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. |
Register:
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ANZCTR |
Last refreshed on:
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13 January 2020 |
Main ID: |
ACTRN12614001206617 |
Date of registration:
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17/11/2014 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A community-based lifestyle intervention program addressing non-communicable disease in islands of the South Pacific
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Scientific title:
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The merged Reflect/Complete Health Improvement Program to manage overweight/obesity, high blood pressure, high plasma lipids and glucose in rural/semi-rural villages in Fiji and Vanuatu. |
Date of first enrolment:
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06/02/2017 |
Target sample size:
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280 |
Recruitment status: |
Not yet recruiting |
URL:
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https://anzctr.org.au/ACTRN12614001206617.aspx |
Study type:
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Interventional |
Study design:
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Purpose: Educational / counselling / training; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy;
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Phase:
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Not Applicable
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Countries of recruitment
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Fiji
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Vanuatu
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Contacts
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Name:
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Dr Lillian Kent
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Address:
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Avondale college of Higher Education,
582 Freemans Drive Cooranbong, NSW 2265
Australia |
Telephone:
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612 4980 2396 |
Email:
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lillian.kent@avondale.edu.au |
Affiliation:
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Name:
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Dr Lillian Kent
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Address:
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Avondale College of Higher Education,
582 Freemans Drive Cooranbong, NSW 2265
Australia |
Telephone:
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612 4980 2396 |
Email:
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lillian.kent@avondale.edu.au |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: waist circumference greater than or equal to 92 cm for men and 80 cm for women, be able to prepare own meals,
Exclusion criteria: unstable angina, experienced myocardial infarcation in previous 12 months, had coronary by-pass surgery in previous 12 months, has other medical contraindication for dietary change or increased physical activity as determined by health professional, has chronic infectious disease/s
Age minimum:
18 Years
Age maximum:
90 Years
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Cardiovascular - Coronary heart disease
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overweight/obesity;high blood pressure;high plasma lipids;high plasma glucose; overweight/obesity high blood pressure high plasma lipids high plasma glucose
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Diet and Nutrition - Obesity
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Metabolic and Endocrine - Diabetes
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Intervention(s)
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Using the Reflect community empowerment methodology to deliver a Pacific Island contextualised version of the Complete Health Improvement Program which addresses the domains of diet, physical activity, substance use, stress and positive psychology. The CHIP intervention has shown benefits for the management and reversal of chronic diseases in adults of all ages and has been described by the American College of Lifestyle Medicine as “achieving some of the most impressive clinical outcomes published in the literature”. The clinical effectiveness of CHIP has been documented in over 25 peer-reviewed publications in medical and scientific academic journals. CHIP programs have been conducted in the Solomon Islands and Fiji, however, the effectiveness of CHIP in these South Pacific countries has not been examined. the CHIP program contains sessions on the prevalence of chronic disease, lifestyle medicine, the common denominators of chronic disease, evidence for lifestyle changes, benefit of a plant-based diet, importance of fibre, exercise, social support, forgiveness, dealing with anger and fostering positive emotions. Reflect is an innovative approach to adult literacy and social changes, which fuses the theories of Brazilian educator Paulo Freire with participatory methodologies. It was developed in the 1990s through pilot projects in Bangladesh, Uganda and El Salvador and is now used by over 500 organisations in over 70 countries worldwide. It is used by local, national and international non-government organisations, by social movements, people’s organisations, district and regional governments. The approach is highly recognised, and programs using Reflect won UNESCO literacy prizes in 2003, 2005, 2007, 2008 and 2010. This methodology uses small group work that is un
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Primary Outcome(s)
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Changes in fasting glucose as measured by Cardiocheck[one month, 3 months, 6 months post-randomisation and measurement of baseline biometrics]
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Changes in body mass index as determined by measuring height and weight, [one month, 3 months, 6 months post randomisation and measurement of baseline biometrics]
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Changes in fasting lipids as measured by the portable blood analyser Cardiocheck[one month, 3 months and 6 months post-randomization and measurement of biometrics at baseline]
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Secondary Outcome(s)
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Changes in diet as measured by a lifestyle questionnaire designed specifically for this study.[one month, 3 months, 6 months post-randomisation and measurement of baseline biometrics]
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Changes in physical activity as measured by a lifestyle questionnaire designed specifically for this study.[one month, 3 months, 6 months post-randomisation and measurement of baseline biometrics]
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Source(s) of Monetary Support
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Adventist Development Relief Agency
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Ethics review
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Status: Approved
Approval date:
Contact:
Avondale College of Higher Education Ethics Committee
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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