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CompletedNCT03254940Updated Apr 10, 2025Results posted

Charge: A Text Messaging-based Weight Loss Intervention

An interventional study of Charge in Weight Loss and Obesity, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-10.

Sponsored by Duke University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
534
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Weight Loss
  • Obesity

Keywords

  • text message
  • digital health
  • weight loss
  • personalized
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Investigator)
Enrollment
534 participants (actual)

Study arms

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

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

    Behavioral: Charge

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

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

    Behavioral: Charge

  • 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

  • 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

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

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

    Behavioral: Charge

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

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

    Behavioral: Charge

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

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

    Behavioral: Charge

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

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

    Behavioral: Charge

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

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

    Behavioral: Charge

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

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

    Behavioral: Charge

  • 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

  • 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

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

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

    Behavioral: Charge

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

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

    Behavioral: Charge

  • 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

  • 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

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

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

    Behavioral: Charge

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

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

    Behavioral: Charge

  • 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

  • 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

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

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

    Behavioral: Charge

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

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

    Behavioral: Charge

  • 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

  • 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

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

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

    Behavioral: Charge

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

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

    Behavioral: Charge

  • 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

  • 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

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

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

    Behavioral: Charge

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

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

    Behavioral: Charge

  • 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

  • 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

Interventions

  • BehavioralCharge

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

05

What researchers measure

Primary outcomes

  1. Average Weight Change

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

    Time frame: baseline, 6 months

Secondary outcomes

  1. 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.

    Time frame: baseline, 6 months

  2. 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).

    Time frame: baseline, 6 months

06

Results

Posted Apr 10, 2025

Participant flow

Participant flow — Overall Study
MilestoneExperimental: Arm 1: WT-SM-OR-SS-CSExperimental: Arm 2: WT-SM-OR-SS-CGExperimental: Arm 3: WT-SM-OR-SF-CSExperimental: Arm 4: WT-SM-OR-SF-CGExperimental: Arm 5: WT-SM-MR-SS-CSExperimental: Arm 6: WT-SM-MR-SS-CGExperimental: Arm 7: WT-SM-MR-SF-CSExperimental: Arm 8: WT-SM-MR-SF-CGExperimental: Arm 9: WT-EM-OR-SS-CSExperimental: Arm 10: WT-EM-OR-SS-CGExperimental: Arm 11: WT-EM-OR-SF-CSExperimental: Arm 12: WT-EM-OR-SF-CGExperimental: Arm 13: WT-EM-MR-SS-CSExperimental: Arm 14: WT-EM-MR-SS-CGExperimental: Arm 15: WT-EM-MR-SF-CSExperimental: Arm 16: WT-EM-MR-SF-CGExperimental: Arm 17: DT-SM-OR-SS-CSExperimental: Arm 18: DT-SM-OR-SS-CGExperimental: Arm 19: DT-SM-OR-SF-CSExperimental: Arm 20: DT-SM-OR-SF-CGExperimental: Arm 21: DT-SM-MR-SS-CSExperimental: Arm 22: DT-SM-MR-SS-CGExperimental: Arm 23: DT-SM-MR-SF-CSExperimental: Arm 24: DT-SM-MR-SF-CGExperimental: Arm 25: DT-EM-OR-SS-CSExperimental: Arm 26: DT-EM-OR-SS-CGExperimental: Arm 27: DT-EM-OR-SF-CSExperimental: Arm 28: DT-EM-OR-SF-CGExperimental: Arm 29: DT-EM-MR-SS-CSExperimental: Arm 30: DT-EM-MR-SS-CGExperimental: Arm 31: DT-EM-MR-GF-CSExperimental: Arm 32: DT-EM-MR-GF-CG
Started1716171716151717181718161615181618161517181615171817171716151917
Completed11121014111113131313913141012131412111113109121214131512131312
Not completed64735444549325634446566563424265

Outcome measures

PrimaryAverage Weight Change

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

Time frame:
baseline, 6 months
Reported as:
Mean · Weight in kg
Average Weight Change
Weight in kgExperimental: Arm 1: WT-SM-OR-SS-CSExperimental: Arm 2: WT-SM-OR-SS-CGExperimental: Arm 3: WT-SM-OR-SF-CSExperimental: Arm 4: WT-SM-OR-SF-CGExperimental: Arm 5: WT-SM-MR-SS-CSExperimental: Arm 6: WT-SM-MR-SS-CGExperimental: Arm 7: WT-SM-MR-SF-CSExperimental: Arm 8: WT-SM-MR-SF-CGExperimental: Arm 9: WT-EM-OR-SS-CSExperimental: Arm 10: WT-EM-OR-SS-CGExperimental: Arm 11: WT-EM-OR-SF-CSExperimental: Arm 12: WT-EM-OR-SF-CGExperimental: Arm 13: WT-EM-MR-SS-CSExperimental: Arm 14: WT-EM-MR-SS-CGExperimental: Arm 15: WT-EM-MR-SF-CSExperimental: Arm 16: WT-EM-MR-SF-CGExperimental: Arm 17: DT-SM-OR-SS-CSExperimental: Arm 18: DT-SM-OR-SS-CGExperimental: Arm 19: DT-SM-OR-SF-CSExperimental: Arm 20: DT-SM-OR-SF-CGExperimental: Arm 21: DT-SM-MR-SS-CSExperimental: Arm 22: DT-SM-MR-SS-CGExperimental: Arm 23: DT-SM-MR-SF-CSExperimental: Arm 24: DT-SM-MR-SF-CGExperimental: Arm 25: DT-EM-OR-SS-CSExperimental: Arm 26: DT-EM-OR-SS-CGExperimental: Arm 27: DT-EM-OR-SF-CSExperimental: Arm 28: DT-EM-OR-SF-CGExperimental: Arm 29: DT-EM-MR-SS-CSExperimental: Arm 30: DT-EM-MR-SS-CGExperimental: Arm 31: DT-EM-MR-GF-CSExperimental: Arm 32: DT-EM-MR-GF-CG
Average Weight Change0.1 ± 3.3-0.4 ± 2.7-3.4 ± 4.3-0.8 ± 4.8-3.3 ± 8.1-1.3 ± 5.8-0.9 ± 5.6-2.3 ± 5.6-2.9 ± 3.8-0.7 ± 2.3-1.0 ± 3.6-3.0 ± 5.8-2.9 ± 6.5-1.5 ± 2.3-2.1 ± 7.2-2.5 ± 2.8-3.1 ± 4.3-4.5 ± 5.9-2.8 ± 2.7-1.9 ± 4.6-1.5 ± 3.0-0.3 ± 4.1-0.5 ± 2.2-1.0 ± 5.9-2.7 ± 6.3-3.3 ± 6.2-2.4 ± 5.5-1.8 ± 3.3-3.5 ± 6.2-2.8 ± 6.40.2 ± 3.6-1.0 ± 6.5
SecondaryChange 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.

Time frame:
baseline, 6 months
Reported as:
Mean · score on a scale
Change in Diet
score on a scaleArm 1: WT-SM-OR-SS-CSArm 2: WT-SM-OR-SS-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-CSArm 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 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 30: DT-EM-MR-SS-CGArm 31: DT-EM-MR-GF-CSArm 32: DT-EM-MR-GF-CG
Change in Diet0.8 ± 42 ± 54.4 ± 3.11.2 ± 3.83.8 ± 5.82.6 ± 3.41.8 ± 3.51.8 ± 3.91.8 ± 3.52 ± 2.92.4 ± 3.22.2 ± 3.62.7 ± 3.32.9 ± 2.73.3 ± 4.71.5 ± 2.32.4 ± 3.13.7 ± 4.81.4 ± 2.50.4 ± 3.22.8 ± 3.61.1 ± 4.62.5 ± 2.91.5 ± 2.51.1 ± 4.63.8 ± 3.12.9 ± 4.11.2 ± 3.41.9 ± 2.51.6 ± 2.70.9 ± 4.03.7 ± 4.7
SecondaryAverage 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).

Time frame:
baseline, 6 months
Reported as:
Mean · minutes per week
Average Change in Physical Activity
minutes per weekExperimental: Arm 1: WT-SM-OR-SS-CSExperimental: Arm 2: WT-SM-OR-SS-CGExperimental: Arm 3: WT-SM-OR-SF-CSExperimental: Arm 4: WT-SM-OR-SF-CGExperimental: Arm 5: WT-SM-MR-SS-CSExperimental: Arm 6: WT-SM-MR-SS-CGExperimental: Arm 7: WT-SM-MR-SF-CSExperimental: Arm 8: WT-SM-MR-SF-CGExperimental: Arm 9: WT-EM-OR-SS-CSExperimental: Arm 10: WT-EM-OR-SS-CGExperimental: Arm 11: WT-EM-OR-SF-CSExperimental: Arm 12: WT-EM-OR-SF-CGExperimental: Arm 13: WT-EM-MR-SS-CSExperimental: Arm 14: WT-EM-MR-SS-CGExperimental: Arm 15: WT-EM-MR-SF-CSExperimental: Arm 16: WT-EM-MR-SF-CGExperimental: Arm 17: DT-SM-OR-SS-CSExperimental: Arm 18: DT-SM-OR-SS-CGExperimental: Arm 19: DT-SM-OR-SF-CSExperimental: Arm 20: DT-SM-OR-SF-CGExperimental: Arm 21: DT-SM-MR-SS-CSExperimental: Arm 22: DT-SM-MR-SS-CGExperimental: Arm 23: DT-SM-MR-SF-CSExperimental: Arm 24: DT-SM-MR-SF-CGExperimental: Arm 25: DT-EM-OR-SS-CSExperimental: Arm 26: DT-EM-OR-SS-CGExperimental: Arm 27: DT-EM-OR-SF-CSExperimental: Arm 28: DT-EM-OR-SF-CGExperimental: Arm 29: DT-EM-MR-SS-CSExperimental: Arm 30: DT-EM-MR-SS-CGExperimental: Arm 31: DT-EM-MR-GF-CSExperimental: Arm 32: DT-EM-MR-GF-CG
Average Change in Physical Activity202.2 ± 718.6103.8 ± 208.5256.8 ± 762.0335.6 ± 449.988.6 ± 138.2241.5 ± 684.8390.6 ± 859.0202.9 ± 385.5106.9 ± 285.8159.2 ± 381.2143.1 ± 413.5319.1 ± 620.381.2 ± 754.5390.0 ± 732.441.1 ± 208.1-26.4 ± 274.2-76.5 ± 382.670.0 ± 548.848.2 ± 264.0-362.7 ± 2225.445.0 ± 154.175.0 ± 171.6-54.4 ± 525.895.9 ± 325.8197.7 ± 401.9201.3 ± 646.4105.8 ± 419.4-21.3 ± 418.1-76.9 ± 272.2408.2 ± 652.0505.5 ± 1167.148.6 ± 302.4

