- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01957800
Weight Loss and Healthy Diet Through Mobile Phone-enabled Social Interactions
31. august 2015 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
102
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Pennsylvania
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Hershey, Pennsylvania, Forente stater, 17033
- Penn State Milton S. Hershey Medical Center
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
21 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
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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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Aktiv komparator: Usual Care
Group will be given access to the online intervention after the 3-month study ends.
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Participants will record their weight and complete surveys online.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Body Weight
Tidsramme: 3 months
|
Body weight will be measured by a research assistant using a portable, digital scale.
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3 months
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Demographics
Tidsramme: 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
Tidsramme: 3 months
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This self-assessment scale has been found to be a reliable instruction for detecting states of depression and anxiety.
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3 months
|
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International Physical Activity Questionnaire
Tidsramme: 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
Tidsramme: 3 months
|
We will measure dose and quantity of all prescribed medications based on standard self-report.
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3 months
|
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Motivation scale
Tidsramme: 3 months
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This questionnaire asks participants how motivated they are to control their weight using non-comparative scaling.
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3 months
|
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Three Factor Eating Questionnaire
Tidsramme: 3 months
|
The questionnaire measures three dimensions of dietary restraint: cognitive restraint, disinhibition, perceived hunger.
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3 months
|
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Weight Loss Habits
Tidsramme: 3 months
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This questionnaire asks participants to rate their frequency of use of weight loss habits using non-comparative scaling.
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3 months
|
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Adherence
Tidsramme: 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
Tidsramme: 3 months
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This questionnaire asks participants to provide feedback about the study.
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3 months
|
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Sedentary Behavior Questionnaire
Tidsramme: 3 months
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3 months
|
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Well Being
Tidsramme: 3 months
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3 months
|
|
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Weight Efficacy Questionnaire
Tidsramme: 3 months
|
3 months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Christopher Sciamanna, MD, MPH, Milton S. Hershey Medical Center
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. oktober 2013
Primær fullføring (Faktiske)
1. november 2014
Studiet fullført (Faktiske)
1. november 2014
Datoer for studieregistrering
Først innsendt
30. september 2013
Først innsendt som oppfylte QC-kriteriene
30. september 2013
Først lagt ut (Anslag)
8. oktober 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
1. september 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
31. august 2015
Sist bekreftet
1. august 2015
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 43474EP
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