Condition category
Nutritional, Metabolic, Endocrine
Date applied
12/07/2017
Date assigned
18/07/2017
Last edited
18/07/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Type 2 diabetes is a lifelong condition where the pancreas doesn't produce enough insulin or the body's cells don't react to insulin, causing a person's blood sugar level to become too high. Mexico has the highest levels of type 2 diabetes (14.7%) in all of the American Continent. In the Mexican Mayan population, factors like poverty and language barriers increase the problems of living with diabetes. Peer support is a promising approach to diabetes care as it helps diabetes patients to support each other throughout their everyday lives with self-management treatment. This program is the first of its kind in Mexico to include peer diabetes support. The aim of this study is to assess the effects of peer support when added to a diabetes education program on blood sugar control, in comparison to a conventional diabetes education program, in patients with type 2 diabetes in a Mexican Mayan community.

Who can participate?
Adults living in the community of Komchen, who are over the age of 18 and who have a physician’s diagnosis of type 2 diabetes

What does the study involve?
The diabetes educational program is first promoted simply using a van with loudspeakers (which is the usual method to inform the community about new events). Posters are pasted in key places in the community (clinics, church, market) and also by word of mouth. Participants must have a previous diagnosis of type 2 diabetes which is corroborated in their health cards. Participants are randomly allocated to one of two groups. Those in the first group are asked to participate in the education program. Those in the second group are asked to participate in the education program and to attend peer-support meetings. The study lasts a total of 8 months. Participants are asked to give blood samples and to complete questionnaires and assessments three times during the study: at the beginning, and at 4 and 8 months.

What are the possible benefits and risks of participating?
The benefits for the participants are that they had free access to diabetes education, physical activity and constant blood sugar measurements. There is no risk of participating in the educational intervention. Giving blood samples has minimal risks; the blood sample collection guidelines are followed to avoid these risks.

Where is the study run from?
The study is run by the Universidad Autonoma de Yucatan and the Universidad Marista de Merida and takes place within the participants’ community.

When is the study starting and how long is it expected to run for?
March 2015 to October 2015

Who is funding the study?
1. Fundacion Bepensa A. C
2. Universidad Marista de Merida
3. Consejo Nacional de Ciencia y Tecnología

Who is the main contact?
1. Prof. Karen Castillo-Hernandez
nutricalli@gmail.com
2. Prof. Hugo Laviada Molina

Trial website

Contact information

Type

Scientific

Primary contact

Prof Karen Castillo-Hernandez

ORCID ID

http://orcid.org/0000-0002-1285-2492

Contact details

Universidad Marista de Merida A.C.
Periférico Norte Tablaje Catastral 13941
Carretera Mérida - Progreso.
Merida
97300
Mexico
+52 (0)999 111 4559
nutricalli@gmail.com

Type

Scientific

Additional contact

Prof Hugo Laviada-Molina

ORCID ID

Contact details

Universidad Marista de Merida A.C.
Periférico Norte Tablaje Catastral 13941
Carretera Mérida - Progreso.
Merida
97300
Mexico

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

FMED-CANH-2015-001

Study information

Scientific title

Peer support added to diabetes education to improve type 2 diabetes outcomes in a Mexican Mayan community: a randomized controlled trial

Acronym

Study hypothesis

Peer education will lead to a more significant reduction in A1c levels at 4 and 8 months of follow-up in comparison to conventional diabetes education in patients with type 2 diabetes in a Mayan Mexican community.

Ethics approval

Ethics Committee of the Faculty of Medicine of the Universidad Autonoma de Yucatan (UADY), 21/11/2014, ref: 21-11-2014-FMed-UADY

Study design

Single-centre pragmatic randomized control trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Type 2 diabetes

Intervention

Fifty-eight adults of the community of Komchen (Yucatan, Merida) with previous diagnosis of type 2 diabetes were recruited from the community clinics and randomized following simple randomization procedures using EpiInfo 6.04 statistical software in a 1:1 ratio to:
1. The Peer Support and Education Group (PSEG)
2. The Education-only Group (EG)

All participants in the study attended a four-month Diabetes Self-Managment Education Program (DSMEP) delivered by a certified diabetes educator. The DSMEP consisted of 16 weekly group sessions of one hour duration. Additionally, all participants completed a comprehensive one-an-one nutrition counseling session with a dietitian during the first month of the study; and had access to four 50-minute weekly exercise sessions lead by certified trainers who had previous experience in working with adults with chronic diseases.
Participants in the PSEG also attended peer support meetings facilitated by nine leaders with type 2 diabetes.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

A1c level, measured from blood samples using NGSP-certified method at baseline, 4 and 8 months

Secondary outcome measures

Measured at baseline, 4 and 8 months:
1. Systolic and diastolic blood pressure; average of two readings measured on an OMRON HEM-7220 Automatic BP monitor
2. BMI: weight measured on an OMRON F514 balance and height measured on a SECA 213 Mobile Stadiometer
3. Diet, assessed by trained dietitians
4. Physical activity, measured with the International Physical Activity Questionnaire
5. Diabetes-related self-care behaviors, assessed using the Summary of Diabetes Self-Care Activities Measure
6. Diabetes-related quality of life, measured using the Diabetes 39 Questionnaire

Overall trial start date

09/09/2014

Overall trial end date

29/10/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Physician diagnosis of type 2 diabetes
2. >18 years of age

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

52

Participant exclusion criteria

1. Severe medical or psychiatric conditions such as hearing impairment or substance abuse
2. Pregnancy

Recruitment start date

12/01/2015

Recruitment end date

19/03/2015

Locations

Countries of recruitment

Mexico

Trial participating centre

Ayudar es compartir
Domicilio conocido Komchen Yucatan
Merida
97302
Mexico

Sponsor information

Organisation

Universidad Autonoma de Yucatan

Sponsor details

Avenida Itzáes No. 498 x 59 y 59A Col. Centro
Merida
97000
Mexico

Sponsor type

University/education

Website

http://www.medicina.uady.mx/principal/index.php

Organisation

Universidad Marista de Merida

Sponsor details

Periférico Norte Tablaje Catastral 13941
Carretera Mérida - Progreso.
Merida
97300
Mexico

Sponsor type

University/education

Website

http://www.marista.edu.mx/

Funders

Funder type

University/education

Funder name

Bepensa Foundation, A. C.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Marista University of Merida

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Consejo Nacional de Ciencia y Tecnología

Alternative name(s)

National Council of Science and Technology, Mexico, CONACYT

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Mexico

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Fernanda Molina (fmolina@marista.edu.mx). The type of data is numeric data on Excel sheets. Since data capture is finished, it is available from now on and until December 2017. Consent was obtained in the Informed Consent Letter which was read and explained to participants. In order to maintain data anonymisation, names were never captured on the computerized data sets, only the ID number. Due to the nature of the intervention which was educational, there were no other ethical or legal restrictions.

Intention to publish date

18/01/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes