ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12617001630303

Ethics application status

Approved

Date submitted

21/11/2017

Date registered

14/12/2017

Date last updated

30/11/2023

Date data sharing statement initially provided

4/03/2019

Date results information initially provided

6/09/2022

Type of registration

Prospectively registered

Titles & IDs

Public title

Fast Track to Health. The effect of intermittent energy restriction on weight loss and well-being among young people above a healthy weight. (Formerly known as Fast Track to Health. The effect of a modified alternate day fasting dietary pattern on weight loss and well-being among young people above a healthy weight).

Scientific title

Fast Track to Health. The effect of intermittent energy restriction on weight loss and well-being in adolescents with obesity: a randomised controlled trial (Formerly known as Fast Track to Health. The alternate day fasting diet on weight loss and well-being in adolescents with obesity: a randomised controlled trial).

Secondary ID [1]

APP1128317

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Obesity

Type 2 diabetes

Cardiovascular disease

Condition category

Condition code

Diet and Nutrition

Obesity

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The Fast Track to Health study is a multi-centre randomised controlled trial weight-loss intervention. The aim of this study is to determine if an intermittent energy restricted dietary pattern results in significant weight loss and a lower body mass index (BMI) z-score after 52 weeks (12 months) of intervention in adolescents with obesity compared to a standard care, reduced calorie dietary pattern. Trained dietitians will be primary contacts for participants. Participants will see the dietitian approximately 10-13 times during the study period. Aside from dietitians, participants will have contact with health professionals including paediatricians and practice nurses during the study. Participants may also be assessed by a clinical psychologist. Most appointments will be 30-45 minutes, however 4 appointments at baseline and weeks 4, 16 and 52 will be longer taking about 3-3.5 hours to allow for collection of outcome measures. Study sites are: The Children's Hospital at Westmead (Sydney), or at the Be Active Sleep Eat (BASE) facility at Monash University (Melbourne) or Monash Children's Hospital (Melbourne).

There are three phases to this study:
Phase 1 (Week 0-4)
All participants will complete a Very Low Energy Diet (VLED) using meal replacements for up to 4 weeks. The diet prescribed during Phase 1 will provide approximately 800kcal/day, consisting of less than 40% of energy from carbohydrate (about 50g/day), 40-55% of energy as protein and less than 20% of energy as fat. Meal replacements will be provided by the study team during phase 1. Blood ketones will be measured weekly via a finger prick meter during phase 1 to evaluate adherence to the VLED protocol. Early transition to the prescribed diet can occur based on dietetic clinical judgement. Participants will see the dietitian weekly during phase 1.

Phase 2: (Week 4-16)
Participants will be randomised to receive one of the two dietary patterns: Intermittent Energy Restriction (IER) or a reduced calorie dietary pattern. The dietitian will provide detailed meal plans and information for both patterns. Participants will choose and pay for their own food for the remainder of the intervention. Participants will have an option to transition off the VLED replacements during weeks 4-6 in which meal replacements will be provided free of charge.

Dietitian visits will be scheduled at weeks 6, 9 and 12. A 'coaching' model will be used during consultations, providing a theoretical basis for psychological variables important in achieving dietary compliance, lifestyle change and weight loss. Additional support via text message, phone or email (depending on participant preference) will also be provided at weeks 8, 11 and 14. Duration of support contacts will be approximately 10-15 minutes.

All participants will be given a commercial multivitamin (containing essential fatty acids) to improve micronutrient intake. Participants will be given a sealed bottle of Cenovis Once Daily 50+ Multivitamin and will be instructed to take 1 capsule daily from week 5 to 52 of the study. Each capsule contains fish oil, b-carotene, vitamins A, B1, B2, B3, B5, B6, B7, B9, B12, C, D, E and K, boric acid, calcium carbonate, cupric sulfate, chromium picolinate, magnesium oxide, ferrous fumarate, manganese sulfate monohydrate, selenomethionine, zinc oxide and potassium iodide, and citrus bioflavonoids and linseed oil. Dietitians will calculate the visit that participants should require a new bottle and record when they need a new bottle as a measure of compliance.

Intermittent Energy Restriction (IER)
This involves a very low energy diet for 3 non-consecutive days per week (approximately 600-700 calories/day) and a standard healthy diet for 4 days per week. No energy restriction will be used on feeding days, but participants will be given healthy eating guidelines based on the Australian Dietary Guidelines. Discretionary foods will be limited to one standard serve per week. Participants will also have one 'meal off' per week included in their meal plan to accommodate occasional eating out or social gatherings.

Standard hypocaloric diet
This involves a higher fibre (>30g per day), moderate carbohydrate (40-50%) and moderate protein (20-25%) dietary pattern. The diet will have prescriptive energy levels based on age: 6000-7000kJ (13-14 years), or 7000-8000kJ (15 - 17 years).

Phase 3: (Week 16-52)
Participants in both the experimental arm and active control arm will continue their prescribed intervention during this phase. The dietitian will review intake and weight loss at each visit, modify goals as necessary and encourage adherence to the intervention. Dietitian visits will be scheduled at weeks 20, 26 and 36. Additional support via phone, email or text message (depending on participant preference) will be offered at week 18, 24, 28, 42 and 48. Duration of support contacts will be approximately 10-15 minutes.

All participants will receive standard advice for physical activity, screen and sleep time as per the Australian Physical Activity & Sedentary Behaviour Guidelines for Young People.

24 month follow up
At the final study appointment (week 52), participants and their parent/guardian will be asked if they agree to be contacted by the study team in 12 months (i.e. 24 months post-baseline). This is not an essential component of the study. A consent form will be signed before contact is made. Participants who consent to be contacted 24-months post-baseline will be invited to attend a single follow-up appointment.

Intervention code [1]

Treatment: Other

Intervention code [2]

Lifestyle

Intervention code [3]

Behaviour

Comparator / control treatment

Comparator Treatment: The standard reduced calorie diet - This is the comparator treatment for the Fast Track to Health Trial. Details for this treatment are described above.

Control group

Active

Outcomes

Primary outcome [1]

Change in Body Mass Index (BMI) z-score assessed using a stadiometer and electronic scales

Timepoint [1]

At 52 weeks post commencement of VLED (week 0)

Secondary outcome [1]

Body composition assessed at Monash University and Monash Children's Hospital using Seca 515 scales and the GE iDXA and at The Children's Hospital at Westmead using a Tanita MC780 body composition analyser and the Prodigy, Lunar-GE DXA .

Timepoint [1]

Baseline, and at 4, 16, 52 and 104 weeks post commencement of VLED (week 0)

Secondary outcome [2]

Systolic and diastolic blood pressure assessed using an automated monitor under standardised conditions by trained study personnel blinded to treatment allocation

Timepoint [2]

Baseline and at 4, 16, 52 and 104 weeks after commencement of VLED (week 0)

Secondary outcome [3]

Biochemistry; high sensitivity CRP, lipid profile, glucose, insulin and liver function assessed via collection of a fasting blood sample by trained study personnel using standard operating procedures. Personnel will be blinded to treatment allocation

Timepoint [3]

Baseline and at 16, 52 and 104 weeks after commencement of VLED (week 0)

Secondary outcome [4]

(Monash Only): Inflammatory markers (adipokines, cytokines, hepatocyte growth factor, nerve growth factor and resistin) assessed using a fasting blood sample collected within the Monash cohort. Samples will be collected by trained personnel using standard operating procedures

Timepoint [4]

Baseline and at 16 and 52 weeks after commencement of VLED (week 0)

Secondary outcome [5]

Body dissatisfaction: using the Body Appreciation Scale

Timepoint [5]

Baseline and at 4, 16, 52 and 104 weeks after commencement of VLED (week 0)

Secondary outcome [6]

Diet quality, food choices and food patterns assessed using the Australian Child and Adolescent Eating Survey (ACAES)

Timepoint [6]

Baseline and at 4, 16, 52 and 104 weeks after commencement of VLED (week 0)

Secondary outcome [7]

Diet acceptability: using a participant acceptability questionnaire and dietary intervention questionnaire (parents). The parents acceptability questionnaire is adapted from a questionnaire used in the RESIST study (HREC/07/CHW/12). The participant questionnaire is adapted from one previously used in the SHAKE IT pilot study (HREC/12/SCHN/297).

Timepoint [7]

At 4, 16 and 52 weeks after commencement of VLED (week 0)

Secondary outcome [8]

Adherence to dietary interventions and diet quality: using the Automated Self-Administered 24 hour dietary assessment tool (ASA24-Australia)

Timepoint [8]

Baseline, week 12 and 36

Secondary outcome [9]

(Monash Only): Resting Energy Expenditure measured by indirect calorimetry to assess the compensatory mechanisms associated with weight loss and REE.

Timepoint [9]

Baseline and at 4, 16 and 52 weeks after commencement of VLED (week 0),

Secondary outcome [10]

Bulimic eating episodes: using the Eating Disorder Examination Questionnaire (EDE-Q) and Binge Eating Scale

Timepoint [10]

Baseline and at 4, 16, 52 and 104 weeks after commencement of VLED (week 0)

Secondary outcome [11]

Psychological and emotional well-being and depression using the Centre for Epidemiologic Studies Depression Scale Revised (CESDR-10) and Depression Anxiety Stress Scale (DASS).

