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

Overweight/Obesity Clinical Trial

Official title:

Trial of a Self-directed Behaviour Change Intervention for Physical Activity and Healthy Eating.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03032731
• Other study ID #: EP 16/17 034
• Status: Completed
• Phase: N/A
• Start date: January 16, 2017
• Est. completion date: September 12, 2017

Study information

• Verified date: March 2019
• Source: University of Bath
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: September 12, 2017
• Est. primary completion date: September 12, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Overweight
• Overweight/Obesity

Intervention

Behavioral:
• Website and pedometer intervention
Self-directed, website-based intervention delivered with a pedometer to promote understanding of health and health behaviour change.

Other:
• Control
Standard, publicly available NHS resources for healthy lifestyles.

Locations

Country	Name	City	State
United Kingdom	University of Bath	Bath

Sponsors (1)

Lead Sponsor	Collaborator
University of Bath

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in mean daily physical activity level (PAL)	Mean daily physical activity level (PAL) will be assessed using accelerometers (BodyMedia, worn on the upper arm), worn for a continuous 7-day period, being removed during this time only for water-based activities such as showering or swimming. The accelerometers gather minute by minute total energy expenditure (TEE) data, which will be used to calculate PAL (PAL = TEE/BMR, where BMR = basal metabolic rate, to be calculated using the Schofield equation).	Baseline, 6 weeks and 12 weeks after starting the intervention/control period
Primary	Change in mean daily energy intake (EI)	Mean daily energy intake (EI) will be assessed using 3-day weighed food diaries, incorporating 2 week days and 1 weekend day .	Baseline, 6 weeks and 12 weeks after starting the intervention/control period
Secondary	Fasting plasma glucose concentration	Comparison of glucose concentration in the blood plasma at rest across all three measurement points.	Baseline, 6 weeks and 12 weeks after starting the intervention/control period
Secondary	Fasting plasma insulin concentration	Comparison of insulin concentration in the blood plasma at rest across all three measurement points.	Baseline, 6 weeks and 12 weeks after starting the intervention/control period
Secondary	Fasting triglyceride concentration	Comparison of triglyceride concentration in the blood serum at rest across all three measurement points.	Baseline, 6 weeks and 12 weeks after starting the intervention/control period
Secondary	Fasting total cholesterol concentration	Comparison of total concentration in the blood serum at rest across all three measurement points.	Baseline, 6 weeks and 12 weeks after starting the intervention/control period
Secondary	Fasting LDL cholesterol concentration	Comparison of LDL concentration in the blood serum at rest across all three measurement points.	Baseline, 6 weeks and 12 weeks after starting the intervention/control period
Secondary	Fasting HDL cholesterol concentration	Comparison of HDL concentration in the blood serum at rest across all three measurement points.	Baseline, 6 weeks and 12 weeks after starting the intervention/control period
Secondary	C-reactive protein (CRP) concentration	Comparison of CRP concentration in the blood serum at rest across all three measurement points.	Baseline, 6 weeks and 12 weeks after starting the intervention/control period
Secondary	Body mass index (BMI)	Comparison of BMI (defined as mass in kg divided by height in metres squared) across all three measurement points.	Baseline, 6 weeks and 12 weeks after starting the intervention/control period
Secondary	Waist circumference	Comparison of waist circumference (in centimetres) across all three measurement points.	Baseline, 6 weeks and 12 weeks after starting the intervention/control period
Secondary	Blood pressure	Comparison of blood pressure (systolic/diastolic mmHG) across all three measurement points.	Baseline, 6 weeks and 12 weeks after starting the intervention/control period
Secondary	Quality of diet	Diet quality will be assessed based on the proportion of fibre, free sugars and refined carbohydrates, and saturated fats in the diet. The intervention aims to promote an increase in fibre intake and decrease in free sugar, refined carbohydrate and saturated fat intake. Data will be collected using 3-day weighed food diaries, incorporating 2 week days and 1 weekend day.	Baseline, 6 weeks and 12 weeks after starting the intervention/control period
Secondary	Motivation for physical activity	Motivation will be assessed using the Behavioural Regulation for Exercise Questionnaire 3 (BREQ 3: Markland & Tobin, 2004; Wilson, Rodgers, Loitz & Scime, 2006) adapted for physical activity.	Baseline, 6 weeks and 12 weeks after starting the intervention/control period
Secondary	Motivation for healthy eating	Motivation will be assessed using the Behavioural Regulation for Exercise Questionnaire 3 (BREQ 3: Markland & Tobin, 2004; Wilson, Rodgers, Loitz & Scime, 2006) adapted for diet.	Baseline, 6 weeks and 12 weeks after starting the intervention/control period
Secondary	Self-efficacy for physical activity and healthy eating	Self-efficacy will be measured using the Barriers Self-Efficacy Scale for Exercise (BARSE; McAuley, 1992) adapted for physical activity.	Baseline, 6 weeks and 12 weeks after starting the intervention/control period
Secondary	Self-efficacy for healthy eating	Self-efficacy will be measured using the self-efficacy scale for eating a healthy diet developed by Pawlak and Colby (2009).	Baseline, 6 weeks and 12 weeks after starting the intervention/control period