跳至主要内容
临床试验/NCT04612088
NCT04612088Unknown不适用

Cognitive Dissonance Based Intervention to Promote Multivitamin Adherence on Bariatric Patients

Universidad Autonoma de Baja California2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2020年9月14日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
34
试验地点
2
主要终点
Therapy adherence using the MBG (Martin-Bayarre-Grau) Questionnaire

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Patients will be blindly randomized to one of the two groups and the Cognitive Dissonance doses will be given by two Psychology undergraduate students that are not part of the research team.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Therapy adherence using the MBG (Martin-Bayarre-Grau) Questionnaire

时间窗: Change from Baseline Adherence level at 3 months

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.

Serum Iron, Copper and Zinc levels assessed by Inductively Coupled Plasma Mass Spectroscopy (ICP-MS)

时间窗: Change from Baseline Iron, Copper and Zinc levels at 3 months

Participants serum levels of Iron, Copper and Zinc in micrograms per deciliter

Serum Albumin and Total Protein levels measured by Colorimetric Spectroscopy

时间窗: Change from Baseline Albumin and Total Protein levels at 3 months

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).

Serum Calcium, Phosphate, levels measured by Colorimetric Spectroscopy

时间窗: Change from Baseline Calcium and Phosphate levels at 3 months

Participants serum levels of Calcium and Phosphate in milligrams per deciliter

Hemoglobin levels measured by the Hematology Analyzer

时间窗: Change from Baseline Hemoglobin levels at 3 months

Participants Hemoglobin levels in grams per deciliter will be obtained using an Hematology Analyzer with a Reagent-Less method.

Serum Vitamin D and Folate levels measured by Enzyme-Linked ImmunoSorbent Assay (ELISA)

时间窗: Change from Baseline Vitamin D and Folate levels at 3 months

Participants serum levels of Vitamin D and Folate in nanograms per mililiter.

次要结局

  • Self-Efficacy assessed using the General Self-Efficacy Scale (GSE)(Change from Baseline Self-Efficacy levels at 3 months after psychological intervention)
  • Psychopathological symptoms assessed using the Symptom Checklist-90-Revised (SCL-90-R)(Change from Baseline Psychopathological symptoms at 3 months after psychological intervention)
  • Self-Care Capacity assessed using the Self-care Agency Appreciation (SAA)(Change from Baseline Self-Care levels at 3 months after psychological intervention)
  • Knowledge of the Multivitaminic supplement assessed using a questionnaire to assess patient knowledge of their medicines(Change from Baseline Knowledge score at 3 months after psychological intervention)

研究者

发起方
Universidad Autonoma de Baja California
申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniela Lilian Gonzalez Sanchez

Principal Investigator

Universidad Autonoma de Baja California

研究点 (2)

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