Condition category
Nutritional, Metabolic, Endocrine
Date applied
25/10/2012
Date assigned
26/10/2012
Last edited
17/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

Sponsor information

Organisation

County Durham and Darlington NHS Foundation Trust (UK)

Sponsor details

North Road
Durham
DH1 5TW
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

16/11/2016: No publications found, verifying study status with principal investigator.