Make Better Choices Study (MBC)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Bonnie Spring, Northwestern University
ClinicalTrials.gov Identifier:
NCT00113672
First received: June 9, 2005
Last updated: April 2, 2013
Last verified: April 2013
  Purpose

The purpose of this study is to examine the impact of diet and exercise on an individual's health.


Condition Intervention
Cardiovascular Diseases
Heart Diseases
Behavioral: Increase healthy activity and increase healthy eating
Behavioral: Decrease unhealthy activity and increase healthy eating
Behavioral: Increase physical activity and decrease unhealthy eating
Behavioral: Decrease sedentary activity and decrease unhealthy eating

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Multiple Behavior Change in Diet and Activity

Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Daily diet and activity (measured at Week 1 and 3, and Month 1, 2, 3, 4, 5, and 6) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 204
Study Start Date: August 2004
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Increase healthy eating and increase healthy activity
Behavioral: Increase healthy activity and increase healthy eating
Increase participants to 60 minutes of activity per day and 5 fruits and vegetables per day over a 3 week prescription phase
Experimental: B
Increase healthy eating and decrease unhealthy activity
Behavioral: Decrease unhealthy activity and increase healthy eating
Decrease sedentary activity by 90 minutes per day and increase fruits and vegetables to 5 servings per day over the course of a 3 week prescription phase
Experimental: C
Decrease unhealthy eating and increase healthy activity
Behavioral: Increase physical activity and decrease unhealthy eating
Increase physical activity up to 60 minutes per day and decrease saturated fat to an average of 8% per day over the course of a 3 week prescription phase
Experimental: D
Decrease unhealthy activity and decrease unhealthy eating
Behavioral: Decrease sedentary activity and decrease unhealthy eating
Decrease sedentary activity by 90 minutes per day and decrease saturated fat to and average of 8% per day over the course of a 3 week prescription phase

Detailed Description:

BACKGROUND:

The majority of adult Americans consume a high saturated fat diet, have a low fruit and vegetable (F/V) intake, and lead a sedentary lifestyle. This unhealthy lifestyle heightens their risk for cardiovascular disease and cancer. Improving diet and activity can reduce risk, but the best prescription to promote a healthier diet and a more active lifestyle remains unknown. This study will randomly assign participants to 4 groups, which will include all combinations of increasing healthy eating and activity and decreasing unhealthy eating and activity. The Familiarity Hypothesis predicts that the most familiar dieting prescription (decrease fat, increase physical activity) will maximize healthy behavior change. The Optimal Substitution Hypothesis, based on Behavioral Economic Theory, predicts that increasing F/V intake while decreasing sedentary behavior will surpass alternative methods by maximizing behavioral substitution of healthful eating and activity for unhealthful eating and activity. The Low Inhibitory Demand Hypothesis, based on Self-Control Theory, predicts that increasing F/Vs while increasing physical activity will be most successful because this prescription places the fewest demands on self-control resources.

DESIGN NARRATIVE:

The study will randomize 200 sedentary community-dwelling adults with a suboptimal diet to 1 of 4 groups including: 1) increase healthy eating and activity; 2) decrease unhealthy eating and activity; 3) increase healthy eating and decrease unhealthy activity; and 4) decrease unhealthy eating and increase healthy physical activity. Subjects will self-monitor diet, physical activity, and mood via PDAs during a 2-week baseline period, a 3-week prescription period (when payment is contingent upon changing eating and activity simultaneously to targeted standards), and a 4-month maintenance period. Targeted and collateral diet and activity changes will be measured by self report, accelerometer, and grocery receipts. Bogus pipeline urinary testing will encourage adherence. Laboratory testing will measure behavioral choices, craving, and attentional allocation to restricted foods and activities in a permissive context in order to shed light on behavioral and psychological processes that mediate healthy lifestyle change. Findings will help to fill an important gap in clinical knowledge about how to optimize healthy simultaneous change in diet and activity among adults.

  Eligibility

Ages Eligible for Study:   21 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Sedentary community dwelling adults with a suboptimal diet
  • Motivated to make changes in diet and activity level

Exclusion Criteria:

  • Few exclusion criteria will be implemented in order to enhance generalizability
  • For safety, participants with unstable medical conditions (uncontrolled hypertension, diabetes, recent myocardial infarction) will be excluded. Those with stable medical conditions will require physician approval to participate but will not be excluded because the prescribed changes in diet and activity match healthy, attainable guidelines for all Americans.
  • Cannot read the study questionnaires
  • Committed to following an incompatible dietary regimen
  • Pregnant, trying to get pregnant, or breastfeeding
  • People with anorexia, bulimia, or report active suicidal ideation will not be enrolled because they might practice overly severe dietary restrictions
  • Binge eating disorder
  • Current substance abuse or dependence, other than nicotine dependence will be excluded because of concern about their ability to maintain accurate records of intake and activity. Smokers will be accepted and during recreational laboratory sessions will be able to smoke cigarettes in an adjoining room that is used as a smoking laboratory.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00113672

Locations
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Bonnie Spring, PhD Northwestern University
  More Information

No publications provided by Northwestern University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bonnie Spring, Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT00113672     History of Changes
Other Study ID Numbers: 182, R01HL075451, R01 HL75451
Study First Received: June 9, 2005
Last Updated: April 2, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 30, 2014