Remote Intervention for Weight Regain After Sleeve Gastrectomy

NCT05122013 | Completed

• 1 other identifier: 0046-21-ASMC
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity

Keywords

Bariatric Surgery; Weight gain; Telemedicine

Outcome Measures

Primary Outcomes (1)

• 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.

  Changes from baseline at 3 months

Secondary Outcomes (17)

• The effect of the intervention on behavioral recommendations.

  Changes from baseline at 3, 6, and 9 months

• The effect of the intervention on grazing.

  Changes from baseline at 3 months

• The effect of the intervention on food tolerance.

  Changes from baseline at 3 months

• The effect of the intervention on subjective binge eating.

  Changes from baseline at 3 months

• The effect of the intervention on dietary intake by food diaries.

  Changes from baseline at 3 months

Study Arms (2)

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.

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.

Behavioral: Control group

Interventions

A comprehensive remote multidisciplinary intervention for weight regain after sleeve gastrectomy 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.

intervention group

Control group 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.

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assuta Medical Center: lead

Study Sites (1)

Assuta Medical Center

Tel Aviv, Israel

Location

Related Publications (1)

• 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.

  PMID: 40846516 DERIVED

MeSH Terms

Conditions

Obesity; Weight Gain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Shiri Sherf-Dagan (RD, PhD) Dietitian and Epidemiologist, Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: October 19, 2021
• First Posted: November 16, 2021
• Study Start: February 18, 2022
• Primary Completion: December 1, 2023
• Study Completion: June 2, 2024
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)