ANZCTR - Registration

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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]

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

Condition category

Condition code

Diet and Nutrition

Obesity

Public Health

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]

Lifestyle

Intervention code [2]

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]

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]

At baseline and at 3 and 6 months after beginning the intervention

Secondary outcome [1]

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]

At baseline and at 3 and 6 months after beginning the intervention

Secondary outcome [2]

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]

At baseline and at 3 and 6 months after beginning the intervention

Secondary outcome [3]

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]

At baseline and at 3 and 6 months after beginning the intervention

Secondary outcome [4]

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]

Participants will wear pedometers for 7 days at baseline and then again at 3 and 6 months after beginning the intervention

Secondary outcome [5]

Dietary intake - measured using a validated Food Frequency Questionnaire (Australian Adult Eating Survey)

Timepoint [5]

At baseline and at 3 and 6 months after beginning the intervention

Secondary outcome [6]

Physical activity, dietary and weight loss cognitions (social support, self efficacy, self management) using validated questionnaires

Timepoint [6]

At baseline and at 3 and 6 months after beginning the intervention

Secondary outcome [7]

Sleepiness - using the Epworth sleepiness scale

Timepoint [7]

At baseline and at 3 and 6 months after beginning the intervention

Secondary outcome [8]

Perceived physical and mental health using the Short Form 12 (SF-12) questionnaire

Timepoint [8]

At baseline and at 3 and 6 months after beginning the intervention

Secondary outcome [9]

Erectile function measured using the International Index of Erectile Function-5 (IIEF-5)

Timepoint [9]

At baseline and at 3 and 6 months after beginning the intervention

Secondary outcome [10]

Fat mass and fat free mass - measured using the InBody720 bioelectrical impendence analyser.

Timepoint [10]

At baseline and at 3 and 6 months after beginning the intervention

Secondary outcome [11]

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]

At baseline and at 3 and 6 months after beginning the intervention

Secondary outcome [12]

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]

Measured at baseline

Secondary outcome [13]

A process evaluation will be performed with a questionnaire to participants examining issues including study feasibility, participant satisfaction and suggestions for improvement.

Timepoint [13]

Measured at 6 months following the intervention

Secondary outcome [14]

Alcohol consumption will be measured using a validated questionnaire.

Timepoint [14]

Measured at baseline and at 3 and 6 months after the intervention

Secondary outcome [15]

Food portion sizes will be assessed using items from the Cancer Council Victoria (CCV) Dietary Questionnaire for Epidemiological Studies (DQES v2)

Timepoint [15]

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]

2038

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Heart Foundation

Address [1]

Level 12, 500 Collins Street
Melbourne VIC NSW 3000

Country [1]

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]

Individual

Name [1]

Professor Ron Plotnikoff

Address [1]

Priority Research Centre in Physical Activity and Nutrition,
Newcastle University,
University Dr,
Callaghan, NSW,
2308

Country [1]

Australia

Secondary sponsor category [2]

Individual

Name [2]

Prof Robin Callister

Address [2]

Priority Research Centre in Physical Activity and Nutrition,
Newcastle University,
University Dr,
Callaghan, NSW,
2308

Country [2]

Australia

Secondary sponsor category [3]

Individual

Name [3]

Professor Clare Collins

Address [3]

Priority Research Centre in Physical Activity and Nutrition,
Newcastle University,
University Dr,
Callaghan, NSW,
2308

Country [3]

Australia

Other collaborator category [1]

Individual

Name [1]

Ms Tracey Burrows

Address [1]

Priority Research Centre in Physical Activity and Nutrition,
Newcastle University,
University Dr,
Callaghan, NSW,
2308

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Newcastle Human Research Ethics Committee

Ethics committee address [1]

University of Newcastle
Callaghan NSW 2308

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/02/2010

Approval date [1]

14/04/2010

Ethics approval number [1]

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

Prof Philip Morgan

Address

Priority Research Centre in Physical Activity and Nutrition,
Newcastle University,
University Dr,
Callaghan, NSW,
2308

Country

Australia

Phone

+61 (0)2 49217265

Fax

philip.morgan@newcastle.edu.au

Contact person for public queries

Name

Philip Morgan

Address

Priority Research Centre in Physical Activity and Nutrition,
Newcastle University,
University Dr,
Callaghan, NSW,
2308

Country

Australia

Phone

61 (0)2 49217265

Fax

61 (0)2 49217407

philip.morgan@newcastle.edu.au

Contact person for scientific queries

Name

Philip Morgan

Address

Priority Research Centre in Physical Activity and Nutrition,
Newcastle University,
University Dr,
Callaghan, NSW,
2308

Country

Australia

Phone

61 (0)2 49217265

Fax

61 (0)2 49217407

philip.morgan@newcastle.edu.au

No information has been provided regarding IPD availability

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No Supporting Document Provided

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Source	Title	Year of Publication	DOI
Embase	Associations between program outcomes and adherence to Social Cognitive Theory tasks: Process evaluation of the SHED-IT community weight loss trial for men.	2014	https://dx.doi.org/10.1186/s12966-014-0089-9

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

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