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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in United States

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.

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 groups in NCT00674518
Study groupRoleWhat they receive
CounselingExperimentalOne-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
GroupExperimentalA 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 AdviceActive comparatorA 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.

  1. Improve physical activity and dietary behaviors among sedentary patients

    Measured: annually x 3 years

Secondary outcomes (1)
  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.

  1. First posted8 May 2008 (estimated)
  2. Study startJan 2005
  3. Primary completionJun 2008
  4. Study completionMar 2009

Resources

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)
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.

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.

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