Condition category
Nutritional, Metabolic, Endocrine
Date applied
26/07/2011
Date assigned
26/07/2011
Last edited
22/11/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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
-
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 measures

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

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

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

Sponsor information

Organisation

University College London (UK)

Sponsor details

Health Behaviour Research Centre
Department of Epidemiology and Public Health
1-19 Torrington Place
London
WC1E 6BT
United Kingdom

Sponsor type

University/education

Website

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

private sector organisation

Funding Body Subtype

other non-profit

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

2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/22898059
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27867204

Publication citations

  1. 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.

Additional files

Editorial Notes

22/11/2016: Publication reference added.