Condition category
Nutritional, Metabolic, Endocrine
Date applied
26/11/2012
Date assigned
18/12/2012
Last edited
15/02/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 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.

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

Trial website

Contact information

Type

Scientific

Primary contact

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 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

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

Trial setting

Other

Trial 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 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.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/01/2013

Overall trial end date

30/06/2014

Reason abandoned

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

Patient

Age group

Adult

Gender

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

United Kingdom

Trial 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
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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26867588

Publication citations

Additional files

Editorial Notes

15/02/2016: Publication reference added.