Intervention for Multivitamin Adherence on Bariatric Patients

Study Overview
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Brief Summary
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This project has a parallel randomized controlled experimental design since within the methodology there will be a control of the conditions under study, that is, the selection of subjects, the way the treatment will be administered, the way in which the observations will be obtained, the use of instruments to perform the measurements and the interpretation of the criteria will be implemented in a homogeneous manner. Convenience sampling was used to obtain the subjects for the study, the sample size was 34 bariatric patients from a private bariatric center in Tijuana, Baja California, Mexico. Participants were randomly assigned to one of two groups. The group understudy or experimental or the control group on the waitlist; that is, no researcher or study participant made the decision of treatment that participants receive. The intervention consists of two psychoeducative sessions and five cognitive dissonance sessions. All participants will receive the same multivitamin for the duration of the study. Validated tests for adherence, medication knowledge, self-care, self-efficacy, and psychopathological symptoms were applied to both groups. Additionally, a blood sample was collected for the determination of Hemoglobin, Iron, Copper, Zinc, Calcium, Phosphate, Vitamin D, and Folate. Measurements using tests and blood samples will be made before and after receiving the intervention [pre and post-test]. For results analysis, Repeated measures ANOVA will be used, the study population shall be stratified into subgroups, by type of bariatric surgery, age, and sex; this in order to restrict comparisons to participants who are part of the same subgroup. The aim of the study is to assess the impact of an intervention based on the cognitive dissonance theory to promote adherence to the bariatric multivitamin. The hypothesis of the study is: Participants exposed to Festinger's theory-based intervention will exhibit changes in their attitude and behavior towards multivitamin intake as a product of cognitive dissonance.

Detailed Description
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According to the World Health Organization (WHO), in 2016, 650 million people around the world were already obese, for their part in 2013 the Organization for Economic Cooperation and Development (OCDE) indicated that globally Mexico and the United States had the highest rate of overweight and obesity in adults. Mexico is the second country, after the United States, with the highest obesity, almost one third of Mexican adults (32.4%) suffered from obesity in that year, a significant increase from 24% in 2000. According to the National Health and Nutrition Survey the states of northern Mexico, as is the case of Baja California, occupy the first places of obesity index nationwide. Morbid Obesity (MO) poses a high health risk in those who suffer from it, as multiple complications arise from it, therefore it is of uttermost importance that this disease is successfully treated and controlled, however, conventional weight loss therapeutics guided by the implementation of behavioral therapy, physical activity, low calorie diet and drug treatment , has shown short-term unsuccessful results. A treatment alternative is Bariatric Surgery (BS) which, according to recommendations issued in 1991 by the U.S. National Institutes of Health (NIH), is considered the treatment of choice for this pathology. While BS has proven to be a successful treatment for long-term sustained weight loss, it is accompanied by major complications such as micronutrient deficiency, which is attributed to intrinsic and extrinsic factors, intrinsic factors refer to deficiencies recorded prior to BS and are related to MO or to the surgical technique itself that induces changes in metabolism in addition to reducing the ability to food in the stomach, limit digestion and cause malabsorption. For their part, extrinsic factors correspond to the lack of adherence in terms of diet and prescribed multivitamin supplementation. Lack of adherence is related to the level of knowledge about the supplementation and behavior of the morbid patient on decision-making, as they tend to present negative thoughts about the prescribed treatment that are usually accompanied by lack of ability to make changes in both attitude and behavior, which will hardly change even after surgery; this is consistent with the results reported in various studies that indicate that the main behavioral factors of non-adherence to treatment in this population are the low self-efficacy and attitudes that the patient adopts towards treatment on self-care, as well as low self-esteem and distortion of self-concept. As described, BS can be considered a process of adaptation that can pose a challenge for those who experience it as the person must be aware of the impact of surgery on the body in order to effectively adhere to the agreed treatment plan, making decisions in conjunction with health professionals in order to reduce risk factors , focusing therefore on prevention and timely intervention of them. In this sense, psychology turns out to be a science that allows to develop instruments that evaluate the congruence between attitudes, thought and behavior, as well as the creation of strategies that promote health promoting the congruence between attitude and behavior. Leon Festinger in 1957 proposed the theory of Cognitive Dissonance, which states that people tend to change their attitudes and behaviors or justify them as a result of the divergence of two cognitions manifested at the same time; according to this theory, the individual strives to achieve consistency within himself. Opinions and attitudes tend to be present in groups that are internally consistent. Population: POST-operated Bariatric Surgery patients Sample: Post-Bariatric Surgery patients who permanently radiate in the Tijuana Co. Sampling type: In the first time, non-probabilistic, convenience sampling for the selection of participants and in a second time for randomization stratification will be performed. Sampling site: One private bariatric center in Tijuana, Baja California, Mexico. Research plan Submission and approval of the research protocol to the bioethics committee of the Faculty of Medicine and Psychology (FMYP) of the Autonomous University of Baja California (UABC) Designing the manuals of psycho-educational intervention and dissonance to promote and improve adherence to the multivitamin prescribed in bariatric patients. Once obtaining the bioethics committee approval, the authorities of a private bariatric center operating patients living in Tijuana were consulted to request their cooperation in conducting the research. (d) Data collection was carried out through the review of clinical records in accordance with the Mexican Official Norm (NOM) NOM-004-SSA3-2012. (e) Persons who meet the inclusion criteria were contacted by telephone in order to recruit the participants who were included in the study. (f) Arrange a face-to-face appointment with the person who decides to participate to sign the document informed consent (IC) version 1.0, in order to clarify doubts about the methodology of the project and inform him that his participation is voluntary, that at any time he may withdraw his consent and that the information he provides will be handled confidentially, in accordance with NOM-012-SSA3-2012 on Human Research. (g) Participants were randomly assigned to the experimental group and control group on the waiting list using the on-line tool GraphPad QuickCalcs. (h) For the application of the measuring instrument (MI) in order to comply with the recommendations of the WHO derived from the COVID pandemic and maintain social distancing, the MI containing all tests was adapted for a digital application using Google Forms and the group sessions were modified to be video conferences through Google Meet. (i) For the sessions of cognitive dissonance and psycho-education, Psychology Bachelors were trained and randomly assigned to the cognitive or psycho-educational intervention. (j) The pre-test and post-test blood samples are taken one day after the application of the MI (before and after the intervention), according to NOM-253-SSA1-2012 for the disposal of human blood. (k) The determination of biomarkers was carried out according to the NOM-007-SSA3-2011 for the operation of clinical laboratories. The analysis of calcium, phosphorus, and serum iron was carried out within the facilities of the UABC Medical Care and Research Centre (CUMAII) using colorimetric spectrophotometry; The levels of Vit-D and Folate were be analyzed by Enzyme-Linked ImmunoSorbent Assay (ELISA), the quantification of hemoglobin was performed during flow cytometry. For the determination of minerals (zinc and copper) in serum, a collaboration agreement will be held with the Graduate Center of the Tijuana Institute of Technology; the method of analysis will be Mass Spectrometry with Inductively Coupled Plasma (ICP/MS). (l) The week following sampling, 90-minute online intervention sessions will begin every two weeks for three months. It is important to mention that, before the first online session (second week) the participants of both groups will be given a bariatric multivitamin supplement with 60 chewable tablets, dispensing a new one of the same brand as the first, this in order to cover three months of treatment. (m) Participants were asked to inform through a phone call to the research team in case of presenting any adverse effects such as nausea, vomit, dizziness, or diarrhea. This will be noted in the corresponding document. (n) Once the post-test data have been obtained, databases will be developed in the SPSS version 26.0 statistical program for Windows, which will be analyzed by repeated-measures ANOVA in order to evaluate the effect of the intervention on adherence to the Multivitamin evidenced by biomarker levels.

Official Title
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Cognitive Dissonance Based Intervention to Promote Multivitamin Adherence on Bariatric Patients

Conditions
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Adherence, Medication

Intervention / Treatment
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* Behavioral: Cognitive Dissonance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Nationality: Mexican. Place of Residence: City of Tijuana. Bariatric techniques: Gastric Sleeve or Bypass Roux in Y. Time after surgery: at least 6 months. Agree to participate voluntarily by leaving it under signature in the informed consent format. Exclusion Criteria: Nationality: foreign Patients who do not reside in the city of Tijuana permanently. Bariatric techniques other than Gastric Sleeve or Bypass Roux in Y. Time: having passed less than 6 months post-operative. Patients who have a cognitive disorder that limits learning or attendance at sessions. Patients who are suspended by prescription from vitamin consumption. Patients with any post-bariatric surgery complications that are under treatment. Patients with a history of alcoholism. Pregnant patients. Patients who practice high-performance exercise. Patients who do not consent to participate.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized controlled trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bariatric Multivitamin<br>Bariatric patients that gave their consent in written will be given a Bariatric Multivitamin containing: Serving Size 2 Tablets: Calories 25, Total Fat 0.5 g, Total Carbohydrates 5g, Total Sugars 2 g, Vitamin A 3,000 mcg, Vitamin C 90 mg, Vitamin D 75 mcg, Vitamin E 100.5 mg, Vitamin K 300 mcg, Thiamin 36 mg, Riboflavin 3.4 mg, Niacin 20 mg, Vitamin B6 4 mg, Folate 1,360 mcg, Vitamin B12 1,000 mcg, Biotin 600 mcg, Pantothenic Acid 20 mg, Calcium 170 mg, Iron 45 mg, Phosphorous 130 mg, Iodine 150 mcg, Magnesium 50 mg, Zinc 16 mg, Selenium 70 mcg, Copper 2 mg, Manganese 2 mg, Chromium 120 mcg, Molybdenum 50 mcg, Sodium 15 mg, Mixed Tocopherols 30 mg, Coenzyme Q10 10 mg and Boron 2 mg.The patients will take 2 tablets once a day for three months. | Behavioral: Cognitive Dissonance<br>* A blood sample will be taken before the first take of the multivitamins and at the end of the intervention to measure: Hemoglobin, Calcium, Phosphorous, Iron, Copper, Zinc, Vitamin D, and Folate. During the three months of the intervention, the intervention group will receive one psycho-educative session and five Cognitive Dissonance sessions. Several tests will be applied to the patients at the beginning of the program and after the sessions to measure: patient knowledge and adherence to the multivitamin, self-efficacy, self-care, and Psycho-pathological symptoms. The No intervention group on the wait list will receive the five Cognitive Dissonance sessions after the three months of the study.<br>|
| No Intervention: Waitlist<br>Bariatric patients that gave their consent in written will be given a Bariatric Multivitamin containing: Serving Size 2 Tablets: Calories 25, Total Fat 0.5 g, Total Carbohydrates 5g, Total Sugars 2 g, Vitamin A 3,000 mcg, Vitamin C 90 mg, Vitamin D 75 mcg, Vitamin E 100.5 mg, Vitamin K 300 mcg, Thiamin 36 mg, Riboflavin 3.4 mg, Niacin 20 mg, Vitamin B6 4 mg, Folate 1,360 mcg, Vitamin B12 1,000 mcg, Biotin 600 mcg, Pantothenic Acid 20 mg, Calcium 170 mg, Iron 45 mg, Phosphorous 130 mg, Iodine 150 mcg, Magnesium 50 mg, Zinc 16 mg, Selenium 70 mcg, Copper 2 mg, Manganese 2 mg, Chromium 120 mcg, Molybdenum 50 mcg, Sodium 15 mg, Mixed Tocopherols 30 mg, Coenzyme Q10 10 mg and Boron 2 mg.The patients will take 2 tablets once a day for three months. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Therapy adherence using the MBG (Martin-Bayarre-Grau) Questionnaire | Adherence of the participants to the multivitamin given, using an instrument validated for the Mexican population. The instrument is based on a Lickert scale, all questions have 5 possible answers that go from Never to Always and have respective values of 0 - 5, the total of the answer points is then recategorized to 0-17 No adherence, 18-37 Partial Adherence, and 38-48 Total Adherence. | Change from Baseline Adherence level at 3 months | 
| Serum Iron, Copper and Zinc levels assessed by Inductively Coupled Plasma Mass Spectroscopy (ICP-MS) | Participants serum levels of Iron, Copper and Zinc in micrograms per deciliter | Change from Baseline Iron, Copper and Zinc levels at 3 months | 
