Sedentary LifestylePEPPERNCT02317003
Physical Exercise Prescription With PEdometeR in General Practice for Patients With Cardiovascular Risk Factors - PEPPER
A study testing Intervention PPIL in people with Sedentary Lifestyle and Cardiovascular Diseases, run by University Hospital, Angers at 1 site in France.
Trial summary
This study evaluates the efficacy, in terms of energy expenditure, physical activity level, quality of life, blood pressure, waist circumference and weight, of a general practice based intervention involving a personalised physical exercise medical prescription, the structured delivery of information on the benefits… Read more about this study
- Who is it for?
- Ages 35 to 74 years
- Conditions the study is for
- Sedentary Lifestyle, Cardiovascular Diseases, Hypertension
- What is being tested?
- Intervention PPIL
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteFrance
- Study dates
- 16 Mar 2015to 1 Aug 2018
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients consulting their general practitioner for a non-urgent matter
- with regular follow-up every 3 months for hypertension, hypercholesterolaemia or non insulin dependent type 2 diabetes.
- judged insufficiently active by their general practitioner based on negative answers to the questions : "Do you practice a physical activity or cycling more than an hour per week?" and "Does your occupation involve physical exertion?"
Who cannot join
- contraindication to moderate physical activity,
- non autonomous for walking,
- with cognitive or psychiatric impairment limiting the full understanding of the study,
- suffering from another limiting disease (coronary insufficiency, chronic cardiac failure, etc),
- who don't speak French,
- refusing to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physical Exercise Prescription With PEdometeR in General Practice for Patients With Cardiovascular Risk Factors - The PEPPER Pragmatic Randomised Controlled Trial
This study evaluates the efficacy, in terms of energy expenditure, physical activity level, quality of life, blood pressure, waist circumference and weight, of a general practice based intervention involving a personalised physical exercise medical prescription, the structured delivery of information on the benefits of physical activity, a pedometer, and a pedometer log book, in 35 to 74 year old patients with cardiovascular risks factors.
Read the detailed description
Background: Health benefits of physical activity have been shown to be at least as important as drug therapies in the prevention of cardiovascular diseases in patients with hypertension, hyperlipidaemia or diabetes. However, few strategies have demonstrated efficacy and practicality in the promotion of physical exercise among these high risk patients in general practice.
The PEPPER clinical study is a pragmatic randomised trial over a period of 12 months to evaluate the efficacy, in terms of physical activity level, of an intervention based on structured information delivery according to cognitive and behavioural theories, a personalised written physical activity prescription in number of steps per day, a pedometer, and a pedometer logbook similar to diabetes logbooks, in 35 to 74 year old patients with cardiovascular risks factors. This strategy will be compared to the commonly used oral recommendation of physical activity. The primary outcome is the change in total energy expenditure measured by accelerometry over a 7-day period. Secondary outcomes include changes in physical activity levels (International Physical Activity Questionnaire), quality of life (SF-36), blood pressure, weight, waist circumference, perceived obstacles to physical activity, and patient and doctors compliance with the suggested strategy. 140 patients will be recruited and followed up in 15 GP practices. Measures will be assessed at baseline, at 3 months and at 12 months (end of intervention).
The results of the PEPPER study are expected at the end of 2016. If the intervention proves effective in increasing durably the level of physical activity, this relatively simple and cheap strategy could help decrease the occurrence of cardiovascular events in a large high-risk population seen in general practice.
- Conditions
- Sedentary Lifestyle, Cardiovascular Diseases, Hypertension, Hypercholesterolemia, Diabetes Mellitus, Type 2
- Being tested
- Intervention PPIL, Control OR
- Keywords
- physical exercise, sedentarity, general practice, family medicine, pedometer
- Medical subject headings
- Sedentary Behavior, Cardiovascular Diseases, Hypertension, Hypercholesterolemia, Diabetes Mellitus, Type 2, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention PPILBehavioural
Also called Prescription, Pedometer, Information, Logbook
Control ORBehavioural
Also called Oral recommendation of physical exercise
| Study group | Role | What they receive |
|---|---|---|
| Intervention PPIL | Experimental | Intervention delivered by the family doctor and based on structured information delivery according to cognitive and behavioural theories, a personalised written physical activity prescription in number of steps per day, a pedometer, and a pedometer logbook similar to diabetes logbooks. Receives: Behavioral: Intervention PPIL |
| Control OR | Active comparator | Oral recommendation of physical exercise delivered by the family doctor. Receives: Behavioral: Control OR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total energy expenditure by accelerometry at 3 months compared to baseline
The total energy expenditure is measured with a wGT3x-BT Actigraph accelerometer worn at the belt during 7 consecutive days from morning to evening. It is measured in Metabolic Equivalent Task-Minutes per Week.
Measured: baseline and 12 weeks
Secondary outcomes (14)
Change in total energy expenditure by accelerometry at 12 months compared to baseline
The total energy expenditure is measured with a wGT3x-BT Actigraph accelerometer worn at the belt during 7 consecutive days from morning to evening. It is measured in Metabolic Equivalent Task-Minutes per Week.
Measured: baseline and 52 weeks
Change in total energy expenditure by questionnaire at 3 months compared to baseline
The total energy expenditure is calculated with the self-administered International Physical Activity Questionaire (IPAQ) short version covering the past 7 days. It is expressed in Metabolic Equivalent Task-Minutes per Week.
Measured: baseline and 12 weeks
Change in total energy expenditure by questionnaire at 12 months compared to baseline
The total energy expenditure is calculated with the self-administered International Physical Activity Questionaire (IPAQ) short version covering the past 7 days. It is expressed in Metabolic Equivalent Task-Minutes per Week.
Measured: baseline and 52 weeks
Change in quality of life at 3 months compared to baseline
Change in quality of life as measured by the self-administered Short Form 36 questionnaire
Measured: baseline and 12 weeks
Change in quality of life at 12 months compared to baseline
Change in quality of life as measured by the self-administered Short Form 36 questionnaire
Measured: baseline and 52 weeks
Change in waist circumference at 3 months compared to baseline
Measured: baseline and 12 weeks
Change in waist circumference at 12 months compared to baseline
Measured: baseline and 52 weeks
Change in weight at 3 months compared to baseline
Measured: baseline and 12 weeks
Change in weight at 12 months compared to baseline
Measured: baseline and 52 weeks
Change in arterial blood pressure at 3 months compared to baseline
Measured: baseline and 12 weeks
Change in arterial blood pressure at 12 months compared to baseline
Measured: baseline and 52 weeks
Perceived obstacles to physical exercise
Perceived obstacles to physical exercise as measured by the Determinant of Physical Activity Questionnaire (DPAQ)
Measured: 52 weeks
Adherence of doctors and patients to the suggested strategy
Measured: 12 weeks
Adherence of doctors and patients to the suggested strategy
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2014 (estimated)
- Study start16 Mar 2015
- Primary completion1 Aug 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sedentary LifestyleStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Denise Jolivot, MD, Study chair, University Hospital, AngersLaurent Connan, MD, Principal investigator, Medical School, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02317003
- Sponsor's protocol ID
- CHU-P 2014-04
- Acronym
- PEPPER
- Status last verified
- Aug 2018
- First submitted
- 10 Dec 2014
- Last updated
- 2 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Bellanger W, Peurois M, Connan L, Navasiolava N, Missud D, Py T, Begue C. Comparing physical activity prescription with verbal advice for general practice patients with cardiovascular risk factors: results from the PEPPER randomised controlled trial. BMC Public Health. 2023 Jul 20;23(1):1402. doi: 10.1186/s12889-023-16302-6.
PubMed 37475036Missud DC, Parot-Schinkel E, Connan L, Vielle B, Huez JF. Physical activity prescription for general practice patients with cardiovascular risk factors-the PEPPER randomised controlled trial protocol. BMC Public Health. 2019 Jun 3;19(1):688. doi: 10.1186/s12889-019-7048-y.
PubMed 31159805
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Exercise Prescription With PEdometeR in General Practice for Patients With Cardiovascular Risk Factors - The PEPPER Pragmatic Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02317003
- Acronym / sponsor ID
- PEPPER / CHU-P 2014-04
- Conditions
- Sedentary Lifestyle, Cardiovascular Diseases, Hypertension, Hypercholesterolemia, Diabetes Mellitus, Type 2
- Keywords
- physical exercise, sedentarity, general practice, family medicine, pedometer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 16 Mar 2015 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 15 Dec 2014 (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.
This study evaluates the efficacy, in terms of energy expenditure, physical activity level, quality of life, blood pressure, waist circumference and weight, of a general practice based intervention involving a personalised physical exercise medical prescription, the structured delivery of information on the benefits of physical activity, a pedometer, and a pedometer log book, in 35 to 74 year old patients with cardiovascular risks factors.
Detailed description
Background: Health benefits of physical activity have been shown to be at least as important as drug therapies in the prevention of cardiovascular diseases in patients with hypertension, hyperlipidaemia or diabetes. However, few strategies have demonstrated efficacy and practicality in the promotion of physical exercise among these high risk patients in general practice.
The PEPPER clinical study is a pragmatic randomised trial over a period of 12 months to evaluate the efficacy, in terms of physical activity level, of an intervention based on structured information delivery according to cognitive and behavioural theories, a personalised written physical activity prescription in number of steps per day, a pedometer, and a pedometer logbook similar to diabetes logbooks, in 35 to 74 year old patients with cardiovascular risks factors. This strategy will be compared to the commonly used oral recommendation of physical activity. The primary outcome is the change in total energy expenditure measured by accelerometry over a 7-day period. Secondary outcomes include changes in physical activity levels (International Physical Activity Questionnaire), quality of life (SF-36), blood pressure, weight, waist circumference, perceived obstacles to physical activity, and patient and doctors compliance with the suggested strategy. 140 patients will be recruited and followed up in 15 GP practices. Measures will be assessed at baseline, at 3 months and at 12 months (end of intervention).
