Plain English 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 studys 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.
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 (UK)
Who is the main contact?
Mr Manbinder Sidhu
m.s.sidhu@bham.ac.uk
Study website
Contact information
Type
Scientific
Contact name
Prof Kate Jolly
ORCID ID
Contact details
University of Birmingham
Public Health
Epidemiology and Biostatistics
School of Health and Population Sciences
College of Medical and Dental Sciences
Edgbaston
Birmingham
B15 2TT
United Kingdom
-
c.b.jolly@bham.ac.uk
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
Lighten Up Plus- V1
Study information
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
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.
Ethics approval(s)
South Birmingham Research Ethics Committee, 20/11/2012, 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.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Other
Study type
Quality of life
Patient information sheet
Participant information sheets disseminated in this study are available, on request, from Professor Kate Jolly, c.b.jolly@bham.ac.uk.
Condition
Treatment for people who are overweight/obese
Intervention
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 participants 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.
Intervention type
Other
Primary outcome measure
Difference between baseline weight and independently measured weight at nine months following randomisation.
Secondary outcome measures
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 9 months and percentage of people achieving 5% loss of body weight from the start of their Lighten Up programme.
Overall study start date
01/01/2013
Overall study end date
30/06/2014
Reason abandoned (if study stopped)
Eligibility
Participant 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).
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
522 participants
Participant 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
Recruitment start date
01/01/2013
Recruitment end date
30/06/2014
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
University of Birmingham
Birmingham
B15 2TT
United Kingdom
Sponsor information
Organisation
Birmingham and Solihull NHS Cluster (UK)
Sponsor details
Bartholomew House
142 Hagley Road
Edgbaston
Birminghm
B16 9PA
England
United Kingdom
Sponsor type
Hospital/treatment centre
Website
http://www.solihull.nhs.uk/About-us/Birmingham---Solihull-Cluster
Funders
Funder type
Hospital/treatment centre
Funder name
Birmingham and Solihull NHS Cluster (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 12/02/2016 | Yes | No |