score the worse depressive symptoms.
18 secondary outcomes
Resilience
Time frame: Baseline
Resilience
Time frame: Week # 8
Resilience
Time frame: Week # 16
Relationship Satisfaction
Time frame: Baseline
Relationship Satisfaction
Time frame: Week #8
Relationship Satisfaction
Time frame: Week #16
Physical Activity
Time frame: Baseline
Physical Activity
Time frame: Week #8
Physical Activity
Time frame: Week #16
Eating Behaviors
Time frame: Baseline
Eating Behaviors
Time frame: Week # 8
Eating Behaviors
Time frame: Week # 16
Weight Maintenance
Time frame: Baseline
Weight Maintenance
Time frame: Week #8
Weight Maintenance
Time frame: Week #16
Anxiety
Time frame: Baseline
Anxiety
Time frame: 8 Weeks
Anxiety
Time frame: Week #16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Larissa McGarrity, PhD principal investigator
University of Utah Craig Neilsen H. Rehabilitation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reimagining Us in the Context of Bariatric Surgery (ReConnect) in people with Obesity, Morbid, run by Larissa McGarrity, Ph.D. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive Symptoms (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.