Trial of a New Online Programme for Physical Activity and Healthy Eating.

University of Bath

Status: Completed

Conditions: Overweight/Obesity

Treatments: Other: Control; Behavioral: Website and pedometer intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03032731

EP 16/17 034

Details and patient eligibility

About

Many healthy lifestyle interventions have been developed to help people change their activity and diet, lose weight and thus reduce their risk of developing type 2 diabetes (T2DM) and cardiovascular disorders (CVD). However, these interventions often fail to engage their target audience, which undermines their effectiveness in changing behaviour and health outcomes.

The purpose of this study is to investigate the effectiveness of a self-directed, website-based intervention to promote physical activity and healthy dietary behaviours. The intervention frames health information from a novel perspective, which our previous work has indicated can help to promote interest in the health information and improve attitudes, self-efficacy and motivation towards physical activity and healthy dietary behaviours.

The intervention comprises a website of information resources and personal recording areas to set goals and monitor activity and diet, weekly emails and pedometers. In this trial we aim to see whether the intervention has any impact on people's physical activity and diet, as well as their risk of developing CVD and T2DM. The intervention will be compared with a control condition in which participants will be shown standard resources available on NHS websites. Overweight/obese (BMI 25 - 39.5) males and females aged 35-74 years will be recruited from the community. The active intervention will last 6 weeks (during this period participants will receive weekly emails from the research team) and there will be a 6-week follow-up phase (in which participants will still have access to the website but contact from the research team). Activity, diet, disease risk markers and psychological antecedents of behaviour will be assessed at baseline, post-intervention (6-weeks) and post follow-up (12- weeks).

Enrollment: 59 patients

Sex: All

Ages: 35 to 74 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Able to give informed consent to participate in the study.
• Male or female and aged between 35-74 years.
• Defined as overweight or obese, i.e. BMI>25kg/m2.
• Able to travel to the university for assessment days.

Exclusion criteria

• Individuals who are not fluent in the English language, and who do not have access to and do not regularly use the internet and an email account.
• Individuals diagnosed with coronary heart disease, chronic kidney disease, type 2 diabetes, stroke, heart failure, severe hypertension (BP>180/110mmHg) and peripheral arterial disease.
• BMI>40kg/m2 (morbidly obese).
• Currently using weight loss drugs or other medication that can affect weight.
• Any reported recent (i.e. last 6 months) shift (>5%) in body mass or large change in habitual lifestyle.
• Individuals unable to change their physical activity (e.g. through disability).
• Current (pre-baseline) or recent (i.e. last 2 months) participation in another research trial or lifestyle supportive intervention or referral.
• Pregnant

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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59 participants in 2 patient groups

Website and pedometer Intervention

Experimental group

Description:

Participants allocated to this group will be given a one-off set-up session in which a researcher will show them the intervention website, create a user profile for them and provide guidance on how to use the site to gain health information, set personal behavioural goals and record and monitor their behaviour in relation to their goals. The researcher will also provide the participant with a pedometer and instruct them how to use this and where they can record their daily steps on the website. For 6 weeks, participants will be asked to use the website and be sent weekly email reminders to do so and log their goal progress. After 6 weeks, no further emails will be sent but participants will still be able to access the website and use the pedometer if they wish.

Treatment:

Behavioral: Website and pedometer intervention

Control

Other group

Description:

Participants allocated to this group will be given a one-off session in which a researcher shows them publicly available web-based resources for health behaviour change (provided by the National Health Service (NHS)). Like those participants in the intervention group, they will be assessed again after 6 and 12 weeks. Participants in the control arm will be offered the intervention (access to the study website and a pedometer) after 12 weeks.

Treatment:

Other: Control