- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01957800
Weight Loss and Healthy Diet Through Mobile Phone-enabled Social Interactions
31 août 2015 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
102
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Pennsylvania
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Hershey, Pennsylvania, États-Unis, 17033
- Penn State Milton S. Hershey Medical Center
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
21 ans à 65 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Comparateur actif: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Body Weight
Délai: 3 months
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Body weight will be measured by a research assistant using a portable, digital scale.
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3 months
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Demographics
Délai: 3 months
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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
Délai: 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
Délai: 3 months
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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.
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3 months
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Medications
Délai: 3 months
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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
Délai: 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
Délai: 3 months
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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
Délai: 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
Délai: 3 months
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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
Délai: 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
Délai: 3 months
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3 months
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Well Being
Délai: 3 months
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3 months
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Weight Efficacy Questionnaire
Délai: 3 months
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3 months
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Christopher Sciamanna, MD, MPH, Milton S. Hershey Medical Center
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 octobre 2013
Achèvement primaire (Réel)
1 novembre 2014
Achèvement de l'étude (Réel)
1 novembre 2014
Dates d'inscription aux études
Première soumission
30 septembre 2013
Première soumission répondant aux critères de contrôle qualité
30 septembre 2013
Première publication (Estimation)
8 octobre 2013
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
1 septembre 2015
Dernière mise à jour soumise répondant aux critères de contrôle qualité
31 août 2015
Dernière vérification
1 août 2015
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 43474EP
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