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The goal of the study is to evaluate the effect of nutrition intervention on gastrointestinal symptoms, treatment discontinuation rate, nutritional parameters (e.g., dietary intake and eating habits), anthropometric measures, functional parameters, and QOL during the initiation and up-titration phase of incretin-based Anti Obesity Medications (AOM) treatment in patients with overweight/obesity.
The nutrition intervention protocol will be developed based on literature review, focus groups with health care professionals, and patient interviews.
A single-center pilot study will be performed at the Tel-Aviv Assuta Medical Center, among 10 patients who are about to initiate long-term weight management treatment with Wegovy© (semaglutide 2.4 mg), followed by a multi-center, parallel design open-label, RCT, which will be conducted at the Tel-Aviv Assuta Medical Center and Rabin Medical Center - Beilinson Hospital, in 120 patients who are about to initiate long-term weight management treatment with Wegovy© or Mounjaro© .
The intervention group will receive nutrition guidance before AOM treatment by registered dietitian (RD) followed by nutrition and behavioral recommendations according to reported gastrointestinal symptom(s). The control group will receive the usual nutrition care for patients treated with AOM.
Primary outcomes (gastrointestinal symptom assessment) and secondary outcomes (incretin-based AOM discontinuation rate, nutritional parameters, anthropometrics, functional parameters and QOL) will be evaluated by interviews, questionnaires and measurements at baseline, at the end of Wegovy© or Mounjaro© titration phase [20 weeks (T1)] and weekly during the study period (for GI symptoms assessment).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nutritional intervention group | Experimental | Nutrition guidance before AOM treatment by registered dietitian (RD) followed by nutrition and behavioral recommendations according to reported gastrointestinal symptom(s). |
|
| Control group | No Intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nutritional intervention | Behavioral | A nutrition guidance before initiation of AOM treatment include recommendations for food choices and eating habits to minimize the occurrence and severity of GI symptoms during the up-titration phase, will be given by registered dietitian (RD) from the study team. Next, each week, participants will provide weekly reports of GI symptoms occurrence and severity, by responding to queries sent via WhatsApp/SMS and for occurring symptoms, an automatically structured nutrition and behavioral treatment recommendations will be sent . If participants expressed an interest in personalized dietary guidance on this matter, the study team RD will contact him/her by telephone, within a range of 48 hours, to provide individualized recommendations. Three days after each report of GI symptom(s), participants will receive an additional message and will be asked to report the occurrence and severity of the GI symptom, and their compliance with the specific dietary instructions received. |
| Measure | Description | Time Frame |
|---|---|---|
| Gastrointestinal symptoms assessment | GI symptoms rating scale (GSRS) - assess the degree of specific GI complaints Every question is rated by seven graded Likert-type scale (1 represents the absence of troublesome symptoms and 7 represents very troublesome symptoms) while a higher score of the whole questionnaire and by dimension represents more severe symptoms. | Baseline and at the end of the study period (20 weeks) |
| Defecation texture | Bristol stool scale - classifying the form of human feces into seven categories. Type 1-2 are considered abnormal hard stools and indicative of constipation type, and type 5-7 are considered abnormally loose/liquid stools and indicative of diarrhea or urgency | Baseline and at the end of the study period (20 weeks) |
| Bowel Movement (BM) frequency | will be assessed according to five acceptable categories: >3 BMs/day, 2-3 BMs/day, 1-2 BMs/day, 3-4 BMs/week, <3 BMs/week | Baseline and at the end of the study period (20 weeks) |
| Participants gastrointestinal symptoms report | Participant subjective and objective reporting of GI symptoms | Baseline, at the end of the study period (20 weeks) and weekly until 20 weeks (for subjective GI symptoms report only) |
| Measure | Description | Time Frame |
|---|---|---|
| Incretin-based AOM treatment discontinuation rate | At the end of the study period (20 weeks) and weekly until 20 weeks | |
| Anthropometric measures - weight | Weight (kg) by digital scale | Change from baseline at the end of the study period (20 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Biochemical tests | Participants will be asked to provide at T0 biochemical tests obtained during the last 3 months, including complete blood count, lipid profile, fasting glucose, HbA1c, iron, transferrin, ferritin, vitamin B12, folate, vitamin D, albumin and total protein | At baseline |
| Demographics - age |
Inclusion Criteria:
Exclusion Criteria:
In addition, participants who decide not to initiate or stop Wegovy© or Mounjaro© treatment for more than two consecutive injections for any reason or who undergo bariatric surgery or endoscopic sleeve gastroplasty during the study period will be excluded from the study
