ISRCTN ISRCTN22806944
DOI https://doi.org/10.1186/ISRCTN22806944
Secondary identifying numbers 16328
Submission date
08/01/2015
Registration date
09/01/2015
Last edited
17/08/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Arie Nouwen
Scientific

Middlesex University
Department of Psychology
The Burroughs
Hendon
NW4 4BT
United Kingdom

Study information

Study designRandomised; Interventional
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleDoes neurocognitive training have the potential to improve dietary self-care in type 2 diabetes?
Study objectivesMany 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(s)14/WM/0056; First MREC approval date 11/07/2014
Health condition(s) or problem(s) studiedTopic: Diabetes, Cardiovascular disease; Subtopic: Type 2, Cardiovascular (all Subtopics); Disease: Diabetic Control, Other
InterventionWorking 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 typeOther
Primary outcome measureWorking memory capacity (trained tasks)
Secondary outcome measuresN/A
Overall study start date01/11/2014
Completion date01/12/2016

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsPlanned Sample Size: 48; UK Sample Size: 48
Total final enrolment81
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/11/2014
Date of final enrolment01/12/2016

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Middlesex University
Department of Psychology
The Burroughs
Hendon
NW4 4BT
United Kingdom

Sponsor information

Middlesex University (UK)
Hospital/treatment centre

Department of Psychology
The Burroughs
Hendon
NW4 4BT
England
United Kingdom

ROR logo "ROR" https://ror.org/01rv4p989

Funders

Funder type

Charity

Diabetes UK
Private sector organisation / Trusts, charities, foundations (both public and private)
Alternative name(s)
DIABETES UK LIMITED, British Diabetic Association
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 01/12/2015 17/08/2020 Yes No
Results article results 01/09/2018 17/08/2020 Yes No
HRA research summary 28/06/2023 No No

Editorial Notes

17/08/2020: The following changes have been made:
1. Publication references added.
2. The final enrolment number has been added from the reference.
16/06/2016: Plain English summary added.