Plain English Summary
Background and study aims?
Over 60% of adults in the UK are overweight or obese. Obesity increases the risk of developing several conditions including heart disease, diabetes and some types of cancer. Achieving a healthy weight not only reduces health risks, but can also improve wellbeing and quality of life. The government identified Primary Care (General Practice) as the first port of call for advice about weight management, creating an urgent need for simple, effective interventions that can be delivered in this setting. Ten Top Tips (10TT) is a simple, leaflet-based intervention using a habit-based model to make healthy behaviours easier. It recommends ten behaviours to help with weight management, alongside advice on how to turn the behaviours into habits. Habits are formed when we repeat an action many times, in a similar place or at a similar time of day (for example brushing teeth before going to bed). Once behaviours have become habitual, they occur without much thought, making it easier to keep doing them. By repeating and monitoring healthy eating and activity behaviours, it is possible to form healthy habits that can help with weight management. A pilot study has already shown that use of the Ten Top Tips was associated with habit development and weight loss. This study will look at whether this simple weight control intervention based on habit-formation theory will achieve a clinically significant loss in body weight over 3 months compared with usual care in obese primary care patients. The secondary research objectives are: i) to examine whether the effects are maintained over at least 12 months, and whether benefits persist up to 24 months; ii) to explore whether the intervention leads to improvements in, and increased automaticity of, diet and physical activity behaviours, alongside improvements in clinical markers for potential co morbidities (blood pressure, total cholesterol/LDL and blood glucose); and iii) to undertake a full economic evaluation to establish cost-efficacy in the NHS context. We are also measuring quality of life (which includes a measure of anxiety/depression), dietary restraint (which measures how confident a person is that they can control their eating in certain situations/moods), weight efficacy (how much a person believes that he/she is capable of performing weight management behaviours), weight-related self-regulation (how much control a person feels they have over their weight and eating behaviours) and social support for engaging in physical activity and healthy eating.
Who can participate?
500 obese adults (BMI ≥ 30; age ≥ 18).
What does the study involve?
Participants will be randomly allocated to a treatment group (intervention group 10TT) or to a usual care group (control group). Participants in the intervention group will meet the practice nurse for baseline measurements of weight and height, waist circumference, blood pressure and a small blood sample will be taken (5-10ml). They will be asked to complete a questionnaire on eating habits, activity levels, quality of life and other psychological measures. They will then be given the 10TT leaflet with additional brief information on forming healthy habits. They will also be given simple diary sheets to record whether they have been able to stick to the tips for the first 3 months, and they will be asked to return completed sheets to the researchers. They may also be invited to take part in a recorded telephone interview describing their experience of 10TT: things they liked and things they found difficult. Over the next two years, the nurse will arrange to meet with them to measure their weight and waist circumference five times, and on each occasion they will also complete a questionnaire. Each appointment will last between 30 and 60 minutes. At the second appointment (3 months after the first assessment), they will have a second blood test and blood pressure measurement. Participants allocated to the control group will meet the practice nurse for baseline measurements of weight and height, waist circumference, blood pressure and a small blood sample (5-10ml), but will not be given the leaflet. They will be offered the usual care for weight management provided by their GP surgery. Over the next two years, the nurse will arrange to meet with them to measure their weight and waist circumference five times, and on each occasion they will also complete a questionnaire. Each appointment will last between 30 and 60 minutes. At the second appointment, 3 months after their first assessment, they will also have a second blood test and blood pressure measurement. The results from the two groups will be analysed at the end of the study to see how the 10TT intervention compares to usual care.
What are the possible benefits and risks of participating?
While additional primary care appointments for intervention/baseline assessment and follow-up may be an inconvenience for participants, appointments will be organised at convenient times whenever possible. Patients taking part in this study will have access to support to initiate and maintain lifestyle changes that might improve their health.
Where is the study run from?
Participants will be recruited from 14 GP surgeries from across England.
When is the study starting and how long is it expected to run for?
