ObesityNCT05122013
Remote Intervention for Weight Regain After Sleeve Gastrectomy
A study testing A comprehensive remote multidisciplinary intervention for weight regain after sleeve gastrectomy in people with Obesity, run by Assuta Medical Center at 1 site in Israel.
Trial summary
The study is designed to assess the effect of a 3-month remote comprehensive intervention program by a multidisciplinary team combined with mobile supportive text messages aimed to raise the level of happiness and subjective wellbeing, on weight outcomes and physical and behavioral parameters among bariatric surgery… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- A comprehensive remote multidisciplinary intervention for weight regain after sleeve gastrectomy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 18 Feb 2022to 2 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Age at the time of BS ≥18 years
- Patients who underwent primary SG at least 2 years ago and regained at least 10% weight from nadir.
- Read and speak Hebrew.
Who cannot join
- Patients who underwent more than one BS in their past.
- Use of weight loss drug therapy currently or 1-month prior to trial entry.
- Currently attending a weight loss program and lost more than 5% of weight at the last month.
- Current pregnancy and women who gave birth in the last 6 months.
- Medical contraindications such as active cancer, organ transplant or unbalanced psychiatric disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comprehensive Remote Intervention Program for Weight Regain After Sleeve Gastrectomy: An Open Label Randomized Controlled Trial
The study is designed to assess the effect of a 3-month remote comprehensive intervention program by a multidisciplinary team combined with mobile supportive text messages aimed to raise the level of happiness and subjective wellbeing, on weight outcomes and physical and behavioral parameters among bariatric surgery patients after sleeve gastrectomy who had a weight regain of ≥10% from nadir, compared to a control group which will receive standard care of a single meeting with the study's registered dietitian at the clinic and then be advised to continue follow up.
Read the detailed description
One hundred patients will be recruited to the study and randomized to intervention or control group. The comprehensive 3-month remote intervention program by the multidisciplinary study team includes 6-weeks of online meetings with the study registered dietitian, sleep and physical activity consultants, followed by another 6-weeks of online meetings with the study RD, overall 12 weeks containing a total of 12 remote consultations (6 dietitian, 3 physical activity consultant, 3 sleep consultant). In addition, the intervention group will receive weekly text messages to their mobile phone, meant to enhance happiness and subjective wellbeing.
The control group will receive standard care of a single meeting with the study's registered dietitian at the clinic including nutrition and behavioral recommendations and then advised to continue follow up, engage in physical activity and general lifestyle recommendations.
Both groups will undergo comprehensive tests at baseline and at the end of intervention after 3 months. Patients from both groups who will arrive to the follow-up appointment after 3 months will receive a participation reward which will include a gift card on the sum of 154 NIS for purchasing a multivitamin package for bariatric patients.
Finally, 3 and 6 months after intervention completion, self-reported data will be collected via phone calls including weight, physical activity (type, times per week and duration per time), professional follow up and adherence to BS recommendations.
- Conditions
- Obesity
- Being tested
- A comprehensive remote multidisciplinary intervention for weight regain after sleeve gastrectomy, Control group
- Keywords
- Bariatric Surgery, Weight gain, Telemedicine
- Medical subject headings
- Obesity, Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A comprehensive remote multidisciplinary intervention for weight regain after sleeve gastrectomyBehavioural
A remote 3-months multidisciplinary intervention for weight regain after sleeve gastrectomy including bi-monthly remote consultations with a registered dietitian, physical activity consultant and sleep consultant, combined with weekly text messages meant to enhance happiness and subjective wellbeing.
Control groupBehavioural
Standard nutritional care: One frontal meeting with the study's registered dietitian at the clinic, including nutritional and behavioral assessment and recommendations, followed by guidance to to continue follow up in order to support healthy lifestyle.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Other | The comprehensive 3-month remote intervention program by the multidisciplinary study team includes 6-weeks of online meetings with the study registered dietitian, sleep and physical activity consultants, followed by another 6-weeks of online meetings with the study's registered dietitian, overall 12 weeks containing a total of 12 remote consultations (6 dietitian, 3 physical activity consultant, 3 sleep consultant). In addition, the intervention group will receive weekly text messages to their mobile phone, meant to enhance happiness and subjective wellbeing. Receives: Behavioral: A comprehensive remote multidisciplinary intervention for weight regain after sleeve gastrectomy |
| control group | Other | The control group will receive standard nutrition care: A one-time meeting with the study's registered dietitian at the clinic, focusing on nutrition and behavioral recommendations, followed by the standard recommendation to continue follow up, engage in physical activity and general lifestyle recommendations. Receives: Behavioral: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of a comprehensive remote multidisciplinary intervention program focused on weight regain after sleeve gastrectomy on weight change, compared to a control group.
Weight change in kilograms will be measured before and at the end of the 3-month intervention, for both intervention and control group.
Measured: Changes from baseline at 3 months
Secondary outcomes (17)
The effect of the intervention on behavioral recommendations.
Compliance to bariatric surgery recommendations will be assessed before and at the end of the 3-month intervention, and also 3 and 6 months after the intervention has ended, for both intervention and control group, each time regarding the last month. Patients will be asked if they currently keep the main recommended bariatric surgery behaviors in the last month (0-never done, 1-partially done, 2-always done).
Measured: Changes from baseline at 3, 6, and 9 months
The effect of the intervention on grazing.
Grazing will be assessed before and at the end of the 3-month intervention, for both intervention and control group, by using two questions from the grazing questionnaire by lane et al: "Do you graze between meals?" and "would you describe the way you generally eat as unplanned and repetitious (i.e. eating between planned meals and snacks)?", each time regarding the last month. Answering Yes for 1 or 2 of the questions will be considered as grazing behaviour.
Measured: Changes from baseline at 3 months
The effect of the intervention on food tolerance.
Food tolerance will be assessed before and at the end of the 3-month intervention, for both intervention and control group, by asking the patients "regarding the last month, Are there any types of foods or beverages that you cannot eat because of intolerance (suffering from pain or discomfort after eating a small amount)?". This question was based on the validated questionnaire by Suter et al. an answer of yes will indicate food intolerance, the more foods and drinks detailed the worse the intolerance is.
Measured: Changes from baseline at 3 months
The effect of the intervention on subjective binge eating.
Subjective binge eating habits will be assessed before and at the end of the 3-month intervention, for both intervention and control group. Patients will be asked it they have had episodes of eating subjectively large amounts of food while experiencing a sense of loss of control at least once a week in the last 3 months, according to the DSM-5 definition.
Measured: Changes from baseline at 3 months
The effect of the intervention on dietary intake by food diaries.
Dietary intake will be assessed before and at the end of the 3-month intervention, for both intervention and control group. Patients will be asked to fill food diaries for 3 days consisting of 2 week days and 1 weekend day. Daily average intake in calories will be calculated based based on the "Nutratio" software.
Measured: Changes from baseline at 3 months
The effect of the intervention on dietary intake by 24-hour recall.
Dietary intake will also be assessed before the intervention, for both intervention and control group, by a 24-hour dietary recall. To reduce information bias, patients will be shown examples of standard cups, spoons, teaspoons and foods using the Israeli food atlas and visual measuring tools. Daily average intake in calories will be calculated based on the "Nutratio" software.
Measured: Changes from baseline at 3 months
The effect of the intervention on dietary intake by food frequency questionnaire (FFQ).
Dietary intake will also be assessed before the intervention, for both intervention and control group, by a FFQ. To reduce information bias, patients will be shown examples of standard cups, spoons, teaspoons and foods using the Israeli food atlas and visual measuring tools. Daily average intake in calories will be calculated based on the "Nutratio" software.
Measured: Changes from baseline at 3 months
The effect of the intervention on food environment's impact on eating behaviors.
Food environment's impact on eating behaviors will be assessed before and at the end of the 3-month intervention, for both intervention and control group, by a validated questionnaire "Power of food scale". Each of the 15 questions gets a score between 0 (Do not agree at all) to 5 (strongly agree). The scores are summed up between 0-75, a higher score indicating higher sensitivity to food environment.
Measured: Changes from baseline at 3 months
The effect of the intervention on physical activity habits.
Patients will be asked at baseline and at the end of the intervention program about their physical activity regimen including type, duration of each session and times per week. In addition, self-reported physical activity levels will be collected via phone calls at 3 and 6 months after the end of the intervention program. Data of minutes of physical activity per week will be compared between groups.
Measured: Changes from baseline at 3, 6, and 9 months
The effect of the intervention on functionality regarding upper extremity strength.
Strength of the upper extremities will be measured before and at the end of the 3-month intervention program, for both intervention and control group, by a digital hand dynamometer (Jamar plus digital). Measurements will be taken three times for the dominant hand with a break of 15 seconds between each measurement, and an average will be calculated. Results in kilograms will be compared to manufacturer's normal values by age and gender.
Measured: Changes from baseline at 3, 6, and 9 months
The effect of the intervention on functionality regarding lower extremity strength .
To assess lower extremity strength, the 5 times sit and stand test will be used before and at the end of the 3-month intervention program, for both intervention and control group. Time in seconds to complete the test will be measured, faster time indicating better lower extremity strength.
Measured: Changes from baseline at 3, 6, and 9 months
The effect of the intervention on sleeping habits.
Sleeping quality will be assessed before and at the end of the 3-month intervention for both intervention and control group, each time regarding the last month, by a validated questionnaire - The Pittsburgh Sleep Quality Index (PSQI).The PSQI includes 19 questions grouped into components, each on a 0-3 point scale. Scores of >5 indicate subjective insomnia. Moreover, 3 and 6 months after the end of the intervention complement, patients from both intervention and control group will be asked by phone call about their average sleeping hours on weekdays and weekends.
Measured: Changes from baseline at 3 months
The effect of the intervention on sleeping hours.
Three and 6 months after the end of the intervention complement, patients from both intervention and control group will be asked by phone call about their average sleeping hours on weekdays and weekends.
Measured: Changes from baseline at 3 months
The effect of the intervention on happiness and subjective wellbeing
Happiness and subjective wellbeing will be assessed before and at the end of the 3-month intervention for both intervention and control group using a structured questionnaire by Sherman and Shavit. The questions include patients subjective well-being by asking them to assess their present life on a Likert-type scale from 0 representing "worst possible life" to 10 representing "best possible life".
Measured: Changes from baseline at 3, 6, and 9 months
The effect of the intervention on weight 3 and 6 months after the end of the intervention.
Self-reported weight in kilograms at 3 and 6 months after the intervention complement will be asked by phone call for both intervention and control group.
Measured: Changes from baseline at 3, 6, and 9 months
The effect of the intervention on attendance to follow up meetings 3 and 6 months after the end of the intervention.
Self-reported number of follow up meetings at 3 and 6 months after the intervention complement will be asked for both intervention and control group. Patients will be asked how many meetings they had with a registered dietitian, a psychologist/social worker, a surgeon and a personal trainer.
Measured: Changes from baseline at 3, 6, and 9 months
The effect of the intervention on supplementation usage 3 and 6 months after the end of the intervention.
Self-reported supplementation usage at 3 and 6 months after the intervention complement will be asked for both intervention and control group regarding the last month.
Measured: Changes from baseline at 3, 6, and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start18 Feb 2022
- Primary completion1 Dec 2023
- Study completion2 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be recruited to the study and randomized to intervention or control group. Medical and demographic data collection as well as measurements and validated questionnaires will be conducted at baseline (T0) and after the intervention (3 months after T0). In addition, at 3- and 6-months post intervention patients will be contacted via phone calls and asked about their weight, physical activity, sleeping and nutritional habits, and adherence to bariatric surgery recommendations. At T0, the intervention group will be scheduled for remote meetings and the the control group will receive a single meeting with the study's registered dietitian at the end of data collection of T0, along with a recommendation to continue follow-up and lifestyle changes.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assuta Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shiri Sherf Dagan, Assuta Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05122013
- Sponsor's protocol ID
- 0046-21-ASMC
- Status last verified
- Dec 2025
- First submitted
- 19 Oct 2021
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kessler Y, Churi G, Boaz M, Mardi-Tilbor L, Raziel A, Sakran N, Sherf-Dagan S. Medical, nutritional, and behavioral characteristics of patients experiencing weight regain following sleeve gastrectomy. Surg Obes Relat Dis. 2025 Nov;21(11):1246-1255. doi: 10.1016/j.soard.2025.07.016. Epub 2025 Jul 30.
PubMed 40846516
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comprehensive Remote Intervention Program for Weight Regain After Sleeve Gastrectomy: An Open Label Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05122013
- Acronym / sponsor ID
- 0046-21-ASMC
- Conditions
- Obesity
- Keywords
- Bariatric Surgery, Weight gain, Telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Assuta Medical CenterUniversity, hospital or other
- Study start
- 18 Feb 2022 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 2 Jun 2024 (actual)
- First posted
- 16 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is designed to assess the effect of a 3-month remote comprehensive intervention program by a multidisciplinary team combined with mobile supportive text messages aimed to raise the level of happiness and subjective wellbeing, on weight outcomes and physical and behavioral parameters among bariatric surgery patients after sleeve gastrectomy who had a weight regain of ≥10% from nadir, compared to a control group which will receive standard care of a single meeting with the study's registered dietitian at the clinic and then be advised to continue follow up.
Detailed description
One hundred patients will be recruited to the study and randomized to intervention or control group. The comprehensive 3-month remote intervention program by the multidisciplinary study team includes 6-weeks of online meetings with the study registered dietitian, sleep and physical activity consultants, followed by another 6-weeks of online meetings with the study RD, overall 12 weeks containing a total of 12 remote consultations (6 dietitian, 3 physical activity consultant, 3 sleep consultant). In addition, the intervention group will receive weekly text messages to their mobile phone, meant to enhance happiness and subjective wellbeing.
The control group will receive standard care of a single meeting with the study's registered dietitian at the clinic including nutrition and behavioral recommendations and then advised to continue follow up, engage in physical activity and general lifestyle recommendations.
Both groups will undergo comprehensive tests at baseline and at the end of intervention after 3 months. Patients from both groups who will arrive to the follow-up appointment after 3 months will receive a participation reward which will include a gift card on the sum of 154 NIS for purchasing a multivitamin package for bariatric patients.
Finally, 3 and 6 months after intervention completion, self-reported data will be collected via phone calls including weight, physical activity (type, times per week and duration per time), professional follow up and adherence to BS recommendations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be recruited to the study and randomized to intervention or control group. Medical and demographic data collection as well as measurements and validated questionnaires will be conducted at baseline (T0) and after the intervention (3 months after T0). In addition, at 3- and 6-months post intervention patients will be contacted via phone calls and asked about their weight, physical activity, sleeping and nutritional habits, and adherence to bariatric surgery recommendations. At T0, the intervention group will be scheduled for remote meetings and the the control group will receive a single meeting with the study's registered dietitian at the end of data collection of T0, along with a recommendation to continue follow-up and lifestyle changes.
| Arm | Type | Receives |
|---|---|---|
| intervention group | Other | Behavioral: A comprehensive remote multidisciplinary intervention for weight regain after sleeve gastrectomyThe comprehensive 3-month remote intervention program by the multidisciplinary study team includes 6-weeks of online meetings with the study registered dietitian, sleep and physical activity consultants, followed by another 6-weeks of online meetings with the study's registered dietitian, overall 12 weeks containing a total of 12 remote consultations (6 dietitian, 3 physical activity consultant, 3 sleep consultant). In addition, the intervention group will receive weekly text messages to their mobile phone, meant to enhance happiness and subjective wellbeing. |
| control group | Other | Behavioral: Control groupThe control group will receive standard nutrition care: A one-time meeting with the study's registered dietitian at the clinic, focusing on nutrition and behavioral recommendations, followed by the standard recommendation to continue follow up, engage in physical activity and general lifestyle recommendations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age at the time of BS ≥18 years
- Patients who underwent primary SG at least 2 years ago and regained at least 10% weight from nadir.
- Read and speak Hebrew.
Key exclusion criteria (5 listed)
- Patients who underwent more than one BS in their past.
- Use of weight loss drug therapy currently or 1-month prior to trial entry.
- Currently attending a weight loss program and lost more than 5% of weight at the last month.
- Current pregnancy and women who gave birth in the last 6 months.
- Medical contraindications such as active cancer, organ transplant or unbalanced psychiatric disorders.
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 |
|---|---|---|
| A comprehensive remote multidisciplinary intervention for weight regain after sleeve gastrectomyA remote 3-months multidisciplinary intervention for weight regain after sleeve gastrectomy including bi-monthly remote consultations with a registered dietitian, physical activity consultant and sleep consultant, combined with weekly text messages meant to enhance happiness and subjective wellbeing. | Behavioural | intervention group |
| Control groupStandard nutritional care: One frontal meeting with the study's registered dietitian at the clinic, including nutritional and behavioral assessment and recommendations, followed by guidance to to continue follow up in order to support healthy lifestyle. | Behavioural | control group |
Primary outcome
The effect of a comprehensive remote multidisciplinary intervention program focused on weight regain after sleeve gastrectomy on weight change, compared to a control group.
Time frame: Changes from baseline at 3 months
Weight change in kilograms will be measured before and at the end of the 3-month intervention, for both intervention and control group.
17 secondary outcomes
The effect of the intervention on behavioral recommendations.
Time frame: Changes from baseline at 3, 6, and 9 months
The effect of the intervention on grazing.
Time frame: Changes from baseline at 3 months
The effect of the intervention on food tolerance.
Time frame: Changes from baseline at 3 months
The effect of the intervention on subjective binge eating.
Time frame: Changes from baseline at 3 months
The effect of the intervention on dietary intake by food diaries.
Time frame: Changes from baseline at 3 months
The effect of the intervention on dietary intake by 24-hour recall.
Time frame: Changes from baseline at 3 months
The effect of the intervention on dietary intake by food frequency questionnaire (FFQ).
Time frame: Changes from baseline at 3 months
The effect of the intervention on food environment's impact on eating behaviors.
Time frame: Changes from baseline at 3 months
The effect of the intervention on physical activity habits.
Time frame: Changes from baseline at 3, 6, and 9 months
The effect of the intervention on functionality regarding upper extremity strength.
Time frame: Changes from baseline at 3, 6, and 9 months
The effect of the intervention on functionality regarding lower extremity strength .
Time frame: Changes from baseline at 3, 6, and 9 months
The effect of the intervention on sleeping habits.
Time frame: Changes from baseline at 3 months
The effect of the intervention on sleeping hours.
Time frame: Changes from baseline at 3 months
The effect of the intervention on happiness and subjective wellbeing
Time frame: Changes from baseline at 3, 6, and 9 months
The effect of the intervention on weight 3 and 6 months after the end of the intervention.
Time frame: Changes from baseline at 3, 6, and 9 months
The effect of the intervention on attendance to follow up meetings 3 and 6 months after the end of the intervention.
Time frame: Changes from baseline at 3, 6, and 9 months
The effect of the intervention on supplementation usage 3 and 6 months after the end of the intervention.
Time frame: Changes from baseline at 3, 6, and 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Derived from this study: PubMed 40846516Kessler Y, Churi G, Boaz M, Mardi-Tilbor L, Raziel A, Sakran N, Sherf-Dagan S. Medical, nutritional, and behavioral characteristics of patients experiencing weight regain following sleeve gastrectomy. Surg Obes Relat Dis. 2025 Nov;21(11):1246-1255. doi: 10.1016/j.soard.2025.07.016. Epub 2025 Jul 30.
- Individual participant dataSharing planned: No
Related trials for Obesity
RecruitingObservational study
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
Metabolic Disease, Obesity
Recruiting
Tailoring Mobile Health Technology to Reduce Obesity and Improve Cardiovascular Health in Resource-Limited Neighborhood Environments
Obesity
RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity
Active, not recruiting
Effect of Exercise Training on Breastmilk Composition
Obesity
Active, not recruiting
Metabolic and Inflammatory Outcomes of the Ketogenic Diet Comparing Saturated and Unsaturated Fat Sources
PreDiabetes, Diabetes Mellitus, Type 2
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A comprehensive remote multidisciplinary intervention for weight regain after sleeve gastrectomy in people with Obesity, run by Assuta Medical Center at 1 site in Israel.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 30 Dec 2025. 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 Israel. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The effect of a comprehensive remote multidisciplinary intervention program focused on weight regain after sleeve gastrectomy on weight change, compared to a control group. (time frame: Changes from baseline at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05122013, which also lists 1 linked publication.
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 30 Dec 2025; AzTrials last refreshed its copy on 27 Oct 2026.