Charge: A Text Messaging-based Weight Loss Intervention

A study testing Charge in people with Weight Loss and Obesity, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Weight Loss, Obesity
What is being tested?: Charge
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 534 participants
Where: 1 siteUnited States
Study dates: 31 Jan 2018to 31 Jan 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Duke University
Durham, North Carolina, 27708

Other trials in United States

About this study

Official title: Charge: Optimizing a Standalone Text Messaging-Based Weight Loss Intervention

Read the 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.

Conditions: Weight Loss, Obesity
Being tested: Charge
Keywords: text message, digital health, weight loss, personalized
Medical subject headings: Weight Loss, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ChargeBehavioural
Text messaging-based study to determine effect of different components on weight loss.

Study groups in NCT03254940
Study group	Role	What they receive
Arm 1: WT-SM-OR-SS-CS	Experimental	Charge: weekly tracking, self-generated motivational messages, one reminder, summary score, compare to self Receives: Behavioral: Charge
Arm 2: WT-SM-OR-SS-CG	Experimental	Charge: weekly tracking, self-generated motivational messages, one reminder, summary score, compare to group Receives: Behavioral: Charge
Arm 3: WT-SM-OR-SF-CS	Experimental	Charge: weekly tracking, self-generated motivational messages, one reminder, specific goal feedback, compare to self Receives: Behavioral: Charge
Arm 4: WT-SM-OR-SF-CG	Experimental	Charge: weekly tracking, self-generated motivational messages, one reminder, specific goal feedback, compare to group Receives: Behavioral: Charge
Arm 5: WT-SM-MR-SS-CS	Experimental	Charge: weekly tracking, self-generated motivational messages, multiple reminders, summary score, compare to self. Receives: Behavioral: Charge
Arm 6: WT-SM-MR-SS-CG	Experimental	Charge: weekly tracking, self-generated motivational messages, multiple reminders, summary score, compare to group. Receives: Behavioral: Charge
Arm 7: WT-SM-MR-SF-CS	Experimental	Charge: weekly tracking, self-generated motivational messages, multiple reminders, specific feedback, compare to self Receives: Behavioral: Charge
Arm 8: WT-SM-MR-SF-CG	Experimental	Charge: weekly tracking, self-generated motivational messages, multiple reminders, specific feedback, compare to group Receives: Behavioral: Charge
Arm 9: WT-EM-OR-SS-CS	Experimental	Charge: weekly tracking, expert-generated motivational messages, one reminder, summary score, compare to self Receives: Behavioral: Charge
Arm 10: WT-EM-OR-SS-CG	Experimental	Charge: weekly tracking, expert-generated motivational messages, one reminder, summary score, compare to group Receives: Behavioral: Charge
Arm 11: WT-EM-OR-SF-CS	Experimental	Charge: weekly tracking, expert-generated motivational messages, one reminder, specific goal feedback, compare to self Receives: Behavioral: Charge
Arm 12: WT-EM-OR-SF-CG	Experimental	Charge: weekly tracking, expert-generated motivational messages, one reminder, specific goal feedback, compare to group. Receives: Behavioral: Charge
Arm 13: WT-EM-MR-SS-CS	Experimental	Charge: weekly tracking, expert-generated motivational messages, multiple reminders, summary score, compare to self Receives: Behavioral: Charge
Arm 14: WT-EM-MR-SS-CG	Experimental	Charge: weekly tracking, expert-generated motivational messages, multiple reminders,summary score, compare to group Receives: Behavioral: Charge
Arm 15: WT-EM-MR-SF-CS	Experimental	Charge: weekly tracking, expert-generated motivational messages, multiple reminders, specific goal feedback, compare to self Receives: Behavioral: Charge
Arm 16: WT-EM-MR-SF-CG	Experimental	Charge: weekly tracking, expert-generated motivational messages, multiple reminders, specific goal feedback, compare to group Receives: Behavioral: Charge
Arm 17: DT-SM-OR-SS-CS	Experimental	Charge: daily tracking, self-generated motivational messages, one reminder, summary score, compare to self. Receives: Behavioral: Charge
Arm 18: DT-SM-OR-SS-CG	Experimental	Charge: daily tracking, self-generated motivational messages, one reminder, summary score, compare to group Receives: Behavioral: Charge
Arm 19: DT-SM-OR-SF-CS	Experimental	Charge: daily tracking, self-generated motivational messages, one reminder, specific goal feedback, compare to self. Receives: Behavioral: Charge
Arm 20: DT-SM-OR-SF-CG	Experimental	Charge: daily tracking, self-generated motivational messages, one reminder, specific goal feedback, compare to group Receives: Behavioral: Charge
Arm 21: DT-SM-MR-SS-CS	Experimental	Charge: daily tracking, self-generated motivational messages, multiple reminders, summary score, compare to self Receives: Behavioral: Charge
Arm 22: DT-SM-MR-SS-CG	Experimental	Charge: daily tracking, self-generated motivational messages, multiple reminders, summary score, compare to group. Receives: Behavioral: Charge
Arm 23: DT-SM-MR-SF-CS	Experimental	Charge: daily tracking, self-generated motivational messages, multiple reminders, specific goal feedback, compare to self. Receives: Behavioral: Charge
Arm 24: DT-SM-MR-SF-CG	Experimental	Charge: daily tracking, self-generated motivational messages, multiple reminders, specific goal feedback, compare to group Receives: Behavioral: Charge
Arm 25: DT-EM-OR-SS-CS	Experimental	Charge: daily tracking, expert-generated motivational messages, one reminder, summary score, compare to self Receives: Behavioral: Charge
Arm 26: DT-EM-OR-SS-CG	Experimental	Charge: daily tracking, expert-generated motivational messages, one reminder, summary score, compare to group Receives: Behavioral: Charge
Arm 27: DT-EM-OR-SF-CS	Experimental	Charge: daily tracking, expert-generated motivational messages, one reminder, specific goal feedback, compare to self Receives: Behavioral: Charge
Arm 28: DT-EM-OR-SF-CG	Experimental	Charge: daily tracking, expert-generated motivational messages, one reminder, specific goal feedback, compare to group Receives: Behavioral: Charge
Arm 29: DT-EM-MR-SS-CS	Experimental	Charge: daily tracking, expert-generated motivational messages, multiple reminders, summary score, compare to self Receives: Behavioral: Charge
Arm 30: DT-EM-MR-SS-CG	Experimental	Charge: daily tracking, expert-generated motivational messages, multiple reminders, summary score, compare to group Receives: Behavioral: Charge
Arm 31: DT-EM-MR-GF-CS	Experimental	Charge: daily tracking, expert-generated motivational messages, multiple reminders, specific goal feedback, compare to self Receives: Behavioral: Charge
Arm 32: DT-EM-MR-GF-CG	Experimental	Charge: daily tracking, expert-generated motivational messages, multiple reminders, specific goal feedback, compare to group. Receives: Behavioral: Charge

What is being measured

The primary outcome is the main question the study is designed to answer.

Average Weight Change
Mean change in weight in kg (6 months post-randomization- baseline weight)
Measured: baseline, 6 months

Secondary outcomes (2)

Change in Diet
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.
Measured: baseline, 6 months
Average Change in Physical Activity
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).
Measured: baseline, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Jan 201831 Jan 2023

First posted21 Aug 2017
Study start31 Jan 2018
Primary completion29 Jun 2019
Study completion31 Jan 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (19)Papers the sponsor has linked to this study.
Other trials for Weight LossStudies of the same condition, open and under way.
More trials run by Duke UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Model description: The investigators will use a full factorial design to randomize participants to experimental conditions that reflect the texting intervention components: motivational messaging (self- vs expert-generated), texting frequency (daily vs weekly), reminders (one reminder v. multiple reminders), feedback type (summary score v. specific feedback) and comparison unit (to self v. to a group of people). The full factorial design is power efficient, logistically feasible (because we manipulate conditions using technology) and will allow the investigators to examine the most important main and interaction effects among components.
Masking: Single blind
Who is masked: Investigator
Enrolment: 534 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03254940
Sponsor's protocol ID: D0752
Status last verified: Apr 2025
First submitted: 12 Jul 2017
Last updated: 10 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 21132416
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.
PubMed 25005661
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.
PubMed 22253363
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.
PubMed 26098405
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.
PubMed 21211165
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.
PubMed 25704352
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.
PubMed 23083085
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.
PubMed 24239920
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.
PubMed 12503980
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.
PubMed 19680230
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.
PubMed 12517229
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.
PubMed 24771654
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.
PubMed 20059708
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.
PubMed 19296777
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.
PubMed 25630361

