Condition category
Nutritional, Metabolic, Endocrine
Date applied
24/07/2012
Date assigned
09/08/2012
Last edited
05/12/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
There is a public health need to find interventions that can be used by health professionals to help patients lose weight and limit weight regain. One simple and sustainable way could be to suggest to obese patients that they weigh themselves regularly and record their weight. Patients can then use this information to set themselves appropriate weight loss targets. There has been no published study of self-weighing as a standalone intervention in obese patients so it is important to investigate this question further. The primary aim of this study is to investigate the effectiveness of regular (daily) self-weighing on weight loss in obese primary care patients after three months compared to a comparator group. If the intervention proves successful at 3 months, a secondary aim is to assess the effectiveness of the regular weighing intervention at 12 months.

Who can participate?
People aged over 18 years with a BMI greater than 30 kg/m2 can participate.

What does the study involve?
Participants will be randomly allocated to either the intervention group or the comparator group. Both groups will receive two consultations about weight management strategies and asked to complete a food diary at the first consultation. This food diary will then be reviewed at the second consultation. In addition, the intervention group will receive a set of weighing scales and asked to weigh themselves daily and record it on a card provided. They will also get weekly text reminders encouraging them to weigh themselves every day. Participants will complete three questionnaires at the start of the study, after 3 months and after 12 months. Height and weight will be measured at these time points.

What are the possible benefits and risks of participating?
The possible benefits for participants are weight loss and improvements in health and well-being. There are no foreseeable risks from participating in the trial.

Where is the study run from?
Patients will be recruited through GP practices in South Birmingham primary care trust and Birmingham East and North primary care trust via letter sent to their home address inviting them to contact the research team. The study is run from the University of Birmingham but the interventions will take place at participating general practices.

When is the study starting and how long is it expected to run for?
The study is starting in August 2012 and is expected to finish by December 2013.

Who is funding the study?
National Institute of Health Research (NIHR) (UK).

Who is the main contact?
Claire Madigan
cdm153@bham.ac.uk  

Trial website

Contact information

Type

Scientific

Primary contact

Miss Claire Madigan

ORCID ID

Contact details

The University of Birmingham
Primary Care Clinical Sciences
Edgbaston
Birmingham
B15 2TT
United Kingdom
+44 (0)121 414 8067
cdm153@bham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

12/WM/0137

Study information

Scientific title

The efficacy of self-weighing as a weight loss intervention: randomised controlled trial

Acronym

Study hypothesis

To investigate the efficacy of regular (daily) self-weighing on weight loss in obese primary care patients at three months (end of intervention), relative to a comparator group.

Ethics approval

NRES Committee West Midlands - Edgbaston, Birmingham, 31 May 2012, ref: 12/WM/0137

Study design

Two arm pragmatic randomised controlled trial (individual randomisation) with participants allocated to daily self-weighing or comparator group.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Screening

Patient information sheet

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

Condition

Weight management

Intervention

At baseline (visit 1), participants will receive a brief consultation to discuss weight management tips; which would be similar to a consultation that a GP or practice nurse might offer. Participants will also receive a booklet detailing weight management tips adapted from the Department of Health publication, Your Weight, Your Health. We will ask participants to complete a four day food diary and this will be discussed with the researcher one week later (i.e. at visit 2). There are two reasons for doing this. We want to make sure participants are weighing themselves daily and that they can identify potential changes that could be made to their diet.

Participants will also receive a leaflet, and have a discussion about the potential benefits of daily self-weighing within the consultation. Participants will be given a set of weighing scales and instructed to weigh themselves daily and record their weight on the report card provided. As this is an efficacy trial it is important to ensure participants weigh themselves daily and therefore brief weekly text message reminders will be sent to participants. At visit 2 the frequency of participants self-weighing over the previous week will be discussed. Those not weighing themselves daily will be further encouraged to do so and given ideas/strategies of how they might implement (frequent) self weighing into their everyday lives (e.g. using social support and cues to action). The benefits of self-weighing will be reiterated. Participants will be advised they should aim to lose 0.5 kg of body weight per week.

The comparator group will receive the same consultations as the intervention group as described above but there will be no mention or encouragement of daily self-weighing.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Weight change between baseline and three months

Secondary outcome measures

1. The difference in weight change from baseline to 12 months between the groups (subject to the results at 3 months)
2. The difference in physical activity, quality of life, and weight management strategies between the groups

Overall trial start date

01/08/2012

Overall trial end date

31/12/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients must be aged >18 years
2. Have a raised BMI of >30 kg/m2
3. Considered suitable to participate by their GP

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

216 participants

Participant exclusion criteria

1. Pregnant or intending to fall pregnant within the study time period
2. Cannot understand or speak English sufficiently to undertake the tasks of the study
3. Currently attending a weight management programme (including pharmacotherapy or bariatric surgery) or has taken part in a formal weight management programme in the previous three months
4. Currently weigh them self at least once per week

Recruitment start date

01/08/2012

Recruitment end date

31/12/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The University of Birmingham
Birmingham
B15 2TT
United Kingdom

Sponsor information

Organisation

University of Birmingham (UK)

Sponsor details

c/o Dr Brendan Laverty
Edgbaston
Birmingham
B15 2TT
United Kingdom
+44 (0)121 414 7618
b.w.laverty@bham.ac.uk

Sponsor type

University/education

Website

http://www.rcs.bham.ac.uk/governance/app/index.shtml

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

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

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25301251

Publication citations

  1. Results

    Madigan CD, Jolly K, Lewis AL, Aveyard P, Daley AJ, A randomised controlled trial of the effectiveness of self-weighing as a weight loss intervention., Int J Behav Nutr Phys Act, 2014, 11, 125, doi: 10.1186/s12966-014-0125-9.

Additional files

Editorial Notes