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Habit App Pre-Pilot (BHT-OWL)

29 de julho de 2022 atualizado por: Sherry Pagoto, University of Connecticut

Building Habits Together: Feasibility Trial of an Integrated Mobile and Social Network Weight Loss Intervention

The purpose of this 6 week single-arm pilot is to evaluate the feasibility of the Habit app plus Facebook group intervention in 20 adults with obesity. Participants will participate in a 6-week version of the intervention which involves receiving a feed based on the Diabetes Prevention Program in a private Facebook group, access to a professional weight loss counselor in the Facebook group, MyFitnessPal, and the Habit app.

Visão geral do estudo

Status

Ativo, não recrutando

Condições

Descrição detalhada

The purpose of this single-arm pilot is to evaluate the feasibility of the intervention in 20 adults with obesity. We define feasibility as use of the mobile app features (dietary self-monitoring, slip tracker, and problem sharing/solving), retention, engagement (overall, problem solving), acceptability, and burden. This study will give us information that we can use to modify the intervention and our procedures before the larger pilot study. We will enroll 20 adults with obesity to participate in the 6-week pilot. Eligible participants will receive a link to complete surveys, mailed a wifi scale, and asked to provide staff with login information for the scale so weight can be recorded during assessments. They will then have a 60-minute call with a counselor to 1) download and receive training on program technology (MyFitnessPal, Habit app, and Fitbit scale) and 2) be entered into the Facebook group. Participants will participate in a 6-week version of the intervention which involves receiving a feed based on the Diabetes Prevention Program in a private Facebook group, access to a professional weight loss counselor in the Facebook group, MyFitnessPal, and the Habit app. Every Monday in the group, participants will be given one diet and one exercise goal for the week and every Sunday they will be asked to share their progress on those goals. Every Friday they will participate in a "weigh in" thread in the group. In addition to the group, for the first two weeks, participants will be asked to use MyFitnessPal; for the second two weeks, they will be asked to use the Temptation/Slip Tracker and Exercise Planner; and for the final two weeks they will be asked to use the Problem Solver. We will ask each participant to share at least one diet or exercise problem with the group over the 6 weeks and to participate in each other's problem solving posts. Participants may attend optional weekly breakout sessions where weight loss related problems will be discussed. On the final day of the intervention, a post will go up in the group asking for a volunteer who used the app enough to brainstorm how to improve it to participate in a team meeting to discuss how to improve the program. If more than one participant volunteers, one will be randomly selected to participate. After the 6-week intervention, participants will complete the weight loss problem solving skills survey, provide a final weight, and complete individual phone interviews to discuss their experience. We will convene a team meeting with the investigators, interventionists, and a participant to discuss the results and any modifications that should be made to the program before progressing to the pilot study.

Tipo de estudo

Intervencional

Inscrição (Real)

20

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

    • Connecticut
      • Storrs, Connecticut, Estados Unidos, 06269
        • University of Connecticut

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 65 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  1. 18-65 years old
  2. BMI 30-45 kg/m2
  3. has wifi connectivity at home (for wifi scale)
  4. logs into Facebook at least 5 days per week over the past 2 weeks, and has posted/replied at least once a week in the past 2 weeks
  5. able to participate in the study in English.

Exclusion Criteria:

  1. Pregnant/lactating or plans to become pregnant during study period
  2. bipolar disorder, substance abuse, psychosis, bulimia, binge eating disorder, or severe depression
  3. had bariatric surgery or plans to have surgery during the study
  4. currently taking medication affecting weight
  5. has lost ≥10% of weight in past year
  6. is participating or intends to participate in another weight loss program during the study that provides coaching or problem solving
  7. chronic pain that interferes with the ability to exercise
  8. Type 1 or 2 Diabetes
  9. unable to make dietary changes or increase physical activity
  10. unable to walk ¼ mile unaided without stopping
  11. currently smokes or vapes nicotine
  12. does not live in the United States
  13. had major surgery in past 6 months
  14. hospitalized for psychiatric reasons in past 12 months
  15. has concerns about being audiotaped during the focus groups
  16. does not have or not willing to create Fitbit account for study
  17. unable to access smartphone at home and at work
  18. does not have FB
  19. has done a study with this PI before
  20. has concerns about being in FB group with faculty/students of same university in which they work/attend
  21. does not have smartphone
  22. smartphone type/version not meeting app requirements
  23. prisoner
  24. unable to provide consent
  25. does not complete onboarding steps for the study

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Outro
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Habit App
Habit Mobile App
The intervention includes: the Facebook-delivered Diabetes Prevention Program (DPP) Lifestyle Intervention, MyFitnessPal and the Habit app. The DPP will be delivered within a counselor-led private Facebook group. It uses behavioral strategies to help participants 1) achieve a program assigned calorie goal based on amount needed to lose 1-2 pounds per week, 2) develop a healthy diet, and 3) engage in 150-300 minutes per week of moderate intensity exercise. Participants will be instructed to use MyFitnessPal for the first two weeks, the Habit app slip tracker and exercise planner for two weeks, and the Habit app problem solver for two weeks.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Mean total days Habit app was used
Prazo: 6 weeks
A backend server for Habit will capture data on total uses of the app, including the use of each feature (diet slip tracker, exercise planner, and problem solver.
6 weeks
Number of participants saying they would be likely or very likely to continue to use the Habit app if given the chance
Prazo: 6 weeks
Participants will rate how likely they would be to continue to use the Habit app (very unlikely to very likely) on 5-point Likert scales.
6 weeks
Number of participants saying they would be likely or very likely to recommend the Habit to a friend
Prazo: 6 weeks
Participants will rate how likely they would be to recommend the Habit app to a friend (very unlikely to very likely) on 5-point Likert scales.
6 weeks
Number of participants rating the slip tracker as time-consuming
Prazo: 6 weeks
Participants will rate their agreement with statements about how time-consuming participation in the program and use of each component (slip tracker, problem solver, and Facebook group) is on 5-point Likert scales. This outcome counts number of participants that Strongly Agree or Agree.
6 weeks
Number of participants rating the problem solver as time-consuming
Prazo: 6 weeks
Participants will rate their agreement with statements about how time-consuming participation in the program and use of each component (slip tracker, problem solver, and Facebook group) is on 5-point Likert scales. This outcome counts number of participants that Strongly Agree or Agree.
6 weeks
Number of participants rating the Facebook group as time-consuming
Prazo: 6 weeks
Participants will rate their agreement with statements about how time-consuming participation in the program and use of each component (slip tracker, problem solver, and Facebook group) is on 5-point Likert scales. This outcome counts number of participants that Strongly Agree or Agree.
6 weeks
Mean total engagements in the Facebook group
Prazo: 6 weeks
Using Grytics, we will retrieve objective engagement data from the Facebook group, including the date and content of all posts, replies, reactions, and poll votes. We will calculate the total number of posts, replies, reactions, and poll votes per participant.
6 weeks

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Mean number of exercises planned using the exercise planner
Prazo: 6 weeks
A backend server for Habit will capture data on participant use of exercise planner feature in Habit app
6 weeks
Mean number of problem-solving attempts created using the problem solver
Prazo: 6 weeks
A backend server for Habit will capture data on participant use of problem solver feature in Habit app
6 weeks
Mean total uses of diet slip tracker
Prazo: 6 weeks
A backend server for Habit will capture data on participant use of diet slip tracker feature in the Habit app
6 weeks
Mean number of problem sharing Facebook posts
Prazo: 6 weeks
All posts and comments in the Facebook group will be qualitatively coded to determine if a participant is sharing a problem they are having with the group either via the app or as an original post.
6 weeks
Mean number of problem solving Facebook comments
Prazo: 6 weeks
All posts and comments in the Facebook group will be qualitatively coded for problem solving if a comment is directed toward another participant (or anonymous post) that serve to help the OP brainstorm ideas on how to solve the problem.
6 weeks
Number of participants that attended at least one breakout session
Prazo: 6 weeks
Participants can attend optional breakout sessions during the intervention to discuss problems related to weight loss and receive peer feedback. We will track attendance and report the number of participants that attended at least one breakout session during the 6-week intervention.
6 weeks

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

18 de julho de 2022

Conclusão Primária (Antecipado)

31 de dezembro de 2022

Conclusão do estudo (Antecipado)

31 de dezembro de 2022

Datas de inscrição no estudo

Enviado pela primeira vez

23 de julho de 2021

Enviado pela primeira vez que atendeu aos critérios de CQ

15 de março de 2022

Primeira postagem (Real)

25 de março de 2022

Atualizações de registro de estudo

Última Atualização Postada (Real)

1 de agosto de 2022

Última atualização enviada que atendeu aos critérios de controle de qualidade

29 de julho de 2022

Última verificação

1 de julho de 2022

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • H20-0060
  • 1R34HL145439-01A1 (Concessão/Contrato do NIH dos EUA)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

Indeciso

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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