Intervention for Multivitamin Adherence on Bariatric Patients

NCT04612088 | Unknown DMC

• 1 other identifier: D240
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Adherence, Medication

Keywords

Adherence; Multivitamin; Bariatric; Gastric Sleeve; Gastric Bypass; Cognitive Dissonance; Intervention

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

• Self-Care Capacity assessed using the Self-care Agency Appreciation (SAA)

  Change from Baseline Self-Care levels at 3 months after psychological intervention

• 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

• 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

Study Arms (2)

Bariatric Multivitamin

EXPERIMENTAL

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

Waitlist

NO INTERVENTION

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.

Interventions

Cognitive Dissonance BEHAVIORAL

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.

Bariatric Multivitamin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Autonoma de Baja California: lead

Study Sites (1)

Universidad Autónoma de Baja California

Tijuana, Estado de Baja California, 22390, Mexico

Location

Related Publications (23)

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MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Gisela Pineda, PhD

  Professor and Researcher

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: October 18, 2020
• First Posted: November 2, 2020
• Study Start: September 14, 2020
• Primary Completion: April 21, 2021
• Study Completion: May 24, 2021
• Last Updated: March 12, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Study data will be available to be requested for five years after the intervention results have been published on an indexed journal.
• Access Criteria: Researchers that wish to obtain our data must contact us via e-mail and provide evidence of their affiliation and research plan.

Locations

ME (1)