Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001206617
Ethics application status
Approved
Date submitted
13/10/2014
Date registered
17/11/2014
Date last updated
6/10/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A community-based lifestyle intervention program addressing non-communicable disease in islands of the South Pacific
Scientific title
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.
Secondary ID [1] 285488 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
overweight/obesity 293272 0
high blood pressure 293329 0
high plasma lipids 293330 0
high plasma glucose 293331 0
Condition category
Condition code
Cardiovascular 293538 293538 0 0
Coronary heart disease
Metabolic and Endocrine 293539 293539 0 0
Diabetes
Diet and Nutrition 293540 293540 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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 unisex or gender specific when dealing with gender related issues to do with social change in a Pacific context. The program is delivered by facilitators sourced from the local village who can speak and read English and have completed at least year 12 of high school. The material for each session is pre-prepared so that the facilitators only need to follow a script.
This program will contextualise CHIP for rural/semi-rural areas of Fiji and Vanuatu using the Reflect methodology to deliver the CHIP content.
The program will be delivered over 6 months, intensive for the first month at 3 x one-hour sessions per week followed by 1 x one-hour session per week for remaining 5 months of the program.
Adherence will be measured by a questionnaire administered at baseline, one month, 3 months and 6 months.,
Intervention code [1] 290427 0
Lifestyle
Intervention code [2] 290428 0
Behaviour
Comparator / control treatment
Control groups will be offered standard readily available in country Ministry of Health health literature.
The following will be supplied:
1. Wellness Rainbow Cycle
2. What's in my meal? Hidden fat
3. What's in my snack? hidden Sugars.
4. What am i eating? Hidden Fat
5. Air for Life - Fijians have the right to breath fresh air
6. Alcohol - A Publication of the healthy Pacific Lifestyle Section of the secretariat of the Pacific Community
7. Cash Calories - Putting Moderation into practice.
8. How much should I be eating?
9. How to help a friend become tobacco -free
10. Tips to help become Tobacco - Free
11. 7 rainbow colors to wellness.
These pamphlets will be distributed to the control participants at the baseline health assessment.
Control group
Active

Outcomes
Primary outcome [1] 293362 0
Changes in body mass index as determined by measuring height and weight,
Timepoint [1] 293362 0
one month, 3 months, 6 months post randomisation and measurement of baseline biometrics
Primary outcome [2] 293515 0
Changes in fasting lipids as measured by the portable blood analyser Cardiocheck
Timepoint [2] 293515 0
one month, 3 months and 6 months post-randomization and measurement of biometrics at baseline
Primary outcome [3] 293516 0
Changes in fasting glucose as measured by Cardiocheck
Timepoint [3] 293516 0
one month, 3 months, 6 months post-randomisation and measurement of baseline biometrics
Secondary outcome [1] 310853 0
Changes in diet as measured by a lifestyle questionnaire designed specifically for this study.
Timepoint [1] 310853 0
one month, 3 months, 6 months post-randomisation and measurement of baseline biometrics
Secondary outcome [2] 311227 0
Changes in physical activity as measured by a lifestyle questionnaire designed specifically for this study.
Timepoint [2] 311227 0
one month, 3 months, 6 months post-randomisation and measurement of baseline biometrics

Eligibility
Key inclusion criteria
waist circumference greater than or equal to 92 cm for men and 80 cm for women, be able to prepare own meals,
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Pacific island villages from Vanuatu and Fiji are recruited into the study and informed that they will be randomly selected into treatment or control. There will be 5 intervention villages and 2 control villages. A member of the team will contact village chiefs to gain support of the program, who will in turn call a community meeting where the program will be described. Volunteers who meet the eligibitiy criteria will be recruited
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The villages from each country will be place in a hat and randomly drawn into treatment and control villages, alternating treatment and control with each draw.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size determined from previous peer review published CHIP programs conducted in the Philippines. Sample size required to achieve the outcome for obese individuals with diabetes was calculated. The population mean and standard deviation for these participants at an alpha of 0.05 and power of 80% gave the number required in the published dataset. The sample size of 75 used for intervention villages in the Pacific study (target 20 per village x 5 villages; two control villages).
Baseline differences between control and intervention participants will be examined by chi-square test for categorical variables and t-test for continuous variables. Also baseline differences between completers and non-completers in intervention and control villages will be compared.
In the first instance, the extent of the changes (percent, and mean with 95% confidence intervals (CI)) in the biometric measures from baseline to one month between control and intervention groups will be analysed using paired t tests.
The extent of changes (percent, and mean with 95% confidence intervals (CI)) from baseline, one month, 3 months and follow-up (6 months) in the biometric measures will be assessed using repeated measures Analysis of Variance (ANOVA).
For the cut-points for each of the biometrics : A P-value of less than 0.05 is considered significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/02/2017
Actual
Date of last participant enrolment
Anticipated
17/02/2017
Actual
Date of last data collection
Anticipated
18/08/2017
Actual
Sample size
Target
280
Accrual to date
Final
Recruitment outside Australia
Country [1] 6408 0
Fiji
State/province [1] 6408 0
Country [2] 6410 0
Vanuatu
State/province [2] 6410 0

Funding & Sponsors
Funding source category [1] 290089 0
Charities/Societies/Foundations
Name [1] 290089 0
Adventist Development Relief Agency
Country [1] 290089 0
Australia
Primary sponsor type
University
Name
Avondale College of Higher Education
Address
582 Freemans Drive, Cooranbong, NSW, 2265
Country
Australia
Secondary sponsor category [1] 288788 0
None
Name [1] 288788 0
Address [1] 288788 0
Country [1] 288788 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291798 0
Avondale College of Higher Education Ethics Committee
Ethics committee address [1] 291798 0
Ethics committee country [1] 291798 0
Australia
Date submitted for ethics approval [1] 291798 0
Approval date [1] 291798 0
09/10/2015
Ethics approval number [1] 291798 0
2014:03

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 52066 0
Dr Lillian Kent
Address 52066 0
Avondale College of Higher Education,
582 Freemans Drive Cooranbong, NSW 2265
Country 52066 0
Australia
Phone 52066 0
612 4980 2396
Fax 52066 0
Email 52066 0
[email protected]
Contact person for public queries
Name 52067 0
Lillian Kent
Address 52067 0
Avondale College of Higher Education,
582 Freemans Drive Cooranbong, NSW 2265
Country 52067 0
Australia
Phone 52067 0
612 4980 2396
Fax 52067 0
Email 52067 0
[email protected]
Contact person for scientific queries
Name 52068 0
Lillian Kent
Address 52068 0
Avondale college of Higher Education,
582 Freemans Drive Cooranbong, NSW 2265
Country 52068 0
Australia
Phone 52068 0
612 4980 2396
Fax 52068 0
Email 52068 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Embase'Live more': Study protocol for a community-based lifestyle education program addressing non-communicable diseases in low-literacy areas of the South Pacific.2015https://dx.doi.org/10.1186/s12889-015-2560-1
N.B. These documents automatically identified may not have been verified by the study sponsor.