Winter Weight Watch Study: Efficacy of a brief public health intervention to prevent weight gain during the Christmas holiday period

ISRCTN ISRCTN15071781
DOI https://doi.org/10.1186/ISRCTN15071781
Secondary identifying numbers 160673
Submission date
10/08/2016
Registration date
17/08/2016
Last edited
12/12/2018
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
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

Contact information

Mrs Frances Mason
Public

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

Study information

Study designRandomised controlled trial and a qualitative study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Home
Study typePrevention
Participant information sheet Not available in web format, please use the contact details to request a participant information sheet.
Scientific titleEfficacy of a brief public health intervention to prevent weight gain during the Christmas holiday period: randomised controlled trial and nested qualitative study
Study acronymWWW
Study objectivesThe 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(s)University of Birmingham Science, Technology, Engineering and Mathematics Ethical Review Committee, 28/07/2016, ref: ERN_16_0673
Health condition(s) or problem(s) studiedObesity and overweight
InterventionParticipants 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 typeBehavioural
Primary outcome measureChange in weight from baseline (mid-late November) to follow up (mid-January – early February)
Secondary outcome measures1. 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 by bioelectrical impedance at baseline and follow up

Added 01/11/2018:
4. Difference between groups in cognitive restraint, emotional eating and uncontrolled eating as measured by the three factor eating questionnaire at baseline and follow up
Overall study start date26/09/2016
Completion date01/08/2019

Eligibility

Participant type(s)All
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants284
Key inclusion criteria1. Aged 18 years or more
2. BMI 20.0 kg/m2 or more
Key exclusion criteria1. 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
Date of first enrolment01/10/2016
Date of final enrolment14/12/2018

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

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

Sponsor information

University of Birmingham
University/education

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

ROR logo "ROR" https://ror.org/03angcq70

Funders

Funder type

University/education

School of Medicine, PhD Studentship award, University of Birmingham

No information available

Results and Publications

Intention to publish date01/08/2020
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planTo be confirmed at a later date
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Statistical Analysis Plan 15/05/2018 15/05/2018 No No
Results article results 10/12/2018 Yes No

Additional files

ISRCTN15071781_SAP_15May2018.docx
Uploaded 15/05/2018

Editorial Notes

12/12/2018: Publication reference added.
01/11/2018: Secondary outcome measures updated.
15/05/2018: Uploaded statistical analysis plan.