Dataset Information

Fit24, a digital health intervention to reduce type 2 diabetes risk among Hispanic youth: Protocol for a feasibility pilot study.

ABSTRACT:

Background

Poor physical activity (PA) and sleep behaviors in Hispanic adolescents contributes to increased risk for type 2 diabetes. Commonly owned digital devices and services like smartphones and text-messaging are highly used among adolescents and are promising intervention tools for reaching this age group. Personal activity trackers assess activity and sleep, making them ideal tools for addressing these behaviors. We propose to examine the feasibility of a 12-week intervention that uses theoretically grounded text messages and a Fitbit device to improve PA and sleep among Hispanic adolescents with obesity, as compared to a wait-list control group with a Fitbit device only.

Methods

Participants (N = 48; 14-16 years) will be randomized (1:1) to the intervention or wait-list control group. Youth in the intervention will receive a Fitbit Charge 5 and daily text messages. Youth in the wait-list control group will receive a Fitbit Charge 5 and information on PA and sleep guidelines.

Results

Feasibility will be examined by collecting process evaluation data on the following criteria: (1) recruit 48 Hispanic adolescents 14-16 years; (2) retain 85% of participants for post-assessments; (3) Fitbit wear ≥4 days/week and respond to 80% of text messages when prompted; (4) ≤10% technical issues; and (5) obtain 80% satisfaction from participants.

Discussion

This study will advance our knowledge on the feasibility of digital prevention strategies to promote PA and sleep behaviors to reduce T2D risk among Hispanic youth. If feasible, this approach has the potential to be a scalable, cost-effective diabetes prevention strategy among high-risk youth.

Trial registration

NCT04953442, registered on July 8, 2021.

SUBMITTER: Soltero EG

PROVIDER: S-EPMC10065958 | biostudies-literature | 2023 Apr

REPOSITORIES: biostudies-literature

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Publications

Fit24, a digital health intervention to reduce type 2 diabetes risk among Hispanic youth: Protocol for a feasibility pilot study.

Soltero Erica G EG Lopez Callie C Musaad Salma M SM O'Connor Teresia M TM Thompson Debbe D

Contemporary clinical trials 20230210

<h4>Background</h4>Poor physical activity (PA) and sleep behaviors in Hispanic adolescents contributes to increased risk for type 2 diabetes. Commonly owned digital devices and services like smartphones and text-messaging are highly used among adolescents and are promising intervention tools for reaching this age group. Personal activity trackers assess activity and sleep, making them ideal tools for addressing these behaviors. We propose to examine the feasibility of a 12-week intervention that ...[more]

PMID: 36775009

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Project description:Background: Loneliness is an emerging issue for young people, but yet many interventions to address loneliness in this group focus on providing social opportunities. While these sorts of interventions may appear to increase social connections, loneliness is more related to quality rather than quantity of social relationships. Thus, interventions addressing loneliness should focus on maximizing the quality of current relationships. Together with youth consumers both with mental ill health and those without, we developed a digital smartphone application (app) called +Connect. The 6-week program delivers positive psychology content designed to improve relationship quality. We tested the acceptability, feasibility, and safety of the program in lonely young people with or without a mental health diagnosis of social anxiety disorder. We used a mixed method study design to triangulate pilot quantitative and qualitative data in young people with and without social anxiety disorder (SAD). Method: Nine participants with a diagnosis of social anxiety disorder (M age = 21.00; SD = 1.41) and 11 participants with no mental health conditions (M age = 20.36; SD = 2.16) completed the +Connect digital intervention. Results: Those with social anxiety disorder reported less acceptable ratings on outcomes. Feasibility ratings, measured by uptake and app completion, met a priori threshold criteria in both groups. Those with social anxiety disorder yielded more attrition, with almost double the attrition rate compared with those without the disorder. There were no safety issues elicited during the pilot study. In terms of outcomes, exploratory analyses indicated that the app itself is likely to be beneficial rather than cause harm. Our qualitative data indicated both groups reported no negative outcomes and noted that positive outcomes were driven by three processes: reflection, learning, and real-life application. Further exploratory data on usability indicated room for improvement in terms of giving more support for different components of the app (i.e., challenges). Conclusion: The pilot findings of this proof-of-concept app indicates some promise in terms of a second iterative version of +Connect.

Project description:BackgroundThe prevalence of type 2 diabetes mellitus (T2DM) is increasing worldwide. Digital interventions that incorporate the use of mobile phones and wearables have been getting popular. A combination of a digital intervention with support from professional management can enhance users' self-efficacy better than a digital intervention alone and provide better accessibility to a lifestyle intervention. However, there are limited studies exploring the feasibility and efficacy of applying a digital intervention in Muslim-majority countries, and none have been conducted in Brunei Darussalam.ObjectiveThe study aims to determine the effectiveness and feasibility of a proposed 16-week digital intervention program for T2DM self-management and to guide the rollout of a mobile app as part of a population health solution for adults with T2DM in Brunei. The primary outcome of this study is to measure the proportion of participants with a hemoglobin A1c (HbA1c) reduction of at least 0.6% from baseline, and the secondary outcomes include a change in HbA1c, BMI, lipid profile, and EQ-5D-5L score.MethodsThis single-arm nonrandomized pilot study will recruit participants using web-based (with the national health care app [BruHealth] and official social media platforms being used for outreach) and offline (in-person recruitment at health centers) approaches. A target of 180 individuals with T2DM aged between 20 and 70 years that meet the inclusion criteria will be enrolled in a 16-week digital intervention program. Baseline and postintervention markers will be evaluated.ResultsThe study received approval from the Medical and Health Research & Ethics Committee of the Brunei Darussalam Ministry of Health (MHREC/MOH/2022/4(1)). The recruitment process is ongoing, and we anticipate that the study will conclude by April 2023. This will be followed by data analysis and the reporting of outcomes with the intention to publish. The results of this study will be disseminated through scientific publications and conferences. This study will serve as a guide to launch T2DM digital therapeutic programs and extend to other noncommunicable diseases (NCDs) if proven as an effective and feasible approach in Brunei.ConclusionsThe Development and Exploration of the Effectiveness and Feasibility of a Digital Intervention for Type 2 Diabetes Mellitus (DEsireD) study will be the first study to investigate the clinical effectiveness and feasibility of the proposed 16-week T2DM digital intervention program tailored for Brunei, a Muslim-majority country. The findings of this study can potentially scale up the proposed model of care to other NCDs as a national approach for health management solutions.Trial registrationClinicalTrials.gov NCT05364476; https://clinicaltrials.gov/ct2/show/NCT05364476.International registered report identifier (irrid)DERR1-10.2196/43208.

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Dataset Information

Fit24, a digital health intervention to reduce type 2 diabetes risk among Hispanic youth: Protocol for a feasibility pilot study.

Background

Methods

Results

Discussion

Trial registration

Publications

Fit24, a digital health intervention to reduce type 2 diabetes risk among Hispanic youth: Protocol for a feasibility pilot study.

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