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Physical Activity clinical trials

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NCT ID: NCT05524909 Active, not recruiting - Type 2 Diabetes Clinical Trials

Full-scale Intervention Study: Genetic Risk Communication and Wearables

Start date: November 1, 2022
Phase: N/A
Study type: Interventional

Background: Communication of information about risk of type 2 diabetes (T2D) alone has not been associated with changes in habitual behaviors among individuals of European ancestry. In contrast, the use of wearable devices that monitor physical activity (PA) has been associated with changes in behavior in some studies. It is uncertain whether risk communication might enhance the effects of wearable devices. We aim to assess the effects on wearable-device-measured PA of communicating genetic risk for T2D alone or in combination with goal setting and activity prompts from a wearable device among overweight or obese East Asians. Methods: In a parallel group, randomized controlled trial, a total of 355 overweight or obese East Asian individuals aged 40-60 years will be allocated into one of three groups: 1 control and 2 intervention groups. Blood samples will be used for estimation of T2D genetic risk and analysis of metabolic risk markers. Genetic risk of T2D will be estimated based on 113 SNPs associated with T2D among East Asians using an established method. All three groups will receive a Fitbit device. Both intervention groups will be given T2D genetic risk estimates along with lifestyle advice, but one of the intervention groups will additionally use Fitbit's step-goal setting and prompt functions. Questionnaires and physical measurements will be administered at baseline, immediately after intervention delivery, and 6 and 12-month post-intervention following standard operating procedures. The primary outcome is time spent in moderate-to-vigorous PA measured through the Fitbit. Secondary outcomes include other parameters of wearable-device-measured PA, sedentary time, and sleep, body mass index, systolic and diastolic blood pressure, five intermediate metabolic risk markers, hand grip strength, self-reported PA, self-reported fruit and vegetable consumption and smoking status, and a list of psychological variables. Discussion: This study will be the first randomized controlled trial using the combination of communication of T2D genetic risk with standard functions of wearable devices in any population. Findings will inform strategies to prevent T2D through lifestyle modification.

NCT ID: NCT05457439 Active, not recruiting - Physical Activity Clinical Trials

Sustainable-psycho-nutritional Intervention Program and Its Effects on Health Outcomes and the Environment

Start date: October 1, 2022
Phase: N/A
Study type: Interventional

Mexico is going through a major environmental and nutritional crisis, which is related to unsustainable dietary behaviors. Sustainable diets could solve both problems together. However, in Mexico and the world, an intervention program oriented to promoting sustainable diets has not been designed. This study protocol aims to design a 3-stages, 15 weeks, sustainable-psycho-nutritional digital intervention program whose objective is to promote the adherence of the Mexican population to a sustainable diet and to evaluate its effects on dietary water and carbon footprints, metabolic biomarkers, and gut microbiota of this population. The behavior change wheel model and the guide for digital interventions design will be followed. In stage 1, the program will be designed using the sustainable diets model, and the behavior change wheel model. A sustainable food guide, sustainable recipes, and food plans as well as a mobile application will be developed. In stage 2, the intervention will be carried out for 7 weeks, and a follow-up period of 7 weeks, in a sample of Mexican young adults (18 to 35 years) randomly divided into an experimental group (n=50) and a control group (n=50). The nutritional care process model will be used. Anthropometric, biochemical, clinical, dietary, environmental, socioeconomic level and cultural aspects, nutritional-sustainable knowledge, behavioral aspects, and physical activity will be considered. Thirteen behavioral objectives will be included using successive approaches in online workshops twice a week. The population will be monitored using the mobile application that will include behavioral change techniques. In stage 3, the effects of the intervention will be assessed on the dietary water and carbon footprint, lipid profile, serum glucose, and gut microbiota composition of the evaluated population. It is expected to find improvements in health outcomes and a decrease in dietary water and carbon footprints. With this study, the first theoretical-methodological approach to the sustainable-psycho-nutrition approach will be generated.

NCT ID: NCT05436145 Active, not recruiting - Depression Clinical Trials

Intern Health Study 2022 and 2023

IHS
Start date: July 1, 2022
Phase: N/A
Study type: Interventional

The aim of this trial is to evaluate the efficacy of an intervention (delivered through a smartphone) for improving the mood, physical activity, and sleep of medical interns.

NCT ID: NCT05376293 Active, not recruiting - Physical Activity Clinical Trials

Be-Active Study - Increasing Physical Activity in Cancer Survivors

Start date: August 23, 2022
Phase: N/A
Study type: Interventional

Rates of cancer survivorship are on the rise and cancer survivors face unique health challenges that are common across cancer types that last well beyond the cessation of cancer treatment (e.g., increased fatigue, anxiety/depression, fear of recurrence, risk of cardiovascular disease, and lower health-related quality of life). While physical activity (PA) has favorable effects on these health parameters and is highly recommended for cancer survivors, this population engages in lower-than-average levels of PA. Effective PA interventions with high translation potential are important for improving the health of this population. The Internet overcome barriers to traditional face-to-face treatment programs (e.g., high cost, participant burden, geographical constraints) and represents a disseminable intervention approach. While behaviorally-based Internet programs significantly increase PA in other health domains, the application of these programs to cancer survivors is relatively new. This study will randomize 50 cancer survivors to a 12-week Internet PA program or usual-care newsletter condition. Primary outcomes include intervention engagement and program satisfaction related to the Internet program and changes in PA by intervention arm at post-treatment (3 months). Secondary aims include comparison of intervention arms on changes in sleep, weight, fatigue, anxiety/depression, health-related quality of life, and fear of recurrence.

NCT ID: NCT05290584 Active, not recruiting - Physical Activity Clinical Trials

Influence of Preschool Children's Fundamental Movement Skills, Physical Activity, and Physical Fitness on Executive Function: A Prospective Observation Study

Start date: October 11, 2021
Phase:
Study type: Observational

Background: Early childhood is the most critical and rapid period of complete and healthy physical and cognitive development in human life. Executive function appears in early childhood and develops rapidly through complex coaction between environment and developmental processes. The preschool period is also characterized by a rapid growth in fundamental movement skills, physical activity and physical fitness. The scientific research on the relationship between fundamental movement skills, physical activity, physical fitness and executive function in preschoolers remains to be explored. Objective: The purpose of this study was to examine the cross-sectional relationship between fundamental movement skills, physical activity, physical fitness and executive function in preschool children while controlling for potential confounding variables, examine the prospective influence (independent and interactive role) of preschooler's fundamental movement skills, physical activity and physical fitness on executive function, observe the preschoolers' fundamental movement skills, physical activity, physical fitness and executive function changes with age, and investigate gender and age differences in preschoolers' fundamental movement skills, physical activity, physical fitness and executive function. Method: The proposed study consists of two phases, phase 1 is a cross-sectional study. Five hundred and five children aged 3-5 years will be recruited. The Test of Gross Motor Development Third Edition (TGMD-3) was used to assess children's fundamental movement skills. Preschool children's physical activity was monitored by accelerometer ActiGraph GT3X-BT. Physical fitness was tested using handgrip, 4*10m shuttle run, 20m shuttle run, 30s sit-ups, sit and reach, and balance beam. Executive function was tested by computer-based tasks including animal stroop, safari training and stop signal task. Phase 2 is a 12-month follow-up study. In the phase 2, all children enrolled in the baseline study will be followed up, the measurements and contents of the follow-up are the same as the baseline instrument.

NCT ID: NCT05231837 Active, not recruiting - Physical Activity Clinical Trials

Neighborhood Park Youth Sports Program Fee Waiver and Intensive Family Outreach

PARKS
Start date: February 15, 2022
Phase: Phase 3
Study type: Interventional

To evaluate a park-level intervention to increase child moderate/vigorous physical activity (MVPA), and decrease sedentary time among low-income racially/ethnically diverse children ages 6-12 yrs. Neighborhood parks (n=20) from Minneapolis (n=8) and Saint Paul (n=12) park systems will be randomized for a 2-year period to one of two arms: 1) Intensive Park Outreach and Youth Sports Program Fee Waiver (n=10); or 2) Youth Sports Program Fee Waiver Only (n=10). The evaluation cohort will consist of 432 children ages 6-12 yrs who reside in one of the 20 randomized park neighborhoods. Measurements from evaluation cohort-enrolled individual children will be collected at baseline, 6, 12, and 24 months.

NCT ID: NCT04942535 Active, not recruiting - Physical Activity Clinical Trials

STEP Together: An Effectiveness-Implementation Study of Social Incentives and Physical Activity

Start date: September 21, 2021
Phase: N/A
Study type: Interventional

Higher levels of physical activity have been demonstrated to improve health across a wide range of contexts and reduce cognitive decline as adults become older, but more than half of all adults in the United States do not meet their physical activity goals. One type of physical activity that is broadly applicable to people of all ages is walking. This study will use a Hybrid Type 1 effectiveness-implementation design to adapt and test the effectiveness of two successful social incentive-based interventions, a gamification strategy and financial incentives donated to charity on the participants behalf, to increase physical activity among low-income, mostly minority families in community settings.

NCT ID: NCT04940481 Active, not recruiting - Physical Activity Clinical Trials

TROLLEY Study - TRansit Opportunities for HeaLth, Livability, Exercise and EquitY

TROLLEY
Start date: July 15, 2021
Phase:
Study type: Observational

The researchers are evaluating longitudinal changes in multiple health, economic, and environmental outcomes over a 3-year COVID recovery period and in the context of a new light rail transit (LRT) line, called the Mid-Coast Trolley, among 465 UC San Diego (UCSD) staff. The primary aim is to evaluate change in objectively measured total and moderate to vigorous physical activity (MVPA), travel mode, and vehicle miles traveled (VMT).

NCT ID: NCT04863040 Active, not recruiting - Obesity Clinical Trials

The Impact of Activity Breaks on Cognitive Function, Adiposity and Fitness in Preschoolers

MOVI-HIIT
Start date: June 1, 2020
Phase: N/A
Study type: Interventional

Project which objective is a) to test the effectiveness, in preschool children, of an integrated physical activity intervention in the classroom based on intervallic training (MOVI-HIIT) on improving executive function, body composition, cardiorespiratory fitness and b) to evaluate teachers' perceptions of barriers and facilitating elements for the implementation and monitoring of MOVI-HIIT interventions in the classroom.

NCT ID: NCT04827212 Active, not recruiting - Physical Activity Clinical Trials

Companion: Sensor-based Two-way Communication for Physical Activity in Older Adults

Start date: March 16, 2021
Phase: Early Phase 1
Study type: Interventional

This pilot study is a small sample (N=46) 16-week clinical trial with a follow-up after 24-weeks among sedentary adults >60 y with a BMI >25 kg/m2 to tests the impact of a hybrid artificial intelligence behavior change system (Companion) on physical activity. Participants will be randomized to a control and intervention group. All participants will engage in a proven supervised exercise program from week 1 to 16. Only the intervention group will receive Companion from week 1 to 16.