Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02185612
Recruitment Status : Unknown
Verified August 2017 by Sanjay Basu, MD, PhD, Stanford University.
Recruitment status was:  Active, not recruiting
First Posted : July 9, 2014
Last Update Posted : August 8, 2017
Sponsor:
Information provided by (Responsible Party):
Sanjay Basu, MD, PhD, Stanford University

Tracking Information
First Submitted Date  ICMJE July 2, 2014
First Posted Date  ICMJE July 9, 2014
Last Update Posted Date August 8, 2017
Study Start Date  ICMJE October 2016
Estimated Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2014)
Self-rated health scales [ Time Frame: 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]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2015)
  • Depression and anxiety symptoms: yes/no questions [ Time Frame: 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.
  • Alcohol abuse screening questions [ Time Frame: 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?
  • Tobacco abuse screening questions [ Time Frame: 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?
  • Locus of control Likert scales [ Time Frame: 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
  • Optimism Likert scales [ Time Frame: 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
  • Spending behaviors [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2014)
  • Depression and anxiety symptoms: yes/no questions [ Time Frame: 12 months ]
    The following yes/no measures are taken from the validated CDC Behavioral Risk Factor Surveillance Study and will be recorded and reported from our study: Please indicate whether these feelings were true much of the time this past week. M1) Did you feel depressed? M2) Did you feel like everything was an effort? M3) Did you feel like your sleep was restless? M4) Did you feel that you were happy? M5) Did you feel lonely? M6) Did you feel that you enjoyed life? M7) Did you feel sad? M8) Did you feel like you could not get going? M9) Are you now taking medicine or receiving treatment from a doctor or other health professional for any type of mental health condition or emotional problem? M10) Has a doctor or other healthcare provider ever told you that you have an anxiety disorder?
  • Alcohol abuse screening questions [ Time Frame: 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) During the past 30 days, on the days when you drank, about how many drinks did you drink on the average? One drink is equivalent to a 12-ounce beer, a 5-ounce glass of wine, or a drink with one shot of liquor. A 40 ounce beer would count as 3 drinks, or a cocktail drink with 2 shots would count as 2 drinks. [ number of drinks ] A3) Considering all types of alcoholic beverages, how many times during the past 30 days did you have X [X = 5 for men, X = 4 for women] or more drinks on an occasion? [ number of times ]
  • Tobacco abuse screening questions [ Time Frame: 12 months ]
    The following survey measures of tobacco use are taken from CDC's Behavioral Risk Factor Surveillance Study and will be recorded and reported from our study: T1) Do you smoke cigarettes at all? yes no Script: If No, go to Part 5, else go to "T2" T2) Over the past week, about how many cigarettes did you smoke per day on average? [ cigarettes per day ]
  • Locus of control Likert scales [ Time Frame: 12 months ]
    The following survey measures are taken from the validated Health and Retirement study to assess locus of control: 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The EARN-Health Trial of Financial Savings and Health
Official Title  ICMJE EARN-Health: A Randomized Controlled Trial of the Effects of an Incentivized Savings Program on Depression, Anxiety, Substance Abuse, and Locus of Control
Brief Summary

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.

Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Depression
  • Anxiety
  • Alcohol Abuse
  • Tobacco Abuse
Intervention  ICMJE Behavioral: Savings program
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.
Study Arms  ICMJE
  • No Intervention: 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.
  • Experimental: 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.
    Intervention: Behavioral: Savings program
Publications * Basu S, Hamad R, White JS, Modrek S, Rehkopf DH, Cullen MR. The EARN-Health Trial: protocol for a randomised controlled trial to identify health effects of a financial savings programme among low-income US adults. BMJ Open. 2015 Oct 6;5(10):e009366. doi: 10.1136/bmjopen-2015-009366.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 3, 2014)
700
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2018
Estimated Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02185612
Other Study ID Numbers  ICMJE 30641
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanjay Basu, MD, PhD, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sanjay Basu Stanford University
PRS Account Stanford University
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP