Cardiovascular DiseasesMBCNCT00113672
Make Better Choices Study
A study testing Increase healthy activity and increase healthy eating, Decrease unhealthy activity and increase healthy eating and Increase physical activity and decrease unhealthy eating in people with Cardiovascular Diseases and Heart Diseases, run by Northwestern University at 1 site in United States.
Trial summary
The purpose of this study is to examine the impact of diet and exercise on an individual's health. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases
- What is being tested?
- Increase healthy activity and increase healthy eating, Decrease unhealthy activity and increase healthy eating and Increase physical activity and decrease unhealthy eating
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2004to Jun 2010
- 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Sedentary community dwelling adults with a suboptimal diet
- Motivated to make changes in diet and activity level
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multiple Behavior Change in Diet and Activity
The purpose of this study is to examine the impact of diet and exercise on an individual's health.
Read the 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.
- Conditions
- Cardiovascular Diseases, Heart Diseases
- Being tested
- Increase healthy activity and increase healthy eating, Decrease unhealthy activity and increase healthy eating, Increase physical activity and decrease unhealthy eating, Decrease sedentary activity and decrease unhealthy eating
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Increase healthy activity and increase healthy eatingBehavioural
Increase participants to 60 minutes of activity per day and 5 fruits and vegetables per day over a 3 week prescription phase
Decrease unhealthy activity and increase healthy eatingBehavioural
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
Increase physical activity and decrease unhealthy eatingBehavioural
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
Decrease sedentary activity and decrease unhealthy eatingBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Increase healthy eating and increase healthy activity Receives: Behavioral: Increase healthy activity and increase healthy eating |
| B | Experimental | Increase healthy eating and decrease unhealthy activity Receives: Behavioral: Decrease unhealthy activity and increase healthy eating |
| C | Experimental | Decrease unhealthy eating and increase healthy activity Receives: Behavioral: Increase physical activity and decrease unhealthy eating |
| D | Experimental | Decrease unhealthy activity and decrease unhealthy eating Receives: Behavioral: Decrease sedentary activity and decrease unhealthy eating |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily diet and activity (measured at Week 1 and 3, and Month 1, 2, 3, 4, 5, and 6)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2005 (estimated)
- Study startAug 2004
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Bonnie Spring, Northwestern University
- Investigators
- Bonnie Spring, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00113672
- Sponsor's protocol ID
- 182
- Other IDs
- R01HL075451
- Acronym
- MBC
- Status last verified
- Apr 2013
- First submitted
- 9 Jun 2005
- Last updated
- 4 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 33185131Spring 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.
PubMed 20920275
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple Behavior Change in Diet and Activity
- ClinicalTrials.gov ID
- NCT00113672
- Acronym / sponsor ID
- MBC / 182
- Conditions
- Cardiovascular Diseases, Heart Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Aug 2004
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 10 Jun 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Behavioral: Increase healthy activity and increase healthy eatingIncrease healthy eating and increase healthy activity |
| B | Experimental | Behavioral: Decrease unhealthy activity and increase healthy eatingIncrease healthy eating and decrease unhealthy activity |
| C | Experimental | Behavioral: Increase physical activity and decrease unhealthy eatingDecrease unhealthy eating and increase healthy activity |
| D | Experimental | Behavioral: Decrease sedentary activity and decrease unhealthy eatingDecrease unhealthy activity and decrease unhealthy eating |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Sedentary community dwelling adults with a suboptimal diet
- Motivated to make changes in diet and activity level
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Increase healthy activity and increase healthy eatingIncrease participants to 60 minutes of activity per day and 5 fruits and vegetables per day over a 3 week prescription phase | Behavioural | A |
| Decrease unhealthy activity and increase healthy eatingDecrease 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 | Behavioural | B |
| Increase physical activity and decrease unhealthy eatingIncrease 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 | Behavioural | C |
| Decrease sedentary activity and decrease unhealthy eatingDecrease 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 | Behavioural | D |
Primary outcome
Daily diet and activity (measured at Week 1 and 3, and Month 1, 2, 3, 4, 5, and 6)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2013.
- Derived from this study: PubMed 33185131Welch 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.
- Derived from this study: PubMed 20920275Spring 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bonnie Spring, PhD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Increase healthy activity and increase healthy eating, Decrease unhealthy activity and increase healthy eating and Increase physical activity and decrease unhealthy eating in people with Cardiovascular Diseases and Heart Diseases, run by Northwestern 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 2 inclusion and 8 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 4 Apr 2013. 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?
Daily diet and activity (measured at Week 1 and 3, and Month 1, 2, 3, 4, 5, and 6) (time frame: 6 months). 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 NCT00113672, which also lists 2 linked publications.
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 4 Apr 2013.