Prohealth@Home: A Feasibility Study Investigating the Use of a Lifestyle App in People at Risk of Type 2 Diabetes

NCT02450500 | Completed

• 1 other identifier: 14/SW/1047
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

More than a third of the adult population in England have prediabetes, a condition that occurs when glucose levels are higher than normal but not high enough to be diagnosed as diabetes. Between 5 and 10% of people with prediabetes will go on to develop diabetes each year. Lifestyle (diet and activity) interventions have been shown to reduce the risk of prediabetes progressing to Type 2 diabetes. However, in practice high levels of professional support coupled with increasing incidence of prediabetes are not sustainable in their current format. The internet has the potential to provide an alternative means of supporting large numbers of individuals in making lifestyle changes. However, provision of information on its own is not enough to engage individuals to change - additional support via personalised feedback is required to sustain the level of motivation needed for long term behaviour change. AIM: The investigators hypothesis is that communicating with individuals at high risk of Type 2 diabetes via a web-based lifestyle app will lead to changes in lifestyle behaviours resulting in an improved glycaemic control and reduction in diabetes risk. METHOD: The study will be conducted over 6 months. Patients identified in GP practice who are at high risk of developing diabetes will be invited to take part in this feasibility study. Intervention (6 months): This will consist of a web-based lifestyle app and personalised behaviour modification advice delivered via messaging by a dietitian. Participants will also be issued with a pedometer. Data on the dietary intake and activity levels will be collected on the web-based lifestyle app. Contact between the dietitian and participants will consist of weekly messaging to facilitate changes in diet and activity behaviour through motivational and cognitive behavioural strategies. Blood biochemistry (HbA1c, FBG, LFT's and lipids), BP, weight, BMI, and waist circumference will be measured at 0, 3 and 6 months. The blood test will be taken by a practice nurse at the GP practices and sent off for analysis. A 5 day food diary, well-being and activity questionnaires will be collected at 0, 3 and 6 months by the researcher. At the end of the intervention period, participants will be invited to attend a focus group to assess participants' perceptions/ease of use and barriers to use of the technology employed to assist behaviour change

Conditions

Pre-diabetes

Outcome Measures

Primary Outcomes (1)

• Participants acceptability of intervention by focus group

  Participants will be invited to attend a focus group at the end of the 6 month intervention period

  6 months

Secondary Outcomes (4)

• Blood biochemistry (HbA1c, FBG, Lipids, LFT) by blood test

  6 months

• Body weight and height to BMI and waist circumference by anthropometric measures

  6 months

• Blood pressure by sphygmomanometer

  6 months

• Health status, well being, food intake and exercise levels by questionnaires

  6 months

Study Arms (1)

Lifestyle counselling

EXPERIMENTAL

This will consist of a web-based lifestyle app and personalised behaviour modification advice by a registered dietitian delivered via messaging.

Behavioral: Lifestyle counselling

Interventions

Lifestyle counselling BEHAVIORAL

This will consist of a web-based lifestyle app and personalised behaviour modification advice by a registered dietitian delivered via messaging. Participants will be issued with a pedometer and instructed to wear this daily. Participants will access web-based material on prediabetes through the lifestyle app. Contact between the dietitian and participants will consist of weekly messaging to facilitate changes in diet and activity behaviour through motivational and cognitive behavioural strategies. Changes in diet and activity levels will be recorded as personalised goals which will be monitored and reviewed by both the participants and dietitian. In addition participants will be encouraged to complete a food diary to self-monitor their progress against dietary recommendations.

