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Brigham and Women's Healthy Weight Study

29. Juli 2020 aktualisiert von: Harvard Pilgrim Health Care

Brigham and Women's Healthy Weight Study: Randomized Controlled Trial of a Financial Incentive for Weight Maintenance

The purpose of this study is to determine if a financial deposit contract is a successful method of helping people to maintain their weight loss. A deposit contract is an agreement in which participants put their own money at risk, with the goal of "earning" it back by achieving a goal, in this case maintaining prior weight loss. The study will also evaluate the interventions using survey research to assess the feasibility and acceptability of the interventions.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Interested participants who can verify >10lb weight-loss over the last year and a half will be randomly assigned to either the control group, in which they will be asked to attend weekly weigh-ins at Brigham and Women's Hospital (BWH) over the course of a year, or to the deposit contract intervention group. Both the control group and the deposit contract group will complete the weekly weigh-ins for one year. The deposit contract group will additionally have a financial component: these participants will be asked to make a deposit of at least $100 each 10-week period over the course of one year (50 weeks), and can recoup this amount as detailed above. All participants will take baseline and end-of-study surveys.

During an enrollment meeting, study staff will request via an authorization form that participants allow approved members of the research staff to examine their electronic medical record for the duration of the study if they receive their care at a BWH-affiliated practice. This will confirm their >10lb weight loss.

At the end of every 10-week period, DC participants will receive an email with how much money they recouped. Participants who did not recoup the full amount they deposited must bring in a check to the following weigh-in to cover the difference so that participants have at least $100 deposited for the following 10-week period. Additionally, participants will have the option to use their initial study baseline weight, or be re-weighed for a new baseline weight for the following 10-week period, for which they will then use as their target weight. They will also have the option to increase or decrease their deposit for the upcoming 10-week period as needed.

Each subject may skip non-consecutive weigh-ins without losing their weekly contribution. However, if subjects skip two or more consecutive weekly weigh-ins, participants may only recoup up to one of those skipped weigh-ins if they are successful in their weight management in the week that they return for a weigh-in. Skipped weigh-ins will not roll over into a new 10-week period.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

42

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Massachusetts
      • Boston, Massachusetts, Vereinigte Staaten, 02115
        • Brigham and Women's Hospital

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • employee of Brigham and Women's Hospital, Dana-Farber Cancer Institute (DFCI), Brigham and Women's Physicians Organization (BWPO), or Partners working at the Francis Street complex of Brigham and Women's Hospital (either part-time or full-time)
  • 18 years of age or older
  • successfully and intentionally lost at least 10lbs within the past 18 months
  • had a BMI over 25 at some point over the previous 18 months

Exclusion Criteria:

  • plan to change jobs outside of the BWH Francis Street complex in the next year
  • had weight-loss surgery in the past 3 years
  • currently on a very low calorie (800 or fewer calories) liquid diet or taking weight loss medicine
  • currently have cancer, a severe psychiatric disorder, an eating disorder, or another severe medical illness that may affect weight beyond control
  • plan to become pregnant in the next year

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Kein Eingriff: Control
Control Participants will complete weekly weigh-ins and receive emails about how their current weight compares to their baseline weight.
Experimental: Deposit Contract
The deposit contract group will also complete weekly weigh-ins and receive emails about how their current weight compares to their baseline weight. In addition, the deposit contract group will be asked to make a deposit of at least $100 each 10-week period over the course of one year (50 weeks). Each week, they will recoup 1/10 of their 10-week deposit if they are within two pounds of their baseline weight or lower. If they are more than two pounds above their baseline weight, they will forfeit 1/10 of their 10-week deposit. The money they forfeited for that week will go into a collective pool to be divided up at the end of each 10-week period by all deposit contract participants who successfully maintained their weight loss at the end of the 10-week period.
Verhalten: Deposit Contract
A deposit contract (DC) is an agreement in which study participants puts their own money at risk, with the goal of "earning" it back by achieving a goal, in this case maintaining prior weight loss. If DC participants successfully maintain their weight, they get their money back. If they are not successful, they lose their money. For each 10 week period for one year, DC participants will make a deposit of at least $100 but will be allowed to increase their contribution if they would prefer.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Weight
Zeitfenster: Weekly weigh-ins from baseline until the end of the study (about 1 year from April 2016-August 2017).
Primary outcome measure will be the difference in weight in pounds between their baseline trial weight and their weight at 1 year, controlling for age, sex, race, and baseline weight.
Weekly weigh-ins from baseline until the end of the study (about 1 year from April 2016-August 2017).

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Success in meeting weight goal
Zeitfenster: Weekly weigh-ins from baseline until the end of the study (about 1 year from April 2016-August 2017).
The binary variable of whether subjects met their goal at the end of one year will be assessed with logistic regression.
Weekly weigh-ins from baseline until the end of the study (about 1 year from April 2016-August 2017).
Number of weeks in which subjects met their weight goal
Zeitfenster: Weekly weigh-ins from baseline until the end of the study (about 1 year from April 2016-August 2017).
The number of weeks in which subjects met their weight goal will be assessed with linear regression.
Weekly weigh-ins from baseline until the end of the study (about 1 year from April 2016-August 2017).
Number of participants who report factors of weight maintenance success as assessed by questionnaires
Zeitfenster: At Baseline (~April-August 2016) and at completion (~June-August 2017)
Surveys at baseline and at follow-up will assess a variety of factors associated with weight maintenance, such as how participants have lost and are seeking to lose weight; how satisfied they are with their weight; their motivation and confidence in losing and maintaining weight loss; and behaviors such as diet, exercise habits, and screen time. These factors will be examined with basic descriptive statistics. Survey analysis will assess whether some of these factors, specifically confidence and motivation to lose or maintain weight, are associated with the primary outcome of weight change at 1 year, using linear regression models.
At Baseline (~April-August 2016) and at completion (~June-August 2017)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Harvard Pilgrim Health Care

Mitarbeiter

Brigham and Women's Hospital

Ermittler

  • Hauptermittler: Jason P Block, MD, MPH, Obesity Prevention Program, Department of Population Medicine, Harvard Medical School, Harvard Pilgrim Health Care Institute, Boston, MA.

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Juni 2016

Primärer Abschluss (Tatsächlich)

1. Juli 2018

Studienabschluss (Tatsächlich)

30. April 2020

Studienanmeldedaten

Zuerst eingereicht

8. März 2016

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

10. März 2016

Zuerst gepostet (Schätzen)

16. März 2016

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

30. Juli 2020

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

29. Juli 2020

Zuletzt verifiziert

1. Juli 2020

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • 1K23HL111211-03 (US NIH Stipendium/Vertrag)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

Individual participant data will be made available on a case-by-case basis.

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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