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Remote Intervention for Weight Regain After Sleeve Gastrectomy

NCT ID: NCT05122013

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-18

Study Completion Date

2024-06-02

Brief Summary

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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

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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

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Obesity

Keywords

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Bariatric Surgery Weight gain Telemedicine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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intervention 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'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.

Group Type OTHER

A comprehensive remote multidisciplinary intervention for weight regain after sleeve gastrectomy

Intervention Type BEHAVIORAL

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 group

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.

Group Type OTHER

Control group

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assuta Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Shiri Sherf Dagan

Dr Shiri Sherf-Dagan (RD, PhD) Dietitian and Epidemiologist, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Assuta Medical Center

Tel Aviv, , Israel

Site Status

Countries

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Israel

Other Identifiers

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0046-21-ASMC

Identifier Type: -

Identifier Source: org_study_id