Trial registered on ANZCTR


Trial ID
ACTRN12614000581662
Ethics application status
Approved
Date submitted
23/05/2014
Date registered
30/05/2014
Date last updated
5/04/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
HealthTrack : a healthy lifestyle intervention for overweight adults
Scientific title
Is a novel lifestyle intervention more effective than usual care in achieving weight loss in overweight/obese adults ?
Secondary ID [1] 284655 0
The HealthTrack Study
Universal Trial Number (UTN)
U1111-1157-2562
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
overweight and obesity 291981 0
Condition category
Condition code
Diet and Nutrition 292321 292321 0 0
Obesity
Mental Health 292322 292322 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 292323 292323 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a 12 month single blinded parallel randomised controlled trial with 3 arms: control (usual care), intervention (multidisciplinary lifestyle support) and intervention (multidisciplinary lifestyle support) + a food supplement. Participants will be randomised into a control or one of the intervention groups testing the effect of a novel versus conventional form of individualised health care targeting diet, exercise and health behaviour. Both control and intervention arms will attend the clinic at baseline, 1,2,3,6,9,12 mo for a face to face session with a health practitioner (nurse/control or dietitian supported by an Exercise Physiologist (EP)/intervention) for 40-60 mins. Participants will be encouraged to set diet and physical activity goals based on either information sheets devised for the control or intervention strategy. A client centred approach will be used, with cognitive behavioural enhancement strategies in the intervention group. A phone call will be made between visits by the nurse/control or a health coach (supervised by psychologists)/intervention. Adherence will be monitored by repeat 4 day food records and pedometers. A subset will be given accelerometers. The food supplement is 30g snack packs of walnuts /day for 12 months. At the end of 12 months all participants will be offered to participate in a further 12 months of follow-up. All consented participants will attend for quarterly visits with a dietitian at 15, 18, 21 and 24 months.
Intervention code [1] 289436 0
Lifestyle
Intervention code [2] 289449 0
Treatment: Other
Intervention code [3] 289450 0
Behaviour
Comparator / control treatment
Control: usual care involving client centred support and general advice on diet and physical activity using national guidelines
Comparator: novel approach to lifestyle counselling with diet, physical activity and health coaching.
All groups will be offered follow up with a dietitian 12 months post enrolment.
Control group
Active

Outcomes
Primary outcome [1] 292183 0
Body weight (kg) will be measured in an upright position in minimal clothing and without shoes using scales with a bio-electrical impedance component to also estimate body fat (%) (Tanita TBF-662).
Timepoint [1] 292183 0
Baseline, 1mo, 2mo, 3, 6,9,12 months, Longer term follow up at 15,18,21,24 months
Secondary outcome [1] 308390 0
Diet intake will be assessed using diet history interview at clinic visits and 4 day food records (including one weekend day) completed in the periods prior to attending the clinic (to correspond with the timepoints below). Participants record all foods consumed including amounts and recipes.
Timepoint [1] 308390 0
Baseline, 3mo , 6mo, 9mo, and 12mo. Longer term follow up assessments at 15,18,21,24 months
Secondary outcome [2] 308408 0
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) will be measured using the Omron BP-203RPEIII VP-1000 device (Omron Health Care, Kyoto, Japan). Measurements to be collected at the end of 5 min resting period in supine position. Arterial stiffness (baPWV) and arterial occlusion (ABI) data also collected from device.
Timepoint [2] 308408 0
Baseline, 3 mo, 12mo. Longer term follow up assessments at 15,18,21,24 months
Secondary outcome [3] 308422 0
Physical activity will be assesed using the International Physical Activity Questionnaire (IPAQ) short form survey questions, along with a set of questions regarding the participants’ perceptions on how much physical activity is necessary for a healthy lifestyle. A scientific grade pedometer will be used that is accurate and reliable for counting steps and can be used to explain physical activity levels and sedentary time (cut-points)
In a subsample participants will be assigned an accelerometer and trained in its use (placement on wrist, record keeping). They will be asked to wear the accelerometer on two week days and one weekend (to coincide with the 4 day food record). Total number of counts will be recorded for each day.
Timepoint [3] 308422 0
Baseline, 3 mo, 12mo. Longer term follow up assessments at 15,18,21,24 months
Secondary outcome [4] 308423 0
A composite psychological assessment will be conducted at 0,3,12 months using items from validated questionnaires to test for psychological flexibility, diet flexibility, and exercise motivation. This assessment will include include items relating to Physical and mental health Sf-12 (12 questions) , Acceptance and action (11 questions),AAQ-W (22 questions), Positive Emotional Well-being (3 questions), Depression anxiety stress short form (DASS – 21; 21 questions), Emotional eating (3 questions), Rigid control of diet (R16; 16 questions), and Motivation for exercise (24 questions)
Timepoint [4] 308423 0
Baseline, 3 mo, 12mo. Longer term follow up 24 months
Secondary outcome [5] 308424 0
Fasting blood lipids (cholesterol, LDL, HDL, Trig),
Blood samples collected at a registered Pathology service (Southern Pathology)