Adverse events

Collected over 1 year, 5 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Experimental: Arm 1: WT-SM-OR-SS-CS0/17 (0%)0/17 (0%)0/17 (0%)
Experimental: Arm 2: WT-SM-OR-SS-CG0/16 (0%)0/16 (0%)0/16 (0%)
Experimental: Arm 3: WT-SM-OR-SF-CS0/17 (0%)0/17 (0%)0/17 (0%)
Experimental: Arm 4: WT-SM-OR-SF-CG0/17 (0%)0/17 (0%)0/17 (0%)
Experimental: Arm 5: WT-SM-MR-SS-CS0/16 (0%)0/16 (0%)0/16 (0%)
Experimental: Arm 6: WT-SM-MR-SS-CG0/15 (0%)0/15 (0%)0/15 (0%)
Experimental: Arm 7: WT-SM-MR-SF-CS0/17 (0%)0/17 (0%)0/17 (0%)
Experimental: Arm 8: WT-SM-MR-SF-CG0/17 (0%)0/17 (0%)0/17 (0%)
Experimental: Arm 9: WT-EM-OR-SS-CS0/18 (0%)0/18 (0%)0/18 (0%)
Experimental: Arm 10: WT-EM-OR-SS-CG0/17 (0%)0/17 (0%)0/17 (0%)
Experimental: Arm 11: WT-EM-OR-SF-CS0/18 (0%)0/18 (0%)0/18 (0%)
Experimental: Arm 12: WT-EM-OR-SF-CG0/16 (0%)0/16 (0%)0/16 (0%)
Experimental: Arm 13: WT-EM-MR-SS-CS0/16 (0%)0/16 (0%)0/16 (0%)
Experimental: Arm 14: WT-EM-MR-SS-CG0/15 (0%)0/15 (0%)0/15 (0%)
Experimental: Arm 15: WT-EM-MR-SF-CS0/18 (0%)0/18 (0%)1/18 (5.6%)
Experimental: Arm 16: WT-EM-MR-SF-CG0/16 (0%)0/16 (0%)0/16 (0%)
Experimental: Arm 17: DT-SM-OR-SS-CS0/18 (0%)0/18 (0%)0/18 (0%)
Experimental: Arm 18: DT-SM-OR-SS-CG0/16 (0%)0/16 (0%)0/16 (0%)
Experimental: Arm 19: DT-SM-OR-SF-CS0/15 (0%)0/15 (0%)0/15 (0%)
Experimental: Arm 20: DT-SM-OR-SF-CG0/17 (0%)0/17 (0%)0/17 (0%)
Experimental: Arm 21: DT-SM-MR-SS-CS0/18 (0%)0/18 (0%)0/18 (0%)
Experimental: Arm 22: DT-SM-MR-SS-CG0/16 (0%)0/16 (0%)0/16 (0%)
Experimental: Arm 23: DT-SM-MR-SF-CS0/15 (0%)0/15 (0%)0/15 (0%)
Experimental: Arm 24: DT-SM-MR-SF-CG0/17 (0%)0/17 (0%)0/17 (0%)
Experimental: Arm 25: DT-EM-OR-SS-CS0/18 (0%)0/18 (0%)0/18 (0%)
Experimental: Arm 26: DT-EM-OR-SS-CG0/17 (0%)0/17 (0%)0/17 (0%)
Experimental: Arm 27: DT-EM-OR-SF-CS0/17 (0%)0/17 (0%)0/17 (0%)
Experimental: Arm 28: DT-EM-OR-SF-CG0/17 (0%)0/17 (0%)0/17 (0%)
Experimental: Arm 29: DT-EM-MR-SS-CS0/16 (0%)0/16 (0%)0/16 (0%)
Experimental: Arm 30: DT-EM-MR-SS-CG0/15 (0%)0/15 (0%)0/15 (0%)
Experimental: Arm 31: DT-EM-MR-GF-CS0/19 (0%)0/19 (0%)0/19 (0%)
Experimental: Arm 32: DT-EM-MR-GF-CG0/17 (0%)0/17 (0%)0/17 (0%)
Most frequent other events
Most frequent other events
EventExperimental: Arm 1: WT-SM-OR-SS-CSExperimental: Arm 2: WT-SM-OR-SS-CGExperimental: Arm 3: WT-SM-OR-SF-CSExperimental: Arm 4: WT-SM-OR-SF-CGExperimental: Arm 5: WT-SM-MR-SS-CSExperimental: Arm 6: WT-SM-MR-SS-CGExperimental: Arm 7: WT-SM-MR-SF-CSExperimental: Arm 8: WT-SM-MR-SF-CGExperimental: Arm 9: WT-EM-OR-SS-CSExperimental: Arm 10: WT-EM-OR-SS-CGExperimental: Arm 11: WT-EM-OR-SF-CSExperimental: Arm 12: WT-EM-OR-SF-CGExperimental: Arm 13: WT-EM-MR-SS-CSExperimental: Arm 14: WT-EM-MR-SS-CGExperimental: Arm 15: WT-EM-MR-SF-CSExperimental: Arm 16: WT-EM-MR-SF-CGExperimental: Arm 17: DT-SM-OR-SS-CSExperimental: Arm 18: DT-SM-OR-SS-CGExperimental: Arm 19: DT-SM-OR-SF-CSExperimental: Arm 20: DT-SM-OR-SF-CGExperimental: Arm 21: DT-SM-MR-SS-CSExperimental: Arm 22: DT-SM-MR-SS-CGExperimental: Arm 23: DT-SM-MR-SF-CSExperimental: Arm 24: DT-SM-MR-SF-CGExperimental: Arm 25: DT-EM-OR-SS-CSExperimental: Arm 26: DT-EM-OR-SS-CGExperimental: Arm 27: DT-EM-OR-SF-CSExperimental: Arm 28: DT-EM-OR-SF-CGExperimental: Arm 29: DT-EM-MR-SS-CSExperimental: Arm 30: DT-EM-MR-SS-CGExperimental: Arm 31: DT-EM-MR-GF-CSExperimental: Arm 32: DT-EM-MR-GF-CG
Low blood sugar (hypoglycemia)Endocrine disorders0/170/160/170/170/160/150/170/170/180/170/180/160/160/151/180/160/180/160/150/170/180/160/150/170/180/170/170/170/160/150/190/17

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Experimental: Arm 1: WT-SM-OR-SS-CSExperimental: Arm 2: WT-SM-OR-SS-CGExperimental: Arm 3: WT-SM-OR-SF-CSExperimental: Arm 4: WT-SM-OR-SF-CGExperimental: Arm 5: WT-SM-MR-SS-CSExperimental: Arm 6: WT-SM-MR-SS-CGExperimental: Arm 7: WT-SM-MR-SF-CSExperimental: Arm 8: WT-SM-MR-SF-CGExperimental: Arm 9: WT-EM-OR-SS-CSExperimental: Arm 10: WT-EM-OR-SS-CGExperimental: Arm 11: WT-EM-OR-SF-CSExperimental: Arm 12: WT-EM-OR-SF-CGExperimental: Arm 13: WT-EM-MR-SS-CSExperimental: Arm 14: WT-EM-MR-SS-CGExperimental: Arm 15: WT-EM-MR-SF-CSExperimental: Arm 16: WT-EM-MR-SF-CGExperimental: Arm 17: DT-SM-OR-SS-CSExperimental: Arm 18: DT-SM-OR-SS-CGExperimental: Arm 19: DT-SM-OR-SF-CSExperimental: Arm 20: DT-SM-OR-SF-CGExperimental: Arm 21: DT-SM-MR-SS-CSExperimental: Arm 22: DT-SM-MR-SS-CGExperimental: Arm 23: DT-SM-MR-SF-CSExperimental: Arm 24: DT-SM-MR-SF-CGExperimental: Arm 25: DT-EM-OR-SS-CSExperimental: Arm 26: DT-EM-OR-SS-CGExperimental: Arm 27: DT-EM-OR-SF-CSExperimental: Arm 28: DT-EM-OR-SF-CGExperimental: Arm 29: DT-EM-MR-SS-CSExperimental: Arm 30: DT-EM-MR-SS-CGExperimental: Arm 31: DT-EM-MR-GF-CSExperimental: Arm 32: DT-EM-MR-GF-CGTotal
<=18 years000000000000000000000000000000000
Between 18 and 65 years1716171716151717181718161615171618161517181614171816171716151916530
>=65 years000000000000001000000010010000014
Age, Continuous
Age, Continuous(years)Experimental: Arm 1: WT-SM-OR-SS-CSExperimental: Arm 2: WT-SM-OR-SS-CGExperimental: Arm 3: WT-SM-OR-SF-CSExperimental: Arm 4: WT-SM-OR-SF-CGExperimental: Arm 5: WT-SM-MR-SS-CSExperimental: Arm 6: WT-SM-MR-SS-CGExperimental: Arm 7: WT-SM-MR-SF-CSExperimental: Arm 8: WT-SM-MR-SF-CGExperimental: Arm 9: WT-EM-OR-SS-CSExperimental: Arm 10: WT-EM-OR-SS-CGExperimental: Arm 11: WT-EM-OR-SF-CSExperimental: Arm 12: WT-EM-OR-SF-CGExperimental: Arm 13: WT-EM-MR-SS-CSExperimental: Arm 14: WT-EM-MR-SS-CGExperimental: Arm 15: WT-EM-MR-SF-CSExperimental: Arm 16: WT-EM-MR-SF-CGExperimental: Arm 17: DT-SM-OR-SS-CSExperimental: Arm 18: DT-SM-OR-SS-CGExperimental: Arm 19: DT-SM-OR-SF-CSExperimental: Arm 20: DT-SM-OR-SF-CGExperimental: Arm 21: DT-SM-MR-SS-CSExperimental: Arm 22: DT-SM-MR-SS-CGExperimental: Arm 23: DT-SM-MR-SF-CSExperimental: Arm 24: DT-SM-MR-SF-CGExperimental: Arm 25: DT-EM-OR-SS-CSExperimental: Arm 26: DT-EM-OR-SS-CGExperimental: Arm 27: DT-EM-OR-SF-CSExperimental: Arm 28: DT-EM-OR-SF-CGExperimental: Arm 29: DT-EM-MR-SS-CSExperimental: Arm 30: DT-EM-MR-SS-CGExperimental: Arm 31: DT-EM-MR-GF-CSExperimental: Arm 32: DT-EM-MR-GF-CGTotal
Mean35.8 ± 8.339.5 ± 12.346.8 ± 10.744.4 ± 12.639.4 ± 10.546.5 ± 11.840.2 ± 14.941.2 ± 11.837.2 ± 8.743.0 ± 12.842.8 ± 13.941.0 ± 11.645.4 ± 13.745.2 ± 12.941.2 ± 13.340.6 ± 11.642.6 ± 13.244.9 ± 12.442.0 ± 10.941.2 ± 11.742.6 ± 12.437.9 ± 7.843.2 ± 14.034.4 ± 5.433.4 ± 5.536.3 ± 6.433.4 ± 6.232.5 ± 6.136.6 ± 7.134.3 ± 3.732.0 ± 4.834.6 ± 7.833.9 ± 6.1
Sex/Gender, Customized
Sex/Gender, Customized(Participants)Experimental: Arm 1: WT-SM-OR-SS-CSExperimental: Arm 2: WT-SM-OR-SS-CGExperimental: Arm 3: WT-SM-OR-SF-CSExperimental: Arm 4: WT-SM-OR-SF-CGExperimental: Arm 5: WT-SM-MR-SS-CSExperimental: Arm 6: WT-SM-MR-SS-CGExperimental: Arm 7: WT-SM-MR-SF-CSExperimental: Arm 8: WT-SM-MR-SF-CGExperimental: Arm 9: WT-EM-OR-SS-CSExperimental: Arm 10: WT-EM-OR-SS-CGExperimental: Arm 11: WT-EM-OR-SF-CSExperimental: Arm 12: WT-EM-OR-SF-CGExperimental: Arm 13: WT-EM-MR-SS-CSExperimental: Arm 14: WT-EM-MR-SS-CGExperimental: Arm 15: WT-EM-MR-SF-CSExperimental: Arm 16: WT-EM-MR-SF-CGExperimental: Arm 17: DT-SM-OR-SS-CSExperimental: Arm 18: DT-SM-OR-SS-CGExperimental: Arm 19: DT-SM-OR-SF-CSExperimental: Arm 20: DT-SM-OR-SF-CGExperimental: Arm 21: DT-SM-MR-SS-CSExperimental: Arm 22: DT-SM-MR-SS-CGExperimental: Arm 23: DT-SM-MR-SF-CSExperimental: Arm 24: DT-SM-MR-SF-CGExperimental: Arm 25: DT-EM-OR-SS-CSExperimental: Arm 26: DT-EM-OR-SS-CGExperimental: Arm 27: DT-EM-OR-SF-CSExperimental: Arm 28: DT-EM-OR-SF-CGExperimental: Arm 29: DT-EM-MR-SS-CSExperimental: Arm 30: DT-EM-MR-SS-CGExperimental: Arm 31: DT-EM-MR-GF-CSExperimental: Arm 32: DT-EM-MR-GF-CGTotal
Gender - Self Described — Other (self described as genderqueer or nonbinary)000000000010000000001000000000103
Gender - Self Described — Male55444455555444645444554454554455145
Gender - Self Described — Female1211131312111212131212121211121213121113121111131313121212111312386
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Experimental: Arm 1: WT-SM-OR-SS-CSExperimental: Arm 2: WT-SM-OR-SS-CGExperimental: Arm 3: WT-SM-OR-SF-CSExperimental: Arm 4: WT-SM-OR-SF-CGExperimental: Arm 5: WT-SM-MR-SS-CSExperimental: Arm 6: WT-SM-MR-SS-CGExperimental: Arm 7: WT-SM-MR-SF-CSExperimental: Arm 8: WT-SM-MR-SF-CGExperimental: Arm 9: WT-EM-OR-SS-CSExperimental: Arm 10: WT-EM-OR-SS-CGExperimental: Arm 11: WT-EM-OR-SF-CSExperimental: Arm 12: WT-EM-OR-SF-CGExperimental: Arm 13: WT-EM-MR-SS-CSExperimental: Arm 14: WT-EM-MR-SS-CGExperimental: Arm 15: WT-EM-MR-SF-CSExperimental: Arm 16: WT-EM-MR-SF-CGExperimental: Arm 17: DT-SM-OR-SS-CSExperimental: Arm 18: DT-SM-OR-SS-CGExperimental: Arm 19: DT-SM-OR-SF-CSExperimental: Arm 20: DT-SM-OR-SF-CGExperimental: Arm 21: DT-SM-MR-SS-CSExperimental: Arm 22: DT-SM-MR-SS-CGExperimental: Arm 23: DT-SM-MR-SF-CSExperimental: Arm 24: DT-SM-MR-SF-CGExperimental: Arm 25: DT-EM-OR-SS-CSExperimental: Arm 26: DT-EM-OR-SS-CGExperimental: Arm 27: DT-EM-OR-SF-CSExperimental: Arm 28: DT-EM-OR-SF-CGExperimental: Arm 29: DT-EM-MR-SS-CSExperimental: Arm 30: DT-EM-MR-SS-CGExperimental: Arm 31: DT-EM-MR-GF-CSExperimental: Arm 32: DT-EM-MR-GF-CGTotal