The study will start around July 2011 and will run for 24 months in total.
Who is funding the study?
The study is funded by the MRC National Prevention Research Initiative.
Who is the main contact?
Dr Rebecca Beeken
r.beeken@ucl.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Rebecca Beeken
ORCID ID
Contact details
Health Behaviour Research Centre
Department of Epidemiology and Public Health
University College London
1-19 Torrington Place
London
WC1E 6BT
United Kingdom
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r.beeken@ucl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
10330
Study information
Scientific title
Randomised controlled trial of habit-based advice for weight control in general practice (10TT Trial)
Acronym
10TT
Study hypothesis
The principal research objective of the Ten Top Tips Trial (10TT) is to test the hypothesis that this simple weight control intervention based on habit-formation theory will achieve clinically significant loss in body weight over 3 months in obese primary care patients, compared with patients placed receiving usual care.
Our secondary research objectives are:
1. To examine whether the effects will be maintained over at least 12 months, and whether benefits persist up to 24 months
2. To explore whether the intervention leads to improvements in, and increased automaticity of, diet and physical activity behaviours, alongside improvements in clinical markers for potential co morbidities [blood pressure, total cholesterol / low density lipoprotein (LDL) and blood glucose] and
3. To undertake a full economic evaluation to establish cost-efficacy in the NHS context
Ethics approval
South East London REC 2, 23/08/2010, ref: 10/H0802/59
Study design
Randomised; Interventional; Design type: Prevention, Treatment
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Topic: Primary Care Research Network for England; Subtopic: Not Assigned; Disease: All Diseases
Intervention
Ten Top Tips (10TT) is a self-guided leaflet for weight management focusing on making simple diet and exercise behaviours habitual. It represents the first behaviour change intervention of which we are aware that has been explicitly based on habit-formation theory. The component behaviours in the 10TT leaflet reflect the consensus among researchers, clinicians and policy makers on healthy diet and lifestyle and were developed with input from these groups.
Follow Up Length: 24 month(s); Study Entry : Single Randomisation only
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Body weight; Timepoint(s): Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
Secondary outcome measures
1. Automaticity of target behaviours; Timepoint(s): Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
2. Blood cholesterol/low density lipoprotein (LDL)/glucose levels; Timepoint(s): Baseline, 3 months
3. Blood pressure; Timepoint(s): Baseline, 3 months
4. Waist circumference; Timepoint(s): Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
5. Diet; Timepoint(s): Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
6. Dietary restraint; Timepoint(s): Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
7. Health-related quality of life; Timepoint(s): Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
8. Physical activity; Timepoint(s): Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
9. Self-regulation of eating behaviour; Timepoint(s): Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
10. Social support for healthy eating and physical activity; Timepoint(s): Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
11. Weight self efficacy; Timepoint(s): Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
Overall trial start date
18/07/2011
Overall trial end date
18/01/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Adults aged more than or equal to 18
2. Body mass index (BMI) more than or equal to 30
Target Gender: Male & Female ; Lower Age Limit 18 years
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 520; UK Sample Size: 520
Total final enrolment
537
Participant exclusion criteria
1. Inability to provide informed consent due to mental incapacity or active psychotic illness
2. Pregnancy
3. Terminal illness
Recruitment start date
02/08/2011
Recruitment end date
31/10/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University College London
London
WC1E 6BT
United Kingdom
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) - National Prevention Research Initiative (NPRI) (UK), Grant Codes: G080202
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
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
Basic results (scientific)
Publication list
2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/22898059
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27867204
2018 economic evaluation in: https://www.ncbi.nlm.nih.gov/pubmed/30104307 (added 23/10/2019)
Publication citations
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Protocol
Beeken RJ, Croker H, Morris S, Leurent B, Omar R, Nazareth I, Wardle J, Study protocol for the 10 Top Tips (10TT) trial: randomised controlled trial of habit-based advice for weight control in general practice., BMC Public Health, 2012, 12, 667, doi: 10.1186/1471-2458-12-667.