- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03491293
Piloting Visual Chat in Internet Obesity Treatment (CHAT)
5 december 2018 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
32
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
South Carolina
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Columbia, South Carolina, Förenta staterna, 29208
- University of South Carolina
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Vermont
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Burlington, Vermont, Förenta staterna, 05405
- Behavioral Weight Management Program/Univ of Vermont
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Kvinna
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: 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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Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Weight loss from baseline
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Attendance at chat
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Jean Harvey, PhD RDN, University of Vermont
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
6 mars 2018
Primärt slutförande (Faktisk)
30 november 2018
Avslutad studie (Faktisk)
30 november 2018
Studieregistreringsdatum
Först inskickad
22 mars 2018
Först inskickad som uppfyllde QC-kriterierna
28 mars 2018
Första postat (Faktisk)
9 april 2018
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
6 december 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
5 december 2018
Senast verifierad
1 december 2018
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 18-0409
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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