Health Effects of a 12-Week Web-Based Lifestyle Intervention for Physically Inactive and Overweight or Obese Adults: Study Protocol of Two Randomized Controlled Clinical Trials
Abstract
:1. Introduction
2. Materials and Methods: Design, Participants, Interventions, and Outcomes
2.1. Study Design, Setting, and Dates
2.2. Eligibility Criteria
2.3. Interventions
2.3.1. Interactive Web-Based Health Program
2.3.2. Non-Interactive Web-Based Health Program
2.4. Outcomes
2.4.1. Primary Outcomes
2.4.2. Secondary Outcomes
2.4.3. Other Outcomes
2.5. Participant Timeline
2.6. Sample Size
2.7. Recruitment
3. Materials and Methods: Assignment of Interventions
3.1. Allocation
3.2. Blinding
4. Materials and Methods: Data Collection, Management, and Analysis
4.1. Data Collection Methods
4.2. Data Management
4.3. Statistical Methods
- Level 1:
- Level 2:
5. Materials and Methods: Monitoring
5.1. Data Monitoring
5.2. Harms
6. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
Ancillary and Post-Trial Care
Dissemination Policy
Abbreviations
References
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Outcome | Measurement Time Point | ||||||||
---|---|---|---|---|---|---|---|---|---|
t0 1 | t1 2 | t2 3 | t3 4 | ||||||
primary | health goal achievement | Fclin | cardiorespiratory fitness | maximum oxygen uptake (VO2max) (ml/min/kg) | x | x | x | x | |
Wclin | anthropometry | body weight (kg) | x | x | x | x | |||
secondary | behavioral | Fclin Wclin | physical activity behavior | steps taken (steps/day) | x | x | x | x | |
sedentary behavior (minutes/day) | |||||||||
physical activity (light, moderate, vigorous intensity) (minutes/week) | |||||||||
Fclin Wclin | dietary behavior | energy and nutrient intake (kcal, µg, mg, g, %) | x | x | x | x | |||
food consumption (HEI-NVS 5) (g, ml, score) | |||||||||
Wclin | energy density (kcal/g) | ||||||||
physiological | Fclin | musculoskeletal fitness | maximum isometric strength (N, kg, lbs) | x | x | x | x | ||
Fclin | anthropometry | body weight (kg) | x | x | x | x | |||
Fclin Wclin | body height (cm) | ||||||||
body mass index (BMI) (kg/m2) | |||||||||
fat mass (kg, %) | |||||||||
fat-free mass (kg, %) | |||||||||
waist circumference (cm) | |||||||||
secondary | physiological | Fclin Wclin | blood pressure | systolic blood pressure (mmHg) | x | x | x | x | |
diastolic blood pressure (mmHg) | |||||||||
heart rate (bpm) | |||||||||
Fclin Wclin | blood levels | blood lipids | total cholesterol (mg/dL) | x | x | x | x | ||
LDL 6 cholesterol (mg/dL) | |||||||||
HDL 7 cholesterol (mg/dL) | |||||||||
triglycerides (mg/dL) | |||||||||
blood glucose | fasting plasma glucose (mg/dL) | x | x | x | x | ||||
HbA1c 8 (mol/mol Hb, %) | |||||||||
Fclin Wclin | vascular health | endothelial function (FMD) 9 (%) | x | x | x | x | |||
vascular age (days) |
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Brame, J.; Kohl, J.; Wurst, R.; Fuchs, R.; Tinsel, I.; Maiwald, P.; Fichtner, U.; Armbruster, C.; Bischoff, M.; Farin-Glattacker, E.; et al. Health Effects of a 12-Week Web-Based Lifestyle Intervention for Physically Inactive and Overweight or Obese Adults: Study Protocol of Two Randomized Controlled Clinical Trials. Int. J. Environ. Res. Public Health 2022, 19, 1393. https://doi.org/10.3390/ijerph19031393
Brame J, Kohl J, Wurst R, Fuchs R, Tinsel I, Maiwald P, Fichtner U, Armbruster C, Bischoff M, Farin-Glattacker E, et al. Health Effects of a 12-Week Web-Based Lifestyle Intervention for Physically Inactive and Overweight or Obese Adults: Study Protocol of Two Randomized Controlled Clinical Trials. International Journal of Environmental Research and Public Health. 2022; 19(3):1393. https://doi.org/10.3390/ijerph19031393
Chicago/Turabian StyleBrame, Judith, Jan Kohl, Ramona Wurst, Reinhard Fuchs, Iris Tinsel, Phillip Maiwald, Urs Fichtner, Christoph Armbruster, Martina Bischoff, Erik Farin-Glattacker, and et al. 2022. "Health Effects of a 12-Week Web-Based Lifestyle Intervention for Physically Inactive and Overweight or Obese Adults: Study Protocol of Two Randomized Controlled Clinical Trials" International Journal of Environmental Research and Public Health 19, no. 3: 1393. https://doi.org/10.3390/ijerph19031393