Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000481471
Ethics application status
Approved
Date submitted
17/09/2007
Date registered
21/09/2007
Date last updated
4/12/2018
Date data sharing statement initially provided
4/12/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of an Internet-based Weight Loss Program for Men
Scientific title
Does an Internet-based weight loss program assist change in body weight for men?
Secondary ID [1] 296789 0
Nil known
Universal Trial Number (UTN)
Trial acronym
SHED-IT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 2381 0
Condition category
Condition code
Diet and Nutrition 2484 2484 0 0
Obesity
Public Health 2485 2485 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
- The duration of the intervention is 3 months. The intervention involves attendance at one 75 minute face-to-face information session covering standard weight control instruction relating to diet, physical activity and behaviour change, focusing on self monitoring, goal setting and social support.
- Self monitoring using online website www.calorieking.com.au, which provides tools and information to help individuals improve their diet and physical activity behaviours, including submission of energy expenditure and intake and online group support.
Participants are provided with individualised feedback sheets weekly for the first month; fortnightly in the second month; and once at the end of the third month. Participants will be instructed to enter daily eating and physical activity diaries each day for the 1st month; for 2 weeks in the 2nd month and for one week in the 3rd month. Participants are encouraged to visit the group forum to elicit social support where questions are answered from the research team and discussions threads are able to be started and answered by participants. There is no mandated use of the group forums (but this will be monitored as part of the process evaluation). Participants will also receive a program handbook.
Intervention code [1] 2105 0
Behaviour
Intervention code [2] 2106 0
Lifestyle
Comparator / control treatment
- The comparison group will only be required to attend one 60 minute face-to-face information session covering standard weight control instruction relating to diet, physical activity and behaviour change, focusing on self monitoring, goal setting and social support. They will receive a program handbook but will not receive any additional support after the initial information session.
Control group
Active

Outcomes
Primary outcome [1] 3383 0
Change in body weight (kg)
Timepoint [1] 3383 0
At baseline and at 3 and 6 months after intervention commencement
Secondary outcome [1] 5609 0
Waist circumference
Timepoint [1] 5609 0
At baseline and at 3 and 6 months after intervention commencement
Secondary outcome [2] 5610 0
Blood pressure
Timepoint [2] 5610 0
At baseline and at 3 and 6 months after intervention commencement
Secondary outcome [3] 5611 0
Physical activity using pedometers
Timepoint [3] 5611 0
At baseline and at 3 and 6 months after intervention commencement
Secondary outcome [4] 5612 0
Dietary intake using the Food Frequency Questionnaire from the Victorian Cancer Council
Timepoint [4] 5612 0
At baseline and at 3 and 6 months after intervention commencement
Secondary outcome [5] 5613 0
Body Mass Index (BMI) calculated using the standard equation (weight[kg]/height[m]2)
Timepoint [5] 5613 0
At baseline and at 3 and 6 months after intervention commencement

Eligibility
Key inclusion criteria
Male staff or students at the University of Newcastle who have a BMI between 25 - 36kg/m2
Minimum age
18 Years
Maximum age
60 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, diabetes, or orthopaedic or joint problems that would be a barrier to physical activity; recent weight loss of 4.5kg or more; taking medications that might be affected by weight loss

