Multiple Risk Behavior Intervention in Health Care Settings (HD2)

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Karen Emmons, PhD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01415492
First received: August 10, 2011
Last updated: December 30, 2014
Last verified: December 2014
  Purpose
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.

Condition Intervention
Health Behavior
Risk Reduction Behavior
Behavioral: HD2
Behavioral: HD2+

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
Official Title: Multiple Risk Behavior Intervention in Health Care Settings

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Change in multiple risk behavior (MRB) score [ Time Frame: 6- and 18- months post intervention follow-ups ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Change in each of the target risk factors [ Time Frame: 6- and 18- months post intervention follow-ups ] [ Designated as safety issue: No ]
    Change in each of the target risk factors intervention dose delivered, reach, and cost-effectiveness.


Other Outcome Measures:
  • Tracking substudy [ Time Frame: starting 7 days after enrollment into the study ] [ Designated as safety issue: No ]
    To determine whether providing assistance with a key component of the web site, behavior tracking, will stimulate higher rates of use.


Enrollment: 2440
Study Start Date: March 2009
Study Completion Date: January 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual Care
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).
Active Comparator: HD2
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
The intervention was delivered via either print materials or access to a HD2 Web Site. ADDITIONAL NOTE: 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.
Active Comparator: HD2+
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+
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • No diagnosis of dementia or psychotic disorders
  • Undergone cancer treatment within past year
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01415492

Locations
United States, Massachusetts
Harvard Vanguard Medical Associates
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Investigators
Principal Investigator: Karen M. Emmons, Ph.D. Dana-Farber Cancer Institute
  More Information

Publications:
Responsible Party: Karen Emmons, PhD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01415492     History of Changes
Other Study ID Numbers: 1810  5R01CA123228 
Study First Received: August 10, 2011
Last Updated: December 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
Exercise
Physical activity
Cigarette Smoking
Smoking cessation
Multi Vitamin intake
Vegetable consumption
Fruit consumption
Meat consumption

ClinicalTrials.gov processed this record on July 27, 2016