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Charge: Optimizing a Standalone Text Messaging-Based Weight Loss Intervention
ClinicalTrials.gov ID: NCT03254940
Acronym / sponsor ID: D0752
Conditions: Weight Loss, Obesity
Keywords: text message, digital health, weight loss, personalized
Study type: Interventional
Recruitment status: Completed
Enrolment: 534 participants (actual)
Lead sponsor: Duke UniversityUniversity, hospital or other
Study start: 31 Jan 2018 (actual)
Primary completion: 29 Jun 2019 (actual)
Study completion: 31 Jan 2023 (actual)
First posted: 21 Aug 2017 (actual)
Results: Posted 10 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind (investigator)
Number of arms: 32
Model description: The investigators will use a full factorial design to randomize participants to experimental conditions that reflect the texting intervention components: motivational messaging (self- vs expert-generated), texting frequency (daily vs weekly), reminders (one reminder v. multiple reminders), feedback type (summary score v. specific feedback) and comparison unit (to self v. to a group of people). The full factorial design is power efficient, logistically feasible (because we manipulate conditions using technology) and will allow the investigators to examine the most important main and interaction effects among components.

Arm	Type	Receives
Arm 1: WT-SM-OR-SS-CS	Experimental	Behavioral: ChargeCharge: weekly tracking, self-generated motivational messages, one reminder, summary score, compare to self
Arm 2: WT-SM-OR-SS-CG	Experimental	Behavioral: ChargeCharge: weekly tracking, self-generated motivational messages, one reminder, summary score, compare to group
Arm 3: WT-SM-OR-SF-CS	Experimental	Behavioral: ChargeCharge: weekly tracking, self-generated motivational messages, one reminder, specific goal feedback, compare to self
Arm 4: WT-SM-OR-SF-CG	Experimental	Behavioral: ChargeCharge: weekly tracking, self-generated motivational messages, one reminder, specific goal feedback, compare to group
Arm 5: WT-SM-MR-SS-CS	Experimental	Behavioral: ChargeCharge: weekly tracking, self-generated motivational messages, multiple reminders, summary score, compare to self.
Arm 6: WT-SM-MR-SS-CG	Experimental	Behavioral: ChargeCharge: weekly tracking, self-generated motivational messages, multiple reminders, summary score, compare to group.
Arm 7: WT-SM-MR-SF-CS	Experimental	Behavioral: ChargeCharge: weekly tracking, self-generated motivational messages, multiple reminders, specific feedback, compare to self
Arm 8: WT-SM-MR-SF-CG	Experimental	Behavioral: ChargeCharge: weekly tracking, self-generated motivational messages, multiple reminders, specific feedback, compare to group
Arm 9: WT-EM-OR-SS-CS	Experimental	Behavioral: ChargeCharge: weekly tracking, expert-generated motivational messages, one reminder, summary score, compare to self
Arm 10: WT-EM-OR-SS-CG	Experimental	Behavioral: ChargeCharge: weekly tracking, expert-generated motivational messages, one reminder, summary score, compare to group
Arm 11: WT-EM-OR-SF-CS	Experimental	Behavioral: ChargeCharge: weekly tracking, expert-generated motivational messages, one reminder, specific goal feedback, compare to self
Arm 12: WT-EM-OR-SF-CG	Experimental	Behavioral: ChargeCharge: weekly tracking, expert-generated motivational messages, one reminder, specific goal feedback, compare to group.
Arm 13: WT-EM-MR-SS-CS	Experimental	Behavioral: ChargeCharge: weekly tracking, expert-generated motivational messages, multiple reminders, summary score, compare to self
Arm 14: WT-EM-MR-SS-CG	Experimental	Behavioral: ChargeCharge: weekly tracking, expert-generated motivational messages, multiple reminders,summary score, compare to group
Arm 15: WT-EM-MR-SF-CS	Experimental	Behavioral: ChargeCharge: weekly tracking, expert-generated motivational messages, multiple reminders, specific goal feedback, compare to self
