此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

The EARN-Health Trial of Financial Savings and Health (EARN-Health)

2021年9月24日 更新者:Stanford University

EARN-Health: A Randomized Controlled Trial of the Effects of an Incentivized Savings Program on Depression, Anxiety, Substance Abuse, and Locus of Control

The current literature in social epidemiology and public health suggests that low financial savings has an unsurprising negative relationship with subjective well-being, and increases the odds of making visits to a healthcare provider, receiving a chronic disease diagnosis, and experiencing medical disability. Earn.org is a community-based non-profit based in San Francisco with a mission to help low-income workers build lifelong savings habits and financial capability. The organization is one of the largest providers of "goal-based savings accounts" or "matched savings accounts" in the US. The investigators propose to conduct a randomized controlled trial to determine the health effects of Earn's savings program. Through this trial, the investigators will test three principal hypotheses: (1) Participants in the Earn account, as compared to a control group, are hypothesized to demonstrate improved scores on mental health scales assessing depression and anxiety.

(2) Participants in the Earn account, as compared to a control group, are hypothesized to experience lower odds of harmful behaviors associated with stress, specifically tobacco and alcohol abuse. The investigators hypothesize that the effect on behaviors will be of smaller effect size, and more delayed, than the effect on mental health outcomes, judging from similar effects observed in the micro-credit literature.

(3) The mediating variables between Earn account participation and beneficial health outcomes will include increased optimism and internal locus of control.

研究概览

详细说明

The investigators plan to conduct an RCT comparing participants in the new EARN program against wait-listed control subjects. The program provides low-wage workers with incentives and rewards for savings. The program involves a web-based platform that permits eligible savers to create a centralized savings account, which is a secure online account without fees. The account offers eligible savers small monetary rewards for dollars saved each month. The investigators plan to conduct a baseline online month 0 survey and a follow-up 6 month and 12 month online survey among participants and wait-listed nonparticipants, with telephone follow-up to maximize 6- and 12-month survey completion. The surveys consist of previously-validated instruments to assess key health behaviors self-reported well-being, and require approximately 20 minutes each. The surveys includes the CDC Behavioral Risk Factor Surveillance System scales for assessing demographics and income, overall self-rated health, tobacco and alcohol use, depression and anxiety symptoms, and optimism and locus of control. Participants will receive prorated a gift card for each survey, to compensate participants for their time while avoiding a direct income effect of a cash incentive for participation.

研究类型

介入性

注册 (实际的)

678

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • California
      • Stanford、California、美国、94305
        • Stanford University

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • English-speaking US residents
  • ages 18 and older
  • below 50% of the area median income
  • have a regular Internet connection

Exclusion Criteria:

  • non-English speakers
  • non-US residents
  • children,
  • history of or current enrollment in other incentivized savings programs

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
无干预:Control
Participants will be randomized to a 1 year wait list. Participants take 0 month, 6 month, and 12 month surveys on depression, anxiety, alcohol and tobacco use, locus of control, and overall self-rated health.
实验性的:Savings program
Participants will be randomized to the EARN.org online savings program for 6 months. Participants take 0 month, 6 month, and 12 month surveys on depression, anxiety, alcohol and tobacco use, locus of control, and overall self-rated health.
The intervention is a web-based centralized savings account, which is a secure online account without fees. The account offers eligible savers nominal financial rewards for each deposit they make, as a financial incentive for savings.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Self-rated health scales
大体时间:12 months

The following survey measures of self-rated health are taken from the validated CDC Behavioral Risk Factor Surveillance Study and will be recorded and reported from our study:

H0) Would you say that in general your health, as compared to other people your age, is…?

[ Excellent Very good Good Fair OR Poor ]

H1) Please think about your physical health. This includes physical illness and injury. How many days during the past 30 days was your physical health not good?

[Number from 0 to 30]

H2) Now please think about your emotional health. This includes stress, depression, and anxiety. How many days during the past 30 days was your emotional health not good?

[Number from 0 to 30]

H3) During the past 30 days, for about how many days did poor physical or emotional health keep you from doing your usual activities, such as self-care, work, or recreation?

[Number from 0 to 30]

12 months

次要结果测量

结果测量
措施说明
大体时间
Depression and anxiety symptoms: yes/no questions
大体时间:12 months

The following survey measures are taken from the validated Patient Health Questionnaire 8 and will be recorded and reported from our study:

M1) Little interest or pleasure in doing things M2) Feeling down, depressed, or hopeless M3) Trouble falling asleep or staying asleep, or sleeping too much M4) Feeling tired or having little energy M5) Poor appetite or overeating M6) Feeling bad about yourself, or that you are a failure, or have let yourself or your family down M7) Trouble concentrating on things, such as reading the newspaper or watching television M8) Moving or speaking so slowly that other people could have noticed. Or the opposite - being so fidgety or restless that you have been moving around a lot more than usual.

12 months
Alcohol abuse screening questions
大体时间:12 months

The following survey measures of alcohol use are taken from the validated CDC Behavioral Risk Factor Surveillance Study and will be recorded and reported from our study:

A1) During the past 30 days, how many days did you have at least one drink of any alcoholic beverage? This includes beer, wine, malt beverages, and liquor.

Days in past 30 days

A2) A drink of alcohol is 1 can or bottle of beer, 1 glass of wine, 1 can or bottle of wine cooler, 1 cocktail, or 1 shot of liquor. During the past 30 days, how many days per week or per month did you have at least one drink of any alcoholic beverage?

A3) Considering all types of alcoholic beverages, how many times during the past 30 days did you have X [Script: X = 5 for men, X = 4 for women] or more drinks on an occasion?

12 months
Tobacco abuse screening questions
大体时间:12 months

The following survey measures of tobacco use are taken from the validated CDC's Behavioral Risk Factor Surveillance Study and will be recorded and reported from our study:

T0) Have you smoked at least 100 cigarettes in your entire life? yes no Script: If NO go to Part 5, else go to "T1"

T1) Do you now smoke cigarettes every day, some days, or not at all? every day some days not at all

T2) During the past 6 months, have you stopped smoking for one day or longer because you were trying to quit smoking?

12 months
Locus of control Likert scales
大体时间:12 months

The following survey measures are taken from the validated Health and Retirement study to assess locus of control, and will be recorded and reported from our study::

Please read the statements below and indicate the extent to which you agree with each statement. Select one of the following: Strongly Agree, Agree, Neutral, Disagree, or Strongly Disagree O1) In uncertain times, I expect the best O2) If something can go wrong for me, it will O3) I'm always optimistic about the future O4) I hardly ever expect things to go my way O5) I rarely count on good things happening to me O6) Overall, I expect more good things to happen to me than bad

12 months
Optimism Likert scales
大体时间:12 months

The following survey measures are taken from the validated Health and Retirement study to assess optimism, and will be recorded and reported from our study::

L1) I have little control over the things that happen to me L2) There is really no way I can solve some of the problems I have L3) There is little I can do to change many of the important things in my life L4) I often feel helpless in dealing with the problems of life L5) Sometimes I feel that I'm being pushed around in life L6) What happens to me in the future mostly depends on me L7) I can do just about anything I really set my mind to do

12 months
Spending behaviors
大体时间:12 months

The following survey measures of spending behaviors will be recorded and reported from our study:

S1) Over the past six months, would you say your household has been... Spending less money than you have had coming in. Spending more money than you have had coming in. Spending about the same amount of money that you have had coming in. S2) Over the past six months, which most accurately describes your household? We put aside money as savings every paycheck or every month. We put aside money as savings when we can, but not regularly. We didn't really put aside money as savings. S3) How much money did your household put aside as savings in an average month? We did not put aside savings in an average month. S4) Does your household have a monthly spending plan? Yes, and we mostly stick to it. Yes, but we don't really stick to it. No, we do not have a plan.

12 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Sanjay Basu, MD. PhD、Stanford University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2016年10月1日

初级完成 (实际的)

2018年4月13日

研究完成 (实际的)

2018年4月13日

研究注册日期

首次提交

2014年7月2日

首先提交符合 QC 标准的

2014年7月3日

首次发布 (估计)

2014年7月9日

研究记录更新

最后更新发布 (实际的)

2021年9月28日

上次提交的符合 QC 标准的更新

2021年9月24日

最后验证

2021年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