ObesityCHOICENCT00674518
Changing Healthy Outcomes In Clinic Environments
A study testing One on one counseling, Group/team - based health education and PACE physician counseling in people with Obesity and Physical Inactivity, run by Oregon Health and Science University at 1 site in United States.
Trial summary
This study will compare three methods of counseling to determine which is most effective at motivating participants to adopt healthy lifestyle habits. The three methods are: individual counseling, working in groups with a health educator, and receiving advice from a physician. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Obesity, Physical Inactivity, Diabetes
- What is being tested?
- One on one counseling, Group/team - based health education and PACE physician counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Mar 2009
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary care patient patients who are sedentary (less than one exercise bout per week
- 30 - 65 years old
- In stable health, defined as an absence of serious chronic disease (i.e., recent myocardial infarction or CVA, uncontrolled metabolic conditions like thyrotoxicosis or poorly controlled diabetes mellitus).
- If the participants are taking medication for medical conditions, they have to be on a stable dose for at least three months with no medication change in past 3 months.
- Participants must be independent in living and able to obtain weekly transportation to OHSU
- able to increase their physical activity.
Who cannot join
- Non ambulatory
- Contraindications to exercise due to medical conditions using the AHA criteria and the ACSM Guidelines For Exercise Testing and Prescription. Examples are CAD, CHF, Recent CVA, poorly controlled DM (fasting glucose over 200 mg/dl), poorly controlled HTN, Severe COPD, Thyrotoxicosis, and Morbid Obesity with BMI > 40.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Health Promotion Intervention: Sedentary Primary Care Patients
This study will compare three methods of counseling to determine which is most effective at motivating participants to adopt healthy lifestyle habits. The three methods are: individual counseling, working in groups with a health educator, and receiving advice from a physician. The health goals for subjects in this study are: 1) increase physical activity to 30 minutes each day, 2) reduce fat intake to less than 30% of total calories, 3) increase consumption of fruits and vegetables to at least 5 servings each day, and 4) reduce percentage of body fat to a healthy level.
Read the detailed description
The benefits of physical activity and proper nutrition have been well established to prevent and reduce the devastating effects of chronic illness including, cardiovascular disease, diabetes, and obesity. Unfortunately, nearly 80% of individuals fail to get enough exercise and eat a proper diet to alter these health disorders. In the United States, physicians do not routinely counsel patients about physical activity and nutrition. Although few studies have examined promotion of physical activity in the primary care setting, most have been disappointing. Achieving and maintaining healthy behaviors remain a major challenge to promoting health and caring for illness. This research proposals aims are to a) evaluate two health behavior change intervention strategies to improve physical activity and dietary behaviors among sedentary patients in a primary care office; and b) assess by cost-benefit analysis, the impact of each model intervention. After initial recruitment from OHSU Internal Medicine and Family Practice clinics, 105 sedentary patients will be randomly assigned to Model 1, Model 2, or Model 3. Model #1, a one-on-one, individualized counseling intervention known as Motivational Interviewing, based on the transtheoretical model of behavior change, will use twelve health educator counseling meetings and ten bi-weekly follow-up phone calls the first year and six 60-minute sessions will occur in the second year of the intervention. Model #2, a team-centered intervention where the health promotion curriculum is delivered by a group facilitator to a team of patients (based on the social influence theory) consists of twelve 60-minute peer facilitated group meetings and ten follow-up phone calls, with six sessions occurring the second year of the full outcome study. Group facilitators will be trained and use scripted lesson plans. Model #3, a usual practice control condition (5 minute physician advice using the Physician Advice Counseling Exercise or PACE format). Models 1 and 2 contact hours are the same. Year 01 is the pilot study to revise and refine the curriculum and study protocol. The full intervention will last two years while the behavior change durability will be assessed over another full year. The study's primary outcomes are increased physical activity as measured by peak oxygen uptake and survey, dietary changes assessed by intake survey, and body composition changes as measured by DEXA. Secondary outcome measures include blood pressure lipid and lipoprotein levels, biochemical markers of inflammation (CRP) and hormonal markers of obesity. Outcomes will be assessed using repeated measures design. Relationships among mediators, the intervention, and the outcome measures will be identified.