| Serum Calcium, Phosphate, levels measured by Colorimetric Spectroscopy | Participants serum levels of Calcium and Phosphate in milligrams per deciliter | Change from Baseline Calcium and Phosphate levels at 3 months | 
| Serum Albumin and Total Protein levels measured by Colorimetric Spectroscopy | Participants serum levels of Albumin and Total Protein in grams per deciliter, the Albumin/Globulin Ratio will also be calculated as: Albumin/(Total Protein-Albumin). | Change from Baseline Albumin and Total Protein levels at 3 months | 
| Serum Vitamin D and Folate levels measured by Enzyme-Linked ImmunoSorbent Assay (ELISA) | Participants serum levels of Vitamin D and Folate in nanograms per mililiter. | Change from Baseline Vitamin D and Folate levels at 3 months | 
| Hemoglobin levels measured by the Hematology Analyzer | Participants Hemoglobin levels in grams per deciliter will be obtained using an Hematology Analyzer with a Reagent-Less method. | Change from Baseline Hemoglobin levels at 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-Care Capacity assessed using the Self-care Agency Appreciation (SAA) | Participants Self-Care Capacity obtained by the Self-care Agency Appreciation (SAA) test that was adapted and validated to be used in Mexican population. The test consists of 24 reagents and aims to assess self-care capabilities by representing all power components. The response pattern of this questionnaire includes four options: total disagreement 1, disagreement 2, agreement 3, and total agreement 4. Each individual gets a score ranging from 24 to 112, where the higher the score higher the Self-Care Capacity. | Change from Baseline Self-Care levels at 3 months after psychological intervention | 
| Self-Efficacy assessed using the General Self-Efficacy Scale (GSE) | Participants level of Self-Efficacy using the validated General Self-Efficacy Scale (GSE), adapted and validated to be used un Mexican population. The test has 10 questions and is based on a Likert scale, with the answer options Not at all true, Hardly true, Moderately true, and Exactly true, each answer scores from 1 to 4. The total score is calculated by finding the sum of the all items. For the GSE, the total score ranges between 10 and 40, with a higher score indicating more self-efficacy. | Change from Baseline Self-Efficacy levels at 3 months after psychological intervention | 
| Psychopathological symptoms assessed using the Symptom Checklist-90-Revised (SCL-90-R) | Participants referred Psychopathological symptomps will be assessed using the Symptom Checklist-90-Revised (SCL-90-R) which contains the following Symptom Scales: Somatization, Obsessive-Compulsive, Interpersonal Sensitivity, Depression, Anxiety, Hostility, Phobic Anxiety, Paranoid Ideation, Psychoticism and some Global Indices like: Global Severity Index (GSI): Designed to measure overall psychological distress, Positive Symptom Distress Index (PSDI): Designed to measure the intensity of symptoms and Positive Symptom Total (PST): Reports number of self-reported symptoms. | Change from Baseline Psychopathological symptoms at 3 months after psychological intervention | 
| Knowledge of the Multivitaminic supplement assessed using a questionnaire to assess patient knowledge of their medicines | The participants Knowledge of the Multivitaminic supplement will be assessed using a test that consists of 11, open questions that gather the patient's knowledge about the therapeutic objective, the process of use, safety and conservation of the medicines that the patient uses. The answers are evaluated by a pharmacist classifying it as follows Incorrect : Score -1, Does not know: Score 0, Insufficient: Score 1 and Correct: Score 2. For the final calculation of total drug knowledge (global PKM) a formula is applied in which each question scored differently based on the conclusions drawn in the different qualitative techniques. The global CPM was categorized into: No knowledge. 0 points, Insufficient knowledge. 0.60 to 1.26 points, Sufficient knowledge. 1.27 to 1.60 points, Optimal knowledge. 1.60 to 2 points. | Change from Baseline Knowledge score at 3 months after psychological intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adherence, Multivitamin, Bariatric, Gastric Sleeve, Gastric Bypass, Cognitive Dissonance, Intervention