NCT05122013

Remote Intervention for Weight Regain After Sleeve Gastrectomy

A Comprehensive Remote Intervention Program for Weight Regain After Sleeve Gastrectomy: An Open Label Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Assuta Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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 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.

Conditions

• Obesity

Interventions

Type	Name	Description
BEHAVIORAL	A comprehensive remote multidisciplinary intervention for weight regain after sleeve gastrectomy	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.
BEHAVIORAL	Control group	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.

Timeline

• Start date: 2022-02-18
• Primary completion: 2023-12-01
• Completion: 2024-06-02
• First posted: 2021-11-16
• Last updated: 2025-12-30

Locations

1 site across 1 country: Israel