Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000699066
Ethics application status
Approved
Date submitted
19/08/2010
Date registered
24/08/2010
Date last updated
15/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
The Self-Help, Exercise, Diet & Information Technology (SHED-IT) community trial of weight-loss programs for Australian men.
Scientific title
The Self-Help, Exercise, Diet & Information Technology (SHED-IT) Community Randomised Controlled Trial for overweight and obese men
Secondary ID [1] 251895 0
No secondary ID
Universal Trial Number (UTN)
U1111-1115-2114
Trial acronym
SHED-IT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight/obesity 257487 0
Condition category
Condition code
Diet and Nutrition 257638 257638 0 0
Obesity
Public Health 257639 257639 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The duration of the intervention is 3 months. Participants will be randomised to one of three groups (i) SHED-IT Resources only (ii) SHED-IT Online and Resources or (iii) waitlist control group. All participants in the resources group will be sent a DVD with a presentation on weight loss for men; two program booklets - The Weight Loss Handbook for Blokes and The Weight Loss Support Book for Blokes; a calorie counter book; a pedometer and tape measure with instructions for use. The DVD will cover weight control instruction relating to diet, physical activity and behaviour change strategies aligned with Bandura's Social Learning Theory (aka Social Cognitive Theory).
Participants in the online group will receive resources as above plus additional behavioural support over the course of the 3 months via use of the online website www.calorieking.com.au. This website reinforces the key strategies of self monitoring, goal setting and social support. The website allows submission of self-monitored energy expenditure and intake, weight and online group support. Participants will be instructed to submit at least 4 daily diaries per week for 3 months. Their diaries will be reviewed (weekly in the 1st month; fortnightly in the 2nd month and monthly thereafter) and individualised feedback provided in the key areas of weight loss; diet (kilojoule intake, saturated fat, sodium and fibre) and physical activity (frequency, intensity, type and time). Participants can email the research team with questions. The waitlist control group will be randomised to either SHED-IT resources only or SHED-IT Online and Resources immediately following the 6 month follow-up assessment
Intervention code [1] 256584 0
Lifestyle
Intervention code [2] 256614 0
Behaviour
Comparator / control treatment
Wait-list control group for 6 months. The wait-list control group will be randomised to one of the two treatment arms immediately following the 6 month follow-up assessment.
Control group
Active

Outcomes
Primary outcome [1] 258548 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] 258548 0
At baseline and at 3 and 6 months after beginning the intervention
Secondary outcome [1] 264393 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] 264393 0
At baseline and at 3 and 6 months after beginning the intervention
Secondary outcome [2] 264460 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] 264460 0
At baseline and at 3 and 6 months after beginning the intervention
Secondary outcome [3] 264461 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] 264461 0
At baseline and at 3 and 6 months after beginning the intervention
Secondary outcome [4] 264462 0
Physical activity measured using Yamax SW700 pedometers (Yamax Corporation, Kumamoto City, Japan). Participants will be asked to wear pedometers for seven consecutive days and keep to their normal routine. At baseline assessments, participants will be instructed on how to attach the pedometers (at the waist on the right hand side) and asked to remove the pedometers only when sleeping, when the pedometer might get wet (e.g. swimming, showering) or during contact sports. At the end of the day participants were instructed to record their steps and reset their pedometers to zero. Once they had completed seven days of monitoring, participants will be instructed to place the pedometer and record sheet in the prepaid envelope provided and return to the research team.
Timepoint [4] 264462 0
Participants will wear pedometers for 7 days at baseline and then again at 3 and 6 months after beginning the intervention
Secondary outcome [5] 264463 0
Dietary intake - measured using a validated Food Frequency Questionnaire (Australian Adult Eating Survey)
Timepoint [5] 264463 0
At baseline and at 3 and 6 months after beginning the intervention
Secondary outcome [6] 264464 0
Physical activity, dietary and weight loss cognitions (social support, self efficacy, self management) using validated questionnaires
Timepoint [6] 264464 0
At baseline and at 3 and 6 months after beginning the intervention
Secondary outcome [7] 264465 0
Sleepiness - using the Epworth sleepiness scale
Timepoint [7] 264465 0
At baseline and at 3 and 6 months after beginning the intervention
Secondary outcome [8] 264467 0
Perceived physical and mental health using the Short Form 12 (SF-12) questionnaire
Timepoint [8] 264467 0
At baseline and at 3 and 6 months after beginning the intervention
Secondary outcome [9] 264468 0
Erectile function measured using the International Index of Erectile Function-5 (IIEF-5)
Timepoint [9] 264468 0
At baseline and at 3 and 6 months after beginning the intervention
Secondary outcome [10] 265019 0
Fat mass and fat free mass - measured using the InBody720 bioelectrical impendence analyser.
Timepoint [10] 265019 0
At baseline and at 3 and 6 months after beginning the intervention
Secondary outcome [11] 265020 0
Sedentary behaviours: will be assessed by a validated questionnaire from Brown et al. Medicine and Science in Sports and Exercise (MSSE) (in press)
Timepoint [11] 265020 0
At baseline and at 3 and 6 months after beginning the intervention
Secondary outcome [12] 265169 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] 265169 0
Measured at baseline
Secondary outcome [13] 265267 0
A process evaluation will be performed with a questionnaire to participants examining issues including study feasibility, participant satisfaction and suggestions for improvement.
Timepoint [13] 265267 0
Measured at 6 months following the intervention
Secondary outcome [14] 265279 0
Alcohol consumption will be measured using a validated questionnaire.
Timepoint [14] 265279 0
Measured at baseline and at 3 and 6 months after the intervention
Secondary outcome [15] 265562 0
Food portion sizes will be assessed using items from the Cancer Council Victoria (CCV) Dietary Questionnaire for Epidemiological Studies (DQES v2)
Timepoint [15] 265562 0
At baseline and at 3 and 6 months after beginning the intervention

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?
Yes
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)
Participants will complete a consent form and a phone eligibility and pre exercise screening questionnaire. Participants over 40 years will be required to receive a doctor's clearance prior to commencement of the study. All eligible volunteers will be randomised into one of three groups (Weight Loss (WL)-Resources, Weight Loss (WL)-Online or wait-list control).

To ensure concealment, the random allocation sequence will be generated by a statistician and given to the chief investigator. Allocation will be concealed as (1) the person who determines subject eligibility is unaware of group allocation (2) resources for the 3 groups will be provided in identical sealed opaque envelopes (3) randomization will be completed by a research assistant who is not involved in the assessment of participants and the allocation sequence will be concealed when enrolling/randomising participants to one of the three groups.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subjects will be randomly allocated to one of the three treatment groups using a randomised block design stratified by their body mass index at baseline. Randomisation will be done with the Plan procedure ( Proc Plan) in the SAS statistical software package.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2010
Actual
26/08/2010
Date of last participant enrolment
Anticipated
Actual
10/09/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
159
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2933 0
2038

Funding & Sponsors
Funding source category [1] 257078 0
Charities/Societies/Foundations
Name [1] 257078 0
Heart Foundation
Country [1] 257078 0
Australia
Primary sponsor type
Individual
Name
Professor Philip Morgan
Address
Priority Research Centre in Physical Activity and Nutrition,
Newcastle University,
University Dr,
Callaghan, NSW,
2308
Country
Australia
Secondary sponsor category [1] 256337 0
Individual
Name [1] 256337 0
Professor Ron Plotnikoff
Address [1] 256337 0
Priority Research Centre in Physical Activity and Nutrition,
Newcastle University,
University Dr,
Callaghan, NSW,
2308
Country [1] 256337 0
Australia
Secondary sponsor category [2] 256365 0
Individual
Name [2] 256365 0
Prof Robin Callister
Address [2] 256365 0
Priority Research Centre in Physical Activity and Nutrition,
Newcastle University,
University Dr,
Callaghan, NSW,
2308
Country [2] 256365 0
Australia
Secondary sponsor category [3] 256366 0
Individual
Name [3] 256366 0
Professor Clare Collins
Address [3] 256366 0
Priority Research Centre in Physical Activity and Nutrition,
Newcastle University,
University Dr,
Callaghan, NSW,
2308
Country [3] 256366 0
Australia
Other collaborator category [1] 1314 0
Individual
Name [1] 1314 0
Ms Tracey Burrows
Address [1] 1314 0
Priority Research Centre in Physical Activity and Nutrition,
Newcastle University,
University Dr,
Callaghan, NSW,
2308
Country [1] 1314 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259101 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 259101 0
University of Newcastle
Callaghan NSW 2308
Ethics committee country [1] 259101 0
Australia
Date submitted for ethics approval [1] 259101 0
01/02/2010
Approval date [1] 259101 0
14/04/2010
Ethics approval number [1] 259101 0
H-2010-0040

