NCT00113672

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
204

participants targeted

Target at P50-P75 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Aug 2004

Longer than P75 for not_applicable cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 10, 2005

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

April 4, 2013

Status Verified

April 1, 2013

Enrollment Period

5.8 years

First QC Date

June 9, 2005

Last Update Submit

April 2, 2013

Conditions

Cardiovascular DiseasesHeart Diseases

Outcome Measures

Primary Outcomes (1)

  • Daily diet and activity (measured at Week 1 and 3, and Month 1, 2, 3, 4, 5, and 6)

    6 months

Study Arms (4)

A

EXPERIMENTAL

Increase healthy eating and increase healthy activity

Behavioral: Increase healthy activity and increase healthy eating

B

EXPERIMENTAL

Increase healthy eating and decrease unhealthy activity

Behavioral: Decrease unhealthy activity and increase healthy eating

C

EXPERIMENTAL

Decrease unhealthy eating and increase healthy activity

Behavioral: Increase physical activity and decrease unhealthy eating

D

EXPERIMENTAL

Decrease unhealthy activity and decrease unhealthy eating

Behavioral: Decrease sedentary activity and decrease unhealthy eating

Interventions

Increase healthy activity and increase healthy eatingBEHAVIORAL

Increase participants to 60 minutes of activity per day and 5 fruits and vegetables per day over a 3 week prescription phase

A
Decrease unhealthy activity and increase healthy eatingBEHAVIORAL

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

B
Increase physical activity and decrease unhealthy eatingBEHAVIORAL

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

C
Decrease sedentary activity and decrease unhealthy eatingBEHAVIORAL

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

D

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (2)

  • Welch WA, Groth CP, Phillips SM, Spring B, Siddique J. Comparing Accelerometer and Self-Reported Treatment Effects in a Technology-Supported Physical Activity Intervention. Health Educ Behav. 2021 Feb;48(1):34-41. doi: 10.1177/1090198120971194. Epub 2020 Nov 13.

    PMID: 33185131DERIVED

  • Spring B, Schneider K, McFadden HG, Vaughn J, Kozak AT, Smith M, Moller AC, Epstein L, Russell SW, DeMott A, Hedeker D. Make Better Choices (MBC): study design of a randomized controlled trial testing optimal technology-supported change in multiple diet and physical activity risk behaviors. BMC Public Health. 2010 Sep 29;10:586. doi: 10.1186/1471-2458-10-586.

    PMID: 20920275DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesHeart Diseases

Study Officials

  • Bonnie Spring, PhD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 9, 2005

First Posted

June 10, 2005

Study Start

August 1, 2004

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

April 4, 2013

Record last verified: 2013-04

Locations

US(1)