- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02985307
Impact of Mobile Phone Texting Service to Support Weight Loss (SMS)
Efficacy of Mobile Telehealth Short Message Service (SMS) as a Facilitator for Weight Management: A Randomised Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Obesity, a chronic progressive disease, has become a major public health concern due to its increasing prevalence and association with many adverse health conditions including type 2 diabetes, many cancers and heart disease. The number of individuals requiring weight management intervention is increasing necessitating the need to explore other initiatives.
Developments in health technology are growing in popularity and there is increasing evidence that this type of intervention for obesity can significantly improve clinical outcomes. Mobile phones are a popular means of communication that provide a convenient, inexpensive means to deliver a health technology intervention.Short message service (SMS) by mobile phone has the potential to serve as an intervention medium to promote weight loss that is accessible and easy to use.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
West Lothian
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Edinburgh, West Lothian, United Kingdom, EH49 6SJ
- Elizabeth McAnally
-
Edinburgh, West Lothian, United Kingdom, EH54 6PP
- NHS Lothian
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Body mass index > 35kg/m requiring to lose weight for an operation or having a co-morbidity including diabetes, osteoarthritis, high cholesterol, asthma, heart disease, high blood pressure or sleep apnoea or with a body mass >40kg/m with no co-morbidities.
- Own a mobile phone
- Have the ability to use short message service
- Have access to weighing scales
- Mentally capable of informed consent
- Have the ability to read and speak English
Exclusion Criteria:
- Uncontrolled Hypothyroidism
- Poorly controlled psychiatric illness
- Current alcohol or drug abuse
- Learning disability
- Do not own a mobile phone
- Do not have access to weighing scales
- Does not have the ability to read or speak English
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Short Message Text Service
Participants receive short messages daily via their mobile phone
|
A service designed by professionals inside the National Health Service (NHS) to provide support and advice for participants to manage weight loss.
It combines the expertise of the healthcare team and the convenience of the participant's own mobile phone to give prompts and advice to act on.
It makes use of the familiar and convenient mobile phone text service 'SMS' to communicate directly with participants.
|
Active Comparator: Standard Weight Management Group
Participants attend standard group weight management sessions
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A standard Lothian NHS group programme facilitated by a Dietitian
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight Loss
Time Frame: 3 months
|
weight recorded in Kg on a Seca 635 medical digital load cell balance
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Behavioural changes necessary for weight loss
Time Frame: 3 months
|
Self reported dietary and physical activity changes using 7-day food and exercise diaries
|
3 months
|
Body fat changes
Time Frame: 3 months
|
Measured using a medically approved and validated scale: Tanita SC-240MA body composition analyser
|
3 months
|
Body Mass index
Time Frame: 3 months
|
calculated using the formula weight in kg divided by height squared in metres
|
3 months
|
Height
Time Frame: 3months
|
Height measured using Seca portable stadiometer with a sliding head plate
|
3months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Douglas McBean, PhD, Queen Margaret University
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 16/SS/0200
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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