Timepoint [11]

Baseline and at 4, 16, 52 and 104 weeks after commencement of VLED (week 0)

Secondary outcome [12]

Weight related quality of life: using the Impact of Weight on Quality of Life - Lite questionnaire

Timepoint [12]

Baseline and at 4, 16, 52 and 104 weeks after commencement of VLED (week 0)

Secondary outcome [13]

External eating habits: using the Dutch Eating Behaviour Questionnaire (DEBQ)

Timepoint [13]

Baseline and at 4, 16, 52 and 104 weeks after commencement of VLED (week 0)

Secondary outcome [14]

Sedentary behaviours and physical activity using the Godin Leisure-time questionnaire

Timepoint [14]

Baseline and at 4, 16, 52 and 104 weeks after commencement of VLED (week 0)

Secondary outcome [15]

Sleep Quality using the Pittsburgh Sleep Quality Index

Timepoint [15]

Baseline and at 4, 16, 52 and 104 weeks after commencement of VLED (week 0)

Secondary outcome [16]

Self esteem using the Rosenberg Self-Esteem Scale

Timepoint [16]

Baseline and at 4, 16, 52 and 104 weeks after commencement of VLED (week 0)

Secondary outcome [17]

Weight bias using the Weight Bias Internalisation Scale

Timepoint [17]

Baseline and at 4, 16, 52 and 104 weeks after commencement of VLED (week 0)

Secondary outcome [18]

Stress and anxiety using the Depression Stress Anxiety Scale (DASS).

Timepoint [18]

Baseline and at 4, 16, 52 and 104 weeks after commencement of VLED (week 0)

Eligibility

Key inclusion criteria

• Adolescents aged 13–17 years (inclusive)
• Obesity (defined as equivalent to adult BMI 30–45 kg/m2) and at least one of the following metabolic complications:
o Pre diabetes: impaired fasting glucose 5.6-6.9mmol/L and/or impaired glucose tolerance 2 hour post load 7.8-11.1mmol/L
o Insulin resistance: fasting insulin (pmol/L)/glucose(mmol/L) ratio greater than 20
o Presence of acanthosis nigricans
o Hypertension: systolic and/or diastolic blood pressure above the 90th percentile for sex, age and height
o Low HDL-C less than 1.03mmol/L
o High triglycerides greater than or equal to 1.7mmol/L
o Abnormal Alanine Transaminase (ALT) or Gamma-Glutamyltransferase (GGT) based on standard PowerChart cut-points (i.e. ALT or GGT greater than 45 U/L)
o Previous diagnosis of polycystic ovary syndrome (PCOS)

Minimum age

13 Years

Maximum age

17 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Secondary obesity
Significant intellectual disability as documented by the referring doctor
Significant medical or psychiatric illness
Currently undergoing treatment for a clinical eating disorder
Pregnancy, or planning to become pregnant within the next 18 months
Taking medications that have an effect on weight in the short term (excluding metformin)
Adolescent of parent with poor level of spoken English
Current enrollment in a weight loss program
BMI in excess of 45kg/m2
Previous diagnosis of type 2 diabetes mellitus

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)

Allocation is concealed and participants will be randomly allocated to one of the two intervention groups, using a computer-generated randomisation schedule (1:1) from the NHMRC Clinical Trials Centre (University of Sydney).

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Random allocation will occur via a process of minimisation with allocations concealed and stratified by intervention site, age (13-14 years; 15-17 years), sex and body mass index (BMI) (equivalent to 30-34.9kg/m2; 35-45kg/m2). Forced allocation will be used for participants who have a family member enrolled in the study to keep family members in the same study arm. The Interactive Voice Response System (IVRS) at the NHMRC Clinical Trials Centre is able to force allocation of new participants based on a previously randomised participant (based on ID number). These new participants will be included in the stratification tables used to randomise subsequent participants.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

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

The Therapeutic Goods Administration (TGA) defines successful weight loss as at least 5% decrease in initial body weight in adults. This is equivalent to approximately 0.12 decrease in BMI z-score in adolescents. This intervention will be considered successful if there is a 5% difference between groups at 52 weeks as defined by the TGA.

Assuming a BMI z-score difference at 52 weeks of 0.12 and a SD of 0.24; 80% power and a two sided significance level of 0.05, a sample size of 65 adolescents per group, 130 in total is required. Assuming 30% attrition rate (consistent with rates from previous studies conducted by the research team), 186 adolescents will be recruited in total; 124 at The Children's Hospital at Westmead and 62 at the BASE facility at Monash University and Monash Children's Hospital. We expect the recruitment period to last approximately 18 months.

Data analyses will be carried out according to a pre-established plan, with the primary analysis based on intention to treat and with statistical support from the Biostatistician in the Office of Research at The Children's Hospital at Westmead. Mixed models will also be used to investigate changes over time. A time by group interaction will be included to investigate whether rates of change of weight loss were significantly different between the two study groups.

Post hoc analysis will compare protocol adherers to non-adherers.

Recruitment

Recruitment status

Active, not recruiting

Date of first participant enrolment

Anticipated

12/02/2018

Actual

26/02/2018

Date of last participant enrolment

Anticipated

31/03/2022

Actual

28/04/2022

Date of last data collection

Anticipated

31/03/2024

Actual

Sample size

Target

186

Accrual to date

Final

143

Recruitment in Australia

Recruitment state(s)

NSW,VIC

Recruitment hospital [1]

The Children's Hospital at Westmead - Westmead

Recruitment hospital [2]

Monash Medical Centre - Clayton campus - Clayton

Recruitment postcode(s) [1]

2145 - Westmead

Recruitment postcode(s) [2]

3168 - Clayton

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

Level 1 16 Marcus Clarke Street, Canberra ACT 2601

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Sydney Medical School Medical Foundation

Address [2]

The University of Sydney, Edward Ford Building A27
Sydney, New South Wales, 2006

Country [2]

Australia

Primary sponsor type

University

Name

The University of Sydney

Address

Jane Foss Russell Building, Level 6, 160 City Road
Darlington, NSW 2006

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sydney Children's Hospital Network Human Research Ethics Committee

Ethics committee address [1]

Corner of Hawkesbury Road and Hainsworth Street
Locked Bag 4001
Westmead NSW 2145

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/05/2017

Approval date [1]

22/08/2017

Ethics approval number [1]

HREC/17/SCHN/164

Summary

Brief summary

One in four Australian adolescents is overweight or obese. While short-term weight loss is possible, keeping the weight off long term is difficult. Intermittent Energy Restriction (IER) has shown success in adults. IER includes 3 days per week of energy restriction and 4 days of an unrestricted, healthy diet. This may be more sustainable and lead to greater weight loss than daily energy restriction. The Fast Track study tests whether IER is more effective at producing weight loss compared to a standard reduced calorie diet. We will also evaluate the safety and effectiveness of IER to adolescents. The study will involve 13 - 17 year old adolescents with obesity. They will be randomly allocated to either an IER or reduced calorie diet and followed for 52 weeks with regular dietitian reviews. Outcome measures will include weight, height, body composition, heart and diabetes risk factors from blood samples and psychological well-being and dietary intake information. The primary aim of the study is to find out if intermittent energy restriction results in significant weight loss (via BMI z-score) after 52 weeks compared to a standard care reduced calorie intervention.

Trial website

www.fasttracktrial.org

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Louise Baur

Address

The Children's Hospital at Westmead
Corner of Hawkesbury Road and Hainsworth Street,
Locked Bag 4001
Westmead NSW 2145

Country

Australia

Phone

+61 2 9845 1903

Fax

+61 2 9845 3389

[email protected]

Contact person for public queries

Name

Ms Eve House

Address

The Children's Hospital at Westmead
Corner of Hawkesbury Road and Hainsworth Street,
Locked Bag 4001
Westmead NSW 2145

Country

Australia

Phone

+61 438 458 405

Fax

[email protected]

Contact person for scientific queries

Name

Prof Louise Baur

Address

The Children's Hospital at Westmead
Corner of Hawkesbury Road and Hainsworth Street,
Locked Bag 4001
Westmead NSW 2145

Country

Australia

Phone

+61 2 9845 1903

Fax

+61 2 9845 3389

[email protected]

Data sharing statement

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

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
4893	Study protocol	Lister, N.B., Jebeile, H., Truby, H., Garnett, S.P., Varady, K.A., Cowell, C.T., Collins, C.E., Paxton, S.J., Gow, M.L., Brown, J., Alexander, S., Chisholm, K., Grunseit, A.M., Aldwell, K., Day, K., Inkster, M., Lang, S., Baur, L.A. 2020. Fast track to health — Intermittent energy restriction in adolescents with obesity. A randomised controlled trial study protocol. Obesity Research & Clinical Practice, 14 (1), 80-90, ISSN 1871-403X, https://doi.org/10.1016/j.orcp.2019.11.005.	https://doi.org/10.1016/j.orcp.2019.11.005	[email protected]

Results publications and other study-related documents

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Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Fast track to health - Intermittent energy restriction in adolescents with obesity. A randomised controlled trial study protocol.	2020	https://dx.doi.org/10.1016/j.orcp.2019.11.005

N.B. These documents automatically identified may not have been verified by the study sponsor.

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