Condition category
Nutritional, Metabolic, Endocrine
Date applied
18/02/2014
Date assigned
31/03/2014
Last edited
13/01/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
There are a range of programmes that help people to lose weight, however most people tend to put weight back on. We need to find simple strategies that we can give to the public to help them maintain their weight, that are also cost effective. One simple strategy may be to ask people to weigh themselves on a daily basis to identify changes in their weight. The aim of this study is to investigate the effect of a brief intervention focused on self-weighing on weight change compared to a usual care group.

Who can participate?
Only people that have taken part in the Birmingham Lighten Up weight loss service, have been weighed at least once during weeks 9-12 of the 12 weeks and have lost at least 5% of their starting weight at the end of their weight loss programme. They must be 18 years or more and own a mobile phone or landline phone that can receive SMS text messages.

What does the study involve?
Participants will be randomly allocated to one of two groups: usual care group or intervention group. The usual care group will receive a hints and tips leaflet about weight maintenance behaviours. The intervention group will receive the same hints and tips leaflets, weighing scales, and will also receive support telephone calls at weeks zero, two and four, that encourage daily self-weighing, together with reminder text messages every other day for the first four weeks, reducing to twice weekly thereafter. Both groups will be weighed at the start f the study, three and 12 months and asked to complete brief questionnaires.

What are the possible benefits and risks of participating?
We cannot promise that participants will maintain weight loss, but similar programmes have helped people in the past. We do not predict any risks or side-effects from the weight maintenance programmes offered in this study. Should participants become pregnant during the study they should no longer take part in the study.

Where is the study run from?
The study is run from the University of Birmingham in partnership

When is the study starting and how long is it expected to run for?
April 2014 to March 2017

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Dr Amanda Daley
a.daley@bham.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Amanda Daley

ORCID ID

Contact details

University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
-
a.daley@bham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Protocol 1

Study information

Scientific title

Lighten Up weight maintenance study: a randomised controlled trial

Acronym

LIMIT

Study hypothesis

The primary aim of this study is to evaluate the effectiveness and cost effectiveness of a brief behavioural intervention delivered by non specialist staff to promote regular self weighing to prevent weight regain after intentional weight loss. The intervention will be compared with usual care.

Ethics approval

University of Birmingham

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Weight management

Intervention

Usual care group
The usual care group will receive the standard Lighten Up maintenance leaflet sent to their home address. The leaflet is very brief with some advice prepared by NHS Birmingham. It mostly consists of a series of bullet points. Other than for follow up, there will be no other contact with the usual care group.

Intervention group
Participants will receive a set of weighing scales and instructed to weigh themselves daily and record it on the record card provided. Participants will also receive three follow-up calls at zero, two and four weeks to encourage self-weighing. They will also receive reminder text messages every other day for the first four weeks, reducing to twice weekly thereafter

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Mean weight change at 12 months follow up.

Secondary outcome measures

1. The proportion of participants in the intervention and usual care groups who regain less than 1 kg from their weight at the end of the weight loss programme at three and 12 month follow up.
2. Mean weight change at three months (post maintenance intervention) follow up.
3. The cost to the NHS per kg, and per kg/m2, of the additional weight loss maintained for the intervention compared to usual care at 12 months, the cost per quality adjusted life years (QALY) during the intervention period and cost per predicted lifetime QALYs gained.
4. The occurrence of adverse effects including uncontrolled eating, emotional eating and weight preoccupation.

Overall trial start date

01/04/2014

Overall trial end date

31/03/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 years or more.
2. People who have attended and therefore been weighed at their Lighten Up weight loss programme at least once during weeks 9-12 of the 12 week programme.
3. People who have lost at least 5% of their starting weight at the end of their weight loss programme. This can be later verified objectively as all participants are weighed by service providers at the start and end of their weight loss programme.
4. Own a mobile phone or landline phone that can receive SMS text messages.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

560 participants

Participant exclusion criteria

1. Unable to understand English
2. Women who are known to be pregnant or intending to become pregnant during the study

Recruitment start date

01/04/2014

Recruitment end date

31/03/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Birmingham
Birmingham
B15 2TT
United Kingdom

Sponsor information

Organisation

University of Birmingham (UK)

Sponsor details

University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
-
resgoviras@lists.bham.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

NIHR (UK) - Public Health Research funding. Reference: 12/179/09

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

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26041653

Publication citations

Additional files

Editorial Notes

13/01/2016: Publication reference added.