Piloting Visual Chat in Internet Obesity Treatment (CHAT)
5 décembre 2018 mis à jour par: Jean R. Harvey, PhD, RD, University of Vermont
CHAT is an internet-based weight loss research program designed for women with overweight or obesity who want to lose weight through dietary change and increased physical activity.
Participants will be randomized into a group-based online program who meet via a text chat or a video chat.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
The overall goal of this project is to determine whether weight losses can be improved if visual chat and electronic smart scales are added to an established 6-month online weight loss program.
The primary aim is to assess weight change differences between subjects randomized to receive an Internet program alone (with text chat; INTERNET) vs. an Internet program with visual chat and electronic scales (VIDEO INTERNET).
A secondary aim is to evaluate differences in social support experienced by subjects in both conditions.
Overweight and obese adults (n=40) at two study sites (UVM and the University of South Carolina) will be randomly assigned to Internet (n=20) or Video Internet (n=20).
All participants will receive the same 24 week web-based group weight control program which features synchronous facilitated chats and online behavioral tools.
The only difference will be the delivery of the chat (text vs. visual) and the electronic smart scales given to the VIDEO INTERNET group.
Assessments will be conducted at 0, 2 and 6 months and will include measures of body weight, treatment engagement (e.g., attendance, self-monitoring, website utilization), social support and treatment satisfaction.
Type d'étude
Interventionnel
Inscription (Réel)
32
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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South Carolina
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Columbia, South Carolina, États-Unis, 29208
- University of South Carolina
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Vermont
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Burlington, Vermont, États-Unis, 05405
- Behavioral Weight Management Program/Univ of Vermont
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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
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Femelle
La description
Inclusion Criteria:
- 18 years old
- BMI between 25 and 55
- Free of medical problems that would preclude participation in a behavioral weight reduction program containing an exercise component
- Not currently pregnant or pregnant in the previous 6 months or breastfeeding
- Must have a computer at home or work with access to the Internet
- Only one member of a household is eligible to participate
- Must successfully complete a self-monitoring diary of foods consumed for 3 days
- must be willing to share access to self monitoring information collected via My Fitness Pal by friending the CHAT research team
- Not currently on medication that might affect weight loss
- Not enrolled in another weight loss program
Exclusion Criteria:
- BMI less than 25 or more than 55
- Lost 10 pounds or more in the last 6 months
- Had a heart attack or stroke in the past 6 months
- Ever had weight loss surgery
- Currently taking medications for weight loss
- Persons required by their doctor to follow a special diet (other than low fat)
- Plans to move from the area in the upcoming 9 months
- Schedules that make it likely someone would have difficulty attending the scheduled chat groups
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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Comparateur actif: Behavioral Weight Loss + Text chat
Internet delivery of a behavioral weight control program via text in a group format facilitated by an experienced registered dietitian.
Participants will have access to study materials including behavioral weight loss lessons on the study's website.
Participants will weigh themselves daily and report their weight privately (data will only be accessible by research personnel) on the study website.
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Participants will attend weekly one hour classes on line.
They will type their input and responses within the chat room.
They will record their calorie and fat intake daily and weigh themselves daily.
Interventionists will review the diaries weekly and provide feedback to reinforce or shape new behaviors and to identify high risk situations for problem solving.
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Expérimental: Behavioral Weight Loss + Video chat
Internet delivery of a behavioral weight control program via video in a group format facilitated by an experienced registered dietitian.
Participants will have access to study materials including behavioral weight loss lessons on the study's website.
Participants will be given smart scales to weigh daily, and weight will be transmitted to a secure website accessible only by research personnel.
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Participants will attend weekly one hour classes on line.
They will have audio and video within the chat room, and will talk with their facilitator and classmates during their weekly meeting.
They will record their calorie and fat intake daily and weigh themselves daily.
Interventionists will review the diaries weekly and provide
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Weight loss from baseline
Délai: baseline, 2 months, 6 months
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The investigators will assess weight change differences between subjects randomized to receive an internet program alone with text chat vs. an internet program with visual chat and bodytrace smart scales.
Weight will be assessed at baseline, 2 months after intervention begins, and at the end of intervention using a calibrated digital scale (Tanita, WB800S) with subjects in street clothes, without shoes.
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baseline, 2 months, 6 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Attendance at chat
Délai: 6 months
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The group facilitator will record attendance at chats.
Attendance at chat will be compared by treatment arm.
Rate of attendance is calculated as number of meetings attended out of a total possible 24 meetings over the course of the study.
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6 months
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Self monitoring dietary intake
Délai: 6 months
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Number of weekly journals submitted out of a possible 24 weeks total will give the investigators the rate of self monitoring.
Rates of self monitoring will be compared by treatment arm.
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6 months
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Self monitoring weight
Délai: 6 months
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Number of daily weights submitted over the course of 24 weeks divided by the possible total of weights will give the rate of weight self-monitoring (7/week x 24 weeks = 168 possible weights).
The VIDEO arm will be provided with BodyTrace electronic scales that report weight to a secure database via cellular connectivity.
Subjects in the TEXT arm will report their weights to their facilitator using their own digital scale at home.
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6 months
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Jean Harvey, PhD RDN, University of Vermont
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 (Réel)
6 mars 2018
Achèvement primaire (Réel)
30 novembre 2018
Achèvement de l'étude (Réel)
30 novembre 2018
Dates d'inscription aux études
Première soumission
22 mars 2018
Première soumission répondant aux critères de contrôle qualité
28 mars 2018
Première publication (Réel)
9 avril 2018
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
6 décembre 2018
Dernière mise à jour soumise répondant aux critères de contrôle qualité
5 décembre 2018
Dernière vérification
1 décembre 2018
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 18-0409
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .