Prohealth@Home: A Feasibility Study Investigating the Use of a Lifestyle App in People at Risk of Type 2 Diabetes
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|ClinicalTrials.gov Identifier: NCT02450500|
Recruitment Status : Completed
First Posted : May 21, 2015
Last Update Posted : April 25, 2016
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
|Condition or disease||Intervention/treatment||Phase|
|Pre-diabetes||Behavioral: Lifestyle counselling||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prohealth@Home: A Feasibility Study Investigating the Application of a Web Based Lifestyle App to Improve Glycaemic Control by Changing Dietary and Activity Behaviours in Individuals at High Risk of Type 2 Diabetes|
|Study Start Date :||March 2015|
|Actual Primary Completion Date :||February 2016|
|Actual Study Completion Date :||February 2016|
Experimental: Lifestyle counselling
This will consist of a web-based lifestyle app and personalised behaviour modification advice by a registered dietitian delivered via messaging.
Behavioral: Lifestyle counselling
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.
- Participants acceptability of intervention by focus group [ Time Frame: 6 months ]Participants will be invited to attend a focus group at the end of the 6 month intervention period
- Blood biochemistry (HbA1c, FBG, Lipids, LFT) by blood test [ Time Frame: 6 months ]The blood test will be taken by a practice nurse at the GP practices and sent off for analysis as per normal protocol
- Body weight and height to BMI and waist circumference by anthropometric measures [ Time Frame: 6 months ]Anthropometric measures will be taken by the research assistant
- Blood pressure by sphygmomanometer [ Time Frame: 6 months ]A practice nurse will take the blood pressure measurements
- Health status, well being, food intake and exercise levels by questionnaires [ Time Frame: 6 months ]A number of questionnaires will be used to assess these parameters
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02450500
|University of Plymouth|
|Plymouth, United Kingdom, PL6 8BH|
|Principal Investigator:||Avril Collinson, PhD||University of Plymouth|