Study Summary
This trial will test different versions of a weight-loss app that uses text messaging. It will enroll 448 adults and follow them for 6 months, with a 6-month follow-up.
Eligible Conditions
- Obesity
- Weight Loss
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 6 Secondary · Reporting Duration: baseline, 6 & 12 months
baseline & 6 months
Compare Cost-effectiveness of interventions
Weight
Month 12
Change in categorical weight loss (> 5%) at 6-months
Change in diet
Change in physical activity
Measure engagement in the intervention
weight loss maintenance
Trial Safety
Safety Progress
Trial Design
32 Treatment Groups
Arm 3: WT-SM-OR-SF-CS
1 of 32
Arm 32: DT-EM-MR-GF-CG
1 of 32
Arm 2: WT-SM-OR-SS-CG
1 of 32
Arm 10: WT-EM-OR-SS-CG
1 of 32
Arm 4: WT-SM-OR-SF-CG
1 of 32
Arm 5: WT-SM-MR-SS-CS
1 of 32
Arm 13: WT-EM-MR-SS-CS
1 of 32
Arm 9: WT-EM-OR-SS-CS
1 of 32
Arm 14: WT-EM-MR-SS-CG
1 of 32
Arm 15: WT-EM-MR-SF-CS
1 of 32
Arm 31: DT-EM-MR-GF-CS
1 of 32
Arm 1: WT-SM-OR-SS-CS
1 of 32
Arm 8: WT-SM-MR-SF-CG
1 of 32
Arm 16: WT-EM-MR-SF-CG
1 of 32
Arm 7: WT-SM-MR-SF-CS
1 of 32
Arm 11: WT-EM-OR-SF-CS
1 of 32
Arm 12: WT-EM-OR-SF-CG
1 of 32
Arm 6: WT-SM-MR-SS-CG
1 of 32
Arm 17: DT-SM-OR-SS-CS
1 of 32
Arm 19: DT-SM-OR-SF-CS
1 of 32
Arm 20: DT-SM-OR-SF-CG
1 of 32
Arm 18: DT-SM-OR-SS-CG
1 of 32
Arm 21: DT-SM-MR-SS-CS
1 of 32
Arm 22: DT-SM-MR-SS-CG
1 of 32
Arm 25: DT-EM-OR-SS-CS
1 of 32
Arm 27: DT-EM-OR-SF-CS
1 of 32
Arm 30: DT-EM-MR-SS-CG
1 of 32
Arm 23: DT-SM-MR-SF-CS
1 of 32
Arm 24: DT-SM-MR-SF-CG
1 of 32
Arm 26: DT-EM-OR-SS-CG
1 of 32
Arm 28: DT-EM-OR-SF-CG
1 of 32
Arm 29: DT-EM-MR-SS-CS
1 of 32
Experimental Treatment
448 Total Participants · 32 Treatment Groups
Primary Treatment: Charge · No Placebo Group · N/A
Arm 3: WT-SM-OR-SF-CS
Behavioral
Experimental Group · 1 Intervention: Charge · Intervention Types: BehavioralArm 32: DT-EM-MR-GF-CG
Behavioral
Experimental Group · 1 Intervention: Charge · Intervention Types: BehavioralArm 2: WT-SM-OR-SS-CG
Behavioral
Experimental Group · 1 Intervention: Charge · Intervention Types: BehavioralArm 10: WT-EM-OR-SS-CG
Behavioral
Experimental Group · 1 Intervention: Charge · Intervention Types: BehavioralArm 4: WT-SM-OR-SF-CG
Behavioral
Experimental Group · 1 Intervention: Charge · Intervention Types: BehavioralArm 5: WT-SM-MR-SS-CS
Behavioral
Experimental Group · 1 Intervention: Charge · Intervention Types: BehavioralArm 13: WT-EM-MR-SS-CS
Behavioral
Experimental Group · 1 Intervention: Charge · Intervention Types: BehavioralArm 9: WT-EM-OR-SS-CS
Behavioral
Experimental Group · 1 Intervention: Charge · Intervention Types: BehavioralArm 14: WT-EM-MR-SS-CG
Behavioral
Experimental Group · 1 Intervention: Charge · Intervention Types: BehavioralArm 15: WT-EM-MR-SF-CS
Behavioral
Experimental Group · 1 Intervention: Charge · Intervention Types: BehavioralArm 31: DT-EM-MR-GF-CS
Behavioral
Experimental Group · 1 Intervention: Charge · Intervention Types: BehavioralArm 1: WT-SM-OR-SS-CS
Behavioral
Experimental Group · 1 Intervention: Charge · Intervention Types: BehavioralArm 8: WT-SM-MR-SF-CG
Behavioral
Experimental Group · 1 Intervention: Charge · Intervention Types: BehavioralArm 16: WT-EM-MR-SF-CG
Behavioral
Experimental Group · 1 Intervention: Charge · Intervention Types: BehavioralArm 7: WT-SM-MR-SF-CS
Behavioral
Experimental Group · 1 Intervention: Charge · Intervention Types: BehavioralArm 11: WT-EM-OR-SF-CS
