Clinical trial NCT02205697: Theory of Planned Behavior and Implementation Intentions
Official title: Theory of Planned Behavior and Implementation Intentions: Effective for Improving Fruit and Vegetable Intake in Women of Low Socioeconomic Status?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Modification
Keywords: Fruit
Vegetable
Lead sponsor: Boston University
Sponsor class: OTHER
First posted: 2014-07-31
Enrollment: 31
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in mean intake of fruit and vegetables (servings per day) both within and between the experimental and control groups.
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University School of Medicine
state: Massachusetts
Study officials:
affiliation: Boston University/Graduate Medical Sciences
name: Michele A DeBiasse, MS, RDN
role: PRINCIPAL_INVESTIGATOR
References: