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Trial registered on ANZCTR


Registration number
ACTRN12617000871347
Ethics application status
Approved
Date submitted
17/05/2017
Date registered
15/06/2017
Date last updated
15/06/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Ka Mau Te Wehi: Culturally appropriate weight Loss intervention for Maori and Pacific people of New Zealand
Scientific title
Ka Mau Te Wehi: a non-randomized controlled trial to investigate a culturally informed weight loss intervention for Maori and Pacific people of New Zealand
Secondary ID [1] 291977 0
Nil
Universal Trial Number (UTN)
U1111-1178-8573
Trial acronym
wehi
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obesity 298928 0
diabetes
303446 0
Cardiovascular Disease 303447 0
Condition category
Condition code
Diet and Nutrition 299005 299005 0 0
Obesity
Cardiovascular 302854 302854 0 0
Other cardiovascular diseases
Metabolic and Endocrine 302855 302855 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a quasi-experimental controlled pilot study that uses the following component to reduce weight for participants who are (pre- or) diabetic or who have (pre- or) cardiovascular disease. The intervention was conducted over 6 months.
Wehi was designed based on Maori and/or Pacific values. That is:
1) the prize was donated to participants selected charity,
2) team, rather than individual focus for competition
3) Maori and Pacific people in NZ have high participation in competition.

Based upon the literature WEHI include the following components:
1) Intervention participants were provided with a list of daily challenges (see details in list below). The participants could choose to perform as many or as few of these challenges as the decide. They were required to fill in a diary of what challenges they did each day. The teams were required to submit the number of members who had done each challenge each day. That is, points were allocated to the teams, but not to the individuals.
Daily challenges list was:
-For 10 daily points:
Sugar-free Drink Day A day without drinking sugar-sweetened soft drinks or fruit juices or cordials.
3+ Vege Day A day when at least 3 servings of vegetables were consumed.
Exercise Day A day when at least half an hour continuous walking or more strenuous exercise was completed.
-For 8 points:
1/4, 1/4, 1/2 dinner Day A day when the main meal is made up of ½ vegetables, ¼ protein and ¼ carbohydrates.
Fast & Fried-Free Day A day without fast or fried food.
Sweet Treat-free Day A day without eating sugar-sweetened biscuits, cakes, lollies, chocolate or desserts.
-For 6 daily points:
Stand Up Day A day when long periods of sitting down are broken up by standing for at least a minute and this is done at least 3 times (once in the morning, once in the afternoon and once in the evening).
Build Me Up Day A day when at least 10 continuous minutes was spent focused on learning about or practising a new behaviour that will reduce stress, improve sleep quality or improve knowledge of nutrition. Visiting the WEHI website, reading the Tip of the Day and posting on your team page can count towards this.
Water First Day A day of drinking a glass of water no more than 5 minutes before eating each of your 3 main meals (breakfast, lunch & dinner).
2)Teams were supported with team activity summary sheets and a fridge magnet as a mnemonic to remind participants of the daily challenges. The teams were supplied with a set of bathroom scales to use as they wish to track their progress.
3)WEHI participants are encouraged, through information provided on a wehi dedicated website (wehi.nz) to use whatever non-surgical methods, diets, programmes or health and fitness providers they want and can access at their own cost. No particular dietary intervention will be promoted, although Ministry of Health guidelines on healthy eating and physical activity will be followed for the development of tips and team weekly challenge activities. Furthermore, the use of supplements will be discouraged as many products are costly with no known scientific basis of efficacy.
Group support
WEHI participants compete in teams of seven, which boost peer social support and enable the dynamics of whanaungatanga (a relationship through familial and shared experiences) to operate. Each team will be self-directing in terms of organising their team meetings and activities. Teams can receive support from the regional intervention worker though this should be equitably provided to each of the teams to avoid advantaging one team over the others.
Incentives
In each region, three prizes are offered:
1) Greatest progress at 2 months - $1000
2) Greatest progress at 4 months - $1000
3) Greatest progress at 6 months - $3000
The prizes are paid out to the team’s nominated charity or community organisation. This fundraising aspect is expected to appeal to participants’ existing sense of duty to raise funds for cultural or local community events and other needs. This may provide additional motivation over and above any motivation to lose weight for their own benefit.
Intervention code [1] 298173 0
Behaviour
Intervention code [2] 298174 0
Lifestyle
Intervention code [3] 298195 0
Treatment: Other
Comparator / control treatment
The intervention group will be compared with a consecutive but separately recruited group of matched (on ethnicity, gender & age) controls. The control group will not receive any treatment, in addition to standard care
Control group
Active

Outcomes
Primary outcome [1] 298472 0
Anthropometric measurements (height and weight) of all participants will collected by a research assistant The equipment used for measurements are SECA813 digital floor scale, and SECA portable stadiometer Height Rod. Based on those measures, BMI was calculated as (weight (kg) / (height (m) x height (m)) at baseline, 6 months, 12 months.
Timepoint [1] 298472 0
data will be collected at baseline, end of programme (at 6 months) and 12 months post start of intervention.
Secondary outcome [1] 324253 0
HbA1c assessed by blood test
Timepoint [1] 324253 0
6 months post intervention (ie 12 months post start of intervention)
Secondary outcome [2] 335319 0
HDL/Total choesterol ration assessed by blood test
Timepoint [2] 335319 0
6 months post intervention (ie 12 months post start of intervention)

Eligibility
Key inclusion criteria
1) who are obese (BMI of 30 or over)
AND either or all of the following:
2a) at risk of developing type 2 diabetes (HbA1c of 41-49 mmol/mol) or who have been diagnosed with type 2 diabetes (HbA1c >50 mmol/mol) or
2b)at risk of cardiovascular disease as defined by a ‘elevated cholesterol’, compared to the laboratories’ normal range, in a test blood during the last 12 months), or who have been diagnosed with cardiovascular disease
AND
3) is enrolled or willing to enrol with a primary health care provider and is willing to have a blood test for HbA1c and cholesterol.
Minimum age
16 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1)Under 16-years old
2)Pregnant or planning a pregnancy within the next year
3)Women who have had a live baby in the past 6-months and who are still breastfeeding
4)People who self-report current smoking of tobacco or marijuana, or who use nicotine replacement products or nicotine from any other source (e.g. electronic devices). This is because nicotine is a known appetite suppressant and could confound the results.

Study design
Purpose of the study
Treatment
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 7922 0
New Zealand
State/province [1] 7922 0
Manawatu, Auckland, Northland

Funding & Sponsors
Funding source category [1] 296487 0
Government body
Name [1] 296487 0
New Zealand Ministry of Health
Address [1] 296487 0
133 Molesworth St, Thorndon, Wellington 6011
Country [1] 296487 0
New Zealand
Primary sponsor type
Individual
Name
Marewa Glover
Address
School of Public Health
College of Health
Massey University
Massey University Auckland (East Precinct)
Albany Expressway (SH17)
Albany 0632
Country
New Zealand
Secondary sponsor category [1] 295444 0
None
Name [1] 295444 0
Address [1] 295444 0
Country [1] 295444 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297708 0
Health and disability ethics committee
Ethics committee address [1] 297708 0
Health and Disability Ethics Committees
Ministry of Health
Freyberg Building
20 Aitken Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 297708 0
New Zealand
Date submitted for ethics approval [1] 297708 0
Approval date [1] 297708 0
05/07/2016
Ethics approval number [1] 297708 0
16/NTB/101

Summary
Brief summary
Objectives:
The objective is to develop and test a community competition-based behaviour change intervention to reduce diabetes and cardiovascular risk among Maori and Pacific adults.
The aim of the study is to incentivise Maori and Pacific adults to lose weight and reduce their waist circumference through a team-based community and online competition.
Study design and methodology:
This is a quasi-experimental controlled pilot study that will compare an intervention group with a consecutive but separately recruited group of matched (on ethnicity, gender & age) controls.
Study population:
Maori people will be recruited in Northland (N=100) and Manawatu (N=100), and 100 Pacific people will be recruited in Auckland.
Number of subjects:
300
Main criteria for inclusion:
The eligibility criteria are:
1) who are obese (BMI of 30 or over)
AND either or all of the following:
2a) at risk of developing type 2 diabetes (HbA1c of 41-49 mmol/mol) or who have been diagnosed with type 2 diabetes (HbA1c >=50 mmol/mol) or
2b) at risk of cardiovascular disease as defined by a ‘elevated cholesterol’, compared to the laboratories’ normal range, in a test blood during the last 12 months), or who have been diagnosed with cardiovascular disease
AND
3) is enrolled or willing to enrol with a primary health care provider and is willing to have a blood test for HbA1c and cholesterol.

Exclusion criteria:
People will be excluded if they are:
1) Under 16-years old
2) Pregnant or planning a pregnancy within the next year
3) Women who have had a live baby in the past 6-months and who are still breastfeeding
4) People who self-report current smoking of tobacco or marijuana, or who use nicotine replacement products or nicotine from any other source (e.g. electronic devices).

Statistical methods:
Descriptive statistics will be produced. Chi-squared tests will be used for categorical variables and ANOVA tests for continuous variables.
Inductive thematic analysis will be used to identify major themes in qualitative data.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66262 0
A/Prof Marewa Glover
Address 66262 0
School of Population Health
College of Health
Private Bag 102904
North Shore
Auckland 0745
Country 66262 0
New Zealand
Phone 66262 0
+64 9 213 6059
Fax 66262 0
Email 66262 0
m.glover@massey.ac.nz
Contact person for public queries
Name 66263 0
A/Prof Marewa Glover
Address 66263 0
School of population health
College of health
Private Bag 102904
North Shore
Auckland 0745
Country 66263 0
New Zealand
Phone 66263 0
+64 9 213 6059
Fax 66263 0
Email 66263 0
m.glover@massey.ac.nz
Contact person for scientific queries
Name 66264 0
A/Prof Marewa Glover
Address 66264 0
School of population health
College of Health
Private Bag 102904
North Shore
Auckland 0745
Country 66264 0
New Zealand
Phone 66264 0
+64 9 213 6059
Fax 66264 0
Email 66264 0
m.glover@massey.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary