Clinical trial NCT03032731: Trial of a New Online Programme for Physical Activity and Healthy Eating.
Official title: Trial of a Self-directed Behaviour Change Intervention for Physical Activity and Healthy Eating.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight/Obesity
Keywords: Physical activity
Diet
Health Behavior
Lead sponsor: University of Bath
Sponsor class: OTHER
First posted: 2017-01-26
Enrollment: 59
Sex: ALL
Minimum age (years): 35
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: Change in mean daily physical activity level (PAL)
timeFrame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
measure: Change in mean daily energy intake (EI)
timeFrame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
Secondary outcomes:
measure: Fasting plasma glucose concentration
timeFrame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
measure: Fasting plasma insulin concentration
timeFrame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
measure: Fasting triglyceride concentration
timeFrame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
measure: Fasting total cholesterol concentration
timeFrame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
measure: Fasting LDL cholesterol concentration
timeFrame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
measure: Fasting HDL cholesterol concentration
timeFrame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
measure: C-reactive protein (CRP) concentration
timeFrame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
measure: Body mass index (BMI)
timeFrame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
measure: Waist circumference
timeFrame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
measure: Blood pressure
timeFrame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
measure: Quality of diet
timeFrame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
measure: Motivation for physical activity
timeFrame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
measure: Motivation for healthy eating
timeFrame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
measure: Self-efficacy for physical activity and healthy eating
timeFrame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
measure: Self-efficacy for healthy eating
timeFrame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
Other outcomes:
Locations:
city: Bath
country: United Kingdom
facility: University of Bath
Study officials:
affiliation: University of Bath
name: Dylan Thompson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grey EB, Thompson D, Gillison FB. Effects of a Web-Based, Evolutionary Mismatch-Framed Intervention Targeting Physical Activity and Diet: a Randomised Controlled Trial. Int J Behav Med. 2019 Dec;26(6):645-657. doi: 10.1007/s12529-019-09821-3.