Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000422224
Ethics application status
Approved
Date submitted
14/02/2018
Date registered
23/03/2018
Date last updated
25/02/2019
Date data sharing statement initially provided
25/02/2019
Date results information initially provided
25/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of an 8-week free pre-prepared meals and prescribed exercise on weight loss in obese and overweight individuals: The Healthy Eating And Living Study (HEALS) randomized controlled trial
Scientific title
Effect of an 8-week free pre-prepared meals and prescribed exercise on weight loss in obese and overweight individuals: The Healthy Eating And Living Study (HEALS) randomized controlled trial
Secondary ID [1] 293582 0
None
Universal Trial Number (UTN)
U1111-1206-4798
Trial acronym
HEALS
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Obesity 305825 0
Physical inactivity 305826 0
Condition category
Condition code
Diet and Nutrition 305043 305043 0 0
Obesity
Physical Medicine / Rehabilitation 305724 305724 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this study participants will be randomized to either a meals and exercise condition or nutritional information and exercise condition. The intervention will run for 8 weeks with assessments of body composition (DEXA), cardio-respiratory fitness (VO2max), hematological functioning (total cholesterol, HDL-C, LDL-C, Triglycerides, C-reactive protein and Adiponectin), blood pressure and psychosocial health (DASS21 & SF12) pre- and post-intervention. The intervention group will be provided with prepared meals for the duration of the intervention whereas the control group will be provided with standard information on healthy eating (according to NHMRC guidelines). Both will be provided with an exercise program by personal trainers consisting of resistance and aerobic exercise. This will include 3 gym sessions per week which include exercises at 75% of max HR and weight training between 60 and 85 of 1 RM (exercises include but are not limited to squats, bench press, leg curls, shoulder pull; the aim is to train all muscle groups within the body).. The sessions will be approximately 45 minutes in duration and include a short warm-up and warm-down with stretching exercises. The participants will also be advised to engage in walking on 2 additional days for 30 minutes on each day. In the first 2 weeks gym exercises are with a personal trainer whereas in the remaining 6 weeks there is 1 session with the personal trainer. All participants will receive a manual with exercises for the 8 weeks (weekly program). There are 3 gym sessions whereas the other activities can be done from home/work place.
In terms of the meals, participants in the experimental arm will be provided with 3 meals per day as well as snacks. The food provided to the experimental group varies according to the exercise program it accompanies. For example, it will include post-exercise snacks on days when there is structured exercise but not on other days. On average the participants will receive about 2000 calories per day of a high fat low carb diet (fat up to 65%, protein 30% and carbs 5%). Examples include: Roast chicken breast with carrots and greens, beef cheeks with broccoli and cauliflower rice;; Snacks include protein bars, almond and chia.; breakfast Granola. The participants will be required to keep a log book as well as send a weekly audio or video blog to the research team. The blog is based on predetermined questions.. The following questions will be asked: 1. How did you get on with this week’s exercise program? What have you found easy? What were your challenges? How did you get on with this week’s nutritional program? What have you found easy? What were your challenges? How are you going to meet these challenges next week? Please comment on any physical or psychological changes that you’ve observed within yourself and record anything else you want to share with the HEALS Team. On a scale from 1 to 10, how confident are you in your ability to achieve your goal for next week?
Intervention code [1] 299836 0
Treatment: Other
Comparator / control treatment
The difference between the control and experimental group is only in nutritional provision. The control group will only be provided with guidance on a healthy diet (written information).
The control arm will be provided with dietary guidelines as developed by the Australian Government (www.eatforhealth.gov.au).
Control group
Active

Outcomes
Primary outcome [1] 304204 0
Body fat. This will assessed using DEXA at the pre- and post-test (following the 8 week intervention)
Timepoint [1] 304204 0
1 week post completion of the 8 week intervention
Primary outcome [2] 305010 0
Body weight (using DEXA and Scale).
Timepoint [2] 305010 0
1 week post completion of the 8 week intervention
Secondary outcome [1] 341245 0
Aerobic fitness as measured by VO2max
Participants will be required to complete a graded exercise (cycling) test during the pre- and post-testing session to determine maximal levels of oxygen consumption.
Timepoint [1] 341245 0
1 week post completion of the 8 week intervention
Secondary outcome [2] 341246 0
Hematological health in terms of total cholesterol, HDL-C, LDL-C, from a fasting blood sample using serum assays.
Timepoint [2] 341246 0
1 week post completion of the 8 week intervention
Secondary outcome [3] 341253 0
Psychosocial health in terms of Depression, Anxiety and Stress (DASS-21)
Timepoint [3] 341253 0
1 week post completion of the 8 week intervention
Secondary outcome [4] 341254 0
Program satisfaction (Overall, delivery, and support provided). Measured on a 5-point Likert scale (1-5) with higher scores representing greater satisfaction.
Timepoint [4] 341254 0
1 week post completion of the 8 week intervention
Secondary outcome [5] 341255 0
Blood pressure (systolic and diastolic). using a manually operated sphygmonanometer (operated by trained researcher).
Timepoint [5] 341255 0
1 week post completion of the 8 week intervention
Secondary outcome [6] 343862 0
Blood health in terms of Triglycerides from a fasting blood sample using a serum assay
Timepoint [6] 343862 0
1 week post completion of the 8 week intervention
Secondary outcome [7] 343863 0
C-reactive protein from a fasting blood sample
Timepoint [7] 343863 0
1 week post completion of the 8 week intervention
Secondary outcome [8] 343864 0
Adiponectin from a fasting blood sample using plasma serum.
Timepoint [8] 343864 0
1 week post completion of the 8 week intervention
Secondary outcome [9] 343865 0
Psychological health in terms of Quality of Life using the SF12.
Timepoint [9] 343865 0
1 week post completion of the 8 week intervention

Eligibility
Key inclusion criteria
- Body mass index (BMI) in the range of 27-35 Kg m-2.
- Aged between 18 and 50 years at enrolment.
- No history of diabetes or eating disorders.
- Not planning or currently pregnant or breastfeeding.
- Not diagnosed with any food allergy.
- No history of bariatric surgery.
- Willing to allow blood collection (No medical issues arising from blood collection or severe phobia of needles).
- Capable of performing a cardiopulmonary fitness test.
- Willingness to participate in a 10 week study.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Inability to participate in exercise because of comorbidity or disability (e.g., severe arthritic condition).
- A history or presence of a comorbid disease for which diet modifications and increased exercise participation may be contraindicated.
- Regular cigarette smoker, has quit smoking in the last 6 months, or are regularly exposed to environmental tobacco smoke.
- History of and severe hypertension (systolic 160-179 mmHg systolic; diastolic 100-109 mmHg).
- If participants have had any recent significant injury that will impede their ability to perform exercise during the study or any other contraindications that will impede their ability/safety during exercise.
- Will not have participated in a diet and/or exercise study in the last 6 months.
- History of significant psychiatric disorder or other condition that, in the judgement of the investigators would interfere with participation.
- If they presented with a diagnosis of any uncontrollable metabolic or cardiovascular disorder (including heart disease), arrhythmias, thyroid disease or hypogonadism, hepatorenal, autoimmune or neurological disease, currently taking dietary supplements for thyroid, hyperlipidemia, hypoglycaemia, or weight loss supplements (e.g., ephedra, thermogenic compounds) within 3 months before the start of the study.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation based on gender, age., and whether partner enrolls.
Participants will be randomly allocated to one of the following conditions: (1) experimental (structured exercise programme + pre-prepared meals) or (2) control (structured exercise programme + standard dietary advice). Block randomization stratification by gender will be undertaken, so that blocks of 12 participants will be recruited at a time, randomized into one experimental condition of six participants and one control condition of six participants. To accommodate couples (e.g. partners/married couples) participation, randomisation by couple will also take place. Assessors will prepare the envelopes with six paper codes (three experimental and three control group) which will be added to opaque not concealed envelopes. There will be three envelopes: one for couples, one for females and one for males. Participants will be asked to pick one paper from their respective envelope and the picked paper will assign the participant to either the experimental or control group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Mixed-linear modeling, correlations, regression analysis (e.g., dose response relationship).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/03/2018
Actual
28/03/2018
Date of last participant enrolment
Anticipated
2/04/2018
Actual
2/07/2018
Date of last data collection
Anticipated
25/06/2018
Actual
17/09/2018
Sample size
Target
70
Accrual to date
Final
64
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 18280 0
4059 - Kelvin Grove

Funding & Sponsors
Funding source category [1] 298198 0
Commercial sector/Industry
Name [1] 298198 0
THR1VE
Country [1] 298198 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
Queensland University of Technology
School of Exercise & Nutrition Sciences
Kelvin Grove Campus
Victoria Park Road,
Kelvin Grove, QLD, 4059
Country
Australia
Secondary sponsor category [1] 297435 0
None
Name [1] 297435 0
Address [1] 297435 0
Country [1] 297435 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299208 0
Bellberry Limited
Ethics committee address [1] 299208 0
129 Glen Osmond Road, Eastwood, South Australia, 5063
Ethics committee country [1] 299208 0
Australia
Date submitted for ethics approval [1] 299208 0
04/01/2018
Approval date [1] 299208 0
09/02/2018
Ethics approval number [1] 299208 0
2017-12-937

Summary
Brief summary
The primary objective of this RCT is to compare the short-term (8-weeks) effects of a protocol developed by a commercial organisation which combines commercially pre-prepared meals and structured exercise programme with a programme which include standard dietary guidelines with a structured exercise programme on body composition changes (body weight and fat mass). The secondary objective is to examine biological factors (fitness and blood profile) and psychosocial well-being and facilitators and barriers to completing the intervention programme and its acceptability.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes
N/A

Contacts
Principal investigator
Name 79658 0
Prof Remco Polman
Address 79658 0
Queensland University of Technology,
School of Exercise and Nutrition Sciences
Kelvin Grove Campus
Victoria park road
Kelvin Grove
QLD 4059
Country 79658 0
Australia
Phone 79658 0
+61 07 31386139
Fax 79658 0
Email 79658 0
remco.polman@qut.edu.au
Contact person for public queries
Name 79659 0
Prof Remco Polman
Address 79659 0
Queensland University of Technology,
School of Exercise and Nutrition Sciences
Kelvin Grove Campus
Victoria park road
Kelvin Grove
QLD 4059
Country 79659 0
Australia
Phone 79659 0
+61 07 31386139
Fax 79659 0
Email 79659 0
remco.polman@qut.edu.au
Contact person for scientific queries
Name 79660 0
Prof Remco Polman
Address 79660 0
Queensland University of Technology,
School of Exercise and Nutrition Sciences
Kelvin Grove Campus
Victoria park road
Kelvin Grove
QLD 4059
Country 79660 0
Australia
Phone 79660 0
+61 07 31386139
Fax 79660 0
Email 79660 0
remco.polman@qut.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
Commercial trial. Data belong to sponsor.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Other filesNo This has been provided to the company.

Documents added automatically
No additional documents have been identified.