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临床试验/NCT04104386
NCT04104386已完成不适用

The Impact of Personal Telomere Testing on Distress and Health Behaviors: A Randomized Controlled Trial of Women With Short and Average Telomere Lengths

University of California, San Francisco0 个研究点目标入组 263 人开始时间: 2010年4月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
263
主要终点
Change sin Impact of Events Scale

研究概览

简要总结

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.

详细描述

Background and Significance: Briefly sketch the scientific background leading to the present proposal, critically evaluate existing knowledge (with references), and specifically identify the gaps the project is intended to fill. State concisely the importance and health relevance of the research described in this application by relating the specific aims to the broad, long-term objectives.

Background and Rationale for Study:

There is now a comprehensive amount of data linking physical health to telomere length. Because of this, telomere length is becoming a commercially available measure. Several companies offer or plan to offer this measure; Spectracell Laboratories (www.spectracell.com) is one example of such a company. In order to have one's own telomere length measured, it's as easy as putting a zip code into a search function on their website to find the geographically closest clinician that will order the test. It is thus important to consider that there are no studies that have examined the possible responses to learning one's telomere length, whether it might be helpful or not, or even harmful. Learning about one's telomere length may motivate healthy behaviors, such as exercise or smoking cessation. The likely possibility of people learning their telomere length diagnostically in the future, and the potential for both positive and negative effects of learning this information, provide a strong rationale for studying the psychological and behavioral effects of learning one's telomere length.

Telomere length is a risk factor for disease:

Telomere length has become a valuable risk factor, as it is now linked to and predictive of many diseases and early mortality. For example, being of below average TL in a healthy population predicts threefold risk of earlier mortality in two studies. This effect size is comparable to other well accepted risk factors. Telomere shortening in these cases is likely acquired from lifetime exposures (lifestyle, cigarette smoking, infections) as well as from some presumably smaller genetic influence.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

Investigators were unfamiliar with who was categorized to which arm, and laboratory technicians were unfamiliar as well.

入排标准

年龄范围
50 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •50-65 year old women

排除标准

  • •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.

研究组 & 干预措施

Non-Disclosure

No Intervention

Telomere Length results were not provided.

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.

干预措施: Telomere Disclosure Impact (Other)

结局指标

主要结局

Change sin Impact of Events Scale

时间窗: 3 months

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.

次要结局

  • change in health behaviors(3 months post-randomization)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elissa Epel

Professor

University of California, San Francisco

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