NCT02015078

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
314

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2013

Completed
Same day until next milestone

Study Start

First participant enrolled

December 14, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 19, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2015

Completed
Last Updated

January 16, 2024

Status Verified

January 1, 2024

Enrollment Period

1.3 years

First QC Date

December 14, 2013

Last Update Submit

January 11, 2024

Conditions

Keywords

African AmericanEating Behavior PhenotypesObesityNatural History

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (1)

African Americans

Targets are family members attending African American family reunions.

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Targets are family members attending African American family reunions.@@@@@@

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Location

Related Publications (4)

  • 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.

    PMID: 23156122BACKGROUND
  • 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.

    PMID: 21475139BACKGROUND
  • 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.

    PMID: 21925344BACKGROUND
  • Persky S, Bouhlal S, Goldring MR, McBride CM. Beliefs about genetic influences on eating behaviors: Characteristics and associations with weight management confidence. Eat Behav. 2017 Aug;26:93-98. doi: 10.1016/j.eatbeh.2017.02.003. Epub 2017 Feb 9.

MeSH Terms

Conditions

NeoplasmsObesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Susan Persky, Ph.D.

    National Human Genome Research Institute (NHGRI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2013

First Posted

December 19, 2013

Study Start

December 14, 2013

Primary Completion

April 15, 2015

Study Completion

June 22, 2015

Last Updated

January 16, 2024

Record last verified: 2024-01

Locations