Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000931875
Ethics application status
Approved
Date submitted
10/05/2021
Date registered
15/07/2021
Date last updated
16/06/2022
Date data sharing statement initially provided
15/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating Buttabean Motivation: a Pacific community-based approach to health
Scientific title
Evaluating BBM Motivation for engagement, and changes in quality of life, weight and weight-related morbidity: a community-based, Pacific-driven approach to health in adults.
Secondary ID [1] 304020 0
University of Auckland 3722251
Health Research Council of New Zealand 21/280
Universal Trial Number (UTN)
Trial acronym
NA
Linked study record
NA

Health condition
Health condition(s) or problem(s) studied:
Obesity 321646 0
Diabetes 322324 0
Obstructive Sleep Apnoea 322326 0
Heart Disease 322573 0
Condition category
Condition code
Diet and Nutrition 319388 319388 0 0
Obesity
Public Health 319389 319389 0 0
Health service research
Metabolic and Endocrine 319390 319390 0 0
Diabetes
Musculoskeletal 319391 319391 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 319392 319392 0 0
Other physical medicine / rehabilitation
Cardiovascular 320189 320189 0 0
Coronary heart disease

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
2
Target follow-up type
Years
Description of intervention(s) / exposure
The programme to be observed is called Buttabean Motivation (BBM Motivation/BBM) which runs a variety of free and open physical activity sessions for groups of individuals and families. BBM's vision is to reduce obesity amongst Maori and Pacific people in New Zealand, and to enable them to choose a sustainable healthy and active lifestyle. The BBM environment is communal, highly supportive, and non-judgmental, so that people feel comfortable participating in physical activity programmes in a safe environment.
We will conduct an observational impact evaluation of the no-cost BBM programmes by following a cohort of members for 24 months. We will not examine the details (purpose, intensity, quality, length, etc) of specific programmes which are highly variable, but rather the longitudinal (2-year) impact on health as a result of engaging with BBM. The training sessions are run by 20 BBM Community Leaders (trainers) who are trained in-house by founder Dave Letele who is PT Level 4 qualified. BBM trainers have gained accreditation through Skills Active Aotearoa with Exercise Industry PT Level 3 NZQA qualification. Many of the trainers have come through BBM as members attending training sessions and the training of trainers at BBM is constant.
For six days a week, BBM conducts over 20 free weekly group sessions of exercise routines, attended by 1000 people in South, West, and Central Auckland. Members of the public register to become BBM members through the BBM website, a process called on-boarding, which allows BBM to track members’ attendance. Once registered, sessions are advertised on the MindBody app where members book a spot for specific sessions. Members must remove their booking if they are subsequently not able to attend. Attendees are signed in electronically by BBM staff. Sessions are carried out either in BBM’s own training facilities or in public spaces ranging from parks, halls, and even carparks. The sessions are designed so that minimal training equipment is not needed where only body movement is required. The intensity of all exercise routines begins with a brief low intensity warm-up, are mostly vigorous throughout, but allow for regression (lower intensity) or progression (higher intensity) training suited to individual capacity. Timing of routines vary from 45 to 60 minutes of 6- to 8-minute sets with 30 second to 1 minute intervals.
Intervention code [1] 321010 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327252 0
Percent change in body weight in kilograms.
Timepoint [1] 327252 0
Baseline and 6-, 12- and 24-months (primary timepoint) from baseline.
Primary outcome [2] 327253 0
Change in quality of life using Hua Oranga (Maori Measure of Mental Health Outcome which includes measures of physical, emotional, spiritual and social health).
Timepoint [2] 327253 0
Baseline and 24-months from baseline.
Primary outcome [3] 327255 0
Change in frequency of engagement in BBMs physical activity sessions.
Timepoint [3] 327255 0
Baseline and 6-, 12- and 24-months (primary timepoint) from baseline
Secondary outcome [1] 394377 0
Change in self-reported diabetes control.
Timepoint [1] 394377 0
Baseline and 24-months from baseline
Secondary outcome [2] 397203 0
Change in self-reported Obstructive Sleep Apnoea,
Timepoint [2] 397203 0
Baseline and 24-months from baseline.

Eligibility
Key inclusion criteria
All BBM members (aged 18 years and above) who consent to take part will be included as participants regardless of ethnicity but most members are Pacific or Maori. This study is focused on adult health.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
There is no control group but there is very strong evidence that a non-intervention counterfactual of no weight change is plausible since the average natural trajectory of people with obesity is no change or slow increases in weight. A sustained weight loss of 5-10 percent is clinically meaningful for health benefits, even if people remain overweight or even obese. The General group will include new entrants who will form a cohort with baseline and follow up data. The numbers of new entrants are very high (since reopening after Covid-19 lockdown, BBM had 158 new registrations over 19 days). These two cohorts will have simple analyses (t-tests for follow up minus baseline data) to define the standard metrics.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
26/05/2022
Actual
26/05/2022
Date of last participant enrolment
Anticipated
31/12/2022
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
1000
Accrual to date
30
Final
Recruitment outside Australia
Country [1] 23686 0
New Zealand
State/province [1] 23686 0
Auckland

Funding & Sponsors
Funding source category [1] 308403 0
Government body
Name [1] 308403 0
Health Research Council NZ
Country [1] 308403 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country
New Zealand
Secondary sponsor category [1] 309416 0
None
Name [1] 309416 0
Address [1] 309416 0
Country [1] 309416 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308364 0
Health & Disability Ethics Committee
Ethics committee address [1] 308364 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 308364 0
New Zealand
Date submitted for ethics approval [1] 308364 0
28/04/2021
Approval date [1] 308364 0
30/06/2021
Ethics approval number [1] 308364 0
21/STH/122

Summary
Brief summary
The primary purpose of this study is to estimate the effectiveness of the Buttabean Motivation (BBM) programme for achieving sustained physical activity participation, weight loss and improved health outcomes for Pacific and Maori participants. The study will use a co-design approach, where researchers will work with personnel and members of BBM to develop the study questions, research processes and information delivery. Consistent with BBM’s Pacific community culture, the study incorporates the Pacific Fonofale model of inquiry which incorporates the values and beliefs of Pacific cultures. Thus, health encompasses different foundations of life including family, cultural values and beliefs, spiritual, physical, mental, and other influences such socioeconomics.
The main hypothesis is that BBM will create valuable, sustained average weight loss (greater than or equal to 5% of baseline weight), and cardiovascular benefits for its members. Secondary hypotheses include that programme participation will result in participants meeting healthy activity and eating guidelines; and that BBM members will experience measurable personal and social benefits such as improved quality of life and social relationships.
The overall aim is to evaluate the effectiveness of BBM for sustained health and wellbeing outcomes among mostly Pacific and Maori participants. This will be achieved by evaluating the effectiveness of BBM's free community exercise programmes.
The first objective of the study is to estimate the medium- and long-term (12 and 24 months) impact on body weight. This will involve recruitment of a cohort of BBM members whose height and weight will be measured at baseline, and at six, 12 and 24 months after baseline.
The second objective will be to evaluate change in participant wellbeing and health conditions after 24 months engagement with BBM. This will involve surveying participants at baseline and two years after. The survey includes using the Hua Oranga questionnaire which measures wellbeing from physical, emotional, spiritual, and social relations dimensions on a Likert-type scale. In addition to demographic information (age, ethnicity, sex), other information to be collected in the survey will include health conditions blood pressure, diabetes, sleep apnoea and heart disease.
The third objective is a systems analysis of the BBM programme to understand the strengths and challenges of delivering a holistic and sustained service for the community. A series of Group Model Building workshops will be carried out with BBM staff to build the systems logic model for the BBM programme. The model will be initiated in year one and be reviewed annually. It will serve as an agreed theory of change for BBM and help evolve effective programme value by providing the basis for continuous quality improvements.
Trial website
Trial related presentations / publications
Public notes
Publication:
(Submitted) Friday 16 April 2021.
Goodyear-Smith, F., Harwood, M., Bagg, W., Letele, U., Letele, D., and Savila, F. 'BBM: much more than an exercise programme.' NZMJ-2021-140-(1522).

Oral presentation. Thursday 15 April 2021. Savila, F. 'Evaluating BBM Motivation: a community-based, Pacific-driven approach to health.' School of Population Health. Quick Fire Research Updates. Building 507 Room G080. Faculty of Medical & Health Sciences, University of Auckland.

Contacts
Principal investigator
Name 110454 0
Dr Fa'asisila Savila
Address 110454 0
The University of Auckland
Private Bag 92019
Auckland 1142
Country 110454 0
New Zealand
Phone 110454 0
+64 276358829
Fax 110454 0
Email 110454 0
[email protected]
Contact person for public queries
Name 110455 0
Dr Fa'asisila Savila
Address 110455 0
The University of Auckland
Private Bag 92019
Auckland 1142
Country 110455 0
New Zealand
Phone 110455 0
+64 276358829
Fax 110455 0
Email 110455 0
[email protected]
Contact person for scientific queries
Name 110456 0
Dr Fa'asisila Savila
Address 110456 0
The University of Auckland
Private Bag 92019
Auckland 1142
Country 110456 0
New Zealand
Phone 110456 0
+64 276358829
Fax 110456 0
Email 110456 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
Individual participant data will not be made available, only de-identified cohort summarised data.
De-identified data may be accessed and used by the following groups:
The Investigator and suitably trained and experienced study staff, to conduct the study.
Sponsor study monitor(s), for source data verification purposes.
The Health and Disability Ethics Committee, to comply with legal duties.
Health, regulatory, or government authorities, to comply with legal duties.
De-identified data may not be shared externally without the explicit and recorded agreement by the Research Steering Committee and consent of participants.
De-identified data may, in summarised form, be included in published study results including, but not limited to, peer-reviewed publications, scientific meetings, and regulatory / marketing submissions.


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
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Documents added automatically
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