Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001676808
Ethics application status
Approved
Date submitted
28/10/2021
Date registered
7/12/2021
Date last updated
10/11/2022
Date data sharing statement initially provided
7/12/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating Buttabean Motivation’s From the Couch programme: a Pacific community-based approach to health and wellbeing among adults with obesity
Scientific title
Evaluating Buttabean Motivation’s From the Couch programme: a Pacific community-based approach to weight loss, chronic health conditions and wellbeing among adults with morbid obesity
Secondary ID [1] 304673 0
University of Auckland 3722251
Secondary ID [2] 304675 0
Health Research Council of New Zealand 21/280
Universal Trial Number (UTN)
U1111-1269-3622
Trial acronym
Linked study record
Evaluating Buttabean Motivation: a Pacific community-based approach to health. Registration application number 381849. ACTRN12621000931875p is linked to this trial (sub-study) in that it includes participants who are part of that larger trial.

Health condition
Health condition(s) or problem(s) studied:
Morbid obesity 322637 0
Condition category
Condition code
Cardiovascular 320255 320255 0 0
Coronary heart disease
Cardiovascular 320256 320256 0 0
Hypertension
Metabolic and Endocrine 320257 320257 0 0
Diabetes
Musculoskeletal 320258 320258 0 0
Osteoarthritis
Diet and Nutrition 320259 320259 0 0
Obesity
Public Health 320260 320260 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
From the Couch (FTC) is a 12-week weight loss programme designed for people who are challenged in getting up from a sitting position or standing for long periods of time due to extreme obesity. FTC is described as ‘a lifestyle support programme held 3 times per week at the Buttabean Motivation (BBM) Head Quarters in Manukau’ Auckland. The sessions are 40-minutes in duration and include specifically designed physical exercises, as well as nutrition and mental wellbeing support. The aim is to get people off the couch, moving their body, and to build confidence to progress into other exercise programmes provided at BBM. Class sizes are limited to 20 people and are run by the founder of BBM who is a qualified Level-4 Personal Trainer (PT), NZ Qualifications Authority accredited.
Participants agree to undergo a health screen before and tests after the programme. These include measures of blood pressure, diabetes risk, respiratory/cardiovascular rate, and body weight measurements. Measurements are carried out by trained BBM staff and study staff.
Acceptance into FTC is not formally described but is determined by a visual body size weight-for-height assessment (all participants must be over 100 kilograms), blood pressure (must get GP sign-off if BP is 160/90 or above), and not engaging in any weekly physical exercise.
Formal registration (on-boarding) into FTC is required and is done through the BBM website. The sessions are closed groups and there is no cost to attend. During the 12-week programme, participants are added to BBM's From the Couch Facebook support chat group where BBM staff can provide motivation and nutrition support. Participants can access free fruit and vegetables that are made available through BBM's foodbank.
FTC participants may go on to participate in other free BBM programmes or classes. If so, participation in those other programmes require registration (booking) and sign-in for attendance. These participants will be tracked similarly to the participants in the General programme study ACTRN12621000931875p. For this study, participants will be observed for a period of 24-months. BBM members who choose not to participate in this observational study are still able to enrol in the FTC program.
Participation involves 10-15mins of physical measurements and a survey questionnaire to be administered at baseline and 24 months. Extra physical measurements will be collected at 12-weeks, 6-months and 24-months after baseline.
As well as physical measurements, data to be collected include a survey which includes demographic information (eg gender, date of birth, ethnicity), length of time engaged with BBM, an indigenous health and wellbeing scale, and diagnosis of health conditions (eg hypertension, diabetes, sleep apnoea, heart disease). Medical records will be requested from participants' health provider at baseline, 12-months and 24-months after baseline. Existing data that BBM hold on registration and frequency of participation in health programs will be obtained at 24-months.
Intervention code [1] 321042 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328893 0
Change in body weight measured in kilograms using digital weight scale.
Timepoint [1] 328893 0
Baseline (enrolment into study), and follow up at 12-weeks, and 6-, 12- and 24-months after enrolment.
Secondary outcome [1] 401625 0
Sustained engagement in BBM programme determined by drop-out data via audit of BBM records.
Timepoint [1] 401625 0
Measured at baseline, 12 weeks, and 6-, 12-, and 24-months after enrolment,
Secondary outcome [2] 401628 0
Change in chronic condition profile observed in participant medical records. Conditions indicated in section 2 (coronary heart disease, hypertension, diabetes, osteoarthritis, and obesity) will not be independently measured but assessed as a composite profile.
Timepoint [2] 401628 0
Medical records collected at baseline (study enrolment), and at 12- and 24-months after enrolment.
Secondary outcome [3] 401629 0
Change in wellbeing (Maori quality of life) score using the Hua Oranga tool.
Timepoint [3] 401629 0
Baseline, and follow-up at 6-, 12- and 24-months.

Eligibility
Key inclusion criteria
All BBM members registered in six From the Couch 12-week programmes will be eligible.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
There no exclusion criteria apart from age.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Convenience sample
Timing
Both
Statistical methods / analysis
The From The Couch group will be a series of three cohorts of about 20 participants each entering the FTC programme. An estimate of 80% recruitment into the study will give 50 participants who will have baseline and follow up data. 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. The counterfactuals will be compared visually with the following groups: 1) similar New Zealand population group. The estimated mean linear weight change of ethnic/gender/age groups will be derived from the last five years of NZ Health Surveys. Longitudinally, weight change in a subpopulation is the additive effects of secular changes to weight (ie each age group gets a little heavier each year) and age-related weight change (ie the person moves to an older age group which has a higher average weight); 2) control groups in similar studies. A literature review has identified five weight loss studies with predominantly Pacific or Maori participants that had control groups. Linear weight change trajectories (kg/year) will be compared to this group; and 3) groups from other interventions. The literature review noted above identified 18 studies with various interventions with weight change outcomes. These results will be combined to show how effective other programmes have been. Since the duration of interventions varies (3-24 months), weight loss is not linear, and many studies did not include error estimates, it is unlikely that statistical comparisons can be made, but a visual comparison with BBM data (with its own error estimates) may nevertheless be valuable for this research question.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/01/2023
Actual
Date of last participant enrolment
Anticipated
1/05/2023
Actual
Date of last data collection
Anticipated
30/01/2026
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 24168 0
New Zealand
State/province [1] 24168 0
Auckland

Funding & Sponsors
Funding source category [1] 309039 0
Government body
Name [1] 309039 0
Health Research Council NZ
Country [1] 309039 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] 309978 0
None
Name [1] 309978 0
Address [1] 309978 0
Country [1] 309978 0
Other collaborator category [1] 282013 0
Charities/Societies/Foundations
Name [1] 282013 0
Buttabean Motivation
Address [1] 282013 0
615 Great South Road, Manukau City Centre, Auckland 2104
Country [1] 282013 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308917 0
Health & Disability Ethics Committees
Ethics committee address [1] 308917 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 308917 0
New Zealand
Date submitted for ethics approval [1] 308917 0
Approval date [1] 308917 0
30/06/2021
Ethics approval number [1] 308917 0
21/STH/122

Summary
Brief summary
The primary purpose of this study is to evaluate the effectiveness of Buttabean Motivation (BBM) for sustained health and wellbeing outcomes among mostly Pacific and Maori participants. This will be achieved by following a cohort of 50 BBM members attending free community exercise programmes. Although small in numbers, this study will be nested within a larger evaluation study which involves surveying up to 1000 participants from BBM. The study uses a co-design approach, where researchers collaborate with personnel and members of BBM to develop the study questions, research processes and information delivery. Consistent with BBM’s Pacific and Maori and community, the study uses holistic Fonofale (Pacific) and Te Whare Tapa Wha (Maori) frameworks of inquiry.
The null hypothesis is that BBM will not result in sustained weight loss (greater than or equal to 5% of baseline weight), physical activity, or improved cardiovascular profiles for participants.
The primary aim is to estimate the two-year effectiveness of BBM’s ‘From the Couch’ (FTC) programme for achieving physical activity participation, weight loss and improved health outcomes for participants. The FTC programme is a free 12-week customised exercise programme for morbidly obese participants (body mass index of 35 kg/m2 and above). Many participants of FTC go on to other programmes within BBM after the 12-week programme.
The first objective of the study is to measure the medium- and long-term (12 and 24 month) impact on body weight after baseline. This will involve recruitment of a cohort of BBM members whose height and weight will be measured at baseline, 12-weeks and at six, 12 and 24 months after baseline. Other data will be collected in a survey, including demographic (age, ethnicity, sex) and chronic health conditions related to obesity data (eg high blood pressure, diabetes, heart disease).
A second objective will be to measure participant wellbeing after 24 months of engagement with BBM. The survey also includes the Maori-developed tool, Hua Oranga, which measures four items of wellbeing: physical, emotional/mental, spiritual and social relations.
A third objective is to investigate objectively measured changes in chronic health related to obesity. The study will request comprehensive medical records from participants which will be collected at baseline and 24 months after baseline.
Trial website
Trial related presentations / publications
Public notes
A development over the NZ lockdown period resulted in another evaluation study being arranged to evaluate BBM's From The Couch (FTC) programme by another university. (This was entirely beyond the control of the researchers in our study.) That study focused on evaluation of recruitment of community members enrolled in a specific primary health organisation with limited focus on health outcomes. Regardless, our evaluation was precluded from enrolling participants from the FTC programme until a time in 2023. Therefore, this evaluation is currently stalled.

There were 20 participants who were previously enrolled but will not be included for analysis; instead, they may rejoin the trial if they choose to do so.

Contacts
Principal investigator
Name 112338 0
Dr Fa'asisila Savila
Address 112338 0
University of Auckland
M&HS BUILDING 507 - Bldg 507
Level 1, Room 1001
28 PARK AVE
GRAFTON
AUCKLAND 1023
New Zealand
Country 112338 0
New Zealand
Phone 112338 0
+64 09 3737999
Fax 112338 0
Email 112338 0
f.savila@auckland.ac.nz
Contact person for public queries
Name 112339 0
Dr Fa'asisila Savila
Address 112339 0
University of Auckland
M&HS BUILDING 507 - Bldg 507
Level 1, Room 1001
28 PARK AVE
GRAFTON
AUCKLAND 1023
New Zealand
Country 112339 0
New Zealand
Phone 112339 0
+64 09 3737999
Fax 112339 0
Email 112339 0
f.savila@auckland.ac.nz
Contact person for scientific queries
Name 112340 0
Prof Boyd Swinburn
Address 112340 0
University of Auckland
M&HS BUILDING 507 - Bldg 507
Level 1, Room 1078
28 PARK AVE
GRAFTON
AUCKLAND 1023
Country 112340 0
New Zealand
Phone 112340 0
+64 9 923 9135
Fax 112340 0
Email 112340 0
boyd.swinburn@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This position may change and data may be made available at a later date. The university is currently evaluating the sharing of data from research with Maori and Pacific peoples as data sovereignty issues are debated.


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Study protocol    Final details are being completed for the study pr... [More Details]
Informed consent form  f.savila@auckland.ac.nz 382320-(Uploaded-28-10-2021-09-54-24)-Study-related document.pdf
Ethical approval    382320-(Uploaded-28-10-2021-09-56-01)-Study-related document.pdf


Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.