- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT05295849
Habit App Pre-Pilot (BHT-OWL)
29 luglio 2022 aggiornato da: 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.
Panoramica dello studio
Stato
Attivo, non reclutante
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Interventistico
Iscrizione (Effettivo)
20
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
Connecticut
-
Storrs, Connecticut, Stati Uniti, 06269
- University of Connecticut
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 65 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Mean total days Habit app was used
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Mean number of exercises planned using the exercise planner
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
18 luglio 2022
Completamento primario (Anticipato)
31 dicembre 2022
Completamento dello studio (Anticipato)
31 dicembre 2022
Date di iscrizione allo studio
Primo inviato
23 luglio 2021
Primo inviato che soddisfa i criteri di controllo qualità
15 marzo 2022
Primo Inserito (Effettivo)
25 marzo 2022
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
1 agosto 2022
Ultimo aggiornamento inviato che soddisfa i criteri QC
29 luglio 2022
Ultimo verificato
1 luglio 2022
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- H20-0060
- 1R34HL145439-01A1 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Indeciso
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .