Clinical trial NCT00113672: Make Better Choices Study
Official title: Multiple Behavior Change in Diet and Activity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Heart Diseases
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2005-06-10
Enrollment: 204
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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 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.

Primary outcomes:
measure: Daily diet and activity (measured at Week 1 and 3, and Month 1, 2, 3, 4, 5, and 6)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Bonnie Spring, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.