Plain English Summary
Background and study aims
Obesity has become a major public health concern with the situation now being referred to as an obesity epidemic. Evidence suggests that traditional primary care treatments (one to one consultations with dieticians or practice nurses) are costly, ineffective and present high attrition rates. These findings suggest that a change in current primary care approaches is required. Therefore research is needed to investigate alternative methods in relation to obesity. This study aims to examine the feasibility and acceptability of using the internet as a method of providing weight management in the NHS.
Who can participate?
The two population groups that will be targeted are men with diabetes and post-partum women with a body mass index (BMI) >30 kg/m2 and <40kg/m2.
What does the study involve?
The web based intervention will deliver consultations, through dietitians and exercise experts, to participants identified as obese via a website (after an initial face to face consultation). The website will also allow participants to enter food intake, physical activity and interact (via messages) with other users. This internet intervention will be compared with a group who will receive usual care through the NHS/GP practice. Comparisons between the internet and usual care groups will be made to identify how acceptable and feasible the intervention is to the participants.
What are the possible benefits and risks of participating?
Participants may lose weight during the course of the programme. There is a possible inconvenience of giving up time to take part in data collection during the course of the programme.
Where is the study run from?
Participants will be recruited from GP Practices within the catchment area of County Durham and Darlington NHS Foundation Trust.
When is the study starting and how long is it expected to run for?
The study is now starting the recruitment stage (November), which will be open to participants for the next 5 months (end of March), and then participants will be required to take part in the project for 12 months.
Who is funding the study?
County Durham and Darlington NHS Foundation Trust (UK)
Who is the main contact?
Anna Sherrington
a.sherrington@ncl.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Ms Ruth Bell
ORCID ID
Contact details
Baddily Clarke Building
Richardson Road
Newcastle upon Tyne
NE2 4AX
United Kingdom
-
ruth.bell@ncl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
13414
Study information
Scientific title
Evaluation of an internet-based weight loss intervention: a randomised trial
Acronym
Study hypothesis
Obesity has become a major public health concern. Evidence suggests that traditional primary care treatments are costly, ineffective and report high attrition rates. These findings suggest that a change in current primary care approaches is required. Therefore research is needed to investigate alternative methods for weight loss. This study is a pilot randomised controlled trial that aims to examine using the internet as a method of providing weight management in the NHS.
Target groups for the study are men with diabetes and post partum women. Both these groups have been shown to have low attendance rates for in person consultations. The web based intervention will deliver dietitian and exercise expert consultations to participants diagnosed as obese (Body Mass Index greater than or equal 30 and less than 40 kg/m2 ) via a website (after an initial face to face consultation). This internet intervention will be compared with a group who will receive usual care (consisting of either no specific treatment or face to face dietitian or practice nurse consultation). Comparisons between the internet and face to face groups will be made in relation to recruitment, retention, attrition and adherence rates to identify how acceptable and feasible the intervention is to the participants.
Participants will be recruited from GP Practices within the catchment area of County Durham and Darlington NHS Foundation Trust (collaborators on the project). The project will take a mixed method approach with outcomes such as weight being recorded, as well as a qualitative study of participants and stakeholders views. The participants will be required to be in the study for a period of twelve months. Participants randomised to the intervention arm will be asked to input daily food intakes and physical activity data, receive feedback from the dietitian and may take part in an interview.
Ethics approval
Cambridge Central Research Ethics Proportionate Review Sub Committee, First MREC approval date 09/08/2012, ref: 12/EE/0361
Study design
Randomised trial
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
Obesity
Intervention
Participants randomised to the internet based weight loss intervention will meet with a dietitian once face to face. After the initial meeting participants will only receive guidance via a website through web based messages. Exercise experts will also give consultations during the 12 month intervention.
Baseline, 3 months and 12 months data collection will be taken. Participants will be reminded to wear the accelerometers for 4-7 days before there next measurement date.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Participant Involvement (recruitment, attrition, retention) at baseline, 3 months and 12 months
Secondary outcome measures
1. 24 hour diet recall at baseline, 3 months and 12 months
2. Acceptability Interviews between 6 and 12 months
3. Anthropometric measures (weight, body fat percentage, waist circumference and BMI) at baseline, 3 months and 12 months
4. Predictors of behaviour change at baseline, 3 months and 12 months
5. Quality of life questionnaire at baseline, 3 months and 12 months
Overall trial start date
22/10/2012
Overall trial end date
01/04/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Two target groups:
1.Women who have had a baby (from 3 months up to 2 years after childbirth) and, who currently have a body mass index (BMI) >≈30 and <40 kg/m2. Women should have previously had a BMI >≈30 and <40 kg/m2 before pregnancy.
2. The other target group are men who have been diagnosed with type 2 diabetes and have a BMI >≈30 and <40 kg/m2.
3. Participants must have access to the internet (this can be in any location [home, office, public location] or on any device [desktop computer, laptop or mobile phone])
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 120; UK Sample Size: 120
Participant exclusion criteria
1. Patients over BMI 40 kg/m2. When a patient reaches a BMI 40kg/m2 lifestyle modification may no longer be appropriate and bariatric surgery may be recommended (National Institute for Health and Clinical Excellence, 2006), making it unsuitable for them to take part in the study.
2. Patients unable to access the internet
3. Patients unable to give written informed consent in English. These patients would be excluded as they would be unable to randomise to the internet intervention which is only available in English. The resources are not available to use a translator in this study or produce the web-based resources in other languages.
4. Patients identified by their GP as having a contraindication making the weight loss intervention inappropriate to recommend
5. Patients who are currently pregnant will be excluded from the study
Recruitment start date
22/10/2012
Recruitment end date
01/04/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Baddily Clarke Building
Newcastle upon Tyne
NE2 4AX
United Kingdom
Funders
Funder type
Research organisation
Funder name
UK Clinical Research Collaboration (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
A study results paper will be submitted for publication by the end of 2016.
Intention to publish date
31/12/2016
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29587868