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shiri Sherf-dagan, Ph.D | Contact | +972747288004 | shiris@ariel.ac.il | |
| Rotem Refaeli | Contact | +972545797995 | rotem2310@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ariel University | Recruiting | Ariel | 40700 | Israel |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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|
| Anthropometric measures - waist circumference (WC) | will be measured by tape measure (cm) | Change from baseline at the end of the study period (20 weeks) |
| Body composition - fat mass (kg) | Body composition analysis using Inbody370S® | Change from baseline at the end of the study period (20 weeks) |
| Dietary intake | 24-hour dietary recall (24HR) | Change from baseline at the end of the study period (20 weeks) |
| Eating habits assessment | General questions regarding eating patterns, hydration and foods intolerance | Change from baseline at the end of the study period (20 weeks) |
| Eating habits assessment - Control of Eating | Control of Eating Questionnaire (CoEQ) - The of CoEQ consists of 21 items (19 questions are rated by 100 mm VAS, and two question are open-ended). Greater score represents greater levels of Craving Control. | Change from baseline at the end of the study period (20 weeks) |
| Functional parameters - muscle strength | Handgrip (HG) muscle Strength - measure static muscle strength (kg) of the upper extremities by a digital hand dynamometer (Jamar plus digital©) | Change from baseline at the end of the study period (20 weeks) |
| Functional parameters- leg strength and endurance | 30-seconds sit and stand test - counts the number of times the patient stands in 30 seconds. Higher scores means a better outcome. | Change from baseline at the end of the study period (20 weeks) |
| Quality of life assessment | EQ-5D-3L questionnaire -include the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS) .The EQ-5D-3L descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems.The EQ VAS records the patient's self-rated health. Participants will be asked to subjectively rate their overall state of health by using a 0 to 100 VAS, with a higher score reflects a better outcome. | Change from baseline at the end of the study period (20 weeks) |
| Eating habits assessment - Food preferences | Leeds Food Preference Questionnaire (LFPQ). The questionnaire involves an explicit evaluation of "liking" and "wanting" for 16 food items that can be categorized as high-fat savory (HFSA), low-fat savory (LFSA), high-fat sweet (HFSW) and low-fat sweet (LFSW). Each food image is scored on a 100-mm VAS, while a higher score indicates a stronger preference for that food category. The second sub-task evaluates "implicit wanting" and requires rapid choice between 96 paired combinations of the food images from different categories | Change from baseline at the end of the study period (20 weeks) |
| Anthropometric measures - height (cm) | (cm) by altimeter | Change from baseline at the end of the study period (20 weeks) |
| Body composition- percentage of body fat (BF%) | Body composition analysis using Inbody370S® | Change from baseline at the end of the study period (20 weeks) |
| Body composition - fat-free mass (kg) | Body composition analysis using Inbody370S® | Change from baseline at the end of the study period (20 weeks) |
| Body composition - skeletal muscle mass (kg) | Body composition analysis using Inbody370S® | Change from baseline at the end of the study period (20 weeks) |
years |
| At baseline |
| Demographics - marital status | married, single, divorced or widowed | At baseline |
| Demographics - education | less than high school, high school graduate, high school diploma, bachelors degree, masters degree, MD or doctoral degree | At baseline |
| Demographics - occupation status | employee full time, employee part time, self-employed or other | At baseline |
| Health status - Number of participants with coexisting medical conditions and their types | T2DM, prediabetes, dyslipidemia, HTN,sleep apnea, orthopedic problems, GERD, mental disorder or other | Baseline and at the end of the study period (20 weeks) |
| Number of participants using regular medications and their types | usual medications | Baseline and at the end of the study period (20 weeks) |
| Smoking habits | smoker, former smoker or never | Baseline and at the end of the study period (20 weeks) |
| Number of participants using supplementation and their Types | multiviamin, Iron, vitamin D, folic acid, vitamin B12, calcium or other | Baseline and at the end of the study period (20 weeks) |
| Lifestyle factors - Sleeping habits | sleeping quality on a scale of 0-3 (0- very good, 1-quite good, 2- quite bad, 3- very bad) | Baseline and at the end of the study period (20 weeks) |
| Lifestyle factors - frequency of physical activity | number of exercises per week | Baseline and at the end of the study period (20 weeks) |
| Lifestyle factors - duration of physical activity | exercise time in minutes | Baseline and at the end of the study period (20 weeks) |
| Lifestyle factors - type of physical activity | aerobic or anaerobic | Baseline and at the end of the study period (20 weeks) |
| Rabin Medical Center, Beilinson Hospital | Not yet recruiting | Petah Tikva | 4941492 | Israel |
|
| Assuta Medical Center | Recruiting | Tel Aviv | 6971028 | Israel |
|
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |