Very low calorie diet, modest dietary restriction and sequential behavioural programme in overweight smokers stopping smoking
| ISRCTN | ISRCTN83865809 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83865809 |
| Protocol serial number | RG_08-166 |
| Sponsor | University of Birmingham (UK) |
| Funder | University of Birmingham (UK) - UKCRC Centre of Excellence in Public Health Research Award |
- Submission date
- 22/12/2008
- Registration date
- 23/01/2009
- Last edited
- 02/10/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
UK Centre for Tobacco Control Studies: a UKCRC Centre of Excellence in Public Health Research
Primary Care Clinical Sciences
University of Birmingham
Birmingham
B15 2TT
United Kingdom
| Phone | +44 (0)121 414 8529 |
|---|---|
| p.n.aveyard@bham.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomised controlled open label trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Randomised controlled trial of very low calorie diet, modest dietary restriction and sequential behavioural programme to effect hunger, urges to smoke, abstinence and weight gain in overweight smokers stopping smoking |
| Study objectives | This is a study to test the hypothesis that a very low calorie diet (VLCD) can reduce urges to smoke, alleviate hunger and manage obesity in those on a smoking cessation programme. Participants will be screened for suitability to take part in the project. The sample population will be smokers who are already overweight (body mass index [BMI] greater than 25). Participants will be randomised into an open label 429 - 559 kcal/day VLCD, 'low fat, energy restricted' or control group. Compliance to dietary advice will be verified by the presence or absence of urinary ketones for those on the VLCD and by 7-day food intake diaries for the other groups. Urges to smoke, hunger and withdrawal will be measured using the Mood and Physical Symptoms Scale (MPSS) recorded daily in a diary. Seven day point prevalence abstinence will be assessed weekly in the clinic and 4-week prolonged abstinence assessed by the Russell Standard. Weight and waist circumference will be measured and analysed in prolonged abstinent smokers. |
| Ethics approval(s) | In progress, submission via IRAS to NHS REC, NHS/HSC R&D, Portfolio Adoption |
| Health condition(s) or problem(s) studied | Healthy, overweight smokers |
| Intervention | Smoking cessation interventions for all patients: All participants will have identical treatment to support smoking cessation. This consists of weekly behavioural support using withdrawal orientated therapy of approximately 60 minutes per occasion. In addition, participants will be given a 25 mg nicotine patch e.g. Nicorette 25 mg transdermal 16 hour patch provided by South Birmingham PCT. This will be used for 8 weeks commencing on the evening of the quit day session, following rapid smoking to quit. Combination NRT will not be provided to avoid the possibility that use of acute form of NRT would differ by group if they experienced more urges to smoke or which might be used to satiate hunger. Participants will be weaned off the patches with a lower dose patch (Nicorette 15 mg, then 10 mg transdermal 16 hour patch) provided every two weeks after that. Behavioural support and provision of NRT will be given only by therapists trained as NHS Stop Smoking Service providers. Step by step (SBS): Standard smoking cessation interventions include aspects of dietary advice. Even detailed dietary advice has not been shown to affect weight gain. However, standard smoking cessation advice includes the following: 1. Avoid hunger, which leads to urges to smoke, and can make lapsing more likely. Eat breakfast if this is normally missed (as it often is in smokers). 2. To satiate hunger and avoid excess weight gain, avoid highly calorie dense high glycaemic index foods, such as Mars bars. Instead prepare for increased hunger by using grapes, or carrot sticks and other immediately available sources of food. There is evidence that glucose tablets satiate urges to smoke within minutes, so these can be used. 3. Avoid excess alcohol and consider avoiding all alcohol for the immediate post-cessation period. This is to avoid lapsing due to disinhibition and the 'cue' which alcohol provides, rather than to avoid calories. 