Adherence Dynamics for Whole Food Interventions in African-American Men (DAPH)

This study has been completed.
Sponsor:
Information provided by:
University of Illinois at Chicago
ClinicalTrials.gov Identifier:
NCT01408459
First received: August 1, 2011
Last updated: August 2, 2011
Last verified: July 2011
  Purpose

The purposes of this study are to explore the dynamics of adherence, using a simple whole food intervention strategy, both prior to and during the intervention period and to identify nutrient shifts in self-selected diets and to determine health risks (blood pressure, hyperlipidemia, and body weight) that may have resulted from increased tomato product consumption.


Condition Intervention
Healthy
Dietary Supplement: Tomato Product
Dietary Supplement: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Adherence Dynamics for Whole Food Interventions in African-American Men

Resource links provided by NLM:


Further study details as provided by University of Illinois at Chicago:

Primary Outcome Measures:
  • Tomato Product Intake [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • diet adherence [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • behavior change [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Leukocyte DNA damages [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Inflammation changes [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Dietary Lycopene Intake [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Plasma lycopene concentration [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: January 2007
Study Completion Date: September 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Tomato product Dietary Supplement: Tomato Product
Motivational Telephone Counseling weekly
Other Name: Intervention group
Placebo Comparator: Control
No Motivation telephone Counseling
Dietary Supplement: Control
No Motivational telephone Counseling
Other Name: Control Group

Detailed Description:

African-American (AA) men suffer the greatest proportion of health disparities of any studied category and adherence to advice among this group has been vastly understudied.

Although there are several ongoing trials for behavioral change, either of diet or lifestyle, enrollment rates of AA men (< 25%) often provide insufficient numbers to evaluate adherence issues separately.

Tomatoes, more than lycopene alone, may have beneficial effects on prostate health, including BPH and prostate cancer. Efficacy trials would require long-term adherence to high levels of tomato product (TP) consumption.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • African-American men aged ≥ 50 yr who recently were found to have serum prostate specific antigen (PSA) concentrations of >2.5 ng/mL with negative prostate biopsy for prostate cancer.
  • English literacy
  • willing to consume tomato products on a regular basis.

Exclusion Criteria:

  • prostate cancer diagnosis
  • other cancers < 5 yrs postdiagnosis except for melanoma
  • already consuming four 1/2 cup servings of tomato products/wk.
  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: NCT01408459

Locations
United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60606
Sponsors and Collaborators
University of Illinois at Chicago
Investigators
Principal Investigator: Phyllis E Bowen, Ph.D University of Illinois at Chicago
  More Information

No publications provided

Responsible Party: Phyllis E. Bowen, Univerisy of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT01408459     History of Changes
Other Study ID Numbers: DAPH2006
Study First Received: August 1, 2011
Last Updated: August 2, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Illinois at Chicago:
Prostate cancer prevention

ClinicalTrials.gov processed this record on July 20, 2014