Summary
Brief summary
Obesity is now the most important avoidable cause of ill health in Australia today. Obesity is an independent risk factor for cardiovascular disease (CVD) and a major cause of preventable death. In Australia, 67% of men are considered to be overweight or obese compared to 52% of women, yet men are less likely to attempt weight loss than women. Men are notoriously difficult to recruit to weight loss programs, despite being more susceptible to many of the serious consequences such as CVD. Overweight men have greater abdominal adiposity than women, which is associated with increased risk of CVD. There is an urgent need to develop and evaluate novel and cost effective approaches to weight loss that engage large numbers of men.
The primary aim of the current study is to explore the efficacy of two SHED-IT behavioural intervention strategies developed specifically for men and involving different modes of delivery in a large community weight loss trial. Key secondary objectives include:
- Determine the relative benefit of two different weight loss programs (Resources and Online) designed to be incremental in extent of interaction & intensity of intervention on weight and other health outcomes;
- Evaluate strategies to improve adherence to online programs and examine what attributes of individuals and website features may predict compliance;
- Determine the characteristics of men for which each program is most effective;
- Compare the effects of the different programs in defined subgroups (age, education, occupation, marital status, SES).
It is hypothesised that:
(1) Compared to baseline, both the SHED-IT Resources and Online interventions will result in a clinically important and statistically significant (a) reduction in weight and (b) improvement in other important secondary outcome measures; at 3 and 6 months post-baseline
(2) The Online intervention, compared to the Resources Intervention, will result in greater improvements in primary and secondary outcomes at 3 and 6 months post-baseline.
RESEARCH PLAN Study design: Assessor-blinded randomised controlled trial. Men randomised to one of three study arms: (i) Resources (ii) Online (iii) Wait list.
Participants - Overweight/obese men (BMI >25 <40kg/m2) aged 18 to 65 years.
Intervention Descriptions: (i) WL Resources (Information and self-help control) resource package includes: DVD on weight loss in men; program booklet; calorie counter. (ii) WL Online (Basic + Internet behavioural therapy): ‘WL Basic’ resources plus access to study website; website user manual; individualised online feedback.
Outcomes: At baseline, 3- and 6-months: weight, waist circumference, BMI, fat free mass, dietary intake (FFQ), physical activity (pedometers), sedentary behaviours, blood pressure, perceived physical/mental health (SF-12), demographics & SES.
Analysis: Linear mixed models to assess all outcomes for the impact of treatment, time and the treatment by time interaction, with these three terms forming the base model.
Trial website
Trial related presentations / publications
Peer Reviewed Journal Publications

• Morgan, P.J., Callister, R., Collins, C.E., Plotnikoff, R.C. Young, M.D., Berry, N., McElduff, P., Burrows, T., Aguiar, E. & Saunders, K.L. The SHED-IT community trial: a randomised controlled trial of Internet- and paper-based weight loss programs tailored for overweight and obese men, Annals of Behavioural Medicine 2013; 45: 139-152

• Morgan, P.J., Collins, C.E., Plotnikoff, R.C., McElduff, P., Burrows, T., Warren, J.M., Young, M.D., Berry, N., Saunders, K.L., Aguiar, E.J., & Callister, R. (2010). The SHED-IT community trial study protocol: a randomized controlled trial of weight loss programs for overweight and obese men. 2010; BMC Public Health: 10, 701.

• Collins, C.E., Jensen, M., Young, M.D., Callister, R., Plotnikoff, R.C., & Morgan, P.J. (2013). Improvement in erectile function following weight loss in obese men: The SHED-IT randomized controlled trial, Obesity Research and Clinical Practice, 7(6), e450-e454. doi: 10.1016/j.orcp.2013.07.004

• Blomfield, R.L., Collins, C.E., Neve, M.J., Young, M.D., Callister, R., & Morgan, P.J. (in press). Impact of Self-help Weight Loss Resources With or Without Online Support on the Dietary Intake of Overweight and Obese Men: The SHED-IT randomised controlled trial, Obesity Research and Clinical Practice, Accepted September, 2013

