Overweight and Obesity Clinical Trial
Official title:
Mechanisms of Adherence to Light Intensity Physical Activity to Prevent Alzheimer's Disease and Related Dementias (ADRD)
The purpose of this study is to determine whether interaction with an adaptive Fitbit-based goal setting application can increase levels of everyday light intensity physical activity in middle-aged adults.
The study is designed to examine the efficacy of a Fitbit-based, goal setting, mHealth intervention to increase light intensity physical activity. The study design is a 2-arm randomized controlled trial. Both groups will receive the underlying goal-setting intervention (adaptive daily step goals). The study involves 3 phases: a run-in ("calibration") phase, the intervention ("training") phase, and follow-up (1- and 12-months post-intervention). To support goal maintenance our team has developed a Fitbit application designed to operate on the Fitbit Versa series watch as a 'clockface'. The application will first calibrate participants' average level of physical activity by recording daily step counts for a period of 14 days (calibration phase). After this period (and following a health education session) the application will begin delivering the underlying intervention to both treatment and control groups for a period of 1 month. The intervention is composed of daily step goals presented via the Fitbit clockface. Each day the application will suggest a daily step goal. The algorithm used to make these suggestions relies on the participant's own activity during the calibration period and is updated each day in study, ensuring all proposed step goals are within their existing repertoire. Follow-up assessments will be completed at 1- and 12-monts post-intervention. Outcomes and moderators will be measured via activity monitors (the Fitbit application and activPals), surveys, and ecological momentary assessments (self-ratings and performance-based ambulatory cognitive assessments) conducted via the Mobile Monitoring of Cognitive Change ("M2C2") platform. Some of the details of the intervention, algorithm, experimental manipulations, and outcomes have been omitted to preserve the scientific integrity of the study. These details will be added after the study is closed. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT03994419 -
PErioperAtive CHildhood ObesitY
|
||
| Recruiting |
NCT05354245 -
Using a Complex Carbohydrate Mixture to Steer Fermentation and Improve Metabolism in Adults With Overweight and Prediabetes (DISTAL)
|
N/A | |
| Completed |
NCT03602001 -
Attentive Eating for Weight Loss
|
N/A | |
| Recruiting |
NCT06269159 -
The Power of 24-hour: Co-designing Intervention Components
|
||
| Completed |
NCT03377244 -
Healthy Body Healthy Souls in the Marshallese Population
|
N/A | |
| Completed |
NCT02996864 -
Location-based Smartphone Technology to Guide College Students Healthy Choices Ph II
|
N/A | |
| Completed |
NCT04647149 -
Effects of Early and Delayed Time-restricted Eating in Adults With Overweight and Obesity
|
N/A | |
| Terminated |
NCT03914066 -
A Group-based Treatment of Overweight and Obesity in Primary Care
|
N/A | |
| Completed |
NCT03685656 -
Effect of ANACA3 Slimming Gel on Loss of Abdominal and Thigh Circumferences in Healthy Volunteers
|
N/A | |
| Completed |
NCT05051579 -
A Study of LY3502970 in Participants With Obesity or Overweight With Weight-related Comorbidities
|
Phase 2 | |
| Completed |
NCT04611477 -
Effect of Synbiotic 365 on Body Composition in Overweight and Obese Individuals
|
N/A | |
| Active, not recruiting |
NCT05330247 -
Cut Down on Carbohydrate in the Dietary Therapy of Type 2 Diabetes - The Meal Box Study
|
N/A | |
| Completed |
NCT03599115 -
Effects of Inhibitory Control Training in Eating Behaviors
|
N/A | |
| Recruiting |
NCT05938894 -
Train Your Brain - Executive Function
|
N/A | |
| Recruiting |
NCT06094231 -
Treating Patients With Renal Impairment and Altered Glucose MetAbolism With TherapeutIc Carbohydrate Restriction and Sglt2-Inhibiton - a Pilot Study
|
N/A | |
| Recruiting |
NCT05987306 -
A Self-compassion Focused Intervention for Internalized Weight Bias and Weight Loss
|
N/A | |
| Completed |
NCT03792685 -
Looking for Personalized Nutrition for Obesity/Type 2 Diabetes Mellitus Prevention
|
N/A | |
| Completed |
NCT05055362 -
Effect a Honey, Spice-blended Baked Good Has on Salivary Inflammation Markers in Adults: a Pilot Study
|
N/A | |
| Completed |
NCT04520256 -
Rapid Evaluation of Innovative Intervention Components to Maximize the Health Benefits of Behavioral Obesity Treatment Delivered Online: An Application of Multiphase Optimization Strategy
|
Phase 2/Phase 3 | |
| Completed |
NCT04979234 -
A Single Centre, Prospective Feasibility Study to Evaluate the Efficacy of an Endoluminal-suturing Device (Endomina) on Severe Obstructive Sleep Apnea Syndrome
|
N/A |