Arm 16: WT-EM-MR-SF-CG	Experimental	Behavioral: ChargeCharge: weekly tracking, expert-generated motivational messages, multiple reminders, specific goal feedback, compare to group
Arm 17: DT-SM-OR-SS-CS	Experimental	Behavioral: ChargeCharge: daily tracking, self-generated motivational messages, one reminder, summary score, compare to self.
Arm 18: DT-SM-OR-SS-CG	Experimental	Behavioral: ChargeCharge: daily tracking, self-generated motivational messages, one reminder, summary score, compare to group
Arm 19: DT-SM-OR-SF-CS	Experimental	Behavioral: ChargeCharge: daily tracking, self-generated motivational messages, one reminder, specific goal feedback, compare to self.
Arm 20: DT-SM-OR-SF-CG	Experimental	Behavioral: ChargeCharge: daily tracking, self-generated motivational messages, one reminder, specific goal feedback, compare to group
Arm 21: DT-SM-MR-SS-CS	Experimental	Behavioral: ChargeCharge: daily tracking, self-generated motivational messages, multiple reminders, summary score, compare to self
Arm 22: DT-SM-MR-SS-CG	Experimental	Behavioral: ChargeCharge: daily tracking, self-generated motivational messages, multiple reminders, summary score, compare to group.
Arm 23: DT-SM-MR-SF-CS	Experimental	Behavioral: ChargeCharge: daily tracking, self-generated motivational messages, multiple reminders, specific goal feedback, compare to self.
Arm 24: DT-SM-MR-SF-CG	Experimental	Behavioral: ChargeCharge: daily tracking, self-generated motivational messages, multiple reminders, specific goal feedback, compare to group
Arm 25: DT-EM-OR-SS-CS	Experimental	Behavioral: ChargeCharge: daily tracking, expert-generated motivational messages, one reminder, summary score, compare to self
Arm 26: DT-EM-OR-SS-CG	Experimental	Behavioral: ChargeCharge: daily tracking, expert-generated motivational messages, one reminder, summary score, compare to group
Arm 27: DT-EM-OR-SF-CS	Experimental	Behavioral: ChargeCharge: daily tracking, expert-generated motivational messages, one reminder, specific goal feedback, compare to self
Arm 28: DT-EM-OR-SF-CG	Experimental	Behavioral: ChargeCharge: daily tracking, expert-generated motivational messages, one reminder, specific goal feedback, compare to group
Arm 29: DT-EM-MR-SS-CS	Experimental	Behavioral: ChargeCharge: daily tracking, expert-generated motivational messages, multiple reminders, summary score, compare to self
Arm 30: DT-EM-MR-SS-CG	Experimental	Behavioral: ChargeCharge: daily tracking, expert-generated motivational messages, multiple reminders, summary score, compare to group
Arm 31: DT-EM-MR-GF-CS	Experimental	Behavioral: ChargeCharge: daily tracking, expert-generated motivational messages, multiple reminders, specific goal feedback, compare to self
Arm 32: DT-EM-MR-GF-CG	Experimental	Behavioral: ChargeCharge: daily tracking, expert-generated motivational messages, multiple reminders, specific goal feedback, compare to group.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ChargeText messaging-based study to determine effect of different components on weight loss.	Behavioural	Arm 10: WT-EM-OR-SS-CG, Arm 11: WT-EM-OR-SF-CS, Arm 12: WT-EM-OR-SF-CG, Arm 13: WT-EM-MR-SS-CS, Arm 14: WT-EM-MR-SS-CG, Arm 15: WT-EM-MR-SF-CS, Arm 16: WT-EM-MR-SF-CG, Arm 17: DT-SM-OR-SS-CS, Arm 18: DT-SM-OR-SS-CG, Arm 19: DT-SM-OR-SF-CS, Arm 1: WT-SM-OR-SS-CS, Arm 20: DT-SM-OR-SF-CG, Arm 21: DT-SM-MR-SS-CS, Arm 22: DT-SM-MR-SS-CG, Arm 23: DT-SM-MR-SF-CS, Arm 24: DT-SM-MR-SF-CG, Arm 25: DT-EM-OR-SS-CS, Arm 26: DT-EM-OR-SS-CG, Arm 27: DT-EM-OR-SF-CS, Arm 28: DT-EM-OR-SF-CG, Arm 29: DT-EM-MR-SS-CS, Arm 2: WT-SM-OR-SS-CG, Arm 30: DT-EM-MR-SS-CG, Arm 31: DT-EM-MR-GF-CS, Arm 32: DT-EM-MR-GF-CG, Arm 3: WT-SM-OR-SF-CS, Arm 4: WT-SM-OR-SF-CG, Arm 5: WT-SM-MR-SS-CS, Arm 6: WT-SM-MR-SS-CG, Arm 7: WT-SM-MR-SF-CS, Arm 8: WT-SM-MR-SF-CG, Arm 9: WT-EM-OR-SS-CS

Primary outcome

Average Weight Change
Time frame: baseline, 6 months
Mean change in weight in kg (6 months post-randomization- baseline weight)

2 secondary outcomes

Change in Diet
Time frame: baseline, 6 months
Average Change in Physical Activity
Time frame: baseline, 6 months

Results and safety

Results posted to the registry on 10 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Experimental: Arm 1: WT-SM-OR-SS-CS	17	11
Experimental: Arm 2: WT-SM-OR-SS-CG	16	12
Experimental: Arm 3: WT-SM-OR-SF-CS	17	10
Experimental: Arm 4: WT-SM-OR-SF-CG	17	14
Experimental: Arm 5: WT-SM-MR-SS-CS	16	11
Experimental: Arm 6: WT-SM-MR-SS-CG	15	11
Experimental: Arm 7: WT-SM-MR-SF-CS	17	13
Experimental: Arm 8: WT-SM-MR-SF-CG	17	13
Experimental: Arm 9: WT-EM-OR-SS-CS	18	13
Experimental: Arm 10: WT-EM-OR-SS-CG	17	13
Experimental: Arm 11: WT-EM-OR-SF-CS	18	9
Experimental: Arm 12: WT-EM-OR-SF-CG	16	13
Experimental: Arm 13: WT-EM-MR-SS-CS	16	14
Experimental: Arm 14: WT-EM-MR-SS-CG	15	10
Experimental: Arm 15: WT-EM-MR-SF-CS	18	12
Experimental: Arm 16: WT-EM-MR-SF-CG	16	13
Experimental: Arm 17: DT-SM-OR-SS-CS	18	14
Experimental: Arm 18: DT-SM-OR-SS-CG	16	12
Experimental: Arm 19: DT-SM-OR-SF-CS	15	11
Experimental: Arm 20: DT-SM-OR-SF-CG	17	11
Experimental: Arm 21: DT-SM-MR-SS-CS	18	13
Experimental: Arm 22: DT-SM-MR-SS-CG	16	10
Experimental: Arm 23: DT-SM-MR-SF-CS	15	9
Experimental: Arm 24: DT-SM-MR-SF-CG	17	12
Experimental: Arm 25: DT-EM-OR-SS-CS	18	12
Experimental: Arm 26: DT-EM-OR-SS-CG	17	14
Experimental: Arm 27: DT-EM-OR-SF-CS	17	13
Experimental: Arm 28: DT-EM-OR-SF-CG	17	15
Experimental: Arm 29: DT-EM-MR-SS-CS	16	12
Experimental: Arm 30: DT-EM-MR-SS-CG	15	13
Experimental: Arm 31: DT-EM-MR-GF-CS	19	13
Experimental: Arm 32: DT-EM-MR-GF-CG	17	12

Primary outcome: Average Weight Change

Time frame: baseline, 6 months. Mean (Standard Deviation). Unit: Weight in kg

Measure	Experimental: Arm 1: WT-SM-OR-SS-CS n = 11	Experimental: Arm 2: WT-SM-OR-SS-CG n = 12	Experimental: Arm 3: WT-SM-OR-SF-CS n = 10	Experimental: Arm 4: WT-SM-OR-SF-CG n = 14	Experimental: Arm 5: WT-SM-MR-SS-CS n = 11	Experimental: Arm 6: WT-SM-MR-SS-CG n = 11	Experimental: Arm 7: WT-SM-MR-SF-CS n = 13	Experimental: Arm 8: WT-SM-MR-SF-CG n = 13	Experimental: Arm 9: WT-EM-OR-SS-CS n = 13	Experimental: Arm 10: WT-EM-OR-SS-CG n = 13	Experimental: Arm 11: WT-EM-OR-SF-CS n = 9	Experimental: Arm 12: WT-EM-OR-SF-CG n = 13	Experimental: Arm 13: WT-EM-MR-SS-CS n = 14	Experimental: Arm 14: WT-EM-MR-SS-CG n = 10	Experimental: Arm 15: WT-EM-MR-SF-CS n = 12	Experimental: Arm 16: WT-EM-MR-SF-CG n = 13	Experimental: Arm 17: DT-SM-OR-SS-CS n = 14	Experimental: Arm 18: DT-SM-OR-SS-CG n = 12	Experimental: Arm 19: DT-SM-OR-SF-CS n = 11	Experimental: Arm 20: DT-SM-OR-SF-CG n = 11	Experimental: Arm 21: DT-SM-MR-SS-CS n = 13	Experimental: Arm 22: DT-SM-MR-SS-CG n = 10	Experimental: Arm 23: DT-SM-MR-SF-CS n = 9	Experimental: Arm 24: DT-SM-MR-SF-CG n = 12	Experimental: Arm 25: DT-EM-OR-SS-CS n = 12	Experimental: Arm 26: DT-EM-OR-SS-CG n = 14

