ISRCTN47845106 - Evaluation of a text supported weight maintenance programme ‘Lighten Up Plus’ following a weight reduction programme in the ‘Lighten Up’ service in Birmingham.

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21 March 2013

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Evaluation of a text supported weight maintenance programme ‘Lighten Up Plus’ following a weight reduction programme in the ‘Lighten Up’ service in Birmingham.

ISRCTN	ISRCTN47845106
DOI	10.1186/ISRCTN47845106
ClinicalTrials.gov identifier
EudraCT number
Public title	Evaluation of a text supported weight maintenance programme ‘Lighten Up Plus’ following a weight reduction programme in the ‘Lighten Up’ service in Birmingham.
Scientific title	Evaluation of a text supported weight maintenance programme ‘Lighten Up Plus’ following a weight reduction programme: a randomised controlled trial.
Acronym	Lighten Up Plus
Serial number at source	Lighten Up Plus- V1
Study hypothesis	It is hypothesised that participants receiving text (SMS) support will maintain their weight or gain less weight compared to those receiving standard care. The null hypothesis is that there will be no difference between treatment groups.
Lay summary	Background and study aims: We are carrying out a study to measure the effectiveness of a service that is designed to help people maintain their weight after attending a weight loss programme. Our aim is to understand how a SMS-text messaging based weight maintenance programme to encourage self-weighing compares to a brief telephone supported programme in terms of weight change after 3 and 9 months after the end of the 12 week weight-loss programme. The study’s findings should help to improve the future design of interventions for overweight people. Who can participate? Participants who have completed the 12 week Lighten Up weight management programme aged over 18 years of age. What does the study involve? All participants eligible for the study will have attended a 12 week weight loss programme. Participants will be randomised to receive weekly text (SMS) based support encouraging weight maintenance or standard care (telephone support post weight loss intervention and information about effective weight maintenance strategies). Participants receiving text based support will be requested to send weight measurements by text. Data will be collected at 3 and 9 months. What are the possible benefits and risks of participating? Participants in either treatment arm will receive support to help maintain their current weight. There are no known risks in taking part in this study. Where is this study run from? University of Birmingham in collaboration with Birmingham and Solihull NHS Cluster. When is the study starting and how long is it expected to run for? Recruitment will begin in January 2013. Participants will be enrolled on the study for 9 months, and there will be a follow up period where intend to explore the attitudes of participants’ in relation to the support they received. Who is funding the study? Birmingham and Solihull NHS Cluster Who is the main contact? Mr Manbinder Sidhu m.s.sidhu@bham.ac.uk
Ethics approval	South Birmingham Research Ethics Committee, 20 November 2012, ref: 12/WM/0372
Study design	Randomised controlled trial with patients individually allocated to one of two weight maintenance programmes. Qualitative interviews will explore the experience of the intervention.
Countries of recruitment	United Kingdom
Disease/condition/study domain	Treatment for people who are overweight/obese
Participants - inclusion criteria	1. Aged≥18 2. People who have a final (week 12) weight recorded or attended the Lighten Up weight management service for a minimum of 9 sessions and have had a weight measured within the past 2 weeks 3. Has access to scales to weigh self 4. Owns a phone (mobile or land-line).
Participants - exclusion criteria	1. Unable to understand English 2. Women who are known to be pregnant 3. People who attended the My Choice pharmacy programme 4. Not willing to be randomised 5. People who have dropped out of the Lighten Up service prior to week 9
Anticipated start date	01/01/2013
Anticipated end date	30/06/2014
Status of trial	Ongoing
Patient information material	Participant information sheets disseminated in this study are available, on request, from Professor Kate Jolly, c.b.jolly@bham.ac.uk.
Target number of participants	522 participants
Interventions	Usual care: Telephone support at end of free weight loss programme and at 3 months with ‘hints and tips’ leaflet about effective weight maintenance strategies; Text intervention: usual care plus texts at weekly interventions. Texts will ask for the participant’s weight and will respond with one of three options: 1. Weight maintenance or weight loss from previous reported weight – congratulatory message and encouragement to keep up the good work; 2. Small gain for one or two weeks in succession – advice to be careful about diet and increase physical activity 3. Gain for three or more weeks in succession – offer of telephone support session The initial support session will be with a member of the call centre staff who will remind them about their strategies for weight loss. If they continue to gain weight they can then be referred on to a health trainer.
Primary outcome measure(s)	Difference between baseline weight and independently measured weight at nine months following randomisation.
Secondary outcome measure(s)	1. Self-reported weight loss at 3 months following randomisation, which will be collected by the Lighten Up call centre by telephone (or questionnaire for people not-contactable by phone) 2. BMI at nine months and percentage of people achieving 5% loss of body weight from the start of their Lighten Up programme.
Sources of funding	Birmingham and Solihull NHS Cluster (UK)
Trial website
Publications
Contact name	Prof Kate Jolly
Address	University of Birmingham Public Health, Epidemiology and Biostatistics School of Health and Population Sciences College of Medical and Dental Sciences Edgbaston
City/town	Birmingham
Zip/Postcode	B15 2TT
Country	United Kingdom
Email	c.b.jolly@bham.ac.uk
Sponsor	Birmingham and Solihull NHS Cluster (UK)
Address	Bartholomew House 142 Hagley Road Edgbaston
City/town	Birminghm
Zip/Postcode	B16 9PA
Country	United Kingdom
Sponsor website:	http://www.solihull.nhs.uk/About-us/Birmingham---Solihull-Cluster
Date applied	26/11/2012
Last edited	18/12/2012
Date ISRCTN assigned	18/12/2012


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