Changing Healthy Outcomes In Clinic Environments

NCT00674518 | Completed DMC

• 1 other identifier: 1K23RR017554-01A2
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Obesity; Physical Inactivity; Diabetes

Keywords

Health Promotion; Health Behavior Change; Physical Activity; Dietary Change; Weight Loss; Obesity

Outcome Measures

Primary Outcomes (1)

• Improve physical activity and dietary behaviors among sedentary patients

  annually x 3 years

Secondary Outcomes (1)

• Improve biomarkers of obesity including glucose, lipid levels, CRP, leptin and insulin.

  annually x 3 years

Study Arms (3)

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.

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

Behavioral: Group/team - based health education

MD Advice

ACTIVE COMPARATOR

A physician will provide exercise and nutrition advice to participants immediately following testing

Behavioral: PACE physician counseling

Interventions

One on one counseling BEHAVIORAL

Motivational Interviewing

Counseling

Group/team - based health education BEHAVIORAL

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.

Group

PACE physician counseling BEHAVIORAL

PACE format for physician exercise and nutrition counseling annually.

MD Advice

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary care patient patients who are sedentary (less than one exercise bout per week
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Publications (1)

• Kuehl KS, Elliot D, Edholm K, Frohnmayer S. Changing Healthy Outcomes In Clinical Environments (CHOICE) Study. Annals of Behavioral Medicine 33(Supplement):S094, 2007.

  BACKGROUND

MeSH Terms

Conditions

Obesity; Sedentary Behavior; Diabetes Mellitus; Motor Activity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Body Weight Changes

Study Officials

• Kerry S Kuehl, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 6, 2008
• First Posted: May 8, 2008
• Study Start: January 1, 2005
• Primary Completion: June 1, 2008
• Study Completion: March 1, 2009
• Last Updated: June 20, 2019

Record last verified: 2019-06

Locations

US (1)