Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000162112
Ethics application status
Approved
Date submitted
19/12/2018
Date registered
5/02/2019
Date last updated
5/02/2019
Date data sharing statement initially provided
5/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of an eHealth type 2 diabetes risk reduction program for weight loss in women with a history of gestational diabetes
Scientific title
Evaluation of an eHealth type 2 diabetes risk reduction program for weight loss in women with a history of gestational diabetes
Secondary ID [1] 296550 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record
ACTRN12617001456347 is the parent study,

Health condition
Health condition(s) or problem(s) studied:
Gestational diabetes
 310333 0
Obesity 310334 0
Type 2 diabetes 310335 0
Condition category
Condition code
Diet and Nutrition 309066 309066 0 0
Obesity
Metabolic and Endocrine 309067 309067 0 0
Diabetes
Reproductive Health and Childbirth 309997 309997 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Medium personalisation group - will receive access to a website tailored to women with a history of gestational diabetes and personalised text messages over a 3 month period.
The materials on the 'Body Balance Beyond' gestational diabetes (BBBGDM) website are predominantly self-directed and designed to promote modest weight loss through supporting participants to make a series of small changes to eating and exercise behaviours and form new healthy habits. Participants will have access to the site for 3 months and can accessed at their discretion. Website usage metrics will be captured using Google Analytics.
The BBBGDM website contains five sections:
a) Managing my risk - outlines the risk factors for developing diabetes in the future and actions which can reduce risk.
b) My Plan - participants will be emailed personalised feedback reports on dietary intake and physical activity (generated from the Australian Eating Survey and Godin activity questionnaires) in comparison to national nutrition and exercise guidelines. This section guides participants through using their reports to set weight-, diet- and exercise-related goals, and strategies for self-monitoring and managing relapses.
c) Eating - contains information and links to resources to promote healthy eating (e.g. portion size, energy density, meal planning, label reading, recipes, breastfeeding).
d) Physical Activity - contains information and links to resources to promote being more active (e.g. types of activity, benefits, suggestions for being active with a family, exercising safely).
e) Wellbeing - contains information and resources on social support, stress management and sleep.
In addition, participants in this group will receive three text messages per week. The messages will consist of reminders to self-monitor or reflect on goals and two personalised messages (one diet-related and one exercise-related) addressing the participant’s self-identified barriers to healthy eating and being more physically active. An example of a personalised text message addressing the factor of improving meal planning skills is "[First Name]: Looking to improve your menu planning skills? Click here [Link] for tips on creating a healthy menu, and other great advice."

2. High personalisation group - access to the BBBGDM website and personalised text messages (as described above for the medium personalisation group). In addition, this group will receive five video coaching sessions (20-30 mins duration each) with a dietitian (Weeks 2 and 5) and exercise physiologist (Weeks 3 and 6), with the participant asked to select which practitioner they wish to see for the final session (Week 9) . The video coaching comprises structured participant-centred coaching sessions to refine participant goals. During these sessions the dietitian and exercise physiologist will personalise strategies to overcome participant's self-identified factors affecting diet and exercise, in addition to review progress and revise goals, and problem solve barriers and revise strategies. Participant attendance will be recorded via checklist.
Intervention code [1] 312861 0
Lifestyle
Comparator / control treatment
Low personalisation group - will receive access to the 'Body Balance Beyond' gestational diabetes (BBBGDM) website (as described above) only.
Control group
Active

Outcomes
Primary outcome [1] 308037 0
Weight (kg); participant reported
Timepoint [1] 308037 0
baseline and 12 weeks (primary timepoint)
Secondary outcome [1] 353777 0
Dietary intake measured using the Australian Eating Survey (FFQ)
Timepoint [1] 353777 0
baseline and 12 weeks
Secondary outcome [2] 353778 0
Physical activity measured by Godin Leisure-time Exercise Questionnaire
Timepoint [2] 353778 0
baseline and 12 weeks
Secondary outcome [3] 353779 0
Quality of Life measured using the AQoL-6D
Timepoint [3] 353779 0
baseline and 12 weeks
Secondary outcome [4] 353780 0
Eating behaviours measured using the Three Factor Eating Questionnaire
Timepoint [4] 353780 0
baseline and 12 weeks
Secondary outcome [5] 353781 0
Eating self-efficacy measured using the Weight Efficacy Lifestyle Questionnaire-Short Form
Timepoint [5] 353781 0
baseline and 12 weeks
Secondary outcome [6] 353782 0
Self-efficacy in relation to physical activity measured using the Self-efficacy for Exercise Scale
Timepoint [6] 353782 0
baseline and 12 weeks
Secondary outcome [7] 353783 0
Habit formation using the Self-report Habit Index
Timepoint [7] 353783 0
baseline and 12 weeks
Secondary outcome [8] 353784 0
Program process evaluation questionnaire completed by participants designed specifically for this study.
Timepoint [8] 353784 0
12 weeks
Secondary outcome [9] 366380 0
Addictive eating behaviours measured using the Modified Yale Food Addition Scale
Timepoint [9] 366380 0
baseline and 12 weeks

Eligibility
Key inclusion criteria
- had a gestational diabetes diagnosis in the last two years
- are at least 3 months post-partum
- have a Body Mass Index between 25 and 50 kg/m2
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Are currently pregnant or trying to fall pregnant
- Have an orthopaedic and/or medical condition that may impact on your ability to safely participate in exercise or you have been diagnosed with diabetes (Type 1 or 2).
-Do not pass the pre-exercise screening tool (or you cannot obtain a Dr’s clearance if do you not pass the screener) for safety to engage in physical activity.
- have a smartphone, desktop computer, laptop or tablet computer and access to a broadband Internet connection suitable for conducting video calls (e.g. Skype).

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/02/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 301130 0
Charities/Societies/Foundations
Name [1] 301130 0
Diabetes Australia
Country [1] 301130 0
Australia
Primary sponsor type
Individual
Name
Professor Clare Collins
Address
ATC Building
Priority Research Centre for Physical Activity and Nutrition
University Drive
The University of Newcastle
Callaghan
2308 NSW
Country
Australia
Secondary sponsor category [1] 300752 0
Individual
Name [1] 300752 0
Dr Megan Rollo
Address [1] 300752 0
ATC Building Priority Research Centre for Physical Activity and Nutrition University Drive The University of Newcastle Callaghan 2308 NSW
Country [1] 300752 0
Australia
Other collaborator category [1] 280470 0
Individual
Name [1] 280470 0
Professor Robin Callister
Address [1] 280470 0
ATC Building Priority Research Centre for Physical Activity and Nutrition University Drive The University of Newcastle Callaghan 2308 NSW
Country [1] 280470 0
Australia
Other collaborator category [2] 280471 0
Individual
Name [2] 280471 0
Dr Katie Wynne
Address [2] 280471 0
Department of Endocrinology, John Hunter Hospital Lookout Road New Lambton Heights 2305 NSW
Country [2] 280471 0
Australia
Other collaborator category [3] 280472 0
Individual
Name [3] 280472 0
Dr Melinda Hutchesson
Address [3] 280472 0
Hunter Building, University Drive, University of Newcastle Callaghan 2308 NSW
Country [3] 280472 0
Australia
Other collaborator category [4] 280473 0
Individual
Name [4] 280473 0
Dr Elroy Aguiar
Address [4] 280473 0
Department of Kinesiology, School of Public Health and Health Sciences University of Massachusetts, Amherst, 30 Eastman Lane Amherst, MA 01003.
Country [4] 280473 0
United States of America
Other collaborator category [5] 280474 0
Individual
Name [5] 280474 0
Mr Ashley Young
Address [5] 280474 0
Hunter New England Health Clinical Telehealth Information Technology & Telecommunications Lookout Rd, New Lambton Heights 2305 NSW
Country [5] 280474 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301881 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 301881 0
Research & Innovation Services Research Integrity Unit University Drive The University of Newcastle Callaghan NSW 2308
Ethics committee country [1] 301881 0
Australia
Date submitted for ethics approval [1] 301881 0
31/05/2017
Approval date [1] 301881 0
11/10/2018
Ethics approval number [1] 301881 0
H-2017-0187

Summary
Brief summary
Women with a history of gestational diabetes (GDM) have up to a 7 times higher risk of developing type 2 diabetes (T2DM) than women without GDM. Many women with GDM report that following delivery, they feel a lack of support and feel abandoned by the health system in terms of T2DM prevention. The risk of developing T2DM can be lowered by adopting a healthy lifestyle. However, women from this group often report that it is challenging to adopt and maintain a healthy lifestyle due to work and family commitments, lack of time, cost constraints, and limited access to information on healthy behaviours. This project aims to assess how feasible, acceptable and effective the Body Balance Beyond program is, with or without individualised video coaching and/or personalised text messages, among women with recent GDM.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88422 0
Prof Clare Collins
Address 88422 0
ATC Building Priority Research Centre for Physical Activity and Nutrition University Drive The University of Newcastle Callaghan 2308 NSW
Country 88422 0
Australia
Phone 88422 0
+61 2 4921 4656
Fax 88422 0
Email 88422 0
[email protected]
Contact person for public queries
Name 88423 0
Dr Megan Rollo
Address 88423 0
ATC Building Priority Research Centre for Physical Activity and Nutrition University Drive The University of Newcastle Callaghan 2308 NSW
Country 88423 0
Australia
Phone 88423 0
+61 2 4921 5649
Fax 88423 0
Email 88423 0
[email protected]
Contact person for scientific queries
Name 88424 0
Dr Megan Rollo
Address 88424 0
ATC Building Priority Research Centre for Physical Activity and Nutrition University Drive The University of Newcastle Callaghan 2308 NSW
Country 88424 0
Australia
Phone 88424 0
+61 2 4921 5649
Fax 88424 0
Email 88424 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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
SourceTitleYear of PublicationDOI
EmbaseEvaluation of a Type 2 diabetes risk reduction online program for women with recent gestational diabetes: a randomised trial.2022https://dx.doi.org/10.1186/s12966-022-01275-3
N.B. These documents automatically identified may not have been verified by the study sponsor.