Timepoint [5] 308424 0
Baseline, 3, 6, 9, 12mo. Longer term follow up 24 months
Secondary outcome [6] 308425 0
Urinary sodium
Participants will be asked to collect a 24 hour urine sample (at 0, 3 and 12 months) prior to their pathology visit and deliver the sample to nursing staff at Southern Pathology. A container and instruction sheet will be provided to participants at the same time as they are provided with the pathology forms. A protocol of contact will be undertaken to remind participants to complete the 24 hour urine collection. This urine sample will test urinary sodium, potassium and creatinine excretion as the gold standard for sodium intake.
Timepoint [6] 308425 0
0,3,12 months
Secondary outcome [7] 308519 0
Fasting blood glucose
Blood samples collected at a registered Pathology service (Southern Pathology)
Timepoint [7] 308519 0
Baseline, 3, 6, 9 12mo. Longer term follow up 24 months
Secondary outcome [8] 308520 0
Serum HBA1c
Timepoint [8] 308520 0
Baseline, 3, 6, 9 12mo. Longer term follow up 24 months

Eligibility
Key inclusion criteria
men and women from the Illawarra community (adults aged 25-54 years, permanent resident, community dwelling), at higher risk of lifestyle related disease (defined by BMI range 25-40kg/m2
Minimum age
25 Years
Maximum age
54 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to communicate in English; severe medical conditions impairing ability to participate in study; other medical conditions thought to limit survival to 1 year; immunodeficiency; reported illegal drug use or regular alcohol intake associated with alcoholism (>50g/day); difficulties or major impediments to participating in the components of the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Recruitment is via advertising to the general media and completion of a screening questionnaire
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A researcher independent of the participant interface will undertake the randomisation of subjects into diet groups (stratified by sex and BMI, block randomised STATA (V12 Cary NC)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Several power calculations were conducted using SAS PROC POWER using a range standard deviations from 3.5 to 5. One hundred subjects per group were considered sufficient to detect a minimum between group weight loss difference of 2.7kg as significant with 90% power and a two tailed a of 0.025 and 0.017 (adjusted for planned contrast between control and each treatment group and a between treatments comparison). This assumes up to ~25% post randomization dropout rate and a within group weight loss standard deviation of 3.5-5kg (using available literature and our own experience)
The analysis will be conducted using a linear mixed model. The use of the mixed model allows partial datasets incorporating all available data regardless of whether or not the subject completes the study. The planned contrasts are between the control and the intervention groups.

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
Anticipated
Actual
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 8137 0
2522 - University Of Wollongong

Funding & Sponsors
Funding source category [1] 289279 0
Other Collaborative groups
Name [1] 289279 0
Illawarra Health and Medical Research Institute
Address [1] 289279 0
University of Wollongong
Wollongong NSW 2522
Country [1] 289279 0
Australia
Funding source category [2] 289280 0
Other Collaborative groups
Name [2] 289280 0
California Walnut Commission
Address [2] 289280 0
101 Parkshore Drive, Suite 250
Folsom CA 95630-4726
USA
Country [2] 289280 0
United States of America
Primary sponsor type
Other Collaborative groups
Name
Illawarra Health and Medical Research Institute
Address
University of Wollongong
Wollongong NSW 2522
Country
Australia
Secondary sponsor category [1] 287954 0
University
Name [1] 287954 0
University of Wollongong
Address [1] 287954 0
Wollongong NSW 2522
Country [1] 287954 0
Australia
Secondary sponsor category [2] 287955 0
Hospital
Name [2] 287955 0
Illawarra Shoalhaven Local Health District
Address [2] 287955 0
Wollongong Hospital
Locked Bag 8808
South Coast Mail Centre
NSW 2521
Country [2] 287955 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291048 0
Human Research Ethics Committee
Ethics committee address [1] 291048 0
University of Wollongong
Wollongong NSW 2522
Ethics committee country [1] 291048 0
Australia
Date submitted for ethics approval [1] 291048 0
22/04/2013
Approval date [1] 291048 0
21/06/2013
Ethics approval number [1] 291048 0
HE13/189

Summary
Brief summary
This is a 12 month single blinded parallel randomised controlled trial with 3 arms: control (usual care), intervention (multidisciplinary lifestyle support). A 3rd arm comprises intervention + a food supplement . Participants will be randomised into a control or one of the intervention groups testing the effect of a novel versus conventional form of individualised health care targeting diet, exercise and health behaviour. An additional 12 month long term follow-up will be offered to all participants. Consenting participants will attend quarterly visits with a dietitian
Trial website
http://www.ihmri.uow.edu.au/healthtrackstudy
Trial related presentations / publications
Public notes
The research is focused on healthy lifestyle which also includes physical activity

Contacts
Principal investigator
Name 48658 0
Prof Linda Tapsell
Address 48658 0
Smart Foods Centre
University of Wollongong
Wollongong NSW 2522
Country 48658 0
Australia
Phone 48658 0
+61 2 4221 3152
Fax 48658 0
+61 2 4221 4844
Email 48658 0
ltapsell@uow.edu.au
Contact person for public queries
Name 48659 0
Ms Rebecca Thorne
Address 48659 0
Smart Foods Centre
University of Wollongong
Wollongong NSW 2522
Country 48659 0
Australia
Phone 48659 0
+61 2 4221 5992
Fax 48659 0
+61 2 4221 4844
Email 48659 0
beck@uow.edu.au
Contact person for scientific queries
Name 48660 0
Prof Linda Tapsell
Address 48660 0
Smart Foods Centre
University of Wollongong
Wollongong NSW 2522
Country 48660 0
Australia
Phone 48660 0
+61 2 4221 3152
Fax 48660 0
+61 2 4221 4844
Email 48660 0
ltapsell@uow.edu.au