NCT03254940

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
534

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 21, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

January 31, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2019

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

April 10, 2025

Completed
Last Updated

April 10, 2025

Status Verified

April 1, 2025

Enrollment Period

1.4 years

First QC Date

July 12, 2017

Results QC Date

January 16, 2024

Last Update Submit

April 9, 2025

Conditions

Keywords

text messagedigital healthweight losspersonalized

Outcome Measures

Primary Outcomes (1)

  • Average Weight Change

    Mean change in weight in kg (6 months post-randomization- baseline weight)

    baseline, 6 months

Secondary Outcomes (2)

  • Change in Diet

    baseline, 6 months

  • Average Change in Physical Activity

    baseline, 6 months

Study Arms (32)

Arm 1: WT-SM-OR-SS-CS

EXPERIMENTAL

Charge: weekly tracking, self-generated motivational messages, one reminder, summary score, compare to self

Behavioral: Charge

Arm 2: WT-SM-OR-SS-CG

EXPERIMENTAL

Charge: weekly tracking, self-generated motivational messages, one reminder, summary score, compare to group

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

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

Behavioral: Charge

Arm 5: WT-SM-MR-SS-CS

EXPERIMENTAL

Charge: weekly tracking, self-generated motivational messages, multiple reminders, summary score, compare to self.

Behavioral: Charge

Arm 6: WT-SM-MR-SS-CG

EXPERIMENTAL

Charge: weekly tracking, self-generated motivational messages, multiple reminders, summary score, compare to group.

Behavioral: Charge

Arm 7: WT-SM-MR-SF-CS

EXPERIMENTAL

Charge: weekly tracking, self-generated motivational messages, multiple reminders, specific feedback, compare to self

Behavioral: Charge

Arm 8: WT-SM-MR-SF-CG

EXPERIMENTAL

Charge: weekly tracking, self-generated motivational messages, multiple reminders, specific feedback, compare to group

Behavioral: Charge

Arm 9: WT-EM-OR-SS-CS

EXPERIMENTAL

Charge: weekly tracking, expert-generated motivational messages, one reminder, summary score, compare to self

Behavioral: Charge

Arm 10: WT-EM-OR-SS-CG

EXPERIMENTAL

Charge: weekly tracking, expert-generated motivational messages, one reminder, summary score, compare to group

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

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.

Behavioral: Charge

Arm 13: WT-EM-MR-SS-CS

EXPERIMENTAL

Charge: weekly tracking, expert-generated motivational messages, multiple reminders, summary score, compare to self

Behavioral: Charge

Arm 14: WT-EM-MR-SS-CG

EXPERIMENTAL

Charge: weekly tracking, expert-generated motivational messages, multiple reminders,summary score, compare to group

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

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

Behavioral: Charge

Arm 17: DT-SM-OR-SS-CS

EXPERIMENTAL

Charge: daily tracking, self-generated motivational messages, one reminder, summary score, compare to self.

Behavioral: Charge

Arm 18: DT-SM-OR-SS-CG

EXPERIMENTAL

Charge: daily tracking, self-generated motivational messages, one reminder, summary score, compare to group

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.

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

Behavioral: Charge

Arm 21: DT-SM-MR-SS-CS

EXPERIMENTAL

Charge: daily tracking, self-generated motivational messages, multiple reminders, summary score, compare to self

Behavioral: Charge

Arm 22: DT-SM-MR-SS-CG

EXPERIMENTAL

Charge: daily tracking, self-generated motivational messages, multiple reminders, summary score, compare to group.

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.

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

Behavioral: Charge

Arm 25: DT-EM-OR-SS-CS

EXPERIMENTAL

Charge: daily tracking, expert-generated motivational messages, one reminder, summary score, compare to self

Behavioral: Charge

Arm 26: DT-EM-OR-SS-CG

EXPERIMENTAL

Charge: daily tracking, expert-generated motivational messages, one reminder, summary score, compare to group

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

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

Behavioral: Charge

Arm 29: DT-EM-MR-SS-CS

EXPERIMENTAL

Charge: daily tracking, expert-generated motivational messages, multiple reminders, summary score, compare to self

Behavioral: Charge

Arm 30: DT-EM-MR-SS-CG

EXPERIMENTAL

Charge: daily tracking, expert-generated motivational messages, multiple reminders, summary score, compare to group

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

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.

Behavioral: Charge

Interventions

ChargeBEHAVIORAL

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

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

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University

Durham, North Carolina, 27708, United States

Location

Related Publications (19)

  • 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.

    PMID: 21132416BACKGROUND
  • 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.

    PMID: 25005661BACKGROUND
  • 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.

    PMID: 22253363BACKGROUND
  • 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.

    PMID: 26098405BACKGROUND
  • 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.

    PMID: 21211165BACKGROUND
  • 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.

    PMID: 25704352BACKGROUND
  • 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.

    PMID: 23083085BACKGROUND
  • 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.

    PMID: 24239920BACKGROUND
  • 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.

    PMID: 12503980BACKGROUND
  • 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.

    PMID: 19680230BACKGROUND
  • 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.

    PMID: 12517229BACKGROUND
  • 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.

    PMID: 24771654BACKGROUND
  • 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.

    PMID: 20059708BACKGROUND
  • 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.

    PMID: 19296777BACKGROUND
  • 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.

    PMID: 25630361BACKGROUND
  • 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.

    PMID: 21672170BACKGROUND
  • 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.

    PMID: 22944150BACKGROUND
  • 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.

    PMID: 24246427BACKGROUND
  • 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.

MeSH Terms

Conditions

Weight LossObesity

Interventions

Fees and Charges

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

EconomicsHealth Care Economics and Organizations

Results Point of Contact

Title
Dr. Gary G. Bennett (PI/Dean of Trinity College of Arts & Sciences)
Organization
Duke University

Study Officials

  • Gary G Bennett, PhD

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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2017

First Posted

August 21, 2017

Study Start

January 31, 2018

Primary Completion

June 29, 2019

Study Completion

January 31, 2023

Last Updated

April 10, 2025

Results First Posted

April 10, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations