Dietary ModificationTPBIIFVNCT02205697
Theory of Planned Behavior and Implementation Intentions
A study testing Implementation intention in people with Dietary Modification, run by Boston University at 1 site in United States.
Trial summary
Diet quality has been associated with a variety of chronic diseases including obesity. One measure that has been studied as an indicator for diet quality is fruit and vegetable intake. Read more about this study
- Who is it for?
- Ages 18 to 72 years, women only
- Conditions the study is for
- Dietary Modification
- What is being tested?
- Implementation intention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Jul 2015
- 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 18 to 72 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Resident of Boston Public Housing
- Identifies as female
- Age 18-72
- Able to give informed consent
- Agrees to be randomized into either the intervention or the control groups
- Understands English sufficient to comprehend purpose, risks, benefits and voluntary nature of the study, and to complete the surveys and provide information in this language
Who cannot join
- Does not consent to study participation
- Currently pregnant
- Identifies as following a strict medically prescribed diet, as having an allergy to fruit and/or vegetables, or as currently taking medications that necessitate the avoidance or reduction of fruit and/or vegetable intake.
- Does not agree to be randomized into either the intervention or control groups
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston University School of Medicine
Boston, Massachusetts, 02118
About this study
Official title: Theory of Planned Behavior and Implementation Intentions: Effective for Improving Fruit and Vegetable Intake in Women of Low Socioeconomic Status?
Diet quality has been associated with a variety of chronic diseases including obesity. One measure that has been studied as an indicator for diet quality is fruit and vegetable intake. Although the US government has suggested that American's increase their intake of fruit and vegetables, epidemiological data suggest that most Americans have not been successful doing do, with the strongest disparity seen in people of low socioeconomic status (SES). This disparity in fruit and vegetable intake is thought to be the result of both individual and environmental factors that influence this health behavior. To help decrease the disparate rise in incidence of chronic disease in people of low SES, effective, cost-efficient and easy to implement interventions to improve fruit and vegetable intake and diet quality are needed.
Theoretical models of health behavior change have been successfully used in research targeting individual factors associated with health behaviors. One theory, the Theory of Planned Behavior (TPB), and a proposed extension of this model (implementation intentions) have been shown to be effective to increase fruit and vegetable intake in (mostly) white adults of average socioeconomic status. It is not know whether an implementation intention intervention to increase fruit and vegetable intake would be effective in women who are of low socioeconomic status. The primary aim of this research is to study (using quantitative and qualitative analysis) an implementation intention intervention to produce a positive change in fruit and vegetable intake. We theorize that the setting of an implementation intention in this group will be effective, cost-effective, and easy to implement intervention to promote an increase in fruit and vegetable intake.
Read the detailed description
Theory of Planned Behavior Variables (attitude, perceived behavioral control, intention) measured via survey using 1 question each, bivariate semantic differential scale.
Main outcomes measure is fruit and vegetable intake. Behavioral Risk Factor Surveillance System Fruit and Vegetable Module (6-item screener) + pictorial of serving sizes.
Demographic data measured via survey. Height measured via tape measure. Weight measured using a standing scale.
- Conditions
- Dietary Modification
- Being tested
- Implementation intention
- Keywords
- Fruit, Vegetable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation intentionBehavioural
The intervention consists of an implementation intention whereby subjects create a unique plan to increase their fruit and vegetable intake by planning the where, when, and what to increase their fruit and vegetable intake.
| Study group | Role | What they receive |
|---|---|---|
| Implementation intention | Experimental | The entire cohort will be asked to create an implementation intention to increase their intake of fruit and vegetables over the study period. Receives: Behavioral: Implementation intention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean intake of fruit and vegetables (servings per day) both within and between the experimental and control groups.
