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Trial registered on ANZCTR


Registration number
ACTRN12617001456347
Ethics application status
Approved
Date submitted
4/10/2017
Date registered
16/10/2017
Date last updated
20/11/2018
Date data sharing statement initially provided
20/11/2018
Date results information initially provided
20/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a type 2 diabetes risk reduction program for weight loss in women with recent gestational diabetes.
Scientific title
Evaluation of a type 2 diabetes risk reduction program for weight loss in women with recent gestational diabetes.
Secondary ID [1] 292807 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 304628 0
Obesity 305060 0
Gestational diabetes 305061 0
Condition category
Condition code
Diet and Nutrition 303947 303947 0 0
Obesity
Metabolic and Endocrine 304355 304355 0 0
Diabetes
Reproductive Health and Childbirth 304356 304356 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Low personalisation group - will receive access to a website tailored to women with a history of gestational diabetes. The materials on the 'Body Balance Beyond' 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 6 months and can accessed at their discretion. Website usage metrics will be captured using Google Analytics.

The 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.

2. High personalisation group - access to the Body Balance Beyond website (as described above). In addition, this group receives six video coaching sessions (20-30 mins duration each) with a dietitian (Weeks 2, 5 and 9) and exercise physiologist (Weeks 3, 6 and 10) over first 3 months. 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.

Text message support is provided over the second 3 months. Three text messages per week will be sent with one consisting of reminders to self-monitor or reflect on goals and two personalised messages (one diet-related and one exercise-related).
Intervention code [1] 299058 0
Lifestyle
Comparator / control treatment
Waitlist control group required to not make any changes to their current diet or exercise or attempt to lose weight during the intervention phase. This groups will be provided with the high personalisation intervention at the end of the active intervention phase (6 months).
Control group
Active

Outcomes
Primary outcome [1] 303295 0
Weight (kg)
Timepoint [1] 303295 0
baseline, and 3, 6 (primary timepoint)
Secondary outcome [1] 339243 0
Waist circumference
Timepoint [1] 339243 0
baseline, and 3, and 6 months after baseline
Secondary outcome [2] 339258 0
Body composition (fat mass and fat free mass) measured using bioelectrical impedance analysis
Timepoint [2] 339258 0
Baseline and 3 and 6 months after baseline
Secondary outcome [3] 339259 0
Skin reflectance measured using spectroscopy
Timepoint [3] 339259 0
Baseline, and 3 and 6 months after baseline
Secondary outcome [4] 339260 0
Resting metabolic rate measured using indirect calorimetry
Timepoint [4] 339260 0
Baseline, and 3 and 6 months after baseline
Secondary outcome [5] 339261 0
Heart rate variability measured using electrocardiogram
Timepoint [5] 339261 0
Baseline, and 3 and 6 months after baseline
Secondary outcome [6] 339262 0
Glycosylated haemoglobin (%) (HbA1c); obtained from fasting blood sample
Timepoint [6] 339262 0
Baseline, and 3 and 6 months after baseline
Secondary outcome [7] 339263 0
Physical activity measured by Godin Leisure-time Exercise Questionnaire
Timepoint [7] 339263 0
Baseline, and 3 and 6 months after baseline
Secondary outcome [8] 339264 0
Dietary intake measured using the Australian Eating Survey (FFQ) and 24-hr recall
Timepoint [8] 339264 0
Baseline, and 3 and 6 months after baseline
Secondary outcome [9] 339265 0
Quality of Life measured using the AQoL-6D
Timepoint [9] 339265 0
baseline, and 3, 6 (primary timepoint)
Secondary outcome [10] 339266 0
Eating behaviours measured using the Three Factor Eating Questionnaire and the Modified Yale Food Addition Scale
Timepoint [10] 339266 0
baseline, and 3, 6 (primary timepoint)
Secondary outcome [11] 339267 0
Eating self-efficacy measured using the Weight Efficacy Lifestyle Questionnaire-Short Form
Timepoint [11] 339267 0
baseline, and 3, 6 (primary timepoint)
Secondary outcome [12] 339268 0
Habit formation using the Self-report Habit Index
Timepoint [12] 339268 0
baseline, and 3, 6 (primary timepoint)
Secondary outcome [13] 339269 0
Program process evaluation questionnaire completed by participants designed specifically for this study.
Timepoint [13] 339269 0
3 and 6 months after baseline.
Secondary outcome [14] 339284 0
Blood pressure (mmHg); measured using the Sphygmocor CPV system
Timepoint [14] 339284 0
Baseline, and 3 and 6 months after baseline
Secondary outcome [15] 339669 0
Hip circumference
Timepoint [15] 339669 0
Baseline, 3, and 6 months after baseline
Secondary outcome [16] 339670 0
Fasting glucose; obtained from fasting blood sample
Timepoint [16] 339670 0
Baseline, and 3 and 6 months after baseline
Secondary outcome [17] 339671 0
Fasting insulin; obtained from fasting blood sample
Timepoint [17] 339671 0
Baseline, and 3 and 6 months after baseline
Secondary outcome [18] 339672 0
Cholesterols - HDL, LDL and total; obtained from fasting blood sample,
Timepoint [18] 339672 0
Baseline, and 3 and 6 months after baseline
Secondary outcome [19] 339673 0
Triglycerides; obtained from a fasting blood sample
Timepoint [19] 339673 0
Baseline, and 3 and 6 months after baseline
Secondary outcome [20] 339674 0
Arterial stiffness markers (central pulse pressure, mmHg, and augmentation index, %); measured using the Sphygmocor CPV system.
Timepoint [20] 339674 0
Baseline, and 3 and 6 months after baseline.
Secondary outcome [21] 339675 0
Self-efficacy in relation to physical activity measured using the Self-efficacy for Exercise Scale
Timepoint [21] 339675 0
baseline, and 3, 6 (primary timepoint)

