Condition category
Nutritional, Metabolic, Endocrine
Date applied
10/08/2016
Date assigned
17/08/2016
Last edited
10/08/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Being obese (very overweight) can increase significantly the risk of serious diseases such as diabetes, heart disease, cancer and stroke. Studies show that many people gain weight over the Christmas period (average gain 0.5-1.0 kg per holiday) which is then not lost again once the holidays are over. . This could mean that a person gains an extra 5-10kg over a ten year period. Whilst there is much publicity about holiday weight gain in the press, few studies address this problem. Many people gain weight over the holiday period because they typically eat a lot of high fat, high calorie food, snack a lot, are less physically active, drink more alcohol, eat more snacks, eat for longer periods and have easy access to food. People often feel holiday periods are a time where they can eat what they choose. There is a need therefore to investigate the effectiveness of simple, low-cost strategies to prevent people from gaining weight. The aims of this study are to assess whether a leaflet can prevent weight gain over the Christmas holiday period; to identify who is most likely to gain weight over Christmas; and to explore what causes people to gain weight.

Who can participate?
Healthy adults aged at least 18 with a BMI of 20.0 kg/m2 or more

What does the study involve?
Participants are randomly allocated to either the intervention (test) group or the usual care group. Those in the usual care group are given a standard information leaflet about healthy lifestyles. Those in the intervention group are given a leaflet that outlines key facts about gaining weight over Christmas and offers top tips to prevent it. This is not a study about dieting over Christmas, as this is unlikely to be acceptable to the public; rather, it is focused on raising awareness about the potential for holiday weight gain and suggests simple ways in which people can ensure a reasonable balance between calories consumed (eaten) and calories burned. The goal is for participants to gain no more than 0.5 kg. Participants are weighed before and after Christmas. Up to 20 participants from the intervention group are also interviewed about their experiences of the study to gain detailed feedback on the strategies used to maintain their weight over Christmas and any barriers they have experienced.

What are the possible benefits and risks of participating?
Potential benefits include prevention of weight gain during Christmas. There are no known risks.

Where is the study run from?
University of Birmingham (UK)

When is the study starting and how long is it expected to run for?
September 2016 to August 2019

Who is funding the study?
University of Birmingham (UK)

Who is the main contact?
Frances Mason

Trial website

Contact information

Type

Public

Primary contact

Mrs Frances Mason

ORCID ID

Contact details

Dept. of Primary Care Clinical Sciences
College of Medical and Dental Sciences
University of Birmingham
Birmingham
B15 2TT
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

160673

Study information

Scientific title

Efficacy of a brief public health intervention to prevent weight gain during the Christmas holiday period: randomised controlled trial and nested qualitative study.

Acronym

WWW

Study hypothesis

The research has several aims:

1. To assess whether a brief low cost intervention can prevent weight gain over the Christmas holiday period
2. To identify who is most susceptible to weight gain over Christmas
3. Explore determinants of weight gain through a secondary analysis of the trial data
4. Understand participants’ experiences and thoughts about conscious energy restraint and energy expenditure at Christmas through semi structured interviews

Ethics approval

University of Birmingham Science, Technology, Engineering and Mathematics Ethical Review Committee, 28/07/2016, ref: ERN_16_0673

Study design

Randomised controlled trial and a qualitative study.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Home

Trial type

Prevention

Patient information sheet

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

Condition

Obesity and overweight

Intervention

Participants will be recruited from community pharmacies, schools (parents) and supermarkets prior to Christmas. They will be randomised to either the intervention or the usual care group.

1. Intervention group: receive a leaflet that outlines key facts about Christmas holiday weight gain and offers top tips (‘Ten Top Tips’ leaflet) to prevent weight gain on holiday. The top ten tips leaflet has already been shown to be effective in community settings and needs minor amendments for use here.
2. Control group: receive an information leaflet about healthy lifestyles.

This is not a study about dieting over Christmas, which would be very unlikely to be acceptable to the public; rather, it is focused on raising awareness about the potential for holiday weight gain and will suggest simple ways in which people can ensure reasonable energy balance, given many never lose the weight gained over Christmas.

The behavioural goal will be for participants to gain no more than 0.5kg of their baseline weight. The primary outcome is change in weight. Participants will be weighed before and after Christmas (follow up). 284 participants will provide 80% power to detect 0.75kg (SD=2.0) difference in weight change between the groups.
Up to 20 participants from the intervention group will be interviewed about their experiences of the study to gain detailed feedback on the behavioural/cognitive strategies used to maintain their weight over Christmas and any barriers they may experienced.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Change in weight from baseline (mid-late November) to follow up (mid-January – early February)

Secondary outcome measures

1. Proportion of participants in both groups who have gained ≤ 0.5 kg at follow up
2. Frequency of self-weighing in the previous two weeks (using a single item measure)
3. Change in percentage body fat (measured at baseline – follow up by bioelectrical impedance)

Overall trial start date

26/09/2016

Overall trial end date

01/08/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 years or more
2. BMI 20.0 kg/m2 or more

Participant type

All

Age group

Adult

Gender

Both

Target number of participants

284

Participant exclusion criteria

1. Unable to understand English sufficiently to provide written informed consent
2. Women who are known to be pregnant or intending to become pregnant during the study period
3. Women who are breastfeeding

Recruitment start date

01/10/2016

Recruitment end date

14/12/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Birmingham
Department of Primary Care Clinical Sciences College of Medical and Dental Sciences
Birmingham
B15 2TT
United Kingdom

Sponsor information

Organisation

University of Birmingham

Sponsor details

Dept. of Primary Care Clinical Sciences
College of Medical and Dental Sciences
Birmingham
B15 2TT
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Not defined

Funder name

School of Medicine, PhD Studentship award, University of Birmingham

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

To be confirmed at a later date.

Intention to publish date

01/08/2020

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes