- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT05295849
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
Intervenção / Tratamento
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
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Storrs, Connecticut, Estados Unidos, 06269
- University of Connecticut
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-
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:
- 18-65 years old
- BMI 30-45 kg/m2
- has wifi connectivity at home (for wifi scale)
- 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
- able to participate in the study in English.
Exclusion Criteria:
- Pregnant/lactating or plans to become pregnant during study period
- bipolar disorder, substance abuse, psychosis, bulimia, binge eating disorder, or severe depression
- had bariatric surgery or plans to have surgery during the study
- currently taking medication affecting weight
- has lost ≥10% of weight in past year
- is participating or intends to participate in another weight loss program during the study that provides coaching or problem solving
- chronic pain that interferes with the ability to exercise
- Type 1 or 2 Diabetes
- unable to make dietary changes or increase physical activity
- unable to walk ¼ mile unaided without stopping
- currently smokes or vapes nicotine
- does not live in the United States
- had major surgery in past 6 months
- hospitalized for psychiatric reasons in past 12 months
- has concerns about being audiotaped during the focus groups
- does not have or not willing to create Fitbit account for study
- unable to access smartphone at home and at work
- does not have FB
- has done a study with this PI before
- has concerns about being in FB group with faculty/students of same university in which they work/attend
- does not have smartphone
- smartphone type/version not meeting app requirements
- prisoner
- unable to provide consent
- 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.
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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.
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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.
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6 weeks
|
Colaboradores e Investigadores
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Patrocinador
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
Palavras-chave
Termos MeSH relevantes adicionais
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
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