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Completed

NCT Number: NCT03032731

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

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).

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Key information

Conditions

Overweight/Obesity Behavior Body Weight Health Behavior Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

35 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Bath

Bath, BA2 7AY, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Website and pedometer intervention

Behavioral

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

Control

Other

Standard, publicly available NHS resources for healthy lifestyles.

Primary outcomes

  1. Change in mean daily physical activity level (PAL)

    Time frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period

    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).

  2. Change in mean daily energy intake (EI)

    Time frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period

    Mean daily energy intake (EI) will be assessed using 3-day weighed food diaries, incorporating 2 week days and 1 weekend day .

Secondary outcomes

  1. Fasting plasma glucose concentration

    Time frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period

    Comparison of glucose concentration in the blood plasma at rest across all three measurement points.

  2. Fasting plasma insulin concentration

    Time frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period

    Comparison of insulin concentration in the blood plasma at rest across all three measurement points.

  3. Fasting triglyceride concentration

    Time frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period

    Comparison of triglyceride concentration in the blood serum at rest across all three measurement points.

  4. Fasting total cholesterol concentration

    Time frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period

    Comparison of total concentration in the blood serum at rest across all three measurement points.

  5. Fasting LDL cholesterol concentration

    Time frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period

    Comparison of LDL concentration in the blood serum at rest across all three measurement points.

  6. Fasting HDL cholesterol concentration

    Time frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period

    Comparison of HDL concentration in the blood serum at rest across all three measurement points.

  7. C-reactive protein (CRP) concentration

    Time frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period

    Comparison of CRP concentration in the blood serum at rest across all three measurement points.

  8. Body mass index (BMI)

    Time frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period

    Comparison of BMI (defined as mass in kg divided by height in metres squared) across all three measurement points.

  9. Waist circumference

    Time frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period

    Comparison of waist circumference (in centimetres) across all three measurement points.

  10. Blood pressure

    Time frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period

    Comparison of blood pressure (systolic/diastolic mmHG) across all three measurement points.

  11. Quality of diet

    Time frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period

    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.

  12. Motivation for physical activity

    Time frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period

    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.

  13. Motivation for healthy eating

    Time frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period

    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.

  14. Self-efficacy for physical activity and healthy eating

    Time frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period

    Self-efficacy will be measured using the Barriers Self-Efficacy Scale for Exercise (BARSE; McAuley, 1992) adapted for physical activity.

  15. Self-efficacy for healthy eating

    Time frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period

    Self-efficacy will be measured using the self-efficacy scale for eating a healthy diet developed by Pawlak and Colby (2009).

Sponsors and collaborators

Lead sponsor

University of Bath

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jan 26, 2017
Registry last updated
Mar 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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