Charge: A Text Messaging-based Weight Loss Intervention

• Sponsor: Duke University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03254940
• Collaborator: (none)
• Enrollment: 448
• Location: 1
• Arms: 32
• Anticipated Duration (Months): 60
• Patients Per Site Per Month: 7.5

Study Details

Study Description

Brief 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. The investigators will recruit 448 adults into a 6-month weight loss program, with an additional follow-up 6-months after the intervention ends.

Condition or Disease	Intervention/Treatment	Phase
Weight Loss; Obesity	Behavioral: Charge	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 448 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Intervention 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.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 (Investigator)
• Primary Purpose: Treatment
• Official Title: Charge: Optimizing a Standalone Text Messaging-Based Weight Loss Intervention
• Actual Study Start Date: Jan 31, 2018
• Actual Primary Completion Date: Jun 29, 2019
• Anticipated Study Completion Date: Jan 31, 2023

Arms and Interventions

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	Behavioral: Charge; 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	Behavioral: Charge; 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	Behavioral: Charge; 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	Behavioral: Charge; 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.	Behavioral: Charge; 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.	Behavioral: Charge; 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	Behavioral: Charge; 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	Behavioral: Charge; 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	Behavioral: Charge; 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	Behavioral: Charge; 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	Behavioral: Charge; 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.	Behavioral: Charge; 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	Behavioral: Charge; 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	Behavioral: Charge; 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	Behavioral: Charge; 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	Behavioral: Charge; 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.	Behavioral: Charge; 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	Behavioral: Charge; 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.	Behavioral: Charge; 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	Behavioral: Charge; 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	Behavioral: Charge; 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.	Behavioral: Charge; 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.	Behavioral: Charge; 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	Behavioral: Charge; 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	Behavioral: Charge; 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	Behavioral: Charge; 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	Behavioral: Charge; 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	Behavioral: Charge; 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	Behavioral: Charge; 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	Behavioral: Charge; 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	Behavioral: Charge; 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.	Behavioral: Charge; Text messaging-based study to determine effect of different components on weight loss.

Outcome Measures

Primary Outcome Measures

1. Weight [baseline & 6 months]

   absolute change in weight

Secondary Outcome Measures

1. Change in diet [baseline, 6 & 12 months]

   To experimentally determine the effects of text messaging components and levels on change in diet

2. Change in physical activity [baseline, 6 & 12 months]

   To experimentally determine the effects of text messaging components and levels on change in physical activity

3. Change in categorical weight loss (> 5%) at 6-months [baseline, 6 & 12 months]

   To experimentally determine the effects of text messaging components and levels on change in categorical weight loss (>5%)

4. weight loss maintenance [baseline, 6 & 12 months]

   To experimentally determine the effects of text messaging components and levels on change in 12-month maintenance of weight loss

5. Measure engagement in the intervention [baseline, 6 & 12 months]

   To determine how many responses we receive to our questions and to measure associations of engagement with weight change at 6- and 12- months. We will also model trajectories of change in engagement over time

6. Compare Cost-effectiveness of interventions [baseline & 6 months]

   To calculate the cost of the intervention's implementation and compare cost effectiveness of each intervention.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke University	Durham	North Carolina	United States	27708

Sponsors and Collaborators

• Duke University

Investigators

• Principal Investigator: Gary G Bennett, PhD, Bishop-MacDermott Family Professor of Psychology, Global Health & Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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. Review.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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. Erratum in: J Am Coll Cardiol. 2014 Jul 1;63(25 Pt B):3029-3030.
• 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.
• 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.
• 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.
• 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.
• 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. Review.
• 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. Review.
• 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.
• 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.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT03254940
• Other Study ID Numbers: D0752
• First Posted: Aug 21, 2017
• Last Update Posted: Mar 22, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Duke University: text message; digital health; weight loss; personalized
• Additional relevant MeSH terms: Body Weight; Weight Loss

Study Results

No Results Posted as of Mar 22, 2022