4. Drink lots of water which helps fill the stomach and satisfies 'oral cravings' The SBS group will receive this advice and be told that they will receive the diet intervention at 3 months. Individually-tailored dietary advice (ITDA): Energy prescriptions used in previous studies of smoking cessation have varied. These include energy requirement minus 150 to 300 kcal/day (which is considered to equate to metabolic slowing upon nicotine withdrawal; the amount depends on number of cigarettes smoked), or a 500 kcal deficit tailored to individual requirements, a 500 kcal deficit tailored to individual requirements should weight increase by 1 kg, or a 1600 kcal diet. Individually tailored dietary advice in this study will be based on conventional dietetic practice. An appropriate number of portions from each of the food groups that make up a healthy diet will be advised. It will be low in fat and restricted in alcohol studies have shown that these significantly increase in the diets of smokers when they quit. The energy prescription will be based on the NICE 2006 guidelines for the management of obesity. It will provide a 600 kcal deficit of energy requirement, (up to a maximum intake of 1800 kcal, which has been considered to work best in clinical practice). Very low calorie diet (VLCD): Lipotrim (Howard Foundation Research Ltd) will be provided for the study at cost price from Howard Foundation Research Ltd purchased by the PCT and provided free to participants. Subjects will take three shakes each day. Female formula totals 425 kcal, male formula totals 559 kcal and is complete in all essential nutrients. This will be provided weekly for 4 weeks. After 4 weeks subjects will be advised to return to eating food but continue to lose weight on an individually tailored calorie controlled diet, identical to that provided to the ITDA group. All dietary interventions will be supervised by a registered dietician who is proficient in VLCD use and has been trained in smoking cessation. Treatment will be provided in a two-hour group setting, with measures taken and energy prescribed on an individual basis at the end of the group sessions. Any significant changes in clinical condition of individual subjects, as measured on a weekly basis, will be discussed with the supervising GP and action taken, e.g. clinically significant fall in blood pressure in subjects on the VLCD taking anti-hypertensives will require adjustment of anti-hypertensive medication. The subject's own GP will be kept informed. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. The combined urge to smoke score from the MPSS (MPSS-C): expecting to see pairwise differences between the VLCD and the other arms in mean MPSS-C score measured at the end of one week of attempted abstinence in abstinent smokers defined as exhaled CO less than 10 ppm. It is standard practice to compare withdrawal scores only in those who are abstinent or largely abstinent |
| Key secondary outcome measure(s) |
Weight gain defined as difference in weight between visit 2 and visit 7 (4 weeks after quit day) in participants who achieve prolonged abstinence defined according to the Russell standard. |
| Completion date | 30/11/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 300 |
| Key inclusion criteria | 1. Aged over 18 years, either sex 2. Daily cigarette smoker with an exhaled carbon monoxide (CO) of at least 10 ppm at least 15 minutes after last smoking 3. BMI of at least 25 kg/m^2 4. Not on a diet or weight loss programme 5. Willing to be randomised to any of the three arms and willing and able to comply with the intervention and all study procedures |
| Key exclusion criteria | 1. If subjects have any of the absolute or relative contra-indications to VLCD use (e.g. recent myocardial infarctions [MI], pregnant, lactose intolerance) 2. Type 2 diabetics on oral hypoglycaemic agents or insulin (diet controlled type 2 diabetics may be included) 3. Previous adverse reaction to nicotine patches (which would preclude their future use) 4. Currently using smoking cessation medication or medication, e.g. nortriptyline that is known to help smokers quit 5. Those already actively losing weight on a diet, currently using sibutramine or orlistat, or scheduled for bariatric surgery 6. Suspected abuse of alcohol or other drug 7. Use of any smokeless tobacco 8. Currently participating in other therapeutic clinical trials |
| Date of first enrolment | 02/03/2009 |
| Date of final enrolment | 30/11/2010 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
B15 2TT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 07/10/2010 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
02/10/2018: Thesis added to publication and dissemination plan.
01/10/2018: No publications found, verifying study status with principal investigator
