Health BehaviorPhase 3GHP CHANGENCT02428920
Grenada Heart Project - Community Health Action to Encourage Healthy Behaviors
A Phase 3 study testing Peer Groups in people with Health Behavior, run by Icahn School of Medicine at Mount Sinai at 1 site in Grenada.
Trial summary
The Grenada Heart Project (GHP) conducted an observational study within a randomly selected adult sample of Grenadians in 2008-2009. The aim of the study was to assess the clinical, biological and psychosocial determinants of the cardiovascular health in Grenada, in order to develop and implement a nationwide… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Health Behavior
- What is being tested?
- Peer Groups
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteGrenada
- Study dates
- Jul 2014to Jul 2016
- Phase
- Phase 3
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Resident of Grenada
- One or more vascular risk factors:
- Borderline to elevated blood pressure (defined as systolic blood pressure ≥120 mm Hg to SBP < 160 or diastolic blood pressure ≥ 80 and < 90 mm Hg)
- Waist circumference of >40 inches for men and >35 inches for women
- Smoking (active self-reported smoking, of any type of tobacco, at least daily)
- Physical inactivity (reporting less than 120 min/week of activity)
Show all 9Show fewer
- Fasting glucose level > 100 mg/dl
- Total Cholesterol >250 mg/dl, LDL > 130 mg/dl
- Fruit/vegetable intake less than 2 servings daily
Who cannot join
- Unable/unwilling to provide consent
- Age of under 18 or more than 70 years old (inclusive) as of December 2012
- Inability of self-monitoring
- Pregnant women
- Morbidly ill with expectation of death within a year
Trial locations and contacts
1 site in 1 country.
Grenada1 site
St. George's University
Saint George's
About this study
The Grenada Heart Project (GHP) conducted an observational study within a randomly selected adult sample of Grenadians in 2008-2009. The aim of the study was to assess the clinical, biological and psychosocial determinants of the cardiovascular health in Grenada, in order to develop and implement a nationwide cardiovascular health promotion program.
The sample of 2,827 adults was randomly selected from the national electronic voter list. The main outcome measures were self-reported cardiovascular disease and behavioral risk factors, anthropometric measures, blood pressure (BP), point-of-care testing for glucose and lipids, and ankle-brachial index. Analysis of the data revealed prevalence rates of obesity, hypertension and diabetes significantly exceeding those seen in the U.S.
Read more
Since the completion of this assessment, an additional effort has contributed significantly to the current project. A parallel community health-promotion project was carried out in Cardona, Spain called the "Cardona Integral Fifty-Fifty" project with 80 subjects. The preliminary results of the Cardona study have a shown that peer motivation may significantly improve healthy behaviors and thus modify cardiovascular risk.
The GHP CHANGE community -based intervention aims to promote positive behaviors and focus more on what creates health, rather than what prevents sickness. It is built on the foundations of social support, assessing whether people going through similar challenges will support each other, work together to identify and address barriers to success, and motivate each other to move forward. In this program we test for the impact of promotion of healthy lifestyle behaviors through peer motivation on blood pressure, physical activity, eating behavior, weight, and smoking.
Read the detailed description
This culturally-tailored intervention program will take place over a 12-month period in the following four regions on the island:
- St. David's Parish
- St. Andrew's Parish
- St. George's Parish
- St. John's/St. Mark's Parish (combined ) •The program will involve approximately 400 randomized participants (100 from each region). Participants, aged 18-70, from each parish will be divided into one of two groups: Intervention Group arm (peer support) or Control Group arm (individual study).
The investigators will identify study participants previously enrolled in the Grenada Heart Project, with at least one vascular risk factor, as defined by the Adult Treatment Panel III guidelines which include: elevated BP, increased blood glucose level, increased waist circumference, minimal reported physical activity, minimally reported fruit and vegetable intake, or current smoking habits. Given a 10% refusal rate and 10% failure rate in the run-in phase, 120 participants from each site will be invited randomly, from the high risk group, to recruit for participation in the study.
All eligible participants are invited to attend an informational half-day session, during which a general overview of the program is presented and participants have an opportunity to have any questions answered. During this session, eligible and interested individuals complete the written consent forms. Upon consenting, participants are informed of their randomization arm (education intervention or group intervention) and entered into a run-in phase. All participants receive a notebook, as well as certain health literate materials, provided by the American Heart Association. The educational materials will promote management of risk factors and the notebook will provide an avenue for recording of lifestyle behaviors, such as health goals, BP values, and eating habits.
•Participants enrolled in the run-in phase will complete the following assessments at three time points (baseline, 6-months, and 12-months):
- Anthropometric measurements
- GHP data collection form
- International physical activity questionnaire (iPAQ)
- Lifestyle Assessment [modified SF-36 questionnaire tailored to the Grenadian population]
- Point-of-care testing using an LDX analyzer (solely for the 12 month assessment).
The investigators have developed a "GHP Health outcomes Score" which captures a person's health profile on a 0-to-3 point scale related to smoking habits, overweight, sedentary lifestyle, and hypertension During the run-in phase, participants will attend a series of core lifestyle and risk factor education workshops related to motivation for change, nutrition (two sessions), smoking cessation, physical education and BP control. Only those participants who attend 4 of the 6 sessions will be eligible for randomization.
Eligible participants will be randomized to the intervention arm or to the control arm, stratified by parish. In the group intervention arm a group leader will be selected internally within the support groups, who will receive additional training from the research team in regards to group motivation and facilitation. Those randomized into the Intervention arm will be organized into peer groups of approximately 10 persons.
The specific aims of this study are:
Specific Aim 1: Hypothesis: Individuals will show an improvement of health-related behaviors through directed peer education groups (intervention group), compared to the individuals not receiving such peer support (control group).
Specific Aim 2: Hypothesis: Individuals will show an improvement in their quality of life through directed peer education groups (intervention group), compared to the individuals not receiving such peer support (control group).
Specific Aim 3: Hypothesis: Individuals will show an improvement in cardiovascular risk factors through directed peer education groups (intervention group), compared to the individuals not receiving such peer support (control group).
- Conditions
- Health Behavior
- Being tested
- Peer Groups
- Keywords
- cardiovascular health, behavior change, community-based, prevention
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer GroupsBehavioural
The intervention group arm will attend biweekly or monthly peer group meetings to discuss health successes and challenges.
| Study group | Role | What they receive |
|---|---|---|
| Peer Groups | Experimental | Individuals in Intervention Group Arm will attend biweekly or monthly peer support groups (approximately 10 people per group) for evaluating changes and promoting mutual support. 12-month duration. Receives: Behavioral: Peer Groups |
| Control Arm | No intervention | The control arm, will attend the initial educational group lectures at baseline assessment and will receive no intervention thereafter. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite GHP outcomes health score
The GHP outcomes health score assimilates scores related to weight, diet, smoking, physical activity, blood pressure and quality of life.
Measured: baseline
Composite GHP outcomes health score
The GHP outcomes health score assimilates scores related to weight, diet, smoking, physical activity, blood pressure and quality of life.
Measured: 6 months
Composite GHP outcomes health score
The GHP outcomes health score assimilates scores related to weight, diet, smoking, physical activity, blood pressure and quality of life.
Measured: 12 months
Secondary outcomes (3)
Change in blood pressure
Change in blood pressure at 12 months as compared to baseline
Measured: baseline and 12 months
Change in body weight
Change in body weight at 12 months as compared to baseline
Measured: baseline and 12 months
Change in behavior
Change in behavior as 12 months as compared to baseline
Measured: baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study startJul 2014
- Primary completionJul 2016
- Study completionJul 2016
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 Health BehaviorStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- St. George's University
- Responsible party
- Principal investigator, Valentin Fuster, Icahn School of Medicine at Mount Sinai
- Investigators
- Valentin Fuster, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02428920
- Sponsor's protocol ID
- GCO 12-2004
- Acronym
- GHP CHANGE
- Status last verified
- Sep 2016
- First submitted
- 24 Apr 2015
- Last updated
- 8 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Latina J, Fernandez-Jimenez R, Bansilal S, Sartori S, Vedanthan R, Lewis M, Kofler C, Hunn M, Martin F, Bagiella E, Farkouh M, Fuster V. Grenada Heart Project-Community Health ActioN to EncouraGe healthy BEhaviors (GHP-CHANGE): A randomized control peer group-based lifestyle intervention. Am Heart J. 2020 Feb;220:20-28. doi: 10.1016/j.ahj.2019.08.022. Epub 2019 Sep 4.
PubMed 31765932
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Grenada Heart Project - Community Health Action to Encourage Healthy Behaviors
- ClinicalTrials.gov ID
- NCT02428920
- Acronym / sponsor ID
- GHP CHANGE / GCO 12-2004
- Conditions
- Health Behavior
- Keywords
- cardiovascular health, behavior change, community-based, prevention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- St. George's University
- Study start
- Jul 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 29 Apr 2015 (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.
The Grenada Heart Project (GHP) conducted an observational study within a randomly selected adult sample of Grenadians in 2008-2009. The aim of the study was to assess the clinical, biological and psychosocial determinants of the cardiovascular health in Grenada, in order to develop and implement a nationwide cardiovascular health promotion program.
The sample of 2,827 adults was randomly selected from the national electronic voter list. The main outcome measures were self-reported cardiovascular disease and behavioral risk factors, anthropometric measures, blood pressure (BP), point-of-care testing for glucose and lipids, and ankle-brachial index. Analysis of the data revealed prevalence rates of obesity, hypertension and diabetes significantly exceeding those seen in the U.S.
Since the completion of this assessment, an additional effort has contributed significantly to the current project. A parallel community health-promotion project was carried out in Cardona, Spain called the "Cardona Integral Fifty-Fifty" project with 80 subjects. The preliminary results of the Cardona study have a shown that peer motivation may significantly improve healthy behaviors and thus modify cardiovascular risk.
The GHP CHANGE community -based intervention aims to promote positive behaviors and focus more on what creates health, rather than what prevents sickness. It is built on the foundations of social support, assessing whether people going through similar challenges will support each other, work together to identify and address barriers to success, and motivate each other to move forward. In this program we test for the impact of promotion of healthy lifestyle behaviors through peer motivation on blood pressure, physical activity, eating behavior, weight, and smoking.
Detailed description
This culturally-tailored intervention program will take place over a 12-month period in the following four regions on the island:
- St. David's Parish
- St. Andrew's Parish
- St. George's Parish
- St. John's/St. Mark's Parish (combined ) •The program will involve approximately 400 randomized participants (100 from each region). Participants, aged 18-70, from each parish will be divided into one of two groups: Intervention Group arm (peer support) or Control Group arm (individual study).
The investigators will identify study participants previously enrolled in the Grenada Heart Project, with at least one vascular risk factor, as defined by the Adult Treatment Panel III guidelines which include: elevated BP, increased blood glucose level, increased waist circumference, minimal reported physical activity, minimally reported fruit and vegetable intake, or current smoking habits. Given a 10% refusal rate and 10% failure rate in the run-in phase, 120 participants from each site will be invited randomly, from the high risk group, to recruit for participation in the study.
All eligible participants are invited to attend an informational half-day session, during which a general overview of the program is presented and participants have an opportunity to have any questions answered. During this session, eligible and interested individuals complete the written consent forms. Upon consenting, participants are informed of their randomization arm (education intervention or group intervention) and entered into a run-in phase. All participants receive a notebook, as well as certain health literate materials, provided by the American Heart Association. The educational materials will promote management of risk factors and the notebook will provide an avenue for recording of lifestyle behaviors, such as health goals, BP values, and eating habits.
•Participants enrolled in the run-in phase will complete the following assessments at three time points (baseline, 6-months, and 12-months):
- Anthropometric measurements
- GHP data collection form
- International physical activity questionnaire (iPAQ)
- Lifestyle Assessment [modified SF-36 questionnaire tailored to the Grenadian population]
- Point-of-care testing using an LDX analyzer (solely for the 12 month assessment).
The investigators have developed a "GHP Health outcomes Score" which captures a person's health profile on a 0-to-3 point scale related to smoking habits, overweight, sedentary lifestyle, and hypertension During the run-in phase, participants will attend a series of core lifestyle and risk factor education workshops related to motivation for change, nutrition (two sessions), smoking cessation, physical education and BP control. Only those participants who attend 4 of the 6 sessions will be eligible for randomization.
Eligible participants will be randomized to the intervention arm or to the control arm, stratified by parish. In the group intervention arm a group leader will be selected internally within the support groups, who will receive additional training from the research team in regards to group motivation and facilitation. Those randomized into the Intervention arm will be organized into peer groups of approximately 10 persons.
The specific aims of this study are:
Specific Aim 1: Hypothesis: Individuals will show an improvement of health-related behaviors through directed peer education groups (intervention group), compared to the individuals not receiving such peer support (control group).
Specific Aim 2: Hypothesis: Individuals will show an improvement in their quality of life through directed peer education groups (intervention group), compared to the individuals not receiving such peer support (control group).
Specific Aim 3: Hypothesis: Individuals will show an improvement in cardiovascular risk factors through directed peer education groups (intervention group), compared to the individuals not receiving such peer support (control group).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peer Groups | Experimental | Behavioral: Peer GroupsIndividuals in Intervention Group Arm will attend biweekly or monthly peer support groups (approximately 10 people per group) for evaluating changes and promoting mutual support. 12-month duration. |
| Control Arm | No intervention | –The control arm, will attend the initial educational group lectures at baseline assessment and will receive no intervention thereafter. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Resident of Grenada
- One or more vascular risk factors:
Key exclusion criteria (5 listed)
- Unable/unwilling to provide consent
- Age of under 18 or more than 70 years old (inclusive) as of December 2012
- Inability of self-monitoring
- Pregnant women
- Morbidly ill with expectation of death within a year
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 |
|---|---|---|
| Peer GroupsThe intervention group arm will attend biweekly or monthly peer group meetings to discuss health successes and challenges. | Behavioural | Peer Groups |
Primary outcome
Composite GHP outcomes health score
Time frame: baseline
The GHP outcomes health score assimilates scores related to weight, diet, smoking, physical activity, blood pressure and quality of life.
Composite GHP outcomes health score
Time frame: 6 months
The GHP outcomes health score assimilates scores related to weight, diet, smoking, physical activity, blood pressure and quality of life.
Composite GHP outcomes health score
Time frame: 12 months
The GHP outcomes health score assimilates scores related to weight, diet, smoking, physical activity, blood pressure and quality of life.
3 secondary outcomes
Change in blood pressure
Time frame: baseline and 12 months
Change in body weight
Time frame: baseline and 12 months
Change in behavior
Time frame: baseline and 12 months
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 8 Sep 2016.
- Derived from this study: PubMed 31765932Latina J, Fernandez-Jimenez R, Bansilal S, Sartori S, Vedanthan R, Lewis M, Kofler C, Hunn M, Martin F, Bagiella E, Farkouh M, Fuster V. Grenada Heart Project-Community Health ActioN to EncouraGe healthy BEhaviors (GHP-CHANGE): A randomized control peer group-based lifestyle intervention. Am Heart J. 2020 Feb;220:20-28. doi: 10.1016/j.ahj.2019.08.022. Epub 2019 Sep 4.
Related trials for Health Behavior
Not yet recruitingObservational study
Validation of the Healthcare Relationship Assessment Scale (ERA) in Health Sciences Students.
Health Adult Subjects, Communication
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
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.
Valentin Fuster, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Peer Groups in people with Health Behavior, run by Icahn School of Medicine at Mount Sinai at 1 site in Grenada.
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 9 inclusion and 5 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 8 Sep 2016. 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 Grenada. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Composite GHP outcomes health score (time frame: baseline). The study lists 3 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 NCT02428920, 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 8 Sep 2016.