NCT02205697

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2014

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 31, 2014

Completed
1 day until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

January 18, 2016

Status Verified

July 1, 2015

Enrollment Period

11 months

First QC Date

July 29, 2014

Last Update Submit

January 15, 2016

Conditions

Keywords

FruitVegetable

Outcome Measures

Primary Outcomes (1)

  • 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.

    30 days

Study Arms (1)

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.

Behavioral: Implementation intention

Interventions

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.

Implementation intention

Eligibility Criteria

Age18 Years - 72 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston University School of Medicine

Boston, Massachusetts, 02118, United States

Location

Study Officials

  • Michele A DeBiasse, MS, RDN

    Boston University/Graduate Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2014

First Posted

July 31, 2014

Study Start

August 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

January 18, 2016

Record last verified: 2015-07

Locations