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

24. září 2021 aktualizováno: 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.

Přehled studie

Detailní popis

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.

Typ studie

Intervenční

Zápis (Aktuální)

678

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

    • California
      • Stanford, California, Spojené státy, 94305
        • Stanford University

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Prevence
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Žádný zásah: 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.
Experimentální: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Self-rated health scales
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Depression and anxiety symptoms: yes/no questions
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

  • Vrchní vyšetřovatel: Sanjay Basu, MD. PhD, Stanford University

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. října 2016

Primární dokončení (Aktuální)

13. dubna 2018

Dokončení studie (Aktuální)

13. dubna 2018

Termíny zápisu do studia

První předloženo

2. července 2014

První předloženo, které splnilo kritéria kontroly kvality

3. července 2014

První zveřejněno (Odhad)

9. července 2014

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

28. září 2021

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

24. září 2021

Naposledy ověřeno

1. září 2021

Více informací

Termíny související s touto studií

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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