Change in mean intake of fruit and vegetables (servings per day) will be assessed in both the experimental and control groups using the Behavioral Risk Factor Surveillance System (BRFSS) Fruit and Vegetable Module. Inferential statistics will be used to assess differences in change in mean fruit and vegetable intake both within and between groups.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2014 (estimated)
- Study startAug 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary ModificationStudies of the same condition, open and under way.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michele A DeBiasse, MS, RDN, Principal investigator, Boston University/Graduate Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02205697
- Sponsor's protocol ID
- mdh-32828
- Acronym
- TPBIIFV
- Status last verified
- Jul 2015
- First submitted
- 29 Jul 2014
- Last updated
- 18 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Theory of Planned Behavior and Implementation Intentions: Effective for Improving Fruit and Vegetable Intake in Women of Low Socioeconomic Status?
- ClinicalTrials.gov ID
- NCT02205697
- Acronym / sponsor ID
- TPBIIFV / mdh-32828
- Conditions
- Dietary Modification
- Keywords
- Fruit, Vegetable
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 31 Jul 2014 (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.
Diet quality has been associated with a variety of chronic diseases including obesity. One measure that has been studied as an indicator for diet quality is fruit and vegetable intake. Although the US government has suggested that American's increase their intake of fruit and vegetables, epidemiological data suggest that most Americans have not been successful doing do, with the strongest disparity seen in people of low socioeconomic status (SES). This disparity in fruit and vegetable intake is thought to be the result of both individual and environmental factors that influence this health behavior. To help decrease the disparate rise in incidence of chronic disease in people of low SES, effective, cost-efficient and easy to implement interventions to improve fruit and vegetable intake and diet quality are needed.
Theoretical models of health behavior change have been successfully used in research targeting individual factors associated with health behaviors. One theory, the Theory of Planned Behavior (TPB), and a proposed extension of this model (implementation intentions) have been shown to be effective to increase fruit and vegetable intake in (mostly) white adults of average socioeconomic status. It is not know whether an implementation intention intervention to increase fruit and vegetable intake would be effective in women who are of low socioeconomic status. The primary aim of this research is to study (using quantitative and qualitative analysis) an implementation intention intervention to produce a positive change in fruit and vegetable intake. We theorize that the setting of an implementation intention in this group will be effective, cost-effective, and easy to implement intervention to promote an increase in fruit and vegetable intake.
Detailed description
Theory of Planned Behavior Variables (attitude, perceived behavioral control, intention) measured via survey using 1 question each, bivariate semantic differential scale.
Main outcomes measure is fruit and vegetable intake. Behavioral Risk Factor Surveillance System Fruit and Vegetable Module (6-item screener) + pictorial of serving sizes.
Demographic data measured via survey. Height measured via tape measure. Weight measured using a standing scale.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implementation intention | Experimental | Behavioral: Implementation intentionThe entire cohort will be asked to create an implementation intention to increase their intake of fruit and vegetables over the study period. |
Who may qualify
- Ages
- 18 to 72 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Resident of Boston Public Housing
- Identifies as female
- Age 18-72
- Able to give informed consent
- Agrees to be randomized into either the intervention or the control groups
Key exclusion criteria (4 listed)
- Does not consent to study participation
- Currently pregnant
- Identifies as following a strict medically prescribed diet, as having an allergy to fruit and/or vegetables, or as currently taking medications that necessitate the avoidance or reduction of fruit and/or vegetable intake.
- Does not agree to be randomized into either the intervention or control groups
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 |
|---|---|---|
| Implementation intentionThe intervention consists of an implementation intention whereby subjects create a unique plan to increase their fruit and vegetable intake by planning the where, when, and what to increase their fruit and vegetable intake. | Behavioural | Implementation intention |
Primary outcome
Change in mean intake of fruit and vegetables (servings per day) both within and between the experimental and control groups.
Time frame: 30 days
Change in mean intake of fruit and vegetables (servings per day) will be assessed in both the experimental and control groups using the Behavioral Risk Factor Surveillance System (BRFSS) Fruit and Vegetable Module. Inferential statistics will be used to assess differences in change in mean fruit and vegetable intake both within and between groups.
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 18 Jan 2016.
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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.
Michele A DeBiasse, MS, RDN principal investigator
Boston University/Graduate Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation intention in people with Dietary Modification, run by Boston 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 6 inclusion and 4 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 18 Jan 2016. 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?
Change in mean intake of fruit and vegetables (servings per day) both within and between the experimental and control groups. (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jan 2016.