Clinical trial NCT05122013: Remote Intervention for Weight Regain After Sleeve Gastrectomy
Official title: A Comprehensive Remote Intervention Program for Weight Regain After Sleeve Gastrectomy: An Open Label Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Keywords: Bariatric Surgery
Weight gain
Telemedicine
Lead sponsor: Assuta Medical Center
Sponsor class: OTHER
First posted: 2021-11-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
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.
timeFrame: Changes from baseline at 3 months
Secondary outcomes:
measure: The effect of the intervention on behavioral recommendations.
timeFrame: Changes from baseline at 3, 6, and 9 months
measure: The effect of the intervention on grazing.
timeFrame: Changes from baseline at 3 months
measure: The effect of the intervention on food tolerance.
timeFrame: Changes from baseline at 3 months
measure: The effect of the intervention on subjective binge eating.
timeFrame: Changes from baseline at 3 months
measure: The effect of the intervention on dietary intake by food diaries.
timeFrame: Changes from baseline at 3 months
measure: The effect of the intervention on dietary intake by 24-hour recall.
timeFrame: Changes from baseline at 3 months
measure: The effect of the intervention on dietary intake by food frequency questionnaire (FFQ).
timeFrame: Changes from baseline at 3 months
measure: The effect of the intervention on food environment's impact on eating behaviors.
timeFrame: Changes from baseline at 3 months
measure: The effect of the intervention on physical activity habits.
timeFrame: Changes from baseline at 3, 6, and 9 months
measure: The effect of the intervention on functionality regarding upper extremity strength.
timeFrame: Changes from baseline at 3, 6, and 9 months
measure: The effect of the intervention on functionality regarding lower extremity strength .
timeFrame: Changes from baseline at 3, 6, and 9 months
measure: The effect of the intervention on sleeping habits.
timeFrame: Changes from baseline at 3 months
measure: The effect of the intervention on sleeping hours.
timeFrame: Changes from baseline at 3 months
measure: The effect of the intervention on happiness and subjective wellbeing
timeFrame: Changes from baseline at 3, 6, and 9 months
measure: The effect of the intervention on weight 3 and 6 months after the end of the intervention.
timeFrame: Changes from baseline at 3, 6, and 9 months
measure: The effect of the intervention on attendance to follow up meetings 3 and 6 months after the end of the intervention.
timeFrame: Changes from baseline at 3, 6, and 9 months
measure: The effect of the intervention on supplementation usage 3 and 6 months after the end of the intervention.
timeFrame: Changes from baseline at 3, 6, and 9 months
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Assuta Medical Center
Study officials:
References: