Adherence Dynamics for Whole Food Interventions in African-American Men

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Tomato Product; Dietary Supplement: Control

• Registration Number: NCT01408459
• Lead Sponsor: University of Illinois at Chicago

Brief Summary

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.

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.

Study Timeline

• Study Start: 2007-01-04
• Primary Completion: 2008-08-30
• Study Completion: 2008-09-30
• Study First Submitted: 2011-08-01
• Study First Submitted QC: 2011-08-02
• Study First Posted: 2011-08-03
• Results First Submitted: 2014-11-05
• Status Verified: 2021-08
• Results First Submitted QC: 2021-08-08
• Last Update Submitted: 2021-08-08
• Results First Posted: 2021-09-02
• Last Update Posted: 2021-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 37

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tomato product	Tomato Product	Motivational telephone counseling weekly
Control	Control	No Motivation telephone Counseling

Primary Outcome Measures

Name	Time	Method
Tomato Product Intake Between Different Groups	3 months	The intervention group: aimed to achieve the goal of more than five servings of TP/week while control group aimed to eat vegetable instead of tomatoes.

Secondary Outcome Measures

Name	Time	Method
Diet Adherence to Tomato Product Consumption Between Different Groups	3 months	Using 24-hr recall weekly, consumption of tomato product was measured by serving size.
Consumption of Tomato Products Between Different Groups	3 months	Using 24-hr diet recall, types of tomato products were counted.
Plasma Lycopene Concentration Between Different Groups	3 months
Differences in Dietary Lycopene Intake Between Different Groups	3 months

Trial Locations

Locations (1)

University of Illinois at Chicago; 🇺🇸 Chicago, Illinois, United States