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Trial registered on ANZCTR


Registration number
ACTRN12622000174785
Ethics application status
Approved
Date submitted
19/01/2022
Date registered
2/02/2022
Date last updated
2/08/2022
Date data sharing statement initially provided
2/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a Community-led nutrition and Lifestyle program for weight loss and metabolic Health
Scientific title
EvaLuation of a Community-led nutrition and Lifestyle program for weight loss and metabolic Health in overweight adults
Secondary ID [1] 306241 0
NHMRC successful funding application ID APP1179067
Universal Trial Number (UTN)
Trial acronym
ELCHO project
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight 324970 0
Obesity 324971 0
Condition category
Condition code
Diet and Nutrition 322405 322405 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Hope for Health (HfH) lifestyle program. A holistic initiative combining traditional indigenous practices with modern approaches to health nutrition and lifestyle. Specifically, the program is divided into two parts:

1. A traditional 2-week retreat, taking people out of their home environment to stay in natural bush land, and providing culturally and linguistically effective two-way education that targets gaps in understanding of nutrition and health. The retreat involves nutrition and health education, training in lifestyle skills, exercise, cooking and stress management. This program (Hope for Health) is a readily available program delivered by Why Warriors Org Ltd.
2. Support and Mentoring (3.5 months) includes individual case management and regular activities, provided for 14 weeks after the retreat. Participants receive support to tackle other systemic barriers that directly affect their ability to instigate lifestyle changes, such as choosing healthy food options at the store, dealing with difficulties in storing fresh produce at home, overcoming poor sleep and family stress from substance abuse and overcrowding, and seeking assistance for gambling. Importantly, dietary advice, home cooking demonstrations (usually conducted outside the house), and fitness activities are open for all household members, with the aim of imparting new knowledge and skills to a broader community.

The support and mentoring will be delivered by the local members of Hope for Health team in conjunction with Miwatj Health and The Arnhem Land Progress Aboriginal Corporation nutritionists. At least weekly activities (health coach appointments) will be organised, determined through a participatory process, emphasising opportunities for peer-support discussion (yarning). Activities include grocery shopping, cooking, dance, walking, and gathering traditional foods. The Hope for Health team will provide outreach to participants households, with a focus on demonstrating preparation of health meals. One-on-one mentoring will assist with problem solving and lifestyle changes, including feedback and review of personal results.

The weekly activities will be delivered through a combination of face-to-face meetings and phone meetings. The frequency of activities will occur at least once a week for a duration of 1-3 hours.

Attendance at scheduled meeting with the Hope for Health coach will be monitored and recorded for active participants and visits to Miwatj Health will be recorded for controls. Significant noncompliance is defined as missing two consecutive health coach appointments. Participants who are significantly noncompliant will be visited by the Hope for Health coach to discuss barriers and challenges to attending, and options for making this easier.

Intervention code [1] 322645 0
Lifestyle
Comparator / control treatment
None.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330166 0
Weight loss of 5% or more from baseline of participants assessed by trained personnel using a validated weighing scale.
Timepoint [1] 330166 0
Baseline and 4 months post commencement of the intervention.
Secondary outcome [1] 405108 0
Weight assessed by two trained personnel measured using standardised measuring scales.
Timepoint [1] 405108 0
Baseline and 4 months post commencement of the intervention.
Secondary outcome [2] 405109 0
Waist circumference measured by two trained personnel using a standardised measuring tape.
Timepoint [2] 405109 0
Baseline and 4 months post commencement of the intervention.
Secondary outcome [3] 405110 0
Risk of obstructive sleep apnea assessed using the STOP BANG questionnaire
Timepoint [3] 405110 0
Baseline and 4 months post commencement of the intervention.
Secondary outcome [4] 405111 0
Body mass index will be calculated using hight and weight measured using standardised measuring scales and stadiometer.
Timepoint [4] 405111 0
Baseline and 4 months post commencement of the intervention.
Secondary outcome [5] 405112 0
Blood pressure and aortic stiffness measured using the SphygmoCor XCEL by two trained personnel.
Timepoint [5] 405112 0
Baseline and 4 months post commencement of the intervention.
Secondary outcome [6] 405113 0
Dietary intake measured using the Menzies Remote Short-item Dietary Assessment Tool, 24-hour dietary recall and the food insecurity experience scale questionnaire.
Timepoint [6] 405113 0
Baseline and 4 months post commencement of the intervention.
Secondary outcome [7] 405114 0
Physical activity measured using the Physical activity and sitting questions using in National Aboriginal and Torres strait Islander Health Survey and seven day objective measurement using wrist worn ActiGraph Link activity monitors.
Timepoint [7] 405114 0
Baseline and 4 months post commencement of the intervention.
Secondary outcome [8] 405115 0
Quality of life measured using the Strong Souls Tool.
Timepoint [8] 405115 0
Baseline and 4 months post commencement of the intervention.
Secondary outcome [9] 405116 0
Clinical Blood Biomarkers blood count, plasma insulin, cholesterol and lipid profile and sensitive markers of inflammation measured using venous blood and fasting glucose and HbA1c measured using finger pick blood test.
Timepoint [9] 405116 0
Baseline and 4 months post commencement of the intervention.
Secondary outcome [10] 412495 0
Body composition measured using body composition scales which use advanced Dual frequency Bioelectric Impedance Analysis to provide accurate and reliable segmental body composition results during the weight measurement.
Timepoint [10] 412495 0
Baseline and 4 months post commencement of the intervention.
Secondary outcome [11] 412496 0
Sleep quality will be analysed using data collected from the activity monitors by applying the Cole Kripke algorithm a validated technique to assess total sleep time, sleep efficiency, wake after sleep onset and sleep fragmentation, all measures of sleep quality.
Timepoint [11] 412496 0
Baseline and 4 months post commencement of the intervention.

