Trial record 3 of 185 for:    NHGRI

Black Family Eating Behaviors Study

This study is currently recruiting participants.
Verified August 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Collaborators:
Duke University
University of North Carolina
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Human Genome Research Institute (NHGRI) )
ClinicalTrials.gov Identifier:
NCT02015078
First received: December 14, 2013
Last updated: March 14, 2014
Last verified: August 2013
  Purpose

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 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 is 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 Sub-study proposes a collaboration with UNC in which aims for the eating behavior Sub-study will 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 describe in broad-brush the larger quantitative study proposed for Phase 2. We will collect information on eating-related behaviors in African American kindreds (N=300). We are also considering Phase 3 activities if we identify clusters of eating-related phenotypes within families. Amended IRB applications will be submitted prior to launching Phases 2 & 3.


Condition
Cancer
Eating Behavior
Chronic Diseases
Obesity

Study Type: Observational
Official Title: Black Family Eating Behaviors Study

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Eating behavior traits [ Time Frame: 1 yr ] [ Designated as safety issue: Yes ]
  • Health Risk Assessment ( CHART ) [ Time Frame: 1 yr ] [ Designated as safety issue: Yes ]
  • Weight history [ Time Frame: 1 yr ] [ Designated as safety issue: Yes ]
  • Life Events Calendar [ Time Frame: 1 yr ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: November 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
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 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 is 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 Sub-study proposes a collaboration with UNC in which aims for the eating behavior Sub-study will 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 describe in broad-brush the larger quantitative study proposed for Phase 2. We will collect information on eating-related behaviors in African American kindreds (N=300). We are also considering Phase 3 activities if we identify clusters of eating-related phenotypes within families. Amended IRB applications will be submitted prior to launching Phases 2 & 3.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Participants will be drawn from African American families who are attending Black family reunion events in North Carolina in the summer of 2014.

In order to participate, individuals must be age 18 or older, be a blood relative, spouse of a blood relative or deemed an honorary family member.

EXCLUSION CRITERIA:

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02015078

Contacts
Contact: Sofia Bouhlal (301) 402-7696 sofia.bouhlal@nih.gov
Contact: Colleen McBride, Ph.D. (301) 594-6788 cmcbride@nhgri.nih.gov

Locations
United States, North Carolina
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States
Contact: Sofia Bouhlal    301-402-7696    sofia.bouhlal@nih.gov   
Duke University Recruiting
Durham, North Carolina, United States, 27710
Contact: Sofia Bouhlal    301-402-7696    sofia.bouhlal@nih.gov   
Sponsors and Collaborators
Duke University
University of North Carolina
Investigators
Principal Investigator: Colleen McBride, Ph.D. National Human Genome Research Institute (NHGRI)
  More Information

Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Human Genome Research Institute (NHGRI) )
ClinicalTrials.gov Identifier: NCT02015078     History of Changes
Other Study ID Numbers: 999914014, 14-HG-N014
Study First Received: December 14, 2013
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Eating Behavior
Cancer
Chronic Diseases
Obesity

Additional relevant MeSH terms:
Chronic Disease
Obesity
Disease Attributes
Pathologic Processes
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 16, 2014