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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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15 March 2021 |
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Main ID: |
ISRCTN40146390 |
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Date of registration:
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18/07/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Peer support added to diabetes education to improve type 2 diabetes outcomes in a Mexican Mayan community
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Scientific title:
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Peer support added to diabetes education to improve type 2 diabetes outcomes in a Mexican Mayan community: a randomized controlled trial |
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Date of first enrolment:
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12/01/2015 |
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Target sample size:
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52 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN40146390 |
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Study type:
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Interventional |
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Study design:
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Single-centre pragmatic randomized control trial (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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Mexico
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Karen
Castillo-Hernandez |
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Address:
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Universidad Marista de Merida A.C.
Periférico Norte Tablaje Catastral 13941
Carretera Mérida - Progreso.
97300
Merida
Mexico |
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Telephone:
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+52 (0)999 111 4559 |
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Email:
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nutricalli@gmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Physician diagnosis of type 2 diabetes
2. >18 years of age
Exclusion criteria:
1. Severe medical or psychiatric conditions such as hearing impairment or substance abuse
2. Pregnancy
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Type 2 diabetes
Nutritional, Metabolic, Endocrine
Type 2 diabetes mellitus
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Intervention(s)
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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.
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Primary Outcome(s)
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A1c level, measured from blood samples using NGSP-certified method at baseline, 4 and 8 months
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Secondary Outcome(s)
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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
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Secondary ID(s)
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FMED-CANH-2015-001
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Source(s) of Monetary Support
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Bepensa Foundation, A. C., Marista University of Merida , Consejo Nacional de Ciencia y Tecnología
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Ethics review
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Status:
Approval date:
Contact:
Ethics Committee of the Faculty of Medicine of the Universidad Autonoma de Yucatan (UADY), 21/11/2014, ref: 21-11-2014-FMed-UADY
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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29/10/2015 |
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URL:
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