Dataset Information

Digital Support for Healthier Eating Habits Among Patients With Type 2 Diabetes: Protocol for a Randomized Clinical Trial Within Primary Care (HAPPY Trial).

ABSTRACT:

Background

Despite the large impact that dietary habits have in the management of diabetes, few tools for supporting healthy eating habits are available for persons with diabetes.

Objective

The aim of this randomized clinical trial is to evaluate the effect of a 12-week, mobile health (mHealth), app-based intervention promoting healthy eating habits among patients with type 2 diabetes.

Methods

The HAPPY (Healthy eating using APP technologY) trial is a randomized clinical trial with two arms aiming to include 200 patients, 18 years of age or older, with type 2 diabetes. Both women and men are eligible for inclusion. Study participants are randomized 1:1 to an intervention group, where they are instructed to use a smartphone app promoting healthy eating, or to a control group, where they receive standard primary care only, for a period of 12 weeks. Each week a new topic (eg, vegetable intake) is introduced via the app. After an introduction text, the user is given a topic-related activity to perform (eg, eat one additional serving of vegetables per day during that week). The app records daily progress and sends automatic reminders or feedback to the user. Dietary intake, body composition, clinical variables, and biomarkers are measured at baseline and at 3- and 6-month follow-ups. An extensive web-based questionnaire comprising several validated questionnaires assessing a number of lifestyle factors is distributed via email at baseline and at 3-, 6-, and 12-month follow-ups; lifestyle factors include, for example, sleep, physical activity, eating behavior, and health-related quality of life. The effect of the intervention on dietary intake (primary outcome) and on glycated hemoglobin and blood lipid levels, body composition, blood pressure, other lifestyle factors, and overall health (secondary outcomes) will be assessed.

Results

Data collection is ongoing. Recruitment of participants started in January 2019. Findings from the study are expected to be published by the end of 2021.

Conclusions

Technology development provides new ways to promote and support long-term adherence to healthier eating habits. mHealth-based approaches allow for real-time interaction and the delivery of an intervention at any time. Further, focusing on overall diet allows the user to apply new knowledge to current eating patterns, creating an individualized approach. In this study, we evaluate the effect of using a new smartphone app promoting healthy eating habits on dietary intake, clinical markers, and lifestyle factors among patients with type 2 diabetes.

Trial registration

ClinicalTrials.gov NCT03784612; https://clinicaltrials.gov/ct2/show/NCT03784612.

International registered report identifier (irrid)

DERR1-10.2196/24422.

SUBMITTER: Trolle Lagerros Y

PROVIDER: S-EPMC7704281 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Digital Support for Healthier Eating Habits Among Patients With Type 2 Diabetes: Protocol for a Randomized Clinical Trial Within Primary Care (HAPPY Trial).

Trolle Lagerros Ylva Y Dahlgren Anna A Sjöblom Linnea L Bonn Stephanie E SE

JMIR research protocols 20201116 11

<h4>Background</h4>Despite the large impact that dietary habits have in the management of diabetes, few tools for supporting healthy eating habits are available for persons with diabetes.<h4>Objective</h4>The aim of this randomized clinical trial is to evaluate the effect of a 12-week, mobile health (mHealth), app-based intervention promoting healthy eating habits among patients with type 2 diabetes.<h4>Methods</h4>The HAPPY (Healthy eating using APP technologY) trial is a randomized clinical tr ...[more]

PMID: 33196448

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Project description:BackgroundChildren living in low and middle-income countries (LMICs) are at greater risk for experiencing adversities that can undermine their health and early development. Recently launched digital early childhood development (ECD) programs attempt to support families with young children in their home environments using digital technologies. However, relatively little is known regarding the effectiveness of these new technologies.ObjectiveThe goal of this study is to rigorously assess the reach, effectiveness, and cost-effectiveness of a newly developed digital ECD platform called Afini. The Afini platform was designed to support parents of young children in low-resource settings to improve ECD and interact with caregivers through messenger services and a chatbot.MethodsThis is a 3-arm cluster randomized controlled trial. In total, 2471 caregivers and their 3- to 9-month-old children were enrolled in the study across 164 study clusters in the San Marcos, Cajabamba, and Cajamarca provinces of Peru. Clusters of participants were randomly assigned to 1 of 3 groups: a control group (72 community clusters and 980 caregiver-child dyads), a home visit intervention group (20 community clusters and 316 caregiver-child dyads), and an Afini intervention group (72 community clusters and 1175 caregiver-child dyads). Families in the control group receive no focused ECD intervention. The home visit group is receiving biweekly home visits by a trained field staff following the national ECD program (Programa Nacional Cuna Más) curriculum and training guidelines. Caregivers in the Afini group are receiving ECD activities and advice through the digital platform. The primary study outcome is children's overall development at the age of 2.5 years, using the internationally validated long form of the Global Scales for Early Development. Secondary outcomes include caregiver engagement; caregiver mental health; screen time; as well as caregiver reports of children's motor, cognitive, language, and socioemotional development measured through locally piloted and validated tools.ResultsEnrollment started in September 2021 and ended in March 2023. Endline assessments will take place between August 2023 and September 2024.ConclusionsThis study is, to our knowledge, the first to rigorously assess the effectiveness and cost-effectiveness of digital ECD technologies in LMICs. Given the large number of children in LMICs currently receiving only limited external support, the evaluated platform has the potential to improve the short- and long-term well-being of millions of children and their parents globally.Trial registrationClinicalTrials.gov NCT05202106; https://clinicaltrials.gov/ct2/show/NCT05202106.International registered report identifier (irrid)DERR1-10.2196/50371.

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Project description:China's government and its people have for a long time focused on food security for its population as one of the most important issues in economic and social development. Many older people in China have lived in times when food security was not stable. Thus, while food has a central position in Chinese culture for all Chinese people, it is of particular pertinence to older people. In this paper we explore the meaning of food and eating in the lives of older Chinese people in China and how it contributes to healthy, thus happy aging. Focus groups and qualitative interviews were used in this study. Participants were recruited from the rural Yongfu Province of Southwest China, and the urban Fangzhuang and Haidan districts in Beijing. Forty-two participants were recruited aged 62-83 years of age. All focus groups and interviews were conducted in Mandarin and audiotaped with the participants' permission. Audio-tapes were transcribed by a Chinese speaking researcher and then were translated into English. Data were analyzed continuously and comparatively, transcripts were coded, and themes and sub-themes were identified. The initial analysis and interpretation were then presented and discussed at a workshop with all the authors. Two major themes emerged-the quantity of food and the quality of food required to have a happy old age. Participants discussed the desire to eat "until you are full" because of their experiences of famine during childhood. However, they also believed that as an older person they should eat less for their health, particularly less high fat foods. The importance of the food quality and food affordability was also discussed. Grain and meat were characterized as "good" foods and important in their diets for a happy old age. The participants, especially those from urban areas, were concerned with food safety. The high cultural importance of food for older Chinese in China was confirmed in this study. Social and economic lifespan experiences continue to impact on the food and eating attitudes and practices of older Chinese. The food related life experiences of older Chinese in China are quite different from younger Chinese and health promotion messaging needs to be informed by these unique perspectives in order to maximize its effectiveness.

Project description:BackgroundMental health issues among emerging adults (aged 19-25 years) on a global scale have underscored the need to address their widespread experiences of depression and anxiety. As a result of the COVID-19 pandemic, emerging studies are being directed toward the development and deployment of digital peer emotional disclosure and support for the psychological well-being of emerging adults. However, it is important to explore the implementation and clinical effectiveness, as well as associated mechanisms of change, for optimal approaches in conducting digital peer support interventions for emerging adults' psychological well-being.ObjectiveWe describe a randomized controlled trial to evaluate the implementation and clinical effectiveness of Acceset, a digital peer support intervention to address emerging adult mental well-being. The intervention has 2 components. First, the digital peer support training equips befrienders (ie, peers who provide support) to harness 4 components of psychological well-being-mattering, selfhood, compassion, and mindfulness-to provide effective peer support for seekers (ie, peers who seek support). Second, Acceset incorporates psychological well-being digital markers and harnesses community engagement to drive emotional disclosure among peers.MethodsA total of 100 participants (aged 19-25 years) from the National University of Singapore will be recruited and randomized into 2 arms. In arm 1 (n=50), the seekers will use Acceset with befrienders (n=30) as well as moderators (n=30) for 3 weeks. Arm 2 comprises a wait-listed control group (n=50). A questionnaire battery will be used to monitor seekers and befrienders at 4 time points. These include baseline (before the intervention), 3 weeks (end of the intervention), and 6 and 9 weeks (carryover effect measurement). Implementation outcomes of the intervention will involve evaluation of the training curriculum with respect to adoption and fidelity as well as user acceptability of the Acceset platform and its feasibility for broader deployment. Clinical outcomes will include mattering, selfhood, compassion, mindfulness, perceived social support, and psychological well-being scores.ResultsThis protocol received National University of Singapore Institutional Ethics Review Board approval in October 2021. Recruitment will commence in January 2022. We expect data collection and analyses to be completed in June 2022. Preliminary findings are expected to be published in December 2022. The Cohen d index will be used for effect size estimation with a .05 (95% reliability) significance level and 80% power.ConclusionsThis protocol considers a novel digital peer support intervention-Acceset-that incorporates components and digital markers of emerging adult mental well-being. Through the validation of the Acceset intervention, this study defines the parameters and conditions for digital peer support interventions for emerging adults.Trial registrationClinicalTrials.gov NCT05083676; https://clinicaltrials.gov/ct2/show/NCT05083676.International registered report identifier (irrid)PRR1-10.2196/34602.

Dataset Information

Digital Support for Healthier Eating Habits Among Patients With Type 2 Diabetes: Protocol for a Randomized Clinical Trial Within Primary Care (HAPPY Trial).

Background

Objective

Methods

Results

Conclusions

Trial registration

International registered report identifier (irrid)

Publications

Digital Support for Healthier Eating Habits Among Patients With Type 2 Diabetes: Protocol for a Randomized Clinical Trial Within Primary Care (HAPPY Trial).

Similar Datasets

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