Lighten Up weight maintenance study

ISRCTN	ISRCTN52341938
DOI	https://doi.org/10.1186/ISRCTN52341938
Protocol serial number	Protocol 1
Sponsor	University of Birmingham (UK)
Funder	Public Health Research Programme Reference: 12/179/09

Submission date: 18/02/2014
Registration date: 31/03/2014
Last edited: 04/03/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Dr Amanda Daley
Scientific

University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom

Email	a.daley@bham.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Lighten Up weight maintenance study: a randomised controlled trial
Study acronym	LIMIT
Study objectives	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(s)	University of Birmingham
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Mean weight change at 12 months follow up.
Key secondary outcome measure(s)	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.
Completion date	31/03/2017

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	560
Total final enrolment	583
Key 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.
Key exclusion criteria	1. Unable to understand English 2. Women who are known to be pregnant or intending to become pregnant during the study
Date of first enrolment	01/04/2014
Date of final enrolment	31/03/2017

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

University of Birmingham

Birmingham
B15 2TT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2019	04/03/2021	Yes	No
Protocol article	protocol	04/06/2015		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

04/03/2021: Publication reference and total final enrolment added.
11/12/2018: No publications found, verifying study status with principal investigator.
13/01/2016: Publication reference added.