Remote Intervention for Weight Regain After Sleeve Gastrectomy

Assuta Medical Center

Status: Completed

Conditions: Obesity

Treatments: Behavioral: A comprehensive remote multidisciplinary intervention for weight regain after sleeve gastrectomy; Behavioral: Control group

Study type: Interventional

Funder types: Other

Identifiers

NCT05122013

0046-21-ASMC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

intervention group

Other group

Description:

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.

Treatment:

Behavioral: A comprehensive remote multidisciplinary intervention for weight regain after sleeve gastrectomy

control group

Other group

Description:

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.

Treatment:

Behavioral: Control group