Black Family Eating Behaviors Study

Obesity Clinical Trial

Official title:

Black Family Eating Behaviors Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02015078
• Other study ID #: 999914014
• Secondary ID: 14-HG-N014
• Status: Completed
• Start date: December 14, 2013
• Est. completion date: June 22, 2015

Study information

• Verified date: January 2024
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 314
• Est. completion date: June 22, 2015
• Est. primary completion date: April 15, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

• 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.

Related Conditions & MeSH terms

• Cancer
• Obesity

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (4)

Lead Sponsor	Collaborator
National Human Genome Research Institute (NHGRI)	Duke University, National Cancer Institute (NCI), University of North Carolina

Country where clinical trial is conducted

United States, 

References & Publications (3)

Akter SM, Roy SK, Thakur SK, Sultana M, Khatun W, Rahman R, Saliheen SS, Alam N. Effects of third trimester counseling on pregnancy weight gain, birthweight, and breastfeeding among urban poor women in Bangladesh. Food Nutr Bull. 2012 Sep;33(3):194-201. doi: 10.1177/156482651203300304. — View Citation

Appelhans BM, Woolf K, Pagoto SL, Schneider KL, Whited MC, Liebman R. Inhibiting food reward: delay discounting, food reward sensitivity, and palatable food intake in overweight and obese women. Obesity (Silver Spring). 2011 Nov;19(11):2175-82. doi: 10.1038/oby.2011.57. Epub 2011 Apr 7. — View Citation

Baranowski T, Baranowski JC, Watson KB, Jago R, Islam N, Beltran A, Martin SJ, Nguyen N, Tepper BJ. 6-n-propylthiouracil taster status not related to reported cruciferous vegetable intake among ethnically diverse children. Nutr Res. 2011 Aug;31(8):594-600. doi: 10.1016/j.nutres.2011.07.004. Epub 2011 Aug 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase 3	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).	Completed
Primary	Phase 2	To assess whether robust phenotypes of eating-related behaviors (e.g., appetite for palatable foods, disinhibition, pickiness, and new food phobia) can be characterized.	Completed
Primary	Phase 1	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.	Completed