Lifestyle counselling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with prediabetes
• years or over
• Access to the internet and a computer/ipad or smart phone

You may not qualify if:

• Diabetes (Type 1 or Type 2)
• Less than 18 years of age
• Treated with metformin
• Mental health problems
• Pregnant
• Following a special diet
• Already participating in another study
• No internet access, computer/ipad or smart phone

Sponsors & Collaborators

• University of Plymouth: lead

Study Sites (1)

University of Plymouth

Plymouth, PL6 8BH, United Kingdom

Location

Related Publications (11)

• Penn L, White M, Lindstrom J, den Boer AT, Blaak E, Eriksson JG, Feskens E, Ilanne-Parikka P, Keinanen-Kiukaanniemi SM, Walker M, Mathers JC, Uusitupa M, Tuomilehto J. Importance of weight loss maintenance and risk prediction in the prevention of type 2 diabetes: analysis of European Diabetes Prevention Study RCT. PLoS One. 2013;8(2):e57143. doi: 10.1371/journal.pone.0057143. Epub 2013 Feb 25.

  PMID: 23451166 BACKGROUND

• Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.

  PMID: 1593914 BACKGROUND

• Johnson M, Jones R, Freeman C, Woods HB, Gillett M, Goyder E, Payne N. Can diabetes prevention programmes be translated effectively into real-world settings and still deliver improved outcomes? A synthesis of evidence. Diabet Med. 2013 Jan;30(1):3-15. doi: 10.1111/dme.12018.

  PMID: 22998334 BACKGROUND

• Mainous AG 3rd, Tanner RJ, Coates TD, Baker R. Prediabetes, elevated iron and all-cause mortality: a cohort study. BMJ Open. 2014 Dec 11;4(12):e006491. doi: 10.1136/bmjopen-2014-006491.

  PMID: 25500370 BACKGROUND

• Al-Janabi H, Flynn TN, Coast J. Development of a self-report measure of capability wellbeing for adults: the ICECAP-A. Qual Life Res. 2012 Feb;21(1):167-76. doi: 10.1007/s11136-011-9927-2. Epub 2011 May 20.

  PMID: 21598064 BACKGROUND

• Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.

  PMID: 12900694 BACKGROUND

• Hajos TR, Pouwer F, Skovlund SE, Den Oudsten BL, Geelhoed-Duijvestijn PH, Tack CJ, Snoek FJ. Psychometric and screening properties of the WHO-5 well-being index in adult outpatients with Type 1 or Type 2 diabetes mellitus. Diabet Med. 2013 Feb;30(2):e63-9. doi: 10.1111/dme.12040.

  PMID: 23072401 BACKGROUND

• Tabak AG, Herder C, Rathmann W, Brunner EJ, Kivimaki M. Prediabetes: a high-risk state for diabetes development. Lancet. 2012 Jun 16;379(9833):2279-90. doi: 10.1016/S0140-6736(12)60283-9. Epub 2012 Jun 9.

  PMID: 22683128 BACKGROUND

• Nes AA, Eide H, Kristjansdottir OB, van Dulmen S. Web-based, self-management enhancing interventions with e-diaries and personalized feedback for persons with chronic illness: a tale of three studies. Patient Educ Couns. 2013 Dec;93(3):451-8. doi: 10.1016/j.pec.2013.01.022. Epub 2013 Feb 21.

  PMID: 23433735 BACKGROUND

• Estabrooks PA, Nelson CC, Xu S, King D, Bayliss EA, Gaglio B, Nutting PA, Glasgow RE. The frequency and behavioral outcomes of goal choices in the self-management of diabetes. Diabetes Educ. 2005 May-Jun;31(3):391-400. doi: 10.1177/0145721705276578.

  PMID: 15919639 BACKGROUND

• Harris J, Felix L, Miners A, Murray E, Michie S, Ferguson E, Free C, Lock K, Landon J, Edwards P. Adaptive e-learning to improve dietary behaviour: a systematic review and cost-effectiveness analysis. Health Technol Assess. 2011 Oct;15(37):1-160. doi: 10.3310/hta15370.

  PMID: 22030014 BACKGROUND

Related Links

• Preventing type 2 diabetes: risk identification and interventions for individuals at high risk \[PH38\]

MeSH Terms

Conditions

Glucose Intolerance

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Avril Collinson, PhD

  University of Plymouth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor/Programme Lead BSc (Hons) Dietetics

Study Record Dates

• First Submitted: May 13, 2015
• First Posted: May 21, 2015
• Study Start: March 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: April 25, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)