Biological Biomarkers in MOMS Partnership

NCT02438514 | Terminated

• 1 other identifier: 1410014845
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators propose to evaluate the potential utility of stress-related biomarkers obtained via dried blood spots (DBS) and retinal scans by collecting new data from mothers and children within the New Haven MOMS Partnership, a well-established community-partnered research setting. The proposed research could greatly advance the application of stress-related biomarkers within community-based research by increasing our understanding of how stress, trauma, and depression influence biology in childhood and adulthood, as measured using minimally-invasive approaches.

Conditions

Psychological Stress

Outcome Measures

Primary Outcomes (3)

• Number of Mother-Child Dyads Who Complete Assessments & Biological Samples

  Feasibility outcome

  End of study (approximately 5 years)

• Telomere Length

  Telomere length will be measured using an adapted method of the Cawthon Telomere Assay

  At baseline-After 90 minutes

• Advanced Glycation End Products (AGEs)

  AGEs or (advanced glycation endproducts) will be measured using a painless non- invasive retinal scanning device that measures autofluorescence of the crystalline lens of the eye

  At baseline-After 90 minutes

Interventions

Biological Sample Collection OTHER

Anthropomorphic biomarkers including height, weight, heart rate, and blood pressure will be taken for each participating mother and child by a research assistant trained to accurately perform these procedures. Blood spots will be collected in finger stick proficiency, using trigger activated lancets to administer finger sticks. Each participating mothers and child will provide a saliva sample using Oragene DNA saliva collection kits

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Low-income, racially and ethnically diverse, un- or under-employed, biological mothers of children in New Haven. Primary source of recruitment will be the screening/needs assessment from our affiliated MOMS Partnership protocol, however, we will actively respond to inquiries from any preliminarily eligible biological mother in the New Haven community who expresses interest in the study

You may qualify if:

• English-speaking adult mothers (age 21 or older) of at least one biological child mothers must be able to answer three verification questions to confirm they are the biological parent of their child

You may not qualify if:

• Non-english speakers
• Women not able to provide informed consent and with no biological children
• Mothers under the age of 21

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale University

New Haven, Connecticut, United States

Location

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2015
• First Posted: May 8, 2015
• Study Start: November 1, 2014
• Primary Completion: January 1, 2019
• Study Completion: November 1, 2019
• Last Updated: March 12, 2020

Record last verified: 2020-03

Locations

US (1)