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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT02985307
Other study ID # 16/SS/0200
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date April 28, 2017
Est. completion date December 1, 2019

Study information

Verified date March 2019
Source NHS Lothian
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study evaluates the efficacy of a mobile telehealth short message service as a facilitator for weight management. Half of the participants will receive a standard care weight management group intervention, while the other half will receive daily text messages via their mobile phone to help facilitate weight loss. It is hypothesized that the intervention group receiving text messages will be as successful as the control group at achieving weight loss over a 3-month period.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 120
Est. completion date December 1, 2019
Est. primary completion date October 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Short Message Text Service
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.
Standard Weight Management Group
A standard Lothian NHS group programme facilitated by a Dietitian

Locations

Country Name City State
United Kingdom Elizabeth McAnally Edinburgh West Lothian
United Kingdom NHS Lothian Edinburgh West Lothian

Sponsors (2)

Lead Sponsor Collaborator
NHS Lothian Queen Margaret University

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Patrick K, Raab F, Adams MA, Dillon L, Zabinski M, Rock CL, Griswold WG, Norman GJ. A text message-based intervention for weight loss: randomized controlled trial. J Med Internet Res. 2009 Jan 13;11(1):e1. doi: 10.2196/jmir.1100. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Weight Loss weight recorded in Kg on a Seca 635 medical digital load cell balance 3 months
Secondary Behavioural changes necessary for weight loss Self reported dietary and physical activity changes using 7-day food and exercise diaries 3 months
Secondary Body fat changes Measured using a medically approved and validated scale: Tanita SC-240MA body composition analyser 3 months
Secondary Body Mass index calculated using the formula weight in kg divided by height squared in metres 3 months
Secondary Height Height measured using Seca portable stadiometer with a sliding head plate 3months
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