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 undertake a phone eligibility screen and are then sent information letters and consent form. When consents are returned, assessments are booked and then participants are randomised by the research assistant. However, only the research assistant is aware of group allocation. No assessor is aware of group allocation. Participants are handed a sealed opaque envelope when they finish baseline assessment and are instructed to open when they leave. The envelope contains information about group allocation and the time and venue for the information session. That is, participants find out group allocation after they have completed baseline assessment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly allocated to one of the two intervention groups using a computer-based random number-producing algorithm. This method ensures an equal chance of allocation to each group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Both participants and assessors are blind to group allocation at baseline assessment.
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/09/2007
Actual
17/09/2007
Date of last participant enrolment
Anticipated
Actual
30/09/2007
Date of last data collection
Anticipated
Actual
1/09/2008
Sample size
Target
45
Accrual to date
Final
65
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2632 0
University
Name [1] 2632 0
The University of Newcastle
Country [1] 2632 0
Australia
Primary sponsor type
Individual
Name
Philip Morgan
Address
School of Education
Faculty of Education and Arts
University of Newcastle
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 2380 0
Individual
Name [1] 2380 0
David Lubans
Address [1] 2380 0
School of Education
Faculty of Education and Arts
University of Newcastle
Callaghan NSW 2308
Country [1] 2380 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302106 0
University of Newcastle's Human Research Ethics Committee
Ethics committee address [1] 302106 0
Human Research Ethics Commitee
University of Newcastle
University Drive
Callaghan, 2308
NSW Australia
Ethics committee country [1] 302106 0
Australia
Date submitted for ethics approval [1] 302106 0
27/07/2007
Approval date [1] 302106 0
07/08/2007
Ethics approval number [1] 302106 0
H-548-0807

Summary
Brief summary
Obesity is a major public health issue in Australia with approximately 67% of men and 52% of women overweight or obese. Obesity is associated with a number of life threatening diseases and is an independent risk factor for a range of cardiovascular diseases. Although group programs that involve weekly visits are regarded as the most effective strategy for treating obesity, there is an urgent need for the development of effective weight loss programs that are more widely accessible. The Internet may have considerable potential to deliver weight management programs for individuals who cannot access clinical programs or where frequent face-to-face contact is a substantial barrier. To date, little is known about the efficacy of online weight loss programs. The aim of the current study is to evaluate the feasibility and efficacy of an Internet-based weight loss program for men that incorporates key behavioural strategies including social support and self monitoring.
Trial website
Trial related presentations / publications
Morgan, P.J., Lubans, D.R., Collins, C.E., Warren, J.M., & Callister, R. (2009).The SHED-IT randomized controlled trial: Evaluation of an internet-based weight-loss program for men. Obesity, 17(11), 2025-2032.

Lubans, D.R., Morgan, P.J., Collins, C.E., Warren, J.M., & Callister, R. (2009). Exploring the mechanisms of weight loss in the SHED-IT intervention for overweight men: a mediation analysis. International Journal of Activity, 6, 76.

Collins, C.E., Morgan, P.J., Warren, J.M., Lubans, D.R., & Callister, R. (2011). Men participating in a weight loss intervention are able to implement key dietary messages, but not those relating to vegetables or alcohol: The Self-Help, Exercise and Diet using Internet Technology (SHED-IT) study. Public Health Nutrition. 14(1), 168-175.

Morgan, P.J., Lubans, D.R., Collins, C.E., Warren, J.M., & Callister, R. (2011). 12-month outcomes and process evaluation of the SHED-IT RCT: An internet-based weight loss program targeting men. Obesity, 19(1), 142-151.

Morgan, P.J., Warren, J.M., Lubans, D.R., Collins, C.E., & Callister, R. (2011). Engaging men in weight loss: Experiences of men who participated in the male only SHED-IT pilot study. Obesity Research and Clinical Practice, 5(3), e239-e248.

Public notes

Contacts
Principal investigator
Name 28059 0
Prof Philip Morgan
Address 28059 0
School of Education Faculty of Education and Arts University of Newcastle Callaghan NSW 2308
Country 28059 0
Australia
Phone 28059 0
+612 4921 7265
Fax 28059 0
Email 28059 0
[email protected]
Contact person for public queries
Name 11216 0
Philip Morgan
Address 11216 0
School of Education
Faculty of Education and Arts
University of Newcastle
Callaghan NSW 2308
Country 11216 0
Australia
Phone 11216 0
61 2 4921 7265
Fax 11216 0
Email 11216 0
[email protected]
Contact person for scientific queries
Name 2144 0
Philip Morgan
Address 2144 0
School of Education
Faculty of Education and Arts
University of Newcastle
Callaghan NSW 2308
Country 2144 0
Australia
Phone 2144 0
61 2 4921 7265
Fax 2144 0
Email 2144 0
[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?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.