Plain English Summary
Background and study aims
Diabetes is a lifelong condition that causes a person's blood sugar level to become too high. Many people with diabetes report difficulty controlling their diet. The aim of this study is to investigate whether working memory training can help people with diabetes to better resist temptation and control their eating habits without adversely affecting quality of life. Known regions of the brain (subcortical regions) respond to tempting food cues. Frontal regions of the brain have control over these subcortical regions. Our working memory is located within the frontal brain regions, so training in working memory could improve control over subcortical responses to foods. A recent study supported this, finding reduced alcohol intake after working memory training in people with alcohol consumption problems. Working memory training could similarly enhance people’s ability to resist tempting foods. Ultimately, this could improve people’s health and quality of life.
Who can participate?
Patients aged between 18 and 70 with type 2 diabetes who are overweight, have poor control of their diabetes and report difficulty following their diet, but are otherwise in good health.
What does the study involve?
Participants are randomly allocated to receive either 25 sessions of web-based working memory training (where the complexity of the memory learning task is adjusted to reflect their level of competence) or placebo training (where only the lowest level of complexity is used). Before, after and at 3 months follow-up, participants’ height and weight are measured and blood tests are conducted. Participants also fill out questionnaires, complete a food diary, do a reaction time computer task involving images of food, and take part in a buffet lunch. Participants are interviewed to gain an understanding of their experience with the training. The working memory training can be completed at home, with participants attending the university for all test.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Middlesex University (UK)
When is the study starting and how long is it expected to run for?
November 2014 to December 2016
Who is funding the study?
Diabetes UK
Who is the main contact?
Dr Arie Nouwen
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
16328
Study information
Scientific title
Does neurocognitive training have the potential to improve dietary self-care in type 2 diabetes?
Acronym
Study hypothesis
Many people with diabetes report difficulty controlling their dietary intake, reducing their quality of life. The aim of this study is to investigate whether working memory training can help people with diabetes to better resist temptation and control their eating habits without adversely affecting quality of life.
Ethics approval
14/WM/0056; First MREC approval date 11/07/2014
Study design
Randomised; Interventional
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: Diabetes, Cardiovascular disease; Subtopic: Type 2, Cardiovascular (all Subtopics); Disease: Diabetic Control, Other
Intervention
Working memory training.
1. Intervention group:The training consists of 25 sessions of working memory training comprising three tasks: letter span task, backwards digit task, visuo-spatial task. In the letter span task, a sequence of letters is presented one at a time in a circle. Once the sequence has finished, one of the positions in the circle is cued and participants have to enter the letter that appeared in this location using the keyboard. In the backwards digit task, several numbers are presented on the screen one at a time, which par
2. Control group: Placebo training (lowest level of competence only)
Intervention type
Other
Phase
Drug names
Primary outcome measures
Working memory capacity (trained tasks)
Secondary outcome measures
N/A
Overall trial start date
01/11/2014
Overall trial end date
01/12/2016
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged between 18 and 70 years
2. Having type 2 diabetes for at least 2 years
3. Poor diabetes control (HbA1c >8.0mmol/l)
4. BMI= 25
5. Self-reported difficulty to follow a healthy diet;
6. Being in general good health
7. Treatment of diabetes by diet only or tablets
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 48; UK Sample Size: 48
Participant exclusion criteria
1. Neurological and psychiatric disorders including eating disorders and clinical depression
2. Alcohol and/or substance abuse
3. Treatment by insulin, GLP-1 or DPP-4 inhibitors
Recruitment start date
01/11/2014
Recruitment end date
01/12/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Middlesex University
Department of Psychology
The Burroughs
Hendon
NW4 4BT
United Kingdom
Funders
Funder type
Charity
Funder name
Diabetes UK
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary