ANZCTR - Registration

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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]

University of Auckland 3722251

Secondary ID [2]

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

Condition category

Condition code

Cardiovascular

Coronary heart disease

Cardiovascular

Hypertension

Metabolic and Endocrine

Diabetes

Musculoskeletal

Osteoarthritis

Diet and Nutrition

Obesity

Public Health

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]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Change in body weight measured in kilograms using digital weight scale.

Timepoint [1]

Baseline (enrolment into study), and follow up at 12-weeks, and 6-, 12- and 24-months after enrolment.

Secondary outcome [1]

Sustained engagement in BBM programme determined by drop-out data via audit of BBM records.

Timepoint [1]

Measured at baseline, 12 weeks, and 6-, 12-, and 24-months after enrolment,

Secondary outcome [2]

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]

Medical records collected at baseline (study enrolment), and at 12- and 24-months after enrolment.

Secondary outcome [3]

Change in wellbeing (Maori quality of life) score using the Hua Oranga tool.

Timepoint [3]

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Auckland

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Health Research Council NZ

Address [1]

Level 3/110 Stanley Street, Grafton, Auckland 1010. New Zealand.

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Charities/Societies/Foundations

Name [1]

Buttabean Motivation

Address [1]

615 Great South Road, Manukau City Centre, Auckland 2104

Country [1]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Health & Disability Ethics Committees

Ethics committee address [1]

Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

Approval date [1]

30/06/2021

Ethics approval number [1]

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

Dr Fa'asisila Savila

Address

University of Auckland
M&HS BUILDING 507 - Bldg 507
Level 1, Room 1001
28 PARK AVE
GRAFTON
AUCKLAND 1023
New Zealand

Country

New Zealand

Phone

+64 09 3737999

Fax

f.savila@auckland.ac.nz

Contact person for public queries

Name

Fa'asisila Savila

Address

University of Auckland
M&HS BUILDING 507 - Bldg 507
Level 1, Room 1001
28 PARK AVE
GRAFTON
AUCKLAND 1023
New Zealand

Country

New Zealand

Phone

+64 09 3737999

Fax

f.savila@auckland.ac.nz

Contact person for scientific queries

Name

Boyd Swinburn

Address

University of Auckland
M&HS BUILDING 507 - Bldg 507
Level 1, Room 1078
28 PARK AVE
GRAFTON
AUCKLAND 1023

Country

New Zealand

Phone

+64 9 923 9135

Fax

boyd.swinburn@auckland.ac.nz

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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?

Doc. No.	Type	Email	Other Details	Attachment
13815	Study protocol		Final details are being completed for the study pr... [More Details]
13816	Informed consent form	f.savila@auckland.ac.nz		382320-(Uploaded-28-10-2021-09-54-24)-Study-related document.pdf
13817	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.

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