Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000749808
Ethics application status
Approved
Date submitted
12/07/2012
Date registered
13/07/2012
Date last updated
4/12/2018
Date data sharing statement initially provided
4/12/2018
Date results information initially provided
4/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Engaging men to maintain weight loss using innovative and cost-effective interventions: The SHED-IT Weight Loss Maintenance pilot study.
Scientific title
Engaging men to maintain weight loss using innovative and cost-effective interventions: The SHED-IT Weight Loss Maintenance pilot randomised controlled trial.
Secondary ID [1] 280604 0
Nil
Universal Trial Number (UTN)
Trial acronym
SHED-IT (Self-help, Exercise and Diet using Information Technology) Weight Loss Maintenance Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight / Obesity 286617 0
Condition category
Condition code
Diet and Nutrition 286889 286889 0 0
Obesity
Public Health 286890 286890 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study contains two distinct phases.


Phase I: A 3-month Weight Loss (WL) phase

All men in the study will receive a WL tool kit which has been developed and extensively tested in our pilot research. The SHED-IT WL Program includes:

1.The ‘SHED-IT WL DVD for Blokes’
2.The ‘SHED-IT WL Handbook for Blokes’
3.The ‘SHED-IT WL Log Book for Blokes'
4. Tools (pedometer, tape measure and kJ counter book).

Men will also be advised to self-monitor their food and exercise diary 4 days each week and record their weight weekly.

Men will receive weekly text messages to reinforce key behaviours for weight loss and to target the hypothesised cognitive and behavioural mediators of behaviour change outlined in Social Cognitive Theory (e.g. self efficacy, social support).


Phase II: A 36-month Weight Loss Maintenance (WLM) phase (6-month WLM Program + additional 30 months of unsupervised follow-up)

The 'baseline' assessment for this RCT will occur at the beginning of Phase II (i.e. 3 months after the commencement of the weight loss program in Phase I).

At this assessment, all men who have lost at least 4 kg during Phase I will be randomised to either a self-help control group (see comparator / control treatment below) or a WLM group. Men who have not lost at least 4 kg will not be eligible for Phase II of this study.

The WLM group will receive the SHED-IT WLM program, which is a six month program that includes:

1. 'The SHED-IT WLM DVD for Blokes'
2. 'The SHED-IT WLM Handbook for Blokes'
3. 'The SHED-IT WLM Logbook for Blokes'
4. A Gymstick (portable, elastic tubing resistance training device).
5. Access to the weekly SHED-IT WLM Online Blog

Men will be advised to engage with the resources at their discretion and to check in with the WLM Blog weekly. A gymstick manual will be provided to men, but the intervention will not involve a specified resistance training program. However men will be advised to aim for at least 300 minutes per week of moderate physical activity.

Men will also be encouraged to continue self-monitoring their food and exercise 2 days per week and to record their weight each week.

Men will receive fortnightly text messages to reinforce key behaviours for weight loss maintenance and to target the hypothesised cognitive and behavioural mediators of behaviour change outlined in Social Cognitive Theory (e.g. self efficacy, social support).
Intervention code [1] 284995 0
Lifestyle
Intervention code [2] 284996 0
Behaviour
Comparator / control treatment
No intervention control group (i.e. no specific weight loss maintenance [WLM] intervention).
Control group
Active

Outcomes
Primary outcome [1] 287244 0
Body weight (kg) measured in light clothing, without shoes on a digital scale to 0.1kg (model CH-150kp, A&D Mercury Pty Ltd, Australia).
Timepoint [1] 287244 0
Phase 1 (Weight Loss) - Entry (0 months) Phase 2 (Weight Loss Maintenance) - Baseline (3 months post weight loss commencement) - 6-months (9 months post weight loss commencement) - 12-months (15 months post weight loss commencement), 36 months (39 months post weight loss commencement)
Secondary outcome [1] 297726 0
Body Mass Index (BMI) - Height will be measured to 0.1 cm using the stretch stature method and a stadiometer (Veeder-Root (VR) High Speed Counter) (Harpenden/Holtain, Mentone Education Centre, Morrabin, Victoria). BMI will be calculated using the standard equation (weight [kg]/height[m]2)
Timepoint [1] 297726 0
Phase 1 (Weight Loss)

- Entry (0 months)

Phase 2 (Weight Loss Maintenance)

- Baseline (3 months post weight loss commencement)

- 6-months (9 months post weight loss commencement)

- 12-months (15 months post weight loss commencement)
Secondary outcome [2] 297727 0
Waist Circumference (cm) - Waist circumference measured at two points (i) level with the umbilicus and (ii) at the narrowest point. Each measurement will be recorded with a non-extensible steel tape (KDSF10-02, KDS Corporation, Osaka, Japan).
Timepoint [2] 297727 0
Phase 1 (Weight Loss)

- Entry (0 months)

Phase 2 (Weight Loss Maintenance)

- Baseline (3 months post weight loss commencement)

- 6-months (9 months post weight loss commencement)

- 12-months (15 months post weight loss commencement)t)
Secondary outcome [3] 297728 0
Systolic and diastolic blood pressure and resting heart rate will be measured using a NISSEI/DS-105E digital electronic blood pressure monitor (Nihon Seimitsu Sokki Co. Ltd., Gunma, Japan) under standardized procedures
Timepoint [3] 297728 0
Phase 1 (Weight Loss)

- Entry (0 months)

Phase 2 (Weight Loss Maintenance)

- Baseline (3 months post weight loss commencement)

- 6-months (9 months post weight loss commencement)

- 12-months (15 months post weight loss commencement)
Secondary outcome [4] 297729 0
Dietary intake - measured using the Australian Adult Eating Survey (AES) Food Frequency Questionnaire
Timepoint [4] 297729 0
Phase 1 (Weight Loss)

- Entry (0 months)

Phase 2 (Weight Loss Maintenance)

- Baseline (3 months post weight loss commencement)

- 6-months (9 months post weight loss commencement)

- 12-months (15 months post weight loss commencement)
Secondary outcome [5] 297730 0
Step counts measured using Yamax SW700 pedometers (Yamax Corporation, Kumamoto City, Japan).
Timepoint [5] 297730 0
Phase 1 (Weight Loss)

- Entry (0 months)

Phase 2 (Weight Loss Maintenance)

- Baseline (3 months post weight loss commencement)

- 6-months (9 months post weight loss commencement)

- 12-months (15 months post weight loss commencement)
Secondary outcome [6] 297747 0
Self-reported physical activity using a modified version of the Godin Leisure-Time Exercise Questionnaire (Godin & Shephard, 1985), which has been validated (Plotnikoff et al., 2006).
Timepoint [6] 297747 0
Phase 1 (Weight Loss)

- Entry (0 months)

Phase 2 (Weight Loss Maintenance)

- Baseline (3 months post weight loss commencement)

- 6-months (9 months post weight loss commencement)

- 12-months (15 months post weight loss commencement)
Secondary outcome [7] 297748 0
Hypothesised Social Cognitive Mediators of Physical Activity will be measured using a number of validated scales.

- Self Efficacy (Plotnikoff, Blanchard, Hotz, & Rhodes, 2001)
- Intention (Courneya, Plotnikoff, Hotz, & Birkett, 2000)
- Goal Setting (Rovniak, Anderson, Winnett, & Stephenson, 2002)
- Planning [Implementation Intentions] (Rhodes, Courneya, Blanchard, & Plotnikoff, 2007)
- Motivation (Ryan & Connell, 1989)
- Outcome Expectations (Plotnikoff, Blanchard, Hotz, & Rhodes, 2001)
- Social Support (Sallis, Grossman, Pinski, Patterson, & Nader, 1987)
- Environment (Sallis, Johnson, Calfas, Caparosa, Nichols, 1997)
Timepoint [7] 297748 0
Phase 1 (Weight Loss)

