Intervention for Multivitamin Adherence on Bariatric Patients
NCT ID: NCT04612088
Last Updated: 2021-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
34 participants
INTERVENTIONAL
2020-09-14
2021-05-24
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Multivitamin Adherence Following Bariatric Surgery
NCT02124889
Supplementation After Bariatric Surgery
NCT04412421
Absorption of Transdermal Vitamins in Post Bariatric Surgery Patients
NCT03360435
Multivitamin Support Following Bariatric Surgery
NCT06152965
Vitamin and Mineral Supplementation Post Bariatric Surgery
NCT02817256
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
1. 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)
2. Designing the manuals of psycho-educational intervention and dissonance to promote and improve adherence to the multivitamin prescribed in bariatric patients.
3. 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Bariatric Multivitamin
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.
Cognitive Dissonance
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.
Waitlist
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.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cognitive Dissonance
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Universidad Autonoma de Baja California
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Daniela Lilian Gonzalez Sanchez
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Gisela Pineda, PhD
Role: STUDY_DIRECTOR
Professor and Researcher
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Universidad Autónoma de Baja California
Tijuana, Estado de Baja California, Mexico
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Gutiérrez JP, Rivera-Dommarco J, Shamah-Levy T, Villalpando-Hernández S, Franco A, Cuevas-Nasu L, Romero-Martínez M, Hernández-Ávila M. Encuesta Nacional de Salud y Nutrición 2012. Resultados Nacionales. Cuernavaca, México: Instituto Nacional de Salud Pública (MX), 2012.
OMS. (2016). WORLD HEALTH STATISTICS MONITORING 2016. In World Health Statistics. https://doi.org/10.1017/CBO9781107415324.004
Wimmelmann CL, Dela F, Mortensen EL. Psychological predictors of weight loss after bariatric surgery: a review of the recent research. Obes Res Clin Pract. 2014 Jul-Aug;8(4):e299-313. doi: 10.1016/j.orcp.2013.09.003. Epub 2013 Oct 13.
Gastrointestinal surgery for severe obesity. Consens Statement. 1991 Mar 25-27;9(1):1-20.
Amaya Garcia MJ, Vilchez Lopez FJ, Campos Martin C, Sanchez Vera P, Pereira Cunill JL. [Micronutrients in bariatric surgery]. Nutr Hosp. 2012 Mar-Apr;27(2):349-61. doi: 10.1590/S0212-16112012000200004. Spanish.
Sierra Murguía, M., L, V., & Torres Tamayo, M. (2014). INTERVENCIÓN COGNITIVO-CONDUCTUAL GRUPAL PARA PÉRDIDA DE PESO Y CALIDAD DE VIDA EN PACIENTES CANDIDATOS A CIRUGÍA BARIÁTRICA. Acta Colombiana de Psicología, 17, 25-34.
Bergh I, Lundin Kvalem I, Risstad H, Sniehotta FF. Preoperative predictors of adherence to dietary and physical activity recommendations and weight loss one year after surgery. Surg Obes Relat Dis. 2016 May;12(4):910-918. doi: 10.1016/j.soard.2015.11.009. Epub 2015 Dec 1.
Vidal P, Ramon JM, Goday A, Parri A, Crous X, Trillo L, Pera M, Grande L. Lack of adherence to follow-up visits after bariatric surgery: reasons and outcome. Obes Surg. 2014 Feb;24(2):179-83. doi: 10.1007/s11695-013-1094-9.
Sunil S, Santiago VA, Gougeon L, Warwick K, Okrainec A, Hawa R, Sockalingam S. Predictors of Vitamin Adherence After Bariatric Surgery. Obes Surg. 2017 Feb;27(2):416-423. doi: 10.1007/s11695-016-2306-x.
