Black Family Eating Behaviors Study

Sponsor
National Human Genome Research Institute (NHGRI) (NIH)
Overall Status
Completed
CT.gov ID
NCT02015078
Collaborator
Duke University (Other), National Cancer Institute (NCI) (NIH), University of North Carolina (Other)
314
1
18.2
17.2

Study Details

Study Description

Brief Summary

Despite broad awareness of the role that diet plays in increasing obesity risk, adherence to public health recommendations for maintaining healthy eating is low. Insights gained from weight loss intervention trials find that trial participants report difficulty in restricting calories, dissatisfaction with the pace of weight loss, inability to control eating, low palatability of recommended foods and strong food cravings. Indeed, recent systematic reviews provide empirical support that these subjective experiences that trial participants describe likely represent eating-related traits or phenotypes . While amassing evidence supports individual variation in these eating-related traits, to date there has been no systematic effort to characterize robust eating-related phenotypes. Proposed is a Sub-study initially planned to be piggy-backed on a planned Study being conducted by investigators at the University of North Carolina (UNC-- Linnan, Dilworth- Anderson & Evans). The UNC Parent Study was a feasibility study using community-based participatory research (CBPR) approaches to explore possible intervention strategies aimed to reduce the burden of chronic disease and cancer among African American families. The NHGRI-led eating behavior Sub-study is proposed to be integrated with the UNC Parent Study (hereafter referred to as Phase 1). The additional aims of the Sub-study (hereafter referred to as Phase 2) are to gain understanding of whether we can characterize clusters of eating-related behaviors that may be associated with adherence to weight management and weight outcomes. This current protocol lays out the specific qualitative activities planned for Phase 1 which include conducting structured interviews with Black Family Reunion organizers (N=8) and a sample of reunion participants (N=40). We also describe the larger quantitative survey proposed for Phase 2. Pending the feasibility of the sub-study with the African-American community, we will collect information on eating-related behaviors in a large sample of individuals (N=350). If the initial assessments (Phase1) prove that this is not a viable study to be conducted in that setting, we will consider other population groups and other settings.

We are also considering Phase 3 activities if we identify clusters of eating-related phenotypes within individuals. Amended IRB applications will be submitted prior to launching Phase 3.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Despite broad awareness of the role that diet plays in increasing obesity risk, adherence to public health recommendations for maintaining healthy eating is low. Insights gained from weight loss intervention trials find that trial participants report difficulty in restricting calories, dissatisfaction with the pace of weight loss, inability to control eating, low palatability of recommended foods and strong food cravings. Indeed, recent systematic reviews provide empirical support that these subjective experiences that trial participants describe likely represent eating-related traits or phenotypes . While amassing evidence supports individual variation in these eating-related traits, to date there has been no systematic effort to characterize robust eating-related phenotypes. Proposed is a Sub-study initially planned to be piggy-backed on a planned Study being conducted by investigators at the University of North Carolina (UNC-- Linnan, Dilworth- Anderson & Evans). The UNC Parent Study was a feasibility study using community-based participatory research (CBPR) approaches to explore possible intervention strategies aimed to reduce the burden of chronic disease and cancer among African American families. The NHGRI-led eating behavior Sub-study is proposed to be integrated with the UNC Parent Study (hereafter referred to as Phase 1). The additional aims of the Sub-study (hereafter referred to as Phase 2) are to gain understanding of whether we can characterize clusters of eating-related behaviors that may be associated with adherence to weight management and weight outcomes. This current protocol lays out the specific qualitative activities planned for Phase 1 which include conducting structured interviews with Black Family Reunion organizers (N=8) and a sample of reunion participants (N=40). We also describe the larger quantitative survey proposed for Phase 2. Pending the feasibility of the sub-study with the African-American community, we will collect information on eating-related behaviors in a large sample of individuals (N=350). If the initial assessments (Phase1) prove that this is not a viable study to be conducted in that setting, we will consider other population groups and other settings.

    We are also considering Phase 3 activities if we identify clusters of eating-related phenotypes within individuals. Amended IRB applications will be submitted prior to launching Phase 3.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    314 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    Black Family Eating Behaviors Study
    Study Start Date :
    Dec 14, 2013
    Actual Primary Completion Date :
    Apr 15, 2015
    Actual Study Completion Date :
    Jun 22, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    African Americans

    Targets are family members attending African American family reunions.

    Outcome Measures

    Primary Outcome Measures

    1. Phase 3 [Completed]

      To assess whether the occurrence of robust eating- related behavior clusters differ significantly between blood relatives and non-blood relatives (i.e., spouses and unrelated kin).

    2. Phase 2 [Completed]

      To assess whether robust phenotypes of eating-related behaviors (e.g., appetite for palatable foods, disinhibition, pickiness, and new food phobia) can be characterized.

    3. Phase 1 [Completed]

      To assess the feasibility of:(a)recruiting African American family reunion-organizers and participants to take part in a health promotion and genetics- related research study. (b)administering survey assessments to assess individual s and kindreds (blood and nonblood relatives ) interest in learning about eating-related (ER) behaviors and weight outcomes.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    • INCLUSION

    • For Phase 1 of the study, targets are family members attending African American family reunions. Therefore, the eligibility to participate will be: age 18 or older; not currently pregnant; attending the targeted family reunion.

    • For Phase 2 of the study, the population for the study are adults (18 to 70 years-old), with the capability to read English. As this is a feasibility and exploration study, the recruitment is intended to be broad and to include various populations and profiles.

    EXCLUSION

    -Pregnant women will be excluded from participation in the study due to the focus on eating behaviors and weight.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of North Carolina at Chapel Hill Chapel Hill North Carolina United States

    Sponsors and Collaborators

    • National Human Genome Research Institute (NHGRI)
    • Duke University
    • National Cancer Institute (NCI)
    • University of North Carolina

    Investigators

    • Principal Investigator: Susan Persky, Ph.D., National Human Genome Research Institute (NHGRI)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    National Human Genome Research Institute (NHGRI)
    ClinicalTrials.gov Identifier:
    NCT02015078
    Other Study ID Numbers:
    • 999914014
    • 14-HG-N014
    First Posted:
    Dec 19, 2013
    Last Update Posted:
    Aug 19, 2022
    Last Verified:
    Feb 7, 2022
    Keywords provided by National Human Genome Research Institute (NHGRI)
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 19, 2022