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

NCT03032731 | Completed

• 1 other identifier: EP 16/17 034
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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).

Conditions

Overweight/Obesity

Keywords

Physical activity; Diet; Health Behavior

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (15)

• Fasting plasma glucose concentration

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

• Fasting plasma insulin concentration

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

• Fasting triglyceride concentration

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

• Fasting total cholesterol concentration

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

• Fasting LDL cholesterol concentration

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

Study Arms (2)

Website and pedometer Intervention

EXPERIMENTAL

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.

Behavioral: Website and pedometer intervention

Control

OTHER

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.

Other: Control

Interventions

Website and pedometer intervention BEHAVIORAL

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

Website and pedometer Intervention

Control OTHER

Standard, publicly available NHS resources for healthy lifestyles.

Control

Eligibility Criteria

• Age: 35 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bath: lead

Study Sites (1)

University of Bath

Bath, BA2 7AY, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 31654276 DERIVED

MeSH Terms

Conditions

Overweight; Obesity; Motor Activity; Health Behavior

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Dylan Thompson, PhD

  University of Bath

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open label
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 19, 2017
• First Posted: January 26, 2017
• Study Start: January 16, 2017
• Primary Completion: September 12, 2017
• Study Completion: September 12, 2017
• Last Updated: March 19, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)