Paredes Despradel, M. E., & Rivero Vergne, A. (2016). Un reto constante: La vida luego de la cirugía bariátrica. Revista Griot, 8(1), 60-72. Recuperado a partir de https://revistas.upr.edu/index.php/griot/article/view/1499
Funnell MM, Anderson RM, Ahroni JH. Empowerment and self-management after weight loss surgery. Obes Surg. 2005 Mar;15(3):417-22. doi: 10.1381/0960892053576794.
Festinger, L. (1957). A theory of cognitive dissonance. Stanford University Press.
Martín Alfonso, Libertad, & Bayarre Vea, Héctor D., & Grau Ábalo, Jorge A. (2008). Validación del cuestionario MBG (Martín-Bayarre-Grau) para evaluar la adherencia terapéutica en hipertensión arterial. Revista Cubana de Salud Pública, 34(1), .[fecha de Consulta 27 de Octubre de 2020]. ISSN: 0864-3466. Disponible en: https://www.redalyc.org/articulo.oa?id=214/21420865012
Weinberg, R. S., Gould, D., & Jackson, A. (1979). Expectations and performance: An empirical test of Bandura's self-efficacy theory. Journal of Sport Psychology, 1(4), 320-331.
Rivera Alvarez LN. [Self-care agency ability in people suffering from high blood pressure hospitalised in Bogota, Colombia]. Rev Salud Publica (Bogota). 2006 Sep-Dec;8(3):235-47. doi: 10.1590/s0124-00642006000300009. Spanish.
Garcia Delgado P, Gastelurrutia Garralda MA, Baena Parejo MI, Fisac Lozano F, Martinez Martinez F. [Validation of a questionnaire to assess patient knowledge of their medicines]. Aten Primaria. 2009 Dec;41(12):661-8. doi: 10.1016/j.aprim.2009.03.011. Epub 2009 May 29. Spanish.
Banik A, Schwarzer R, Knoll N, Czekierda K, Luszczynska A. Self-efficacy and quality of life among people with cardiovascular diseases: A meta-analysis. Rehabil Psychol. 2018 May;63(2):295-312. doi: 10.1037/rep0000199.
Modi AC, Zeller MH, Xanthakos SA, Jenkins TM, Inge TH. Adherence to vitamin supplementation following adolescent bariatric surgery. Obesity (Silver Spring). 2013 Mar;21(3):E190-5. doi: 10.1002/oby.20031.
Parrott J, Frank L, Rabena R, Craggs-Dino L, Isom KA, Greiman L. American Society for Metabolic and Bariatric Surgery Integrated Health Nutritional Guidelines for the Surgical Weight Loss Patient 2016 Update: Micronutrients. Surg Obes Relat Dis. 2017 May;13(5):727-741. doi: 10.1016/j.soard.2016.12.018. Epub 2017 Jan 19.
Savino, P., Carvajal, C., Nassar, R., & Zundel, N. (2013). Necesidades nutricionales específicas después de cirugía bariátrica: Specific nutritional requirements following bariatric surgery. Revista Colombiana de Cirugía, 28(2), 161-171. http://www.scielo.org.co/scielo.php?script=sci_arttext&pid=S2011-75822013000200009&lng=en&nrm=iso&tlng=
Kalarchian MA, Marcus MD. Psychosocial Interventions Pre and Post Bariatric Surgery. Eur Eat Disord Rev. 2015 Nov;23(6):457-62. doi: 10.1002/erv.2392. Epub 2015 Sep 14.
Mahawar KK, Clare K, O'Kane M, Graham Y, Callejas-Diaz L, Carr WRJ. Patient Perspectives on Adherence with Micronutrient Supplementation After Bariatric Surgery. Obes Surg. 2019 May;29(5):1551-1556. doi: 10.1007/s11695-019-03711-z.
Derogatis LR, Lipman RS, Covi L. SCL-90: an outpatient psychiatric rating scale--preliminary report. Psychopharmacol Bull. 1973 Jan;9(1):13-28. No abstract available.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
D240
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.