Published Conference Abstracts in a Refereed Journal:

• Morgan, P., Callister, R., Collins, C., Plotnikoff, R., Young, M., Berry, N., McElduff, P., Burrows, T., Aguiar, E., & Saunders, K. Physical activity outcomes from the SHED-IT RCT: An evaluation of theoretically-based, gender-sensitised weight loss programs for men. 4th International Congress on Physical Activity and Public Health, Australian Conference of Science and Medicine in Sport, 31 October-3 November 2012, Sydney, Australia. Journal of Science and Medicine in Sport, 2012 15(6) (Dec 2012 Suppl.), 367. ORAL PRESENTATION

• Morgan, P.J., Callister, R., Collins, C.E., Plotnikoff, R.C., Young, M.D., Berry, N., McElduff, P., Burrows, T., Aguiar, E., and Saunders, K.L. The SHED-IT community trial: a randomised controlled trial of Internet- and paper-based weight loss programs tailored for overweight and obese men. Australian and New Zealand Obesity Society Annual Scientific Meeting, 18-20 October 2012, Auckland, New Zealand. Obesity Research & Clinical Practice, 2012 6(Supplement1): 30-31. ORAL PRESENTATION

• Saunders, K., Morgan, P., Callister, R., Collins, C., Plotnikoff, R., Young, M., Berry, N., McElduff, P., Burrows, T., & Aguiar, E. Insights into engaging men in weight loss: Process evaluation of the SHED-IT RCT of gender-sensitised weight loss programs for overweight men. 4th International Congress on Physical Activity and Public Health, Australian Conference of Science and Medicine in Sport, 31 October-3 November 2012, Sydney, Australia. Journal of Science and Medicine in Sport, 2012 15(6) (Dec 2012 Suppl.), 348. POSTER PRESENTATION

• Young, M., Morgan, P., Plotnikoff, R., Collins, C., & Callister, R. Relationship between physical activity outcomes and adherence to paper-based social cognitive tasks in a weight loss program for men. 4th International Congress on Physical Activity and Public Health, Australian Conference of Science and Medicine in Sport, 31 October-3 November 2012, Sydney, Australia. Journal of Science and Medicine in Sport, 2012 15(6) (Dec 2012 Suppl.), 351. POSTER PRESENTATION

• Young, M.D., Morgan, P.J., Hollis, J.L., Collins, C.E., & Teixeira, P.J. (2014). Sitting time at work and marital status: novel pre-treatment predictors of weight loss success in overweight and obese men. Obesity Reviews, 15(Supplement 2): 149. POSTER.

• Morgan, P.J., Scott, H., Young, M.D., Callister, R., Collins, C.E., & Plotnikoff, R.C. (2014). Process evaluation of the SHED-IT community weight loss program for men: program engagement and its association with changes to weight, physical activity, and dietary intake. Obesity Reviews, 15(Supplement 2): 149. POSTER.
Public notes

Contacts
Principal investigator
Name 31240 0
Prof Philip Morgan
Address 31240 0
Priority Research Centre in Physical Activity and Nutrition,
Newcastle University,
University Dr,
Callaghan, NSW,
2308
Country 31240 0
Australia
Phone 31240 0
+61 (0)2 49217265
Fax 31240 0
Email 31240 0
[email protected]
Contact person for public queries
Name 14487 0
Prof Philip Morgan
Address 14487 0
Priority Research Centre in Physical Activity and Nutrition,
Newcastle University,
University Dr,
Callaghan, NSW,
2308
Country 14487 0
Australia
Phone 14487 0
61 (0)2 49217265
Fax 14487 0
61 (0)2 49217407
Email 14487 0
[email protected]
Contact person for scientific queries
Name 5415 0
Prof Philip Morgan
Address 5415 0
Priority Research Centre in Physical Activity and Nutrition,
Newcastle University,
University Dr,
Callaghan, NSW,
2308
Country 5415 0
Australia
Phone 5415 0
61 (0)2 49217265
Fax 5415 0
61 (0)2 49217407
Email 5415 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAssociations between program outcomes and adherence to Social Cognitive Theory tasks: Process evaluation of the SHED-IT community weight loss trial for men.2014https://dx.doi.org/10.1186/s12966-014-0089-9
N.B. These documents automatically identified may not have been verified by the study sponsor.