- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03254940
Charge: A Text Messaging-based Weight Loss Intervention
April 9, 2025 updated by: Duke University
Charge: Optimizing a Standalone Text Messaging-Based Weight Loss Intervention
This study evaluates different versions of a text messaging-based app for weight loss.
This study will place participants to 1 of 32 experimental conditions that reflect different texting components and levels.
Participants will be randomized to a condition.
The investigators will recruit 448 adults into a 6-month weight loss program, with an additional follow-up 6-months after the intervention ends.
Study Overview
Detailed Description
Standalone text messaging-based weight loss treatments are scalable and can achieve population reach.
However, these interventions are also modular; they can be delivered independently to maximize cost-effectiveness or combined with other approaches (e.g.
provider counseling) to maximize outcomes.
This study is a 12-month experimental trial among 448 adults with obesity.
All participants will receive a core 6-month weight loss texting intervention that includes tailored behavior change goals, interactive self-monitoring, automated feedback, and skills training.
Participants will be randomly assigned to 1 of 32 different experimental conditions.
Study Type
Interventional
Enrollment (Actual)
534
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
-
Durham, North Carolina, United States, 27708
- Duke University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- males and females aged 18-65 years
- participants have English language proficiency
- participants have a BMI between 25-40 kg/m2
- Participants will own a smartphone
- Participants will be willing to receive multiple text messages daily.
Exclusion Criteria:
- prior or planned bariatric surgery
- psychiatric hospitalization in past 12 months
- pregnancy, nursing, or planned pregnancy
- history of a cardiovascular event
- history of an eating disorder
- history of a condition (e.g., end stage renal disease, cancer, schizophrenia) or use of medications (e.g., lithium, steroids, anti-psychotics) that would affect weight measurement, for which weight loss is contraindicated, or might promote weight change
- current participation in a weight loss trial and/or recent weight loss > 10%
- investigator discretion for safety reasons
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm 1: WT-SM-OR-SS-CS
Charge: weekly tracking, self-generated motivational messages, one reminder, summary score, compare to self
|
Text messaging-based study to determine effect of different components on weight loss.
|
|
Experimental: Arm 2: WT-SM-OR-SS-CG
Charge: weekly tracking, self-generated motivational messages, one reminder, summary score, compare to group
|
Text messaging-based study to determine effect of different components on weight loss.
|
|
Experimental: Arm 3: WT-SM-OR-SF-CS
Charge: weekly tracking, self-generated motivational messages, one reminder, specific goal feedback, compare to self
|
Text messaging-based study to determine effect of different components on weight loss.
|
|
Experimental: Arm 4: WT-SM-OR-SF-CG
Charge: weekly tracking, self-generated motivational messages, one reminder, specific goal feedback, compare to group
|
Text messaging-based study to determine effect of different components on weight loss.
|
|
Experimental: Arm 5: WT-SM-MR-SS-CS
Charge: weekly tracking, self-generated motivational messages, multiple reminders, summary score, compare to self.
|
Text messaging-based study to determine effect of different components on weight loss.
|
|
Experimental: Arm 6: WT-SM-MR-SS-CG
Charge: weekly tracking, self-generated motivational messages, multiple reminders, summary score, compare to group.
|
Text messaging-based study to determine effect of different components on weight loss.
|
|
Experimental: Arm 7: WT-SM-MR-SF-CS
Charge: weekly tracking, self-generated motivational messages, multiple reminders, specific feedback, compare to self
|
Text messaging-based study to determine effect of different components on weight loss.
|
|
Experimental: Arm 8: WT-SM-MR-SF-CG
Charge: weekly tracking, self-generated motivational messages, multiple reminders, specific feedback, compare to group
|
Text messaging-based study to determine effect of different components on weight loss.
|
|
Experimental: Arm 9: WT-EM-OR-SS-CS
Charge: weekly tracking, expert-generated motivational messages, one reminder, summary score, compare to self
|
Text messaging-based study to determine effect of different components on weight loss.
|
|
Experimental: Arm 10: WT-EM-OR-SS-CG
Charge: weekly tracking, expert-generated motivational messages, one reminder, summary score, compare to group
|
Text messaging-based study to determine effect of different components on weight loss.
|
|
Experimental: Arm 11: WT-EM-OR-SF-CS
Charge: weekly tracking, expert-generated motivational messages, one reminder, specific goal feedback, compare to self
|
Text messaging-based study to determine effect of different components on weight loss.
|
|
Experimental: Arm 12: WT-EM-OR-SF-CG
Charge: weekly tracking, expert-generated motivational messages, one reminder, specific goal feedback, compare to group.
|
Text messaging-based study to determine effect of different components on weight loss.
|
|
Experimental: Arm 13: WT-EM-MR-SS-CS
Charge: weekly tracking, expert-generated motivational messages, multiple reminders, summary score, compare to self
|
Text messaging-based study to determine effect of different components on weight loss.
|
|
Experimental: Arm 14: WT-EM-MR-SS-CG
Charge: weekly tracking, expert-generated motivational messages, multiple reminders,summary score, compare to group
|
Text messaging-based study to determine effect of different components on weight loss.
|
|
Experimental: Arm 15: WT-EM-MR-SF-CS
Charge: weekly tracking, expert-generated motivational messages, multiple reminders, specific goal feedback, compare to self
|
Text messaging-based study to determine effect of different components on weight loss.
|
|
Experimental: Arm 16: WT-EM-MR-SF-CG
Charge: weekly tracking, expert-generated motivational messages, multiple reminders, specific goal feedback, compare to group
|
Text messaging-based study to determine effect of different components on weight loss.
|
|
Experimental: Arm 17: DT-SM-OR-SS-CS
Charge: daily tracking, self-generated motivational messages, one reminder, summary score, compare to self.
|
Text messaging-based study to determine effect of different components on weight loss.
|
|
Experimental: Arm 18: DT-SM-OR-SS-CG
Charge: daily tracking, self-generated motivational messages, one reminder, summary score, compare to group
|
Text messaging-based study to determine effect of different components on weight loss.
|
|
Experimental: Arm 19: DT-SM-OR-SF-CS
Charge: daily tracking, self-generated motivational messages, one reminder, specific goal feedback, compare to self.
|
Text messaging-based study to determine effect of different components on weight loss.
|
|
Experimental: Arm 20: DT-SM-OR-SF-CG
Charge: daily tracking, self-generated motivational messages, one reminder, specific goal feedback, compare to group
|
Text messaging-based study to determine effect of different components on weight loss.
|
|
Experimental: Arm 21: DT-SM-MR-SS-CS
Charge: daily tracking, self-generated motivational messages, multiple reminders, summary score, compare to self
|
Text messaging-based study to determine effect of different components on weight loss.
|
|
Experimental: Arm 22: DT-SM-MR-SS-CG
Charge: daily tracking, self-generated motivational messages, multiple reminders, summary score, compare to group.
|
Text messaging-based study to determine effect of different components on weight loss.
|
|
Experimental: Arm 23: DT-SM-MR-SF-CS
Charge: daily tracking, self-generated motivational messages, multiple reminders, specific goal feedback, compare to self.
|
Text messaging-based study to determine effect of different components on weight loss.
|
|
Experimental: Arm 24: DT-SM-MR-SF-CG
Charge: daily tracking, self-generated motivational messages, multiple reminders, specific goal feedback, compare to group
|
Text messaging-based study to determine effect of different components on weight loss.
|
|
Experimental: Arm 25: DT-EM-OR-SS-CS
Charge: daily tracking, expert-generated motivational messages, one reminder, summary score, compare to self
|
Text messaging-based study to determine effect of different components on weight loss.
|
|
Experimental: Arm 26: DT-EM-OR-SS-CG
Charge: daily tracking, expert-generated motivational messages, one reminder, summary score, compare to group
|
Text messaging-based study to determine effect of different components on weight loss.
|
|
Experimental: Arm 27: DT-EM-OR-SF-CS
Charge: daily tracking, expert-generated motivational messages, one reminder, specific goal feedback, compare to self
|
Text messaging-based study to determine effect of different components on weight loss.
|
|
Experimental: Arm 28: DT-EM-OR-SF-CG
Charge: daily tracking, expert-generated motivational messages, one reminder, specific goal feedback, compare to group
|
Text messaging-based study to determine effect of different components on weight loss.
|
|
Experimental: Arm 29: DT-EM-MR-SS-CS
Charge: daily tracking, expert-generated motivational messages, multiple reminders, summary score, compare to self
|
Text messaging-based study to determine effect of different components on weight loss.
|
|
Experimental: Arm 30: DT-EM-MR-SS-CG
Charge: daily tracking, expert-generated motivational messages, multiple reminders, summary score, compare to group
|
Text messaging-based study to determine effect of different components on weight loss.
|
|
Experimental: Arm 31: DT-EM-MR-GF-CS
Charge: daily tracking, expert-generated motivational messages, multiple reminders, specific goal feedback, compare to self
|
Text messaging-based study to determine effect of different components on weight loss.
|
|
Experimental: Arm 32: DT-EM-MR-GF-CG
Charge: daily tracking, expert-generated motivational messages, multiple reminders, specific goal feedback, compare to group.
|
Text messaging-based study to determine effect of different components on weight loss.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Average Weight Change
Time Frame: baseline, 6 months
|
Mean change in weight in kg (6 months post-randomization- baseline weight)
|
baseline, 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Diet
Time Frame: baseline, 6 months
|
To experimentally determine the effects of text messaging components and levels on change in dietary intake using The Rapid Eating Assessment for Participants - Shortened version (REAP-S).
The range of score is 13 to 39, where a higher score indicates more healthy dietary intake.
|
baseline, 6 months
|
|
Average Change in Physical Activity
Time Frame: baseline, 6 months
|
To experimentally determine the effects of text messaging components and levels on change in weekly minutes of physical activity based on the WHO Global Physical Activity Questionnaire version 2 (GPAC 2).
The range of scores is 0 minutes/week to 10,080 minutes/week (maximum number of minutes in a week).
|
baseline, 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gary G Bennett, PhD, Bishop-MacDermott Family Professor of Psychology, Global Health & Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Finkelstein EA, Brown DS, Wrage LA, Allaire BT, Hoerger TJ. Individual and aggregate years-of-life-lost associated with overweight and obesity. Obesity (Silver Spring). 2010 Feb;18(2):333-9. doi: 10.1038/oby.2009.253. Epub 2009 Aug 13.
- 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.
- 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.
- Flegal KM, Carroll MD, Kit BK, Ogden CL. Prevalence of obesity and trends in the distribution of body mass index among US adults, 1999-2010. JAMA. 2012 Feb 1;307(5):491-7. doi: 10.1001/jama.2012.39. Epub 2012 Jan 17.
- Collins LM, Baker TB, Mermelstein RJ, Piper ME, Jorenby DE, Smith SS, Christiansen BA, Schlam TR, Cook JW, Fiore MC. The multiphase optimization strategy for engineering effective tobacco use interventions. Ann Behav Med. 2011 Apr;41(2):208-26. doi: 10.1007/s12160-010-9253-x.
- 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.
- 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.
- 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.
- Ogden CL, Lamb MM, Carroll MD, Flegal KM. Obesity and socioeconomic status in adults: United States, 2005-2008. NCHS Data Brief. 2010 Dec;(50):1-8.
- 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.
- Befort CA, Nazir N, Perri MG. Prevalence of obesity among adults from rural and urban areas of the United States: findings from NHANES (2005-2008). J Rural Health. 2012 Fall;28(4):392-7. doi: 10.1111/j.1748-0361.2012.00411.x. Epub 2012 May 31.
- Han X, Stevens J, Truesdale KP, Bradshaw PT, Kucharska-Newton A, Prizment AE, Platz EA, Joshu CE. Body mass index at early adulthood, subsequent weight change and cancer incidence and mortality. Int J Cancer. 2014 Dec 15;135(12):2900-9. doi: 10.1002/ijc.28930. Epub 2014 May 8.
- 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.
- 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.
- Evans W, Nielsen PE, Szekely DR, Bihm JW, Murray EA, Snider J, Abroms LC. Dose-response effects of the text4baby mobile health program: randomized controlled trial. JMIR Mhealth Uhealth. 2015 Jan 28;3(1):e12. doi: 10.2196/mhealth.3909.
- 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.
- Shapiro JR, Koro T, Doran N, Thompson S, Sallis JF, Calfas K, Patrick K. Text4Diet: a randomized controlled study using text messaging for weight loss behaviors. Prev Med. 2012 Nov;55(5):412-7. doi: 10.1016/j.ypmed.2012.08.011. Epub 2012 Aug 27.
- Steinberg DM, Levine EL, Askew S, Foley P, Bennett GG. Daily text messaging for weight control among racial and ethnic minority women: randomized controlled pilot study. J Med Internet Res. 2013 Nov 18;15(11):e244. doi: 10.2196/jmir.2844.
- Bennett GG, Steinberg D, Bolton J, Gallis JA, Treadway C, Askew S, Kay MC, Pollak KI, Turner EL. Optimizing an Obesity Treatment Using the Multiphase Optimization Strategy Framework: Protocol for a Randomized Factorial Trial. JMIR Res Protoc. 2021 Jan 18;10(1):e19506. doi: 10.2196/19506.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 31, 2018
Primary Completion (Actual)
June 29, 2019
Study Completion (Actual)
January 31, 2023
Study Registration Dates
First Submitted
July 12, 2017
First Submitted That Met QC Criteria
August 16, 2017
First Posted (Actual)
August 21, 2017
Study Record Updates
Last Update Posted (Actual)
April 10, 2025
Last Update Submitted That Met QC Criteria
April 9, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D0752
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obesity
-
Dr. Christopher McGowanRecruitingObesity Prevention | Obesity Recidivism | Obesity and Overweight | Obesity and Obesity-related Medical ConditionsUnited States
-
Central Hospital, Nancy, FranceNot yet recruiting
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsCompletedOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
The Hospital for Sick ChildrenCompleted
-
Ihuoma EneliCompletedObesity, ChildhoodUnited States
-
Dr. Christopher McGowanRecruitingObesity Prevention | Obesity Recidivism | Obesity and Overweight | GLP-1 | Obesity and Obesity-related Medical Conditions | Ablation TechniquesUnited States
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
Clinical Trials on Charge
-
QuickSilver ScientificKGK Science Inc.Recruiting
-
Boston Children's HospitalJohns Hopkins University; Children's Hospital Medical Center, Cincinnati; Cystic...CompletedCystic Fibrosis in ChildrenUnited States
-
University Health Network, TorontoCompleted
-
Massachusetts General HospitalUniversity Medical Center Groningen; Massachusetts Institute of TechnologyWithdrawnInflammatory Bowel Diseases | Crohn Disease | Ulcerative Colitis
-
Fondazione Policlinico Universitario Agostino Gemelli...Recruiting
-
Vanderbilt UniversityCompleted
-
VU University of AmsterdamActive, not recruitingIntervention Effectiveness | Implementation ResearchNetherlands
-
Johns Hopkins UniversityNational Institute on Minority Health and Health Disparities (NIMHD)CompletedViolenceUnited States
-
North Texas Veterans Healthcare SystemUnknown
-
Sheba Medical CenterNot yet recruitingChild Behavior Disorders