Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001783112
Ethics application status
Approved
Date submitted
4/12/2019
Date registered
17/12/2019
Date last updated
17/12/2019
Date data sharing statement initially provided
17/12/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Twelve-week lifestyle intervention to reduce weight in Maori men at risk of diabetes, cardiovascular disease and obesity: A single group pilot study
Scientific title
Twelve-week lifestyle intervention to reduce weight in Maori men at risk of diabetes, cardiovascular disease and obesity: A single group pilot study
Secondary ID [1] 299993 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 315481 0
pre-diabetes 315482 0
cardiovascular disease 315483 0
Condition category
Condition code
Public Health 313772 313772 0 0
Health promotion/education
Cardiovascular 313884 313884 0 0
Other cardiovascular diseases
Diet and Nutrition 313885 313885 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two cohorts were identified based on contacts from the community researcher. One cohort was through a church and the second group was through a gym. The groups operated sequentially and were not randomly assigned to the intervention. Each cohort was given the opportunity to adapt the basic 12 week lifestyle intervention.
Cohort/Intervention 1: Four activity groups that met weekly for 12 weeks: a) walking group + box fit (moderate intensity) or Zuu fit (high intensity interval training; ZUU uses seven primal and natural human movements for a full body workout: push, pull, bend, twist, squat, lunge, locomotion); b) walking group only; c) Box and/or Zuu fit; and d) self-organising group involving various activities including walking and touch rugby. The self-organising group was able to complete activities at their own discretion. The groups were administered/led by a tuakana (senior mentor) who was also a participant in activities. Participants were asked to hold activities at least three times per week for a hour each time (participants were encouraged to engage in the activities on their own as well to reach the target). The tuakana identified the level of intensity of activities based on participant abilities; participants were able to select intensity level as well. Participants were able to self-select the group they belonged to and hence could involve in multiple activities: walking only= 4; walking + Box/Zuu fit = 8; boxfit and/or Zuu fit = 5; self-organising = 17. The groups had structured weekly activity groups and monthly prizes for greatest percentages of weight loss. Weekly support messages were shared in a Facebook group consisting of reminders and positive reinforcement. There was also a single one-hour weekly session that focused on nutrition, meal preparation and food diaries delivered by the tuakana and a community researcher. Weekly logs of nutrition and activity were provided to participants although these were not used much at all.
Cohort/Intervention 2: A kaiarahi (guide; community health worker) worked with participants as individuals to provided education and support on activity and nutrition. The kaiarahi worked with the men in whatever context they needed (e.g., face-to-face meetings, home visits, group meetings, phone meetings etc.). The kaiarahi provided an average of 30 minutes education per week for 12 weeks about activity and nutrition, and set up sessions for the men. All education sessions were recorded by the kairahi to monitor adherence. The kaiarahi was willing to provide more education if desired by the participants. Nutrition information was provided in a booklet as well. It was created for this study and consisted of foods to consume/avoid and recipes.
Intervention code [1] 316268 0
Lifestyle
Comparator / control treatment
No control group; while there were two different cohorts, each were treated as single group analysis because each intervention was co-designed and thus not directly comparable.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322182 0
Weight measured by a digital scale
Timepoint [1] 322182 0
12 week follow-up relative to baseline
Secondary outcome [1] 377602 0
Body mass index as measured by weight with digital scale and height with measuring tape
Timepoint [1] 377602 0
12 week follow-up relative to baseline
Secondary outcome [2] 377603 0
Health related quality of life as measured by items from the Medical Outcomes Study; Wu A, Rubin H, Matthews W, Ware J, Brysk L, Hardy W, Bozzette S, Spector S, Richman D. A health status questionnaire using 30 items from the medical outcomes study. Medical Care. 1991; 29:786-798
Timepoint [2] 377603 0
12 week follow-up relative to baseline
Secondary outcome [3] 377604 0
self-rated health as measured by single item used in another study: Achat HM, Thomas P, Close GR, Moerkerken LR, Harris MF. General health care service utilisation: where, when and by whom in a socioeconomically disadvantaged population. Aust J Prim Health. 2010; 16:132-40
Timepoint [3] 377604 0
12 week follow-up relative to baseline
Secondary outcome [4] 377605 0
total days with 30 minutes moderate/15 minutes vigourous exercise as measured by single items from Ministry of Health. Content Guide 2015-16 New Zealand Health Survey. Wellington, New Zealand: Ministry of Health; 2016
Timepoint [4] 377605 0
12 week follow up relative to baseline
Secondary outcome [5] 377606 0
general nutritional intake as measured by 9 items from University of Otaho and Ministry of Health. A focus on nutrition : Key findings of the 2008/09 New Zealand Adult Nutrition Survey. Wellington, New Zealand: Ministry of Health; 2011
Timepoint [5] 377606 0
12 week follow up relative to baseline

Eligibility
Key inclusion criteria
Maori male; family member of Maori male
Minimum age
25 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
none

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Each cohort was treated as a non-random single group; the two groups were not randomly assigned and not comparable because the interventions were distinct and created through a co-design process.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Demographic details were analysed using frequencies or mean/standard deviations. Constructs with multiple items were checked for internal consistency (Cronbach’s alpha) and with sufficient alpha were averaged for a scale score. All items used the original scale scoring except for self-rated health and HRQOL which were converted to 100-point scoring following the RAND method. Data analysis for the outcome measures utilised paired sample t-tests with SPSS 25.0. Qualitative follow-up data analysed with thematic analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/09/2018
Date of last participant enrolment
Anticipated
Actual
1/03/2019
Date of last data collection
Anticipated
Actual
28/06/2019
Sample size
Target
65
Accrual to date
Final
65
Recruitment outside Australia
Country [1] 22165 0
New Zealand
State/province [1] 22165 0
Bay of Plenty

Funding & Sponsors
Funding source category [1] 304453 0
Government body
Name [1] 304453 0
Ministry of Business, Innovation and Employment--Healthier Lives National Science Challenge
Country [1] 304453 0
New Zealand
Primary sponsor type
University
Name
University of Waikato
Address
Private Bag 3105
Hamilton 3240
Country
New Zealand
Secondary sponsor category [1] 304721 0
Charities/Societies/Foundations
Name [1] 304721 0
Poutiri Trust
Address [1] 304721 0
74 Jellicoe Street, Te Puke 3119
Country [1] 304721 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304888 0
University of Waikato, Waikato Management School
Ethics committee address [1] 304888 0
Ethics committee country [1] 304888 0
New Zealand
Date submitted for ethics approval [1] 304888 0
01/12/2015
Approval date [1] 304888 0
18/12/2015
Ethics approval number [1] 304888 0
15/202

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

Contacts
Principal investigator
Name 98534 0
Prof John Oetzel
Address 98534 0
Private Bag 3105
University of Waikato
Hamilton 3240
Country 98534 0
New Zealand
Phone 98534 0
+64 7 838 4431
Fax 98534 0
Email 98534 0
[email protected]
Contact person for public queries
Name 98535 0
John Oetzel
Address 98535 0
Private Bag 3105
University of Waikato
Hamilton 3240
Country 98535 0
New Zealand
Phone 98535 0
+64 7 838 4431
Fax 98535 0
Email 98535 0
[email protected]
Contact person for scientific queries
Name 98536 0
John Oetzel
Address 98536 0
Private Bag 3105
University of Waikato
Hamilton 3240
Country 98536 0
New Zealand
Phone 98536 0
+64 7 838 4431
Fax 98536 0
Email 98536 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We did not have prior approval to share data from partner organisations and participants. If desired, we will retrospectively asked for permission to share upon a reasonable request.


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
EmbaseA case study of using the He Pikinga Waiora Implementation Framework: Challenges and successes in implementing a twelve-week lifestyle intervention to reduce weight in Maori men at risk of diabetes, cardiovascular disease and obesity.2020https://dx.doi.org/10.1186/s12939-020-01222-3
N.B. These documents automatically identified may not have been verified by the study sponsor.