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Group versus Individual Education for Diabetes Control in Obese Adults.

A parallel group pilot randomised controlled trial testing the effect of Group versus Individual Education on Diabetes Distress in Obese (BMI>35kg/m2) Adults with requiring Insulin for Type 2 Diabetes Mellitus.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622001530718
Enrollment
50
Registered
2022-12-12
Start date
2020-02-26
Completion date
2021-06-09
Last updated
2023-01-09

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

Conditions

None listed

Brief summary

National statistics from Australian sources predict normal-weight adults will comprise less than one third of the population by 2025. Evidence suggests there are synergies between obesity and type 2 diabetes mellitus (T2D). Insulin resistance is common in patients with obesity and results in a 7-12 fold increase in the risk of developing T2D. It is not unusual for patients attending the Metabolic and Weight Loss Program at our hospital to have large daily doses of insulin to manage their T2D. These patients often report fatigue, poorly controlled diabetes and difficulty managing their blood glucose level. Evidence from patients indicates lifestyle changes, psychosocial issues, insulin side-effects, dietary perceptions and a lack of confidence in diabetes self-care also influences blood glucose management. Evidence focused on support networks or education programs to improve self-management of T2D for obese patients is difficult to locate. The aim of this study was to determine whether group based education led to a reduction in diabetes distress when compared to usual care.

Interventions

Following general practice referral to the Metabolic and Weight Loss Clinic eligible patients are invited to participate in a program of education titled 'Healthy with Diabetes'. The program is comprised of six modules, delivered over 6 weeks. Each module is delivered weekly in a one hour time slot with 35 to 40 minutes of content and 20 to 25 minutes of additional time for discussion. The modules are provided face-to-face or via Telehealth, with a focus on a motivational education content deliv

Following general practice referral to the Metabolic and Weight Loss Clinic eligible patients are invited to participate in a program of education titled 'Healthy with Diabetes'. The program is comprised of six modules, delivered over 6 weeks. Each module is delivered weekly in a one hour time slot with 35 to 40 minutes of content and 20 to 25 minutes of additional time for discussion. The modules are provided face-to-face or via Telehealth, with a focus on a motivational education content delivery. The program of delivery follows a systematic design and complete modules are completed in order in sequenced order. In the intervention group, patients participate in group based education delivery. If a week/module is missed participants are re-scheduled into the next available module session. As such, group size can vary from between 6 to 10 participants in any given session. Session attendance and module completion are monitored and recorded for each participant to ensure program completion, which is a pre-requisite for additional treatment referral pathways offered by the clinic. The Week 1 module addresses endogenous Insulin and how it works in the context of homeostasis. Week 2 is focused on the practical aspects of monitoring blood glucose levels, achieving glucose targets and how blood glucose can influence appetite, mood and body function. Week 3 unpacks causes of type 2 diabetes mellitus, body changes associated with this condition and global changes that impact on maintaining a healthy lifestyle. Week 4 content relates to changes in diabetes as people get older, the need for additional care in periods of illness and self-management using the 'Annual Cycle of Care' checklist and 'Sick Day Management' strategies developed by Diabetes Australia. Week 5 focuses on the impact reducing Insulin resistance can have on health and well-being and Week 6 addresses being medication wise including reading medication labels, understanding medications taken for diabetes, medication side effects and how these medications influence weight.

Sponsors

Western Sydney Local Health District
Lead SponsorGovernment body

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients will be eligible for inclusion if they have a BMI >35 kg/m2, and a HbA1c >9%, or are an insulin-requiring type 2 diabetic on > 1U/kg/day.

Exclusion criteria

Exclusion criteria include BMI <35 kg/m2, and a HbA1c <9%, non insulin-requiring type 2 diabetic, current smoker not willing to commence treatment to quit smoking, pregnant.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026