Eligibility
Key inclusion criteria
Additional inclusion of participants with a body mass index (BMI) greater than or equal to 25 kg/m2 or waist circumference greater than >94cm for males and >80cm for females. I.e updated Key inclusion criteria should be as following:

1. Adults greater than or equal to 18 years of age to less than or equal to 65 years of age
2. Body mass index (BMI) greater than or equal to 25 kg/m2 or waist circumference greater than 94cm for males and greater than 80cm for females
3. Residents of Elcho Island
4. Expressed interest and agreed to undertake the HfH program
5. Not expected to leave the Island for more than 2 weeks in the 4 months after enrolment
6. Provided a signed and dated informed consent form
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Has unstable diabetes with episodes of hypoglycaemia and/or ketoacidosis in the last 12 mo
2. Has insulin dependent diabetes
3. Has chronic renal failure that impairs daily function
4. Has cardiac failure
5. Has cirrhosis
6. Has other factors limiting ability to participate
7. Past participants on the HfH program
8. Women who are pregnant


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)
n/a
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
n/a
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
n/a
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
In a preliminary Hope for Health (HfH) evaluation, 10 of 21 participants lost at least 5% weight at four months from baseline (48%, Wilson’s 95% CI: 28-68%). Assuming 35% of the HfH participants will experience at least 5% weight loss at four months in this study, a total of 43 participants will provide >95% power to demonstrate that the primary outcome is different from what is expected to be observed under usual care (i.e. 10%) at a two-sided alpha of 5%. Usual care would include care provided by Miwatj Health Clinic, consisting of demand driven access to nurses and LMOs as well as contact with the Miwatj chronic disease team. Allowing for approximately 25% attrition, 60 participants will be required.

The primary outcome of at least 5% weight loss from baseline to endline (yes/no) will be analysed using a binomial regression model with identify link. The primary hypothesis will be evaluated by obtaining an estimate of the proportion of participants with at least 5% weight loss, a two-sided 95% confidence interval (CI), and a p-value (of the test that the primary outcome is different from 10%).

Secondary outcomes at endline will be analysed using a linear model adjusted for the baseline. An estimate of the absolute mean change from baseline to post-baseline, two-sided 95% CI, and p-value (of the test that the change is difference from 0) will be obtained from this model. Secondary binary outcomes will be analysed similarly as the primary outcome and secondary continuous outcomes will be analysed in a similar way to the anthropometric outcomes, with any markedly skewed continuous outcomes transformed before analysis.
Subgroups of interest are participants defined by sex, having concomitant anti-diabetes/anti-obesity medication and having concurrent illness by expanding the models to include the subgroup to allow estimation within subgroup and testing between subgroups.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/03/2022
Actual
28/04/2022
Date of last participant enrolment
Anticipated
31/05/2022
Actual
29/07/2022
Date of last data collection
Anticipated
30/11/2022
Actual
Sample size
Target
70
Accrual to date
Final
67
Recruitment in Australia
Recruitment state(s)
NT
Recruitment postcode(s) [1] 36419 0
0822 - East Arnhem

Funding & Sponsors
Funding source category [1] 310589 0
Government body
Name [1] 310589 0
National Health and Medical Research Council
Country [1] 310589 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Parkville, Victoria, 3010.
Country
Australia
Secondary sponsor category [1] 311780 0
None
Name [1] 311780 0
Address [1] 311780 0
Country [1] 311780 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310193 0
Human Research Ethics Committee of the Northern Territory Department of Health and Menzies School of Health Research
Ethics committee address [1] 310193 0
Ethics committee country [1] 310193 0
Australia
Date submitted for ethics approval [1] 310193 0
27/10/2021
Approval date [1] 310193 0
07/12/2021
Ethics approval number [1] 310193 0
HREC Reference Number: 2021-4166

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

Contacts
Principal investigator
Name 116822 0
Prof Beverley-Ann Biggs
Address 116822 0
Professor Beverley-Ann Biggs
The Peter Doherty Institute for Infection and Immunity
792 Elizabeth St, Melbourne VIC 3000
Country 116822 0
Australia
Phone 116822 0
+61 3 8344 3256
Fax 116822 0
Email 116822 0
babiggs@unimelb.edu.au
Contact person for public queries
Name 116823 0
Beverley-Ann Biggs
Address 116823 0
Professor Beverley-Ann Biggs
The Peter Doherty Institute for Infection and Immunity
792 Elizabeth St, Melbourne VIC 3000
Country 116823 0
Australia
Phone 116823 0
+61 3 8344 3256
Fax 116823 0
Email 116823 0
babiggs@unimelb.edu.au
Contact person for scientific queries
Name 116824 0
Beverley-Ann Biggs
Address 116824 0
Professor Beverley-Ann Biggs
The Peter Doherty Institute for Infection and Immunity
792 Elizabeth St, Melbourne VIC 3000
Country 116824 0
Australia
Phone 116824 0
+61 3 8344 3256
Fax 116824 0
Email 116824 0
babiggs@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
No additional documents have been identified.