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Development and evaluation of lifestyle interventions for patients with pre-diabetes

Development and evaluation of an Acceptance and Commitment Therapy (ACT) based lifestyle education intervention for patients with pre-diabetes: A randomised controlled trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619001374156
Enrollment
87
Registered
2019-10-09
Start date
2015-02-09
Completion date
2016-03-30
Last updated
2019-10-14

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

Conditions

None listed

Brief summary

The primary purpose of this study is to develop and adapt two intervention approaches for patients with pre-diabetes; lifestyle education alone and lifestyle education combined with Acceptance and Commitment Therapy (ACT). The goal of the ACT/Education approach is to connect participants’ lifestyle goals to personally meaningful values, and equip them with skills to deal with difficult emotions that can function as barriers to goal attainment. A randomised controlled design is used to compare the effectiveness of these approaches with the provision of standard medical care. It is predicted that ACT and Education combined will produce greater improvements in physiological indicators of pre-diabetes management, self-report measures of lifestyle change (diet and exercise), quality of life and emotional functioning (depression, anxiety and distress tolerance).

Interventions

Participants were randomly assigned to 1 of 3 intervention conditions: ACT and Education (ACT/ED), Education Only (ED Only) or Standard Care (this is described in the control treatment section) The ED Only and ACT/ED interventions were designed to be delivered in a brief, manualised, workshop format, based around a power-point presentation. Both of the interventions were 4.5 hours duration and delivered across two morning sessions held on consecutive weeks. The first session was 2 hours and th

Participants were randomly assigned to 1 of 3 intervention conditions: ACT and Education (ACT/ED), Education Only (ED Only) or Standard Care (this is described in the control treatment section) The ED Only and ACT/ED interventions were designed to be delivered in a brief, manualised, workshop format, based around a power-point presentation. Both of the interventions were 4.5 hours duration and delivered across two morning sessions held on consecutive weeks. The first session was 2 hours and the second was 2.5 hours. Due to the researcher being unable to access a single venue that was available for the scheduled workshop dates and times, the workshops were held at two venues; Wharerata Conference Facilities at Massey University and The Bank of New Zealand Conference Facilities located in central Palmerston North. The ED Only and ACT/ED groups were facilitated by the lead researcher, a female senior Clinical Psychologist, and a female senior Dietitian with the Manawatu Diabetes Trust. The Clinical Psychologist had 8 years experience working with patients affected by long-term physical health conditions. Throughout the course of the study, she was employed by the Massey University Long-term Health Conditions Service; a psychology service that provides assessment and therapeutic support for adults with a variety of long-term health conditions, including diabetes and cardiovascular disease. In addition, prior to embarking on this research, she had attended advanced training opportunities focused on the use of ACT with patients with long-term health conditions. The Dietitian had over 10 years experience working with people with diabetes and was employed by the Manawatu Diabetes Trust. Intervention 1: ED Only The ED Only intervention was developed based on pre-diabetes advice/guidelines provided by the New Zealand Ministry of Health, and then extended for the purposes of this research by including key lifestyle messages/goals taken from international pre-diabetes intervention trials that have been demonstrated to reduce diabetes risk. The aim of this intervention was to provide participants with education about what it means to have pre-diabetes and diabetes, risk factors for the development of type 2 diabetes (with an emphasis on diet and exercise), potential physical/psychological consequences of developing T2 Diabetes, and lifestyle changes that can be made to reduce their risk. Intervention 2: ACT plus Education (ACT/ED) This intervention protocol was based on an existing protocol developed by Gregg and colleagues (Gregg et al., 2007) for client’s with type 2 diabetes, which was modified for patients with pre-diabetes. Session one of this covered the same areas as the ED Only intervention but in a condensed form. Session two explored participants' personal values related to managing pre-diabetes; helped them connect these values to concrete behavioural goals; and taught them skills to deal with thoughts and feelings that functioned as barriers to attaining/maintaining lifestyle changes to improve their health. Session 2 involved teaching (through a combination of didactic methods, metaphor, and experiential exercises) core ACT therapeutic processes: values, self as context, defusion, acceptance, contact with the present moment, values, and committed action. The examples and/or metaphors used were tailored to issues identified in the literature to be relevant for individuals with pre-diabetes. For the ACT/ED and ED Only interventions, a PowerPoint presentation accompanied the facilitator manual. This presentation was adapted from an existing pre-diabetes workshop developed by Kauri Health (a local integrated family heath centre), reviewed and updated by Manawatu/Horowhenua Diabetes Trust, and endorsed by a Diabetes Lifestyle Centre Nurse Practitioner with MidCentral District Health). The PowerPoint was based on pre-diabetes advice/guidelines for the lifestyle management of pre-diabetes published by the New Zealand Ministry of Health (2013). This PowerPoint was previously used by the Manawatu Diabetes Trust in workshops for consumers with pre-diabetes. Group guides were provided to participants during both ACT/ED and ED Only workshops to facilitate effective learning. The group guides contained all of the PowerPoint slides shown during the workshops, the key messages presented by the facilitators, and the handouts and exercises used. During the workshops, all participants also received a Diabetes New Zealand portion size plate, a wallet-sized food label reading card, a calorie and fat counter (Borushek, 2014), and carbohydrate counting cards. These tools were designed to facilitate ongoing learning post-intervention. Additionally, at the start of the first workshop, all participants were given an information pack containing seven pamphlets created by Diabetes New Zealand. These were the same pamphlets given to participants in the Standard Care condition (see below). Treatment fidelity The use of a treatment manual, which specified the duration and timing of the intervention components and provided sample dialogue to assist facilitators with information delivery, was intended to increase treatment fidelity and consistency. In addition, the primary researcher was a co-facilitator of the workshops, which allowed her to monitor the dietician’s consistency with and adherence to the manual.

Sponsors

Massey University Psychology Department, Palmerston North
Lead SponsorUniversity

Study design

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

Eligibility

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

Inclusion criteria

Inclusion criteria required that patients were: 1. Over the age of 18 2. Fluent in spoken and written English 3. Had a formal classification of pre-diabetes from a registered medical professional. The prediabetes inclusion criteria were based on World Health Organisation (WHO) criteria for pre-diabetes classification. This requires patients to have an impaired fasting glucose (IFG between 6.1 and 6.9 mmol-1 inclusive) and an impaired glucose tolerance (IGT 2 hour postprandial glucose concentration between 7.8 and 11 mmol), and/or an HbA1c between 41 and 49.

Exclusion criteria

1. Cognitively impaired. 2. At risk of harm to/from themselves or others (i.e., suicidal/homicidal ideation). 3. Comorbid medical diagnosis or condition that is terminal and likely to be fatal within one year. 4. Already participating in a formal pre-diabetes lifestyle education intervention. 5. Receiving psychiatric or psychological intervention at the time of recruitment or has a severe psychiatric disorder (e.g., schizophrenia). 6. Meets criteria for type 2 diabetes. Again, this is based on WHO criteria (i.e., IFG greater than or equal to 7mmol/l, and/or 2-hour plasma glucose of greater than or equal to 11.1 mmol/l and/or HbA1c of 50 mmol/l or greater).

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026