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year, 5 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Experimental: Arm 1: WT-SM-OR-SS-CS	0 of 17 (0%)	0 of 17 (0%)	0 of 17
Experimental: Arm 2: WT-SM-OR-SS-CG	0 of 16 (0%)	0 of 16 (0%)	0 of 16
Experimental: Arm 3: WT-SM-OR-SF-CS	0 of 17 (0%)	0 of 17 (0%)	0 of 17
Experimental: Arm 4: WT-SM-OR-SF-CG	0 of 17 (0%)	0 of 17 (0%)	0 of 17
Experimental: Arm 5: WT-SM-MR-SS-CS	0 of 16 (0%)	0 of 16 (0%)	0 of 16
Experimental: Arm 6: WT-SM-MR-SS-CG	0 of 15 (0%)	0 of 15 (0%)	0 of 15
Experimental: Arm 7: WT-SM-MR-SF-CS	0 of 17 (0%)	0 of 17 (0%)	0 of 17
Experimental: Arm 8: WT-SM-MR-SF-CG	0 of 17 (0%)	0 of 17 (0%)	0 of 17
Experimental: Arm 9: WT-EM-OR-SS-CS	0 of 18 (0%)	0 of 18 (0%)	0 of 18
Experimental: Arm 10: WT-EM-OR-SS-CG	0 of 17 (0%)	0 of 17 (0%)	0 of 17
Experimental: Arm 11: WT-EM-OR-SF-CS	0 of 18 (0%)	0 of 18 (0%)	0 of 18
Experimental: Arm 12: WT-EM-OR-SF-CG	0 of 16 (0%)	0 of 16 (0%)	0 of 16
Experimental: Arm 13: WT-EM-MR-SS-CS	0 of 16 (0%)	0 of 16 (0%)	0 of 16
Experimental: Arm 14: WT-EM-MR-SS-CG	0 of 15 (0%)	0 of 15 (0%)	0 of 15
Experimental: Arm 15: WT-EM-MR-SF-CS	0 of 18 (0%)	1 of 18 (5.6%)	0 of 18
Experimental: Arm 16: WT-EM-MR-SF-CG	0 of 16 (0%)	0 of 16 (0%)	0 of 16
Experimental: Arm 17: DT-SM-OR-SS-CS	0 of 18 (0%)	0 of 18 (0%)	0 of 18
Experimental: Arm 18: DT-SM-OR-SS-CG	0 of 16 (0%)	0 of 16 (0%)	0 of 16
Experimental: Arm 19: DT-SM-OR-SF-CS

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 21132416Collins 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.
Background: PubMed 25005661Ogden 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.
Background: PubMed 22253363Flegal 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.
Background: PubMed 26098405Yang 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.
Background: PubMed 21211165Ogden 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.
Background: PubMed 25704352Rodriguez 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.
Background: PubMed 23083085Befort 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.
Background: PubMed 24239920Jensen 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.
Background: PubMed 12503980Mokdad 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.
Background: PubMed 19680230Finkelstein 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.
Background: PubMed 12517229Fontaine 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.
Background: PubMed 24771654Han 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gary G Bennett, PhD principal investigator

Bishop-MacDermott Family Professor of Psychology, Global Health & Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Charge in people with Weight Loss and Obesity, run by Duke University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average Weight Change (time frame: baseline, 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03254940, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.