- Entry (0 months)

Phase 2 (Weight Loss Maintenance)

- Baseline (3 months post weight loss commencement)

- 6-months (9 months post weight loss commencement)

- 12-months (15 months post weight loss commencement)
Secondary outcome [8] 297749 0
Perceived physical and mental health using the Short Form 12 (SF-12) questionnaire.
Timepoint [8] 297749 0
Phase 1 (Weight Loss)

- Entry (0 months)

Phase 2 (Weight Loss Maintenance)

- Baseline (3 months post weight loss commencement)

- 6-months (9 months post weight loss commencement)

- 12-months (15 months post weight loss commencement)
Secondary outcome [9] 297750 0
Sedentary behaviours will be assessed using the validated Sitting Time Questionnaire (Miller and Brown, 2004)
Timepoint [9] 297750 0
Phase 1 (Weight Loss)

- Entry (0 months)

Phase 2 (Weight Loss Maintenance)

- Baseline (3 months post weight loss commencement)

- 6-months (9 months post weight loss commencement)

- 12-months (15 months post weight loss commencement)
Secondary outcome [10] 297751 0
Depressive symptoms will be measured using the validated Patient Health Questionnaire-8 (Kroenke et al., 2009)
Timepoint [10] 297751 0
Phase 1 (Weight Loss)

- Entry (0 months)

Phase 2 (Weight Loss Maintenance)

- Baseline (3 months post weight loss commencement)

- 6-months (9 months post weight loss commencement)

- 12-months (15 months post weight loss commencement)
Secondary outcome [11] 297752 0
Sexual Function measured using the International Index of Erectile Function-5 (IIEF-5; Rhoden et al., 2002)
Timepoint [11] 297752 0
Phase 1 (Weight Loss)

- Entry (0 months)

Phase 2 (Weight Loss Maintenance)

- Baseline (3 months post weight loss commencement)

- 6-months (9 months post weight loss commencement)

- 12-months (15 months post weight loss commencement)
Secondary outcome [12] 297753 0
Demographics and socio-economic status. A questionnaire will obtain demographic information e.g. age, ethnicity, marital status, language spoken at home, income and postcode
Timepoint [12] 297753 0
Entry only (0 months)
Secondary outcome [13] 297754 0
Hypothesised Social Cognitive Mediators of Junk Food Intake will be measured using a number of validated scales

- Confidence (adapted from Plotnikoff, Hotz, Johnson, Hansen, Birkett, Leonard, Flaman, 2009)
- Intention (adapted from Courneya, Plotnikoff, Hotz, & Birkett, 2000)
- Self-regulation [Behaviour change strategies] (adapted from Norman, Carlson, Sallis, Wagner, Calfas and Patrick, 2010)
- Social Support (adapted from Sallis, Grossman, Pinski, Patterson, & Nader, 1987)
- Outcome Expectations (adapted from Anderson-Bill, Winett, Wojcik, & Winett, 2011)
- Environment (adapted from Ball, MacFarlane, Crawford, Savige, Andrianopoulos, & Worsley, 2009)
Timepoint [13] 297754 0
Phase 1 (Weight Loss)

- Entry (0 months)

Phase 2 (Weight Loss Maintenance)

- Baseline (3 months post weight loss commencement)

- 6-months (9 months post weight loss commencement)

- 12-months (15 months post weight loss commencement)
Secondary outcome [14] 297755 0
Alcohol Risk Score measured using the Alcohol Risk Score sub-scale of the Australian Government Department of Veteran
Affairs, Alcohol Use Disorders Identification Test
(AUDIT) 2009 (Saunders et al., 1993).
Timepoint [14] 297755 0
Phase 1 (Weight Loss)

- Entry (0 months)

Phase 2 (Weight Loss Maintenance)

- Baseline (3 months post weight loss commencement)