The results of the PEPPER study are expected at the end of 2016. If the intervention proves effective in increasing durably the level of physical activity, this relatively simple and cheap strategy could help decrease the occurrence of cardiovascular events in a large high-risk population seen in general practice.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention PPIL | Experimental | Behavioral: Intervention PPILIntervention delivered by the family doctor and based on structured information delivery according to cognitive and behavioural theories, a personalised written physical activity prescription in number of steps per day, a pedometer, and a pedometer logbook similar to diabetes logbooks. |
| Control OR | Active comparator | Behavioral: Control OROral recommendation of physical exercise delivered by the family doctor. |
Who may qualify
- Ages
- 35 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients consulting their general practitioner for a non-urgent matter
- with regular follow-up every 3 months for hypertension, hypercholesterolaemia or non insulin dependent type 2 diabetes.
- judged insufficiently active by their general practitioner based on negative answers to the questions : "Do you practice a physical activity or cycling more than an hour per week?" and "Does your occupation involve physical exertion?"
Key exclusion criteria (6 listed)
- contraindication to moderate physical activity,
- non autonomous for walking,
- with cognitive or psychiatric impairment limiting the full understanding of the study,
- suffering from another limiting disease (coronary insufficiency, chronic cardiac failure, etc),
- who don't speak French,
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 |
|---|---|---|
| Intervention PPILAlso: Prescription, Pedometer, Information, Logbook | Behavioural | Intervention PPIL |
| Control ORAlso: Oral recommendation of physical exercise | Behavioural | Control OR |
Primary outcome
Change in total energy expenditure by accelerometry at 3 months compared to baseline
Time frame: baseline and 12 weeks
The total energy expenditure is measured with a wGT3x-BT Actigraph accelerometer worn at the belt during 7 consecutive days from morning to evening. It is measured in Metabolic Equivalent Task-Minutes per Week.
14 secondary outcomes
Change in total energy expenditure by accelerometry at 12 months compared to baseline
Time frame: baseline and 52 weeks
Change in total energy expenditure by questionnaire at 3 months compared to baseline
Time frame: baseline and 12 weeks
Change in total energy expenditure by questionnaire at 12 months compared to baseline
Time frame: baseline and 52 weeks
Change in quality of life at 3 months compared to baseline
Time frame: baseline and 12 weeks
Change in quality of life at 12 months compared to baseline
Time frame: baseline and 52 weeks
Change in waist circumference at 3 months compared to baseline
Time frame: baseline and 12 weeks
Change in waist circumference at 12 months compared to baseline
Time frame: baseline and 52 weeks
Change in weight at 3 months compared to baseline
Time frame: baseline and 12 weeks
Change in weight at 12 months compared to baseline
Time frame: baseline and 52 weeks
Change in arterial blood pressure at 3 months compared to baseline
Time frame: baseline and 12 weeks
Change in arterial blood pressure at 12 months compared to baseline
Time frame: baseline and 52 weeks
Perceived obstacles to physical exercise
Time frame: 52 weeks
Adherence of doctors and patients to the suggested strategy
Time frame: 12 weeks
Adherence of doctors and patients to the suggested strategy
Time frame: 52 weeks
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 2 Aug 2022.
- Derived from this study: PubMed 37475036Bellanger W, Peurois M, Connan L, Navasiolava N, Missud D, Py T, Begue C. Comparing physical activity prescription with verbal advice for general practice patients with cardiovascular risk factors: results from the PEPPER randomised controlled trial. BMC Public Health. 2023 Jul 20;23(1):1402. doi: 10.1186/s12889-023-16302-6.
- Derived from this study: PubMed 31159805Missud DC, Parot-Schinkel E, Connan L, Vielle B, Huez JF. Physical activity prescription for general practice patients with cardiovascular risk factors-the PEPPER randomised controlled trial protocol. BMC Public Health. 2019 Jun 3;19(1):688. doi: 10.1186/s12889-019-7048-y.
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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.
Denise Jolivot, MD study chair
University Hospital, Angers
Laurent Connan, MD principal investigator
Medical School, Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention PPIL in people with Sedentary Lifestyle and Cardiovascular Diseases, run by University Hospital, Angers at 1 site in France.
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 3 inclusion and 6 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 2 Aug 2022. 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 France. 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 total energy expenditure by accelerometry at 3 months compared to baseline (time frame: baseline and 12 weeks). 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 NCT02317003, which also lists 2 linked publications.
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 2 Aug 2022.