Intervention for Multivitamin Adherence on Bariatric Patients

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

Interventions

BEHAVIORAL

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.

Sponsors & Collaborators

• Universidad Autonoma de Baja California

  lead OTHER

Principal Investigators

• Gisela Pineda, PhD · Professor and Researcher

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-09-14

Primary Completion

2021-04-21

Completion

2021-05-24

Countries

• Mexico

Study Locations