Overweight/ObesityNCT03032731
Trial of a New Online Programme for Physical Activity and Healthy Eating.
A study testing Website and pedometer intervention in people with Overweight/Obesity, run by University of Bath at 1 site in United Kingdom.
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). Read more about this study
- Who is it for?
- Ages 35 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight/Obesity
- What is being tested?
- Website and pedometer intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Jan 2017to 12 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Trial of a Self-directed Behaviour Change Intervention 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).
- Conditions
- Overweight/Obesity
- Being tested
- Website and pedometer intervention, Control
- Keywords
- Physical activity, Diet, Health Behavior
- Medical subject headings
- Overweight, Obesity, Motor Activity, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Website and pedometer interventionBehavioural
Self-directed, website-based intervention delivered with a pedometer to promote understanding of health and health behaviour change.
ControlOther
Standard, publicly available NHS resources for healthy lifestyles.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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 .
Measured: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
Secondary outcomes (15)
Fasting plasma glucose concentration
Comparison of glucose concentration in the blood plasma at rest across all three measurement points.
Measured: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
Fasting plasma insulin concentration
Comparison of insulin concentration in the blood plasma at rest across all three measurement points.
Measured: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
Fasting triglyceride concentration
Comparison of triglyceride concentration in the blood serum at rest across all three measurement points.
Measured: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
Fasting total cholesterol concentration
Comparison of total concentration in the blood serum at rest across all three measurement points.
Measured: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
Fasting LDL cholesterol concentration
Comparison of LDL concentration in the blood serum at rest across all three measurement points.
Measured: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
Fasting HDL cholesterol concentration
Comparison of HDL concentration in the blood serum at rest across all three measurement points.
Measured: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
C-reactive protein (CRP) concentration
Comparison of CRP concentration in the blood serum at rest across all three measurement points.
Measured: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
Body mass index (BMI)
Comparison of BMI (defined as mass in kg divided by height in metres squared) across all three measurement points.
Measured: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
Waist circumference
Comparison of waist circumference (in centimetres) across all three measurement points.
Measured: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
Blood pressure
Comparison of blood pressure (systolic/diastolic mmHG) across all three measurement points.
Measured: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
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.
Measured: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
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.
Measured: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
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.
Measured: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
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.
Measured: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
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).
Measured: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study start16 Jan 2017
- Primary completion12 Sep 2017
- Study completion12 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight/ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bath
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elisabeth Grey, University of Bath
- Investigators
- Dylan Thompson, PhD, Principal investigator, University of Bath
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03032731
- Sponsor's protocol ID
- EP 16/17 034
- Status last verified
- Mar 2019
- First submitted
- 19 Jan 2017
- Last updated
- 19 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31654276
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of a Self-directed Behaviour Change Intervention for Physical Activity and Healthy Eating.
- ClinicalTrials.gov ID
- NCT03032731
- Acronym / sponsor ID
- EP 16/17 034
- Conditions
- Overweight/Obesity
- Keywords
- Physical activity, Diet, Health Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University of BathUniversity, hospital or other
- Study start
- 16 Jan 2017 (actual)
- Primary completion
- 12 Sep 2017 (actual)
- Study completion
- 12 Sep 2017 (actual)
- First posted
- 26 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Website and pedometer Intervention | Experimental | Behavioral: Website and pedometer interventionParticipants 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. |
| Control | Other | Other: ControlParticipants 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. |
Who may qualify
- Ages
- 35 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Website and pedometer interventionSelf-directed, website-based intervention delivered with a pedometer to promote understanding of health and health behaviour change. | Behavioural | Website and pedometer Intervention |
| ControlStandard, publicly available NHS resources for healthy lifestyles. | Other | Control |
Primary outcome
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).
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 .
15 secondary outcomes
Fasting plasma glucose concentration
Time frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
Fasting plasma insulin concentration
Time frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
Fasting triglyceride concentration
Time frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
Fasting total cholesterol concentration
Time frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
Fasting LDL cholesterol concentration
Time frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
Fasting HDL cholesterol concentration
Time frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
C-reactive protein (CRP) concentration
Time frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
Body mass index (BMI)
Time frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
Waist circumference
Time frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
Blood pressure
Time frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
Quality of diet
Time frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
Motivation for physical activity
Time frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
Motivation for healthy eating
Time frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
Self-efficacy for physical activity and healthy eating
Time frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
Self-efficacy for healthy eating
Time frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
- Derived from this study: PubMed 31654276Grey 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dylan Thompson, PhD principal investigator
University of Bath
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Website and pedometer intervention in people with Overweight/Obesity, run by University of Bath at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean daily physical activity level (PAL) (time frame: Baseline, 6 weeks and 12 weeks after starting the intervention/control period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03032731, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2019.