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Evaluation of a type 2 diabetes risk reduction program for weight loss in women with recent gestational diabetes.

Evaluation of a type 2 diabetes risk reduction program for weight loss in women with recent gestational diabetes.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617001456347
Enrollment
42
Registered
2017-10-16
Start date
2018-02-08
Completion date
2018-08-30
Last updated
2018-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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).

Sponsors

Professor Clare Collins
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
Yes

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).

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026