- 6-months (9 months post weight loss commencement)

- 12-months (15 months post weight loss commencement)
Secondary outcome [15] 297863 0
Cognitive Restraint will be measured with the Cognitive Restraint Subscale from the 3-Factor Eating Questionnaire (Stunkard, 1985) as identified by (Karlsson et al, 2000)
Timepoint [15] 297863 0
Phase 1 (Weight Loss)

- Entry (0 months)

Phase 2 (Weight Loss Maintenance)

- Baseline (3 months post weight loss commencement)

- 6-months (9 months post weight loss commencement)

- 12-months (15 months post weight loss commencement)
Secondary outcome [16] 297864 0
Portion Size measured using portion size photographs
from the Dietary Questionnaire for Epidemiological Studies
Version 2 (DQES v2), FFQ from the Cancer Council
Victoria.
Timepoint [16] 297864 0
Phase 1 (Weight Loss)

- Entry (0 months)

Phase 2 (Weight Loss Maintenance)

- Baseline (3 months post weight loss commencement)

- 6-months (9 months post weight loss commencement)

- 12-months (15 months post weight loss commencement)
Secondary outcome [17] 298013 0
A process evaluation will be performed with a questionnaire to participants examining issues including study feasibility, participant satisfaction and suggestions for improvement.
Timepoint [17] 298013 0
Process Evaluation of Weight Loss Intervention: Measured at baseline assessment (3 months post weight loss commencement)

Process Evaluation of Weight Loss Maintenance Intervention: Measured 6-month assessment (9 months post weight loss commencement)

Eligibility
Key inclusion criteria
Overweight or obese men (BMI between 25 and 40 kg/[m2])
Minimum age
18 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
History of major medical problems such as heart disease in the last 5 years, Insulin-Dependent Diabetes Mellitus (IDDM), or orthopaedic or joint problems that would be a barrier to physical activity. Participants with recent weight loss of 5% of total body mass or more or who are taking medications that might be affected by weight loss or participating in other weight loss programs or without internet access will also be excluded.

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)
Study information for the two different groups (SHED-IT Weight Loss Maintenance and Self-help control) will be pre-packed into identical black plastic opaque envelopes
and consecutively numbered and ordered according to the randomisation schedule.

The packing and sequencing of these envelopes will be completed by a research assistant who will not be involved in enrolment, assessment or allocation of participants.

Study participants will complete all 3-month assessments before proceeding to a separate room to meet with a research assistant who will not be involved with the baseline assessments. The allocation sequence will be concealed during this process.

Participants who have not lost 4 kg or more will not be eligible for entry into Phase II of this study and will not be randomised.

Participants who have lost at least 4 kg will be stratified by weight loss and 3-month weight and their name will be written down in the next available position in their relevant strata before being provided with their information pack.

At this point the envelope will be opened by the research assistant and details of the particular information pack will be provided to the participant using a standardised protocol.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation allocation sequence will be generated by a statistician who will not have any contact with participants during the trial. Allocation will be stratified by weight loss and 3-month weight and the allocation sequence within strata will be generated by a computer based random number producing algorithm. Randomisation codes will be stored in a restricted computer folder, which will not be accessible by those assessing participants, those involved in group allocating participants or those participating in data entry for the study.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/07/2012
Actual
6/08/2012
Date of last participant enrolment
Anticipated
Actual
6/09/2012
Date of last data collection
Anticipated
Actual
10/11/2015
Sample size
Target
195
Accrual to date
Final
209
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 285368 0
Other Collaborative groups
Name [1] 285368 0
Hunter Medical Research Institute (HMRI)
Country [1] 285368 0
Australia
Funding source category [2] 285369 0
University
Name [2] 285369 0
Priority Research Centre in Physical Activity & Nutrition (University of Newcastle)
Country [2] 285369 0
Australia
Primary sponsor type
Individual
Name
Prof. Philip Morgan
Address
School of Education
University of Newcastle
University Drive
Callaghan NSW 2308
AUSTRALIA
Country
Australia
Secondary sponsor category [1] 284223 0
Individual
Name [1] 284223 0
Prof. Robin Callister
Address [1] 284223 0
School of Biomedical Sciences and Pharmacy
University of Newcastle
University Drive
Callaghan NSW 2308
AUSTRALIA
Country [1] 284223 0
Australia
Other collaborator category [1] 276836 0
Individual
Name [1] 276836 0
Prof. Clare Collins
Address [1] 276836 0
School of Health Sciences
University of Newcastle
University Drive
Callaghan NSW 2308
AUSTRALIA
Country [1] 276836 0
Australia
Other collaborator category [2] 276837 0
Individual
Name [2] 276837 0
Prof. Ron Plotnikoff
Address [2] 276837 0
School of Education
University of Newcastle
University Drive
Callaghan NSW 2308
AUSTRALIA
Country [2] 276837 0
Australia
Other collaborator category [3] 276838 0
Individual
Name [3] 276838 0
Prof. Chris Doran
Address [3] 276838 0
School of Medicine and Public Health
University of Newcastle
University Drive
Callaghan NSW 2308
AUSTRALIA
Country [3] 276838 0
Australia
Other collaborator category [4] 276839 0
Individual
Name [4] 276839 0
Mr. Myles Young
Address [4] 276839 0
School of Education
University of Newcastle
University Drive
Callaghan NSW 2308
AUSTRALIA
Country [4] 276839 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287384 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 287384 0
Research Services
Research Office
The University of Newcastle
University Drive
Callaghan NSW 2308
Ethics committee country [1] 287384 0
Australia
Date submitted for ethics approval [1] 287384 0
Approval date [1] 287384 0
11/07/2012
Ethics approval number [1] 287384 0
H-2011-0361

Summary
Brief summary
Obesity in men is one of the greatest public health challenges facing Australia. Obesity is an independent risk factor for cardiovascular disease (CVD) and a major cause of preventable death and disability. With 70% of Australian men overweight or obese, the current and predicted financial and human costs are alarming. Despite men being more susceptible than women to many of the serious consequences of obesity such as CVD, men rarely engage in weight loss (WL) programs, and when they do lose weight they rarely maintain the WL. There is an urgent need to develop and evaluate novel and cost effective approaches that achieve long-term WL in men. The aim of this pilot study is to develop and evaluate the feasibility and efficacy of a WL maintenance (WLM) program specifically for men.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34253 0
Prof Philip Morgan
Address 34253 0
Priority Research Centre in Physical Activity and Nutrition
University Drive
University of Newcastle
Callaghan, NSW, 2308
Country 34253 0
Australia
Phone 34253 0
+61249217265
Fax 34253 0
Email 34253 0
[email protected]
Contact person for public queries
Name 17500 0
Prof Philip Morgan
Address 17500 0
Priority Research Centre in Physical Activity and Nutrition, University of Newcastle, University Drive, Callaghan, NSW, 2308
Country 17500 0
Australia
Phone 17500 0
+61 2 49 217265
Fax 17500 0
+61 2 49 212084
Email 17500 0
[email protected]
Contact person for scientific queries
Name 8428 0
Prof Philip Morgan
Address 8428 0
Priority Research Centre in Physical Activity and Nutrition, University of Newcastle, University Drive, Callaghan, NSW, 2308
Country 8428 0
Australia
Phone 8428 0
+61 2 49 217265
Fax 8428 0
+61 2 49 212084
Email 8428 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
Please contact [email protected] for data sharing requests.


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
Study results articleYes Young, M.D., Callister, R., Collins, C.E., Plotnik... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEfficacy of a gender-tailored intervention to prevent weight regain in men over 3 years: A weight loss maintenance RCT.2017https://dx.doi.org/10.1002/oby.21696
N.B. These documents automatically identified may not have been verified by the study sponsor.