- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01957800
Weight Loss and Healthy Diet Through Mobile Phone-enabled Social Interactions
31. August 2015 aktualisiert von: Christopher Sciamanna, MD, MPH, Milton S. Hershey Medical Center
Enhancing the Sustainability of Weight Loss and Healthy Diet Through Mobile Phone-enabled Social Interactions
A randomized controlled trial comparing the effects of the social-enabled internet weight loss and diet change intervention with the delayed treatment group for 3 months.
We will study the effect of adding social interactions and supports to an Internet weight loss and diet change intervention.
The website intervention will have action planning with social interactions and support features for sharing, reusing, recommending, and discussing strategies for improving habits.
We hypothesize that the intervention group with access to the website will lose more weight than the delayed treatment group after three months.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Over the past two decades a very simple, low-cost and consistently effective intervention has been developed that we believe has potential to be disseminated online in primary care.
The intervention, "action planning" (AP), is also known as "if-then planning" or "implementation intentions".
Action Planning is one element of the process of self-regulation (Wing et al 2006; Luszczynska et al 2007), in which individuals identify (1) situations that challenge their ability to perform a behavior and (2) make a specific plan for what they will do when the situation is next encountered.
Luszczynska and colleagues observed that adding a single session of action planning onto a portion-controlled meal intervention increased the weight lost from 2.1 kg to 4.2 kg (Luszczynska et al 2007).
A meta-analysis of 94 studies using AP, nearly all of which included a single-dose, observed a mean effect size of Cohen's d=.65, consistent with a medium to large effect.
Studies of repeated doses appear to have even greater effects (Chapman and Armitage 2010).
Dr. Sciamanna recently completed a pilot feasibility study in which 53 subjects used an AP intervention for weight loss for 2 months.
All subjects attended a 1-hour introductory session about the use of portion-controlled meals and pedometers.
Subjects were then emailed one AP writing prompt each day, representing one of the 21 of the most common barriers to weight control (Bond et al 2001).
Despite receiving no personalized feedback, over 2 months the subjects wrote action plans, on an average of 4.2 days per week.
After 2 months, the average weight loss was 7.7 pounds.
These adherence levels, though short-term, are greater than typical web-based weight control interventions included in a recent Cochrane review (Wieland 2012).
This pilot study suggests that this low-cost intervention approach may have unusual levels of fidelity.
Even though the average activities of user engagement with AP is quite high in the first two months, there is a slight decline toward the third month.
In focus group discussions after a pilot conducted by Dr. Sciamanna in the Philadelphia area, participants of the pilot indicated consistent difficulties in coming up with ideas for habits that might be useful.
These observations motivates this proposed study.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
102
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Pennsylvania
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Hershey, Pennsylvania, Vereinigte Staaten, 17033
- Penn State Milton S. Hershey Medical Center
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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
21 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria:
- Between 21-65 years old
- English speaking
- BMI from 27-50 kg/m2
- Access to the Internet at home or work for most days of the week
- Have current service for a smart phone with a camera and texting capability
- Able to use mobile phone to take a picture and send it to someone
- Able to use mobile phone to look for information on the internet using a search engine (such as Google)
- Able to use mobile phone to send and receive text messages
- Able to use mobile phone to send and receive emails
- Access to a scale at home
Exclusion Criteria:
- Pregnant or planning to become pregnant in the next 3 months
- Planning on moving out of the area in the next 6 months
- Weigh more than 300 pounds
- Participating in an internet or community weight loss program
- Taking medication, prescription or over the counter for weight loss
- Doctor has said you have a heart condition and should only do physical activity recommended by a doctor
- Feel pain in chest when doing physical activity
- In the past month feel pain in chest when not doing physical activity
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Website
Group will be asked to complete a daily plan online for specific situations that tempt people to overeat.
The website can be accessed online using a computer or smart phone and will allow participants to view others' plans.
Participants will also be asked to enter their weight online every week.
|
Website will have action planning with social interactions and support features for sharing, reusing, and recommending strategies for improving habits.
Participants will record their weight and complete surveys online.
|
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Aktiver Komparator: Usual Care
Group will be given access to the online intervention after the 3-month study ends.
|
Participants will record their weight and complete surveys online.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Body Weight
Zeitfenster: 3 months
|
Body weight will be measured by a research assistant using a portable, digital scale.
|
3 months
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Demographics
Zeitfenster: 3 months
|
We will measure age, gender, race and ethnicity, smoking status, education and other demographics, based on standard self-report.
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3 months
|
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Hospital and Anxiety Scale
Zeitfenster: 3 months
|
This self-assessment scale has been found to be a reliable instruction for detecting states of depression and anxiety.
|
3 months
|
|
International Physical Activity Questionnaire
Zeitfenster: 3 months
|
The survey comprises a set of 4 questionnaires.
The purpose of the questionnaires is to provide common instruments that can be used to obtain internationally comparable data on health-related physical activity.
|
3 months
|
|
Medications
Zeitfenster: 3 months
|
We will measure dose and quantity of all prescribed medications based on standard self-report.
|
3 months
|
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Motivation scale
Zeitfenster: 3 months
|
This questionnaire asks participants how motivated they are to control their weight using non-comparative scaling.
|
3 months
|
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Three Factor Eating Questionnaire
Zeitfenster: 3 months
|
The questionnaire measures three dimensions of dietary restraint: cognitive restraint, disinhibition, perceived hunger.
|
3 months
|
|
Weight Loss Habits
Zeitfenster: 3 months
|
This questionnaire asks participants to rate their frequency of use of weight loss habits using non-comparative scaling.
|
3 months
|
|
Adherence
Zeitfenster: 3 months
|
We will examine daily journal completion data overall (mean and median) and as percentage.
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3 months
|
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Satisfaction
Zeitfenster: 3 months
|
This questionnaire asks participants to provide feedback about the study.
|
3 months
|
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Sedentary Behavior Questionnaire
Zeitfenster: 3 months
|
3 months
|
|
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Well Being
Zeitfenster: 3 months
|
3 months
|
|
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Weight Efficacy Questionnaire
Zeitfenster: 3 months
|
3 months
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Christopher Sciamanna, MD, MPH, Milton S. Hershey Medical Center
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. Oktober 2013
Primärer Abschluss (Tatsächlich)
1. November 2014
Studienabschluss (Tatsächlich)
1. November 2014
Studienanmeldedaten
Zuerst eingereicht
30. September 2013
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
30. September 2013
Zuerst gepostet (Schätzen)
8. Oktober 2013
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
1. September 2015
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
31. August 2015
Zuletzt verifiziert
1. August 2015
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 43474EP
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