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Completed

NCT Number: NCT03339050

Reducing Cardiovascular Risk of African Americans

Diseases such as hypertension and stroke affect mid-life and older African Americans at higher rates than Whites, negatively affecting health status of this group. This project determine the effectiveness of a faith-based health intervention for mid-life and older African Americans using community-based participatory research approaches.

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Key information

Conditions

Cardiovascular Risk Factor

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Mid-life and older African Americans (AAs), a population that is increasing in number, have high rates of cardiovascular-related morbidity and mortality in relation to Whites. For this population, dietary and physical activity behaviors are related to the incidence of cardiovascular disease (CVD). Few tested health promotion interventions tailored for mid-life and older AAs are available yet churches have been shown to be an effective environment for AA health programs. Thus, the overall goal of this project is to reduce CVD risk factors in mid-life and older AAs through implementing and evaluating a church-based health intervention. Using the Transtheoretical Model of Behavior Change (TTM) and Socio-ecological theory (SE), the objectives of this project were to: 1) determine the effectiveness of a church-based intervention in relation to dietary behaviors (food choice, dietary quality), habitual physical activity) and CVD clinical risk factors of mid-life and older African Americans by increasing consumption of fruits, vegetables and calcium-rich foods; decreasing consumption of fat, sugar and sodium; increasing habitual physical activity; and improving selected clinical outcomes (blood pressure, body weight, glucose, among others); 2) identify the differential influence of program components of the intervention; 3) examine variables that might mediate the process of goal achievement; and 4) determine variables that are related to stage of change progression in goal achievement. Midlife and older AAs (n=221) from six churches, three treatment and three comparison, in North Florida were randomly selected from the churches, stratifying by age and gender. The intervention, Health for Hearts United, was developed using a community-based participatory approach and included literature-based conceptual elements of awareness building, clinical learning and efficacy development. Instruments included a food and lifestyle habits questionnaire (food frequency, NCI fruit and vegetable screener, NCI fat screener, physical activity items, TTM items, background characteristics, among others). Clinical data, including 24 hour recall, were collected from a subsample of participants (n=104). Data were collected at four points: Baseline, 6 ,18 and 24 month. The project was guided by research and community advisory committees.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 45 years of age or older
  • African American
  • member and regular attender of church (at least twice a month)
  • resident of Gadsden and Leon counties in North Florida.

Exclusion criteria

  • Under 45 years of age
  • not African American
  • not a member and regular attender of church
  • not a resident of Gadsden and Leon counties in North Florida.

Treatment and study plan

Health for Hearts United

Behavioral

The intervention was framed around three conceptual components (awareness building, clinical learning, and efficacy development), and four types of programming (church-initiated, joint programming, standard programming (culturally tailored post cards and newsletters), and data collection health promotion (generic materials, clinical sessions with an Registered Dietitian). Key messages were identified for the intervention including eating better, moving around more, reducing stress, and taking charge of your health.

Primary outcomes

  1. Increase in fruit and vegetable consumption assessed by a single item on number of servings of fruits and vegetables consumed daily.

    Time frame: Change from Baseline, 6 months, 18 months and 24 months

    The single item measure was "How many servings of fruits and vegetables do you usually eat each day?" The item had the following possible responses: zero, one, two, three, four, five and six or more servings daily. The range of scores was zero to six, with six representing the highest number of servings daily and zero representing the lowest.

  2. Decrease in saturated fat intake (g) as assessed by the multiple pass 24 hour recall.

    Time frame: Change from Baseline, 6 months, 18 months and 24 months

    The multiple pass 24 hour food recall was taken on three days (two week days and one weekend day) by trained interviewers. Data were analyzed using Food Processor (Esha, Salem, Oregon). The unit of measure was grams (g).

  3. Decrease in total sugar intake (g) as assessed by the multiple pass 24 hour recall.

    Time frame: Change from Baseline, 6 months, 18 months and 24 months

    The multiple pass 24 hour food recall was taken on three days (two week days and one weekend day) by trained interviewers. Data were analyzed using Food Processor (Esha, Salem, Oregon). The unit of measure was grams (g).

  4. Decrease in total sodium intake (g) as assessed by the multiple pass 24 hour recall.

    Time frame: Change from Baseline, 6 months, 18 months and 24 months

    The multiple pass 24 hour food recall was taken on three days (two week days and one weekend day) by trained interviewers. Data were analyzed using Food Processor (Esha, Salem, Oregon). The unit of measure was grams (g).

Secondary outcomes

  1. Increase in habitual physical activity (total kilocalories per week) as assessed by the Yale Physical Activity Scale (YPAS).

    Time frame: Change from Baseline, 6 months, 18 months and 24 months

    The Yale Physical Activity Scale (YPAS) uses a simple checklist to provide estimates of caloric expenditure from activity time (minutes per day or week) and activity dimensions (working, yard work, caretaking, exercising, and recreational activities) during a typical day or week. The unit of measure is kilocalories per week (kcal/week) and is computed by converting all activities into minutes per week, multiplying each by an intensity code for kilocalories, and then summing to determine an energy expenditure summary index (kcal/week). The range of possible scores varies per study but the literature on older adult populations suggests low scores on the YPAS in the 300 kcal/week range and high scores of over 20,000 kcal/week.

  2. Decrease in girth circumference of abdomen (cm) as assessed using clinical measurements by trained staff.

    Time frame: Change from Baseline, 6 months, 18 months and 24 months

    The abdomen was measured in centimeters (cm) with a plastic non-flexible measuring tape (Issaquah, WA). The abdomen was measured at the top of the iliac crest while each participant was exhaling.

  3. Decrease in systolic and diastolic blood pressure (mmHg) as assessed using clinical measurements by trained staff.

    Time frame: Change from Baseline, 6 months, 18 months and 24 months

    Three blood pressure measurements were taken on the non-dominant arm after each participant rested for a few minutes, using a digital device (A&D Medical, Miltitas, CA). The three readings were then averaged. The unit of measure was millimeter of mercury (mmHg).

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Collaborators

  • Florida A&M University
  • University of Georgia

Registry information

Official study title

Reducing Cardiovascular Risk of Mid-life and Older African Americans

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Nov 13, 2017
Registry last updated
Nov 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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