- Conditions
- Obesity, Physical Inactivity, Diabetes
- Being tested
- One on one counseling, Group/team - based health education, PACE physician counseling
- Keywords
- Health Promotion, Health Behavior Change, Physical Activity, Dietary Change, Weight Loss, Obesity
- Medical subject headings
- Obesity, Sedentary Behavior, Diabetes Mellitus, Motor Activity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One on one counselingBehavioural
Motivational Interviewing
Group/team - based health educationBehavioural
peer led, scripted health promotion curriculum in groups of 4-5 individual, with team building activities and health education for 12, 1-hour sessions per year.
PACE physician counselingBehavioural
PACE format for physician exercise and nutrition counseling annually.
| Study group | Role | What they receive |
|---|---|---|
| Counseling | Experimental | One-on-one sessions conducted by a professional motivational counselor to explore ways to help motivate participants to exercise, eat healthier, and lose weight. Receives: Behavioral: One on one counseling |
| Group | Experimental | A nutrition and exercise specialist will lead and teach a group of 4 to 5 subjects in healthy nutrition, exercise and weight loss habits Receives: Behavioral: Group/team - based health education |
| MD Advice | Active comparator | A physician will provide exercise and nutrition advice to participants immediately following testing Receives: Behavioral: PACE physician counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improve physical activity and dietary behaviors among sedentary patients
Measured: annually x 3 years
Secondary outcomes (1)
Improve biomarkers of obesity including glucose, lipid levels, CRP, leptin and insulin.
Measured: annually x 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2008 (estimated)
- Study startJan 2005
- Primary completionJun 2008
- Study completionMar 2009
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 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kerry Kuehl, Oregon Health and Science University
- Investigators
- Kerry S Kuehl, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00674518
- Sponsor's protocol ID
- 1K23RR017554-01A2
- Acronym
- CHOICE
- Status last verified
- Jun 2019
- First submitted
- 6 May 2008
- Last updated
- 20 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kuehl KS, Elliot D, Edholm K, Frohnmayer S. Changing Healthy Outcomes In Clinical Environments (CHOICE) Study. Annals of Behavioral Medicine 33(Supplement):S094, 2007.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Promotion Intervention: Sedentary Primary Care Patients
- ClinicalTrials.gov ID
- NCT00674518
- Acronym / sponsor ID
- CHOICE / 1K23RR017554-01A2
- Conditions
- Obesity, Physical Inactivity, Diabetes
- Keywords
- Health Promotion, Health Behavior Change, Physical Activity, Dietary Change, Weight Loss, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Jan 2005 (actual)
- Primary completion
- Jun 2008 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 8 May 2008 (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 will compare three methods of counseling to determine which is most effective at motivating participants to adopt healthy lifestyle habits. The three methods are: individual counseling, working in groups with a health educator, and receiving advice from a physician. The health goals for subjects in this study are: 1) increase physical activity to 30 minutes each day, 2) reduce fat intake to less than 30% of total calories, 3) increase consumption of fruits and vegetables to at least 5 servings each day, and 4) reduce percentage of body fat to a healthy level.
Detailed description
The benefits of physical activity and proper nutrition have been well established to prevent and reduce the devastating effects of chronic illness including, cardiovascular disease, diabetes, and obesity. Unfortunately, nearly 80% of individuals fail to get enough exercise and eat a proper diet to alter these health disorders. In the United States, physicians do not routinely counsel patients about physical activity and nutrition. Although few studies have examined promotion of physical activity in the primary care setting, most have been disappointing. Achieving and maintaining healthy behaviors remain a major challenge to promoting health and caring for illness. This research proposals aims are to a) evaluate two health behavior change intervention strategies to improve physical activity and dietary behaviors among sedentary patients in a primary care office; and b) assess by cost-benefit analysis, the impact of each model intervention. After initial recruitment from OHSU Internal Medicine and Family Practice clinics, 105 sedentary patients will be randomly assigned to Model 1, Model 2, or Model 3. Model #1, a one-on-one, individualized counseling intervention known as Motivational Interviewing, based on the transtheoretical model of behavior change, will use twelve health educator counseling meetings and ten bi-weekly follow-up phone calls the first year and six 60-minute sessions will occur in the second year of the intervention. Model #2, a team-centered intervention where the health promotion curriculum is delivered by a group facilitator to a team of patients (based on the social influence theory) consists of twelve 60-minute peer facilitated group meetings and ten follow-up phone calls, with six sessions occurring the second year of the full outcome study. Group facilitators will be trained and use scripted lesson plans. Model #3, a usual practice control condition (5 minute physician advice using the Physician Advice Counseling Exercise or PACE format). Models 1 and 2 contact hours are the same. Year 01 is the pilot study to revise and refine the curriculum and study protocol. The full intervention will last two years while the behavior change durability will be assessed over another full year. The study's primary outcomes are increased physical activity as measured by peak oxygen uptake and survey, dietary changes assessed by intake survey, and body composition changes as measured by DEXA. Secondary outcome measures include blood pressure lipid and lipoprotein levels, biochemical markers of inflammation (CRP) and hormonal markers of obesity. Outcomes will be assessed using repeated measures design. Relationships among mediators, the intervention, and the outcome measures will be identified.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Counseling | Experimental | Behavioral: One on one counselingOne-on-one sessions conducted by a professional motivational counselor to explore ways to help motivate participants to exercise, eat healthier, and lose weight. |
| Group | Experimental | Behavioral: Group/team - based health educationA nutrition and exercise specialist will lead and teach a group of 4 to 5 subjects in healthy nutrition, exercise and weight loss habits |
| MD Advice | Active comparator | Behavioral: PACE physician counselingA physician will provide exercise and nutrition advice to participants immediately following testing |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Primary care patient patients who are sedentary (less than one exercise bout per week
- 30 - 65 years old
- In stable health, defined as an absence of serious chronic disease (i.e., recent myocardial infarction or CVA, uncontrolled metabolic conditions like thyrotoxicosis or poorly controlled diabetes mellitus).
- If the participants are taking medication for medical conditions, they have to be on a stable dose for at least three months with no medication change in past 3 months.
- Participants must be independent in living and able to obtain weekly transportation to OHSU
Key exclusion criteria (2 listed)
- Non ambulatory
- Contraindications to exercise due to medical conditions using the AHA criteria and the ACSM Guidelines For Exercise Testing and Prescription. Examples are CAD, CHF, Recent CVA, poorly controlled DM (fasting glucose over 200 mg/dl), poorly controlled HTN, Severe COPD, Thyrotoxicosis, and Morbid Obesity with BMI > 40.
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 |
|---|---|---|
| One on one counselingMotivational Interviewing | Behavioural | Counseling |
| Group/team - based health educationpeer led, scripted health promotion curriculum in groups of 4-5 individual, with team building activities and health education for 12, 1-hour sessions per year. | Behavioural | Group |
| PACE physician counselingPACE format for physician exercise and nutrition counseling annually. | Behavioural | MD Advice |
Primary outcome
Improve physical activity and dietary behaviors among sedentary patients
Time frame: annually x 3 years
1 secondary outcome
Improve biomarkers of obesity including glucose, lipid levels, CRP, leptin and insulin.
Time frame: annually x 3 years
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 20 Jun 2019.
- BackgroundKuehl KS, Elliot D, Edholm K, Frohnmayer S. Changing Healthy Outcomes In Clinical Environments (CHOICE) Study. Annals of Behavioral Medicine 33(Supplement):S094, 2007.
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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.
Kerry S Kuehl, MD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One on one counseling, Group/team - based health education and PACE physician counseling in people with Obesity and Physical Inactivity, run by Oregon Health and Science University at 1 site in United States.
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 6 inclusion and 2 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 20 Jun 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 States. 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?
Improve physical activity and dietary behaviors among sedentary patients (time frame: annually x 3 years). 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 NCT00674518, 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 20 Jun 2019.