Eligibility
Key inclusion criteria
• Gestational diabetes diagnosis in the last two years
• 3-12 months post-partum
• Body Mass Index of 25-50 kg/m2
• Smartphone, desktop computer laptop or tablet computer and access to a broadband Internet connection suitable for conducting video calls (e.g. Skype).
Minimum age
18 Years
Maximum age
45 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Currently pregnant or trying to fall pregnant
• Orthopaedic and/or medical condition that may impact ability to safely participate in exercise or have since been diagnosed with diabetes (Type 1 or 2).
• Fail pre-exercise screening tool (or obtain a Dr’s clearance) for safety to engage in physical activity

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Wait-list control group will receive the high personalisation intervention at the 6- months time-point. They will be followed up 6-months later (12 month time-point).
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 297437 0
Charities/Societies/Foundations
Name [1] 297437 0
Diabetes Australia
Address [1] 297437 0
Level 1, 101 Northbourne Ave
Turner ACT 2612 Australia
Country [1] 297437 0
Australia
Funding source category [2] 297648 0
Charities/Societies/Foundations
Name [2] 297648 0
Hunter Medical Research Institute
Address [2] 297648 0
Hunter Medical Research Institute
HMRI Clinical Research Centre
Level 3 John Hunter Hospital
Lookout Road
New Lambton Heights
NSW, 2305
Country [2] 297648 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] 296434 0
Individual
Name [1] 296434 0
Dr Megan Rollo
Address [1] 296434 0
ATC Building
Priority Research Centre for Physical Activity and Nutrition
University Drive
The University of Newcastle
Callaghan
2308 NSW
Country [1] 296434 0
Australia
Other collaborator category [1] 279752 0
Individual
Name [1] 279752 0
Professor Robin Callister
Address [1] 279752 0
ATC Building
Priority Research Centre for Physical Activity and Nutrition
University Drive
The University of Newcastle
Callaghan
2308 NSW
Country [1] 279752 0
Australia
Other collaborator category [2] 279753 0
Individual
Name [2] 279753 0
Dr Katie Wynne
Address [2] 279753 0
Department of Endocrinology,
John Hunter Hospital
Lookout Road
New Lambton Heights
2305 NSW
Country [2] 279753 0
Australia
Other collaborator category [3] 279754 0
Individual
Name [3] 279754 0
Dr Melinda Hutchesson
Address [3] 279754 0
Hunter Building,
University Drive,
University of Newcastle
Callaghan
2308 NSW
Country [3] 279754 0
Australia
Other collaborator category [4] 279755 0
Individual
Name [4] 279755 0
Dr Elroy Aguiar
Address [4] 279755 0
Department of Kinesiology, School of Public Health and Health Sciences
University of Massachusetts, Amherst,
30 Eastman Lane
Amherst, MA 01003.
Country [4] 279755 0
United States of America
Other collaborator category [5] 279756 0
Individual
Name [5] 279756 0
Mr Ashley Young
Address [5] 279756 0
Hunter New England Health
Clinical Telehealth
Information Technology & Telecommunications
Lookout Rd,
New Lambton Heights
2305 NSW
Country [5] 279756 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298546 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 298546 0
Research & Innovation Services
Research Integrity Unit
University Drive
The University of Newcastle
Callaghan NSW 2308
Ethics committee country [1] 298546 0
Australia
Date submitted for ethics approval [1] 298546 0
31/05/2017
Approval date [1] 298546 0
22/08/2017
Ethics approval number [1] 298546 0
H-2017-0187

Summary
Brief summary
Once a woman with gestational diabetes mellitus (GDM) gives birth and her GDM resolves, Little attention is paid to her future risk of developing type 2 diabetes mellitus (T2DM). Women with GDM have up to a 7 times greater risk of developing T2DM than women without GDM. Despite this increased risk, ongoing care or support programs tailored to the unique characteristics on this group are not currently available nor easily accessible. This study proposes to address this gap. We will evaluate the impact of a tailored, self-administered Internet program, with or without individualised video coaching to empower women with a history of GDM to improve their nutrition and physical activity behaviours and reduce their T2DM risk.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 77414 0
Prof Clare Collins
Address 77414 0
ATC Building
Priority Research Centre for Physical Activity and Nutrition
University Drive
The University of Newcastle
Callaghan
2308 NSW
Country 77414 0
Australia
Phone 77414 0
+61 2 4921 4656
Fax 77414 0
Email 77414 0
clare.collins@newcastle.edu.au
Contact person for public queries
Name 77415 0
Dr Megan Rollo
Address 77415 0
ATC Building
Priority Research Centre for Physical Activity and Nutrition
University Drive
The University of Newcastle
Callaghan
2308 NSW
Country 77415 0
Australia
Phone 77415 0
+61 2 4921 5649
Fax 77415 0
Email 77415 0
megan.rollo@newcastle.edu.au
Contact person for scientific queries
Name 77416 0
Dr Megan Rollo
Address 77416 0
ATC Building
Priority Research Centre for Physical Activity and Nutrition
University Drive
The University of Newcastle
Callaghan
2308 NSW
Country 77416 0
Australia
Phone 77416 0
+61 2 4921 5649
Fax 77416 0
Email 77416 0
megan.rollo@newcastle.edu.au

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 other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary