Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 79 of 660 for:    applied AND web-

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02450500
Recruitment Status : Completed
First Posted : May 21, 2015
Last Update Posted : April 25, 2016
Sponsor:
Information provided by (Responsible Party):
Avril Collinson, University of Plymouth

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


Condition or disease Intervention/treatment Phase
Pre-diabetes Behavioral: Lifestyle counselling Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Blood pressure by sphygmomanometer [ Time Frame: 6 months ]
    A practice nurse will take the blood pressure measurements

  4. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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


Locations
Layout table for location information
United Kingdom
University of Plymouth
Plymouth, United Kingdom, PL6 8BH
Sponsors and Collaborators
University of Plymouth
Investigators
Layout table for investigator information
Principal Investigator: Avril Collinson, PhD University of Plymouth

Additional Information:
Publications:

Layout table for additonal information
Responsible Party: Avril Collinson, Associate Professor/Programme Lead BSc (Hons) Dietetics, University of Plymouth
ClinicalTrials.gov Identifier: NCT02450500     History of Changes
Other Study ID Numbers: 14/SW/1047
First Posted: May 21, 2015    Key Record Dates
Last Update Posted: April 25, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Participants will be provided with their biochemical results from their GPs and have access to dietary, weight and activity data through the lifestyle app.

Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Prediabetic State
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia