Black Family Eating Behaviors Study

Completed

• Conditions: Cancer; Obesity

• Registration Number: NCT02015078
• Lead Sponsor: National Human Genome Research Institute (NHGRI)

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.

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 Timeline

• Study Start: 2013-12-14
• Study First Submitted: 2013-12-14
• Study First Submitted QC: 2013-12-14
• Study First Posted: 2013-12-19
• Primary Completion: 2015-04-15
• Study Completion: 2015-06-22
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-11
• Last Update Posted: 2024-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 314

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
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).
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.

Trial Locations

Locations (1)

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States