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Exploring the Optimal Duration of a Group-based Online Behavioral Weight Loss Program

12 listopada 2020 zaktualizowane przez: Jean R. Harvey, PhD, RD, University of Vermont
This online pilot weight loss study will explore the feasibility of recruiting individuals to an established online behavioral weight loss program of varying duration (4 months vs. 6 months), We will compare 6-month weight losses between the two programs of shorter and longer duration, respectively, and obtain data to characterize weight maintenance experiences and retention. Both groups will receive the same intervention; the only difference is the number of weeks the group will meet. Both groups will complete follow ups at 2, 4, 6, and 12 months (12 months after the study begins).

Przegląd badań

Status

Wycofane

Warunki

Interwencja / Leczenie

Szczegółowy opis

Obesity presents a vexing public health challenge. Effective behavioral weight control treatments are available, loss, and projections show these interventions could have a significant impact on overall population health if the interventions were more broadly available. Internet delivery of behavioral lifestyle interventions has potential for broad reach and is thus an attractive option, although average weight losses tend to be lower than in a comparable behavioral program delivered in-person. Nonetheless, internet-delivered group behavioral weight control programs which incorporate synchronous chat "group sessions" can produce an average of 5% weight loss, with almost a quarter of participants losing at least 10% of their body weight at 6-months, and thus offer weight losses which are clinically significant. Online programs are more cost effective than in-person delivery of the same program, but efforts to optimize the delivery of online programs to achieve the best weight outcomes balanced against delivery cost are in their infancy. The current feasibility study seeks to explore critical elements to allow testing of whether a moderate dose program (16 online weekly video chat sessions) can produce weight losses comparable to the higher dose (24 weekly video chat sessions) internet-delivered behavioral weight loss program which is the established standard which we have demonstrated effective in the past. This pilot study will provide proof-of-concept to determine whether the approach is promising and if it is feasible to conduct. The pilot will explore the feasibility of recruiting individuals to weight loss programs of varying duration (4 months vs. 6 months), refine our ability to deliver the 16-session program, compare 6-month weight losses between the two programs of shorter and longer duration, respectively, and obtain data to characterize weight maintenance experiences and retention over the 12-month study period.

Up to 80 individuals will be randomized into an online behavioral weight loss program lasting 4 months or 6 months. Individuals will meet weekly for one hour in a synchronous chat session with an experienced behavioral weight control counselor. Participants will be followed over 12 months from study start.

Typ studiów

Interwencyjne

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Stany Zjednoczone
    • South Carolina
      • Columbia, South Carolina, Stany Zjednoczone, 29208
        • University of South Carolina
    • Vermont
      • Burlington, Vermont, Stany Zjednoczone, 05405
        • Behavioral Weight Management Program/Univ of Vermont

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Kobieta

Opis

Inclusion Criteria:

  • female
  • BMI between 25-55
  • free of medical problems that might contraindicate participation in a behavioral weight reduction program containing an exercise component
  • not currently on medication that might affect weight loss
  • not currently pregnant or pregnant in the previous 6 months or currently breastfeeding
  • not enrolled in another weight reduction program
  • must have a computer (at home or work) with access to the Internet and a video camera
  • must have a smart phone (to allow use of step counting and dietary intake self-monitoring apps)
  • Only one member of a household will be eligible to participate
  • must successfully complete a self-monitoring diary of foods consumed for a week during screening for study eligibility
  • demonstrate the ability to access the website successfully (practice chat)
  • agree to be randomized to either group
  • must be willing to share access to self-monitoring information collected via the app MyFitnessPal, and Fitbit.com weight data collected via the digital smart scale (scale will be provided)

Exclusion Criteria:

  • have had a heart attack or a stroke in the past 6 months,
  • have ever had weight loss surgery,
  • have lost more than 10 pounds in the previous 6 months,
  • are currently taking medications for weight loss,
  • are required by their doctor to follow a special diet (other than a low fat diet)
  • have plans to move from the area in the upcoming 12 months
  • who have schedules that will make it likely that they will have difficulty attending the scheduled "chat" groups

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Four Month Duration
Participants will meet weekly online via video chat with an experienced behavioral weight loss counselor in a synchronous 1-hour chat session for 16 weeks in a well-established behavioral weight loss program.
Behawioralne: Four Month Duration Online Behavioral Weight Loss Program
Participants meet weekly on line with other group participants for 16 weeks. The group-based online behavioral weight control program incorporates the elements of current thinking and empirical data on successful weight loss programs, including restricted calorie intake and increased physical activity. Key behavioral strategies to facilitate making sustained changes in dietary habits and activity patterns are introduced, promoted, and reinforced throughout the program. Weekly "group meetings" in a video chat forum led by an experienced group weight control counselor are the venue for the group process, and extensive web-based resources to support behavior changes are offered. The online groups are "closed" such that those individuals who start the group remain in that group for the duration of their participation. Weight loss counselor will provide feedback and encouragement to participants after reviewing food diaries via weekly emails.
Aktywny komparator: Six Month Duration
Participants will meet weekly online via video chat with an experienced behavioral weight loss counselor in a synchronous 1-hour chat session for 24 weeks in a well-established behavioral weight loss program.
Behawioralne: Six Month Duration Online Behavioral Weight Loss Program
Participants meet weekly on line with other group participants for 24 weeks. The group-based online behavioral weight control program incorporates the elements of current thinking and empirical data on successful weight loss programs, including restricted calorie intake and increased physical activity. Key behavioral strategies to facilitate making sustained changes in dietary habits and activity patterns are introduced, promoted, and reinforced throughout the program. Weekly "group meetings" in a video chat forum led by an experienced group weight control counselor are the venue for the group process, and extensive web-based resources to support behavior changes are offered. The online groups are "closed" such that those individuals who start the group remain in that group for the duration of their participation. Weight loss counselor will provide feedback and encouragement to participants after reviewing food diaries via weekly emails.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in Weight from baseline to 2, 4, 6 and 12 months
Ramy czasowe: 2 months, 4 months, 6 months, 12 months
Weight loss at each follow-up will be calculated as % kg lost from baseline.
2 months, 4 months, 6 months, 12 months

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Process measures: Attendance by subjects at weekly online meetings
Ramy czasowe: 2,4,6 months
The group facilitator will take attendance at weekly online class meetings. Attendance at on-line meetings will be calculated as % of meetings actually attended out of 16 or 24 meetings that were scheduled according to condition assignment
2,4,6 months
Process measures: Completion of weekly online treatment modules by subjects
Ramy czasowe: 2, 4, 6 months
Completion of online treatment modules by each subject by condition will be calculated as % modules completed out of 16 or 24 modules scheduled according to condition assignment. Module completion is defined as viewing the module and completing the online activity questions associated with each respective module.
2, 4, 6 months

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of Vermont

Współpracownicy

University of South Carolina
University of Tennessee

Śledczy

  • Główny śledczy: Delia Smith West, PhD, University of South Carolina
  • Główny śledczy: Jean R Harvey, PhD, University of Vermont

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Oczekiwany)

1 lipca 2020

Zakończenie podstawowe (Oczekiwany)

1 stycznia 2021

Ukończenie studiów (Oczekiwany)

1 lutego 2021

Daty rejestracji na studia

Pierwszy przesłany

2 listopada 2020

Pierwszy przesłany, który spełnia kryteria kontroli jakości

12 listopada 2020

Pierwszy wysłany (Rzeczywisty)

13 listopada 2020

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

13 listopada 2020

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

12 listopada 2020

Ostatnia weryfikacja

1 listopada 2020

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • CHRBSS #STUDY00000761

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

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