Telomere Disclosure and Impact on Psychological Distress and Health Behaviors

NCT04104386 | Completed

• 1 other identifier: H11640-33841-01
• Study Type: interventional
• Target: 263
• Locations: 0 countries
• Sites: N/A

Brief Summary

There is now a critical mass of data linking health to telomere length, and blood telomere length is starting to become a commercially available measure, with several companies either offering or planning to offer this measure. With the growing intrigue and interest in telomeres and its commercial measurement, it is becoming increasingly important to understand the psychological and behavioral impact of receiving information about one's own telomere length. Therefore, the primary purpose of this study is to provide results of blood telomere length (from immune cells) to individuals, and to examine the subsequent psychological and lifestyle factors associated with learning one's personal results. Specifically, the investigators will assess if providing both telomere length and educational material on how cell aging is related to health and how it is modifiable, might lead to improvements in salutary health behaviors, and consequently, changes in telomere length. A secondary goal of the study is methodological in nature. Human studies have mainly been limited to immune cells from blood, which requires a blood draw. The relation between blood telomere length and telomere length from other cells that are more easily accessible has not been assessed. Therefore, this study will assess relations between blood telomere length from venous blood draw with telomere lengths from buccal cells, hair follicle cells, and blood cells from a finger prick. This study will assess whether a new measure of telomere damage (TIFS) is related to other measures of cell aging. This study will also assess the reliability of the venous blood draw telomere length across three different assays (PCR, southern blot, and fluorescent in situ hybridization or FISH). To meet these aims, this study will collect samples of these cells from 240 healthy volunteers from the community.

Conditions

Telomere Length, Mean Leukocyte

Outcome Measures

Primary Outcomes (1)

• Change sin Impact of Events Scale

  Change in distress between groups in psychological distress between 1 week and 3 month followup. The IES scale quantifies the symptoms of distress into two sub-categories: Intrusion (7 items, max score 35) and Avoidance (8 items, max score 40). A subscale score ≥20 or a total score ≥40 indicates clinically significant levels of distress.

  3 months

Secondary Outcomes (1)

• change in health behaviors

  3 months post-randomization

Study Arms (2)

Disclosure of Telomere Length Arm

EXPERIMENTAL

Telomere Length results were provided (personal value, means, and standard deviation of the group), and categorized as 'short' telomere length (bottom quartile) and 'not short' (above the bottom quartile) based on age related norms available from research literature.

Other: Telomere Disclosure Impact

Non-Disclosure

NO INTERVENTION

Telomere Length results were not provided.

Interventions

Telomere Disclosure Impact OTHER

Participants were either provided or not provided information about their personal telomere length and how they compared to the rest of the sample.

Disclosure of Telomere Length Arm

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• year old women

You may not qualify if:

• Women were excluded from the study if they had a major medical condition (cancer diagnosis in the past five years, cancer treatment within the past ten years, diagnosis of an autoimmune disorder) or reported currently smoking.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigators were unfamiliar with who was categorized to which arm, and laboratory technicians were unfamiliar as well.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 19, 2019
• First Posted: September 26, 2019
• Study Start: April 4, 2010
• Primary Completion: November 10, 2011
• Study Completion: November 15, 2011
• Last Updated: September 26, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share