NCT01415492

Brief Summary

This study (aka Healthy Directions2 or HD2) builds on an earlier study titled Healthy Directions (aka Healthy Directions 1 or HD1). HD1 was an intervention designed to target cancer prevention among multi-ethnic populations; it led to significant improvements in the multiple risk behavior score (consumption of red meat, fruits and vegetables, and multi-vitamins). Building on the success of HD1, HD2 further expanded the intervention to include smoking and physical activity. In addition, it expanded the study goals to include increasing efficacy across all target risk behaviors, and promoting long-term maintenance of behavior change.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,440

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2009

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

August 10, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 12, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

December 19, 2018

Status Verified

December 1, 2018

Enrollment Period

2.8 years

First QC Date

August 10, 2011

Last Update Submit

December 16, 2018

Conditions

Health BehaviorRisk Reduction Behavior

Keywords

ExercisePhysical activityCigarette SmokingSmoking cessationMulti Vitamin intakeVegetable consumptionFruit consumptionMeat consumption

Outcome Measures

Primary Outcomes (1)

  • Change in multiple risk behavior (MRB) score

    Change in multiple risk behavior (MRB) score at the 6- and 18-months post-intervention follow-ups. This score is a composite measure comprised of status on 5 individual risk factors: red meat intake, multi-vitamin intake, and fruit and vegetable intake, physical activity, and smoking cessation

    6- and 18- months post intervention follow-ups

Secondary Outcomes (1)

  • Change in each of the target risk factors

    6- and 18- months post intervention follow-ups

Other Outcomes (1)

  • Tracking substudy

    starting 7 days after enrollment into the study

Study Arms (3)

Usual Care

NO INTERVENTION

At recruitment this group only received five pamphlets from the study. Four of these pamphlets were from the American Cancer Society, and one from Quitworks (a smoking cessation program).

HD2

ACTIVE COMPARATOR

The intervention study information was delivered via print materials or access to a HD2 Web Site. Patients chose modality. ADDITIONAL NOTE: A sub-set of these participants was randomly selected to receive the Electronic Reminders through the intervention.

Behavioral: HD2

HD2+

ACTIVE COMPARATOR

The intervention study information was delivered via print materials or access to a HD2 Web Site. Patients chose modality. In addition participants received two coaching calls from Health Coaches. ADDITIONAL NOTE: A sub-set of these participants was randomly selected to receive the Electronic Reminders through the intervention.

Behavioral: HD2+

Interventions

HD2+BEHAVIORAL

The intervention was delivered via either print materials or access to a HD2 Web Site. In addition participants received two coaching calls from Health Coaches. ADDITIONAL NOTE: as noted above, a sub-set of these participants was randomly selected to receive the Electronic Reminders through the intervention. Those who were selected could choose to receive the Electronic Reminders either as text messages or as automated phone reminders.

HD2+

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HVMA patient seeing a provider participating in HD2 for annual well visit
  • years of age or older
  • Able to read in English

You may not qualify if:

  • No diagnosis of dementia or psychotic disorders
  • Undergone cancer treatment within past year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harvard Vanguard Medical Associates

Boston, Massachusetts, 02215, United States

Location

Related Publications (5)

  • Greaney ML, Puleo E, Bennett GG, Haines J, Viswanath K, Gillman MW, Sprunck-Harrild K, Coeling M, Rusinak D, Emmons KM. Factors associated with choice of web or print intervention materials in the healthy directions 2 study. Health Educ Behav. 2014 Feb;41(1):52-62. doi: 10.1177/1090198113486803. Epub 2013 May 29.

    PMID: 23720532BACKGROUND

  • Lewis KH, Gillman MW, Greaney ML, Puleo E, Bennett GG, Emmons KM. Relationships between Social Resources and Healthful Behaviors across the Age Spectrum. J Aging Res. 2012;2012:501072. doi: 10.1155/2012/501072. Epub 2012 Aug 30.

    PMID: 22970369BACKGROUND

  • Greaney ML, Puleo E, Sprunck-Harrild K, Bennett GG, Cunningham MA, Gillman MW, Coeling M, Emmons KM. Electronic reminders for cancer prevention: factors associated with preference for automated voice reminders or text messages. Prev Med. 2012 Aug;55(2):151-4. doi: 10.1016/j.ypmed.2012.05.014. Epub 2012 May 30.

    PMID: 22659227RESULT

  • Greaney ML, Sprunck-Harrild K, Bennett GG, Puleo E, Haines J, Viswanath KV, Emmons KM. Use of email and telephone prompts to increase self-monitoring in a Web-based intervention: randomized controlled trial. J Med Internet Res. 2012 Jul 27;14(4):e96. doi: 10.2196/jmir.1981.

    PMID: 22842775RESULT

  • Emmons KM, Puleo E, Greaney ML, Gillman MW, Bennett GG, Haines J, Sprunck-Harrild K, Viswanath K. A randomized comparative effectiveness study of Healthy Directions 2--a multiple risk behavior intervention for primary care. Prev Med. 2014 Jul;64:96-102. doi: 10.1016/j.ypmed.2014.03.011. Epub 2014 Mar 16.

    PMID: 24642140RESULT

MeSH Terms

Conditions

Health BehaviorRisk Reduction BehaviorMotor ActivityCigarette SmokingSmoking Cessation

Condition Hierarchy (Ancestors)

BehaviorTobacco SmokingSmokingTobacco Use

Study Officials

  • Karen M. Emmons, Ph.D.

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 10, 2011

First Posted

August 12, 2011

Study Start

March 1, 2009

Primary Completion

December 1, 2011

Study Completion

January 1, 2012

Last Updated

December 19, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)