Behavioral
Experimental Group · 1 Intervention: Charge · Intervention Types: BehavioralArm 12: WT-EM-OR-SF-CG
Behavioral
Experimental Group · 1 Intervention: Charge · Intervention Types: BehavioralArm 6: WT-SM-MR-SS-CG
Behavioral
Experimental Group · 1 Intervention: Charge · Intervention Types: BehavioralArm 17: DT-SM-OR-SS-CS
Behavioral
Experimental Group · 1 Intervention: Charge · Intervention Types: BehavioralArm 19: DT-SM-OR-SF-CS
Behavioral
Experimental Group · 1 Intervention: Charge · Intervention Types: BehavioralArm 20: DT-SM-OR-SF-CG
Behavioral
Experimental Group · 1 Intervention: Charge · Intervention Types: BehavioralArm 18: DT-SM-OR-SS-CG
Behavioral
Experimental Group · 1 Intervention: Charge · Intervention Types: BehavioralArm 21: DT-SM-MR-SS-CS
Behavioral
Experimental Group · 1 Intervention: Charge · Intervention Types: BehavioralArm 22: DT-SM-MR-SS-CG
Behavioral
Experimental Group · 1 Intervention: Charge · Intervention Types: BehavioralArm 25: DT-EM-OR-SS-CS
Behavioral
Experimental Group · 1 Intervention: Charge · Intervention Types: BehavioralArm 27: DT-EM-OR-SF-CS
Behavioral
Experimental Group · 1 Intervention: Charge · Intervention Types: BehavioralArm 30: DT-EM-MR-SS-CG
Behavioral
Experimental Group · 1 Intervention: Charge · Intervention Types: BehavioralArm 23: DT-SM-MR-SF-CS
Behavioral
Experimental Group · 1 Intervention: Charge · Intervention Types: BehavioralArm 24: DT-SM-MR-SF-CG
Behavioral
Experimental Group · 1 Intervention: Charge · Intervention Types: BehavioralArm 26: DT-EM-OR-SS-CG
Behavioral
Experimental Group · 1 Intervention: Charge · Intervention Types: BehavioralArm 28: DT-EM-OR-SF-CG
Behavioral
Experimental Group · 1 Intervention: Charge · Intervention Types: BehavioralArm 29: DT-EM-MR-SS-CS
Behavioral
Experimental Group · 1 Intervention: Charge · Intervention Types: BehavioralTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 6 & 12 months
Who is running the clinical trial?
Duke UniversityLead Sponsor
2,185 Previous Clinical Trials
3,210,788 Total Patients Enrolled
75 Trials studying Obesity
30,962 Patients Enrolled for Obesity
Gary G Bennett, PhDPrincipal InvestigatorBishop-MacDermott Family Professor of Psychology, Global Health & Medicine
5 Previous Clinical Trials
982 Total Patients Enrolled
3 Trials studying Obesity
628 Patients Enrolled for Obesity
Eligibility Criteria
Age 18 - 65 · All Participants · 5 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| North Carolina | 33.3% |
| Oregon | 33.3% |
| South Carolina | 33.3% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Duke University | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 66.7% |
| Did not meet criteria | 33.3% |
References
- Ogden, Cynthia L., Margaret D. Carroll, and Katherine M. Flegal. 2014. “Prevalence of Obesity in the United States”. Jama. American Medical Association (AMA). doi:10.1001/jama.2014.6228.
- Shapiro, Jennifer R., Tina Koro, Neal Doran, Sheri Thompson, James F. Sallis, Karen Calfas, and Kevin Patrick. 2012. “Text4diet: A Randomized Controlled Study Using Text Messaging for Weight Loss Behaviors”. Preventive Medicine. Elsevier BV. doi:10.1016/j.ypmed.2012.08.011.
- Yang, Lin, and Graham A. Colditz. 2015. “Prevalence of Overweight and Obesity in the United States, 2007-2012”. JAMA Internal Medicine. American Medical Association (AMA). doi:10.1001/jamainternmed.2015.2405.
- Jordan, Elizabeth T., Ellen M. Ray, Pamela Johnson, and W. Douglas Evans. 2011. “Text4baby: Using Text Messaging to Improve Maternal and Newborn Health”. Nursing for Women's Health. Elsevier BV. doi:10.1111/j.1751-486x.2011.01635.x.
- Evans, William, Peter E Nielsen, Daniel R Szekely, Jasmine W Bihm, Elizabeth A Murray, Jeremy Snider, and Lorien C Abroms. 2015. “Dose-response Effects of the Text4baby Mobile Health Program: Randomized Controlled Trial”. JMIR Mhealth and Uhealth. JMIR Publications Inc.. doi:10.2196/mhealth.3909.
- Collins, Linda M., Timothy B. Baker, Robin J. Mermelstein, Megan E. Piper, Douglas E. Jorenby, Stevens S. Smith, Bruce A. Christiansen, Tanya R. Schlam, Jessica W. Cook, and Michael C. Fiore. 2010. “The Multiphase Optimization Strategy for Engineering Effective Tobacco Use Interventions”. Annals of Behavioral Medicine. Oxford University Press (OUP). doi:10.1007/s12160-010-9253-x.
- Fontaine, Kevin R., David T. Redden, Chenxi Wang, Andrew O. Westfall, and David B. Allison. 2003. “Years of Life Lost Due to Obesity”. Jama. American Medical Association (AMA). doi:10.1001/jama.289.2.187.
- Han, Xuesong, June Stevens, Kimberly P. Truesdale, Patrick T. Bradshaw, Anna Kucharska-Newton, Anna E. Prizment, Elizabeth A. Platz, and Corinne E. Joshu. 2014. “Body Mass Index at Early Adulthood, Subsequent Weight Change and Cancer Incidence and Mortality”. International Journal of Cancer. Wiley. doi:10.1002/ijc.28930.
- Flegal, Katherine M., Margaret D. Carroll, Brian K. Kit, and Cynthia L. Ogden. 2012. “Prevalence of Obesity and Trends in the Distribution of Body Mass Index Among US Adults, 1999-2010”. Jama. American Medical Association (AMA). doi:10.1001/jama.2012.39.
- Befort, Christie A., Niaman Nazir, and Michael G. Perri. 2012. “Prevalence of Obesity Among Adults from Rural and Urban Areas of the United States: Findings from NHANES (2005-2008)”. The Journal of Rural Health. Wiley. doi:10.1111/j.1748-0361.2012.00411.x.
- Bennett, Gary G., and Russell E. Glasgow. 2009. “The Delivery of Public Health Interventions via the Internet: Actualizing Their Potential”. Annual Review of Public Health. Annual Reviews. doi:10.1146/annurev.publhealth.031308.100235.
- Mokdad, Ali H., Earl S. Ford, Barbara A. Bowman, William H. Dietz, Frank Vinicor, Virginia S. Bales, and James S. Marks. 2003. “Prevalence of Obesity, Diabetes, and Obesity-related Health Risk Factors, 2001”. Jama. American Medical Association (AMA). doi:10.1001/jama.289.1.76.
- Steinberg, Dori M, Erica L Levine, Sandy Askew, Perry Foley, and Gary G Bennett. 2013. “Daily Text Messaging for Weight Control Among Racial and Ethnic Minority Women: Randomized Controlled Pilot Study”. Journal of Medical Internet Research. JMIR Publications Inc.. doi:10.2196/jmir.2844.
- Bennett, Gary G, Dori Steinberg, Jamiyla Bolton, John A Gallis, Cayla Treadway, Sandy Askew, Melissa C Kay, Kathryn I Pollak, and Elizabeth L Turner. 2021. “Optimizing an Obesity Treatment Using the Multiphase Optimization Strategy Framework: Protocol for a Randomized Factorial Trial”. JMIR Research Protocols. JMIR Publications Inc.. doi:10.2196/19506.
- Finkelstein, Eric A., Derek S. Brown, Lisa A. Wrage, Benjamin T. Allaire, and Thomas J. Hoerger. 2010. “Individual and Aggregate Years-of-life-lost Associated with Overweight and Obesity”. Obesity. Wiley. doi:10.1038/oby.2009.253.
- Osei-Assibey, G., I. Kyrou, Y. Adi, S. Kumar, and K. Matyka. 2010. “Dietary and Lifestyle Interventions for Weight Management in Adults from Minority Ethnic/non-white Groups: A Systematic Review”. Obesity Reviews. Wiley. doi:10.1111/j.1467-789x.2009.00695.x.
- Chang, Virginia W., and Diane S. Lauderdale. 2005. “Income Disparities in Body Mass Index and Obesity in the United States, 1971-2002”. Archives of Internal Medicine. American Medical Association (AMA). doi:10.1001/archinte.165.18.2122.
- Rodriguez, Fátima, and Keith C. Ferdinand. 2015. “Hypertension in Minority Populations: New Guidelines and Emerging Concepts”. Advances in Chronic Kidney Disease. Elsevier BV. doi:10.1053/j.ackd.2014.08.004.
- Jensen, Michael D., Donna H. Ryan, Caroline M. Apovian, Jamy D. Ard, Anthony G. Comuzzie, Karen A. Donato, Frank B. Hu, et al.. 2014. “2013 AHA/ACC/TOS Guideline for the Management of Overweight and Obesity in Adults”. Journal of the American College of Cardiology. Elsevier BV. doi:10.1016/j.jacc.2013.11.004.
- Ogden, Cynthia L., Margaret D. Carroll, and Katherine M. Flegal. 2014. “Prevalence of Obesity in the United States”. Jama. American Medical Association (AMA). doi:10.1001/jama.2014.6228.
- Steinberg, Dori M, Erica L Levine, Sandy Askew, Perry Foley, and Gary G Bennett. 2013. “Daily Text Messaging for Weight Control Among Racial and Ethnic Minority Women: Randomized Controlled Pilot Study”. Journal of Medical Internet Research. JMIR Publications Inc.. doi:10.2196/jmir.2844.
- Flegal, Katherine M., Margaret D. Carroll, Brian K. Kit, and Cynthia L. Ogden. 2012. “Prevalence of Obesity and Trends in the Distribution of Body Mass Index Among US Adults, 1999-2010”. Jama. American Medical Association (AMA). doi:10.1001/jama.2012.39.
- Jordan ET, Ray EM, Johnson P, Evans WD. Text4Baby: using text messaging to improve maternal and newborn health. Nurs Womens Health. 2011 Jun-Jul;15(3):206-12. doi: 10.1111/j.1751-486X.2011.01635.x. No abstract available.
- Yang L, Colditz GA. Prevalence of Overweight and Obesity in the United States, 2007-2012. JAMA Intern Med. 2015 Aug;175(8):1412-3. doi: 10.1001/jamainternmed.2015.2405. No abstract available.
- Mokdad AH, Ford ES, Bowman BA, Dietz WH, Vinicor F, Bales VS, Marks JS. Prevalence of obesity, diabetes, and obesity-related health risk factors, 2001. JAMA. 2003 Jan 1;289(1):76-9. doi: 10.1001/jama.289.1.76.
- Bennett GG, Glasgow RE. The delivery of public health interventions via the Internet: actualizing their potential. Annu Rev Public Health. 2009;30:273-92. doi: 10.1146/annurev.publhealth.031308.100235.
- Osei-Assibey G, Kyrou I, Adi Y, Kumar S, Matyka K. Dietary and lifestyle interventions for weight management in adults from minority ethnic/non-White groups: a systematic review. Obes Rev. 2010 Nov;11(11):769-76. doi: 10.1111/j.1467-789X.2009.00695.x.
- Ogden CL, Carroll MD, Flegal KM. Prevalence of obesity in the United States. JAMA. 2014 Jul;312(2):189-90. doi: 10.1001/jama.2014.6228. No abstract available.
- Rodriguez F, Ferdinand KC. Hypertension in minority populations: new guidelines and emerging concepts. Adv Chronic Kidney Dis. 2015 Mar;22(2):145-53. doi: 10.1053/j.ackd.2014.08.004.
- Fontaine KR, Redden DT, Wang C, Westfall AO, Allison DB. Years of life lost due to obesity. JAMA. 2003 Jan 8;289(2):187-93. doi: 10.1001/jama.289.2.187.
- Jensen MD, Ryan DH, Apovian CM, Ard JD, Comuzzie AG, Donato KA, Hu FB, Hubbard VS, Jakicic JM, Kushner RF, Loria CM, Millen BE, Nonas CA, Pi-Sunyer FX, Stevens J, Stevens VJ, Wadden TA, Wolfe BM, Yanovski SZ; American College of Cardiology/American Heart Association Task Force on Practice Guidelines; Obesity Society. 2013 AHA/ACC/TOS guideline for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. J Am Coll Cardiol. 2014 Jul 1;63(25 Pt B):2985-3023. doi: 10.1016/j.jacc.2013.11.004. Epub 2013 Nov 12. No abstract available. Erratum In: J Am Coll Cardiol. 2014 Jul 1;63(25 Pt B):3029-3030.
- 2018. "Charge: A Text Messaging-based Weight Loss Intervention". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03254940.
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Conditions
Cancer Related
Treatments