Race/Ethnicity — Non-Hispanic Black1024342254222334113333520212401377
Race/Ethnicity — Non-Hispanic White111415121010101311111511121011111315111013121014131412139141813391
Race/Ethnicity — Hispanic (all races)2100301120032131300210012021300136
Race/Ethnicity — Non-Hispanic Other3101014102100110101211003121010030
Region of Enrollment
Region of Enrollment(participants)Experimental: Arm 1: WT-SM-OR-SS-CSExperimental: Arm 2: WT-SM-OR-SS-CGExperimental: Arm 3: WT-SM-OR-SF-CSExperimental: Arm 4: WT-SM-OR-SF-CGExperimental: Arm 5: WT-SM-MR-SS-CSExperimental: Arm 6: WT-SM-MR-SS-CGExperimental: Arm 7: WT-SM-MR-SF-CSExperimental: Arm 8: WT-SM-MR-SF-CGExperimental: Arm 9: WT-EM-OR-SS-CSExperimental: Arm 10: WT-EM-OR-SS-CGExperimental: Arm 11: WT-EM-OR-SF-CSExperimental: Arm 12: WT-EM-OR-SF-CGExperimental: Arm 13: WT-EM-MR-SS-CSExperimental: Arm 14: WT-EM-MR-SS-CGExperimental: Arm 15: WT-EM-MR-SF-CSExperimental: Arm 16: WT-EM-MR-SF-CGExperimental: Arm 17: DT-SM-OR-SS-CSExperimental: Arm 18: DT-SM-OR-SS-CGExperimental: Arm 19: DT-SM-OR-SF-CSExperimental: Arm 20: DT-SM-OR-SF-CGExperimental: Arm 21: DT-SM-MR-SS-CSExperimental: Arm 22: DT-SM-MR-SS-CGExperimental: Arm 23: DT-SM-MR-SF-CSExperimental: Arm 24: DT-SM-MR-SF-CGExperimental: Arm 25: DT-EM-OR-SS-CSExperimental: Arm 26: DT-EM-OR-SS-CGExperimental: Arm 27: DT-EM-OR-SF-CSExperimental: Arm 28: DT-EM-OR-SF-CGExperimental: Arm 29: DT-EM-MR-SS-CSExperimental: Arm 30: DT-EM-MR-SS-CGExperimental: Arm 31: DT-EM-MR-GF-CSExperimental: Arm 32: DT-EM-MR-GF-CGTotal
United States1716171716151717181718161615181618161517181615171817171716151917534
BMI
BMI(kg/m^2)Experimental: Arm 1: WT-SM-OR-SS-CSExperimental: Arm 2: WT-SM-OR-SS-CGExperimental: Arm 3: WT-SM-OR-SF-CSExperimental: Arm 4: WT-SM-OR-SF-CGExperimental: Arm 5: WT-SM-MR-SS-CSExperimental: Arm 6: WT-SM-MR-SS-CGExperimental: Arm 7: WT-SM-MR-SF-CSExperimental: Arm 8: WT-SM-MR-SF-CGExperimental: Arm 9: WT-EM-OR-SS-CSExperimental: Arm 10: WT-EM-OR-SS-CGExperimental: Arm 11: WT-EM-OR-SF-CSExperimental: Arm 12: WT-EM-OR-SF-CGExperimental: Arm 13: WT-EM-MR-SS-CSExperimental: Arm 14: WT-EM-MR-SS-CGExperimental: Arm 15: WT-EM-MR-SF-CSExperimental: Arm 16: WT-EM-MR-SF-CGExperimental: Arm 17: DT-SM-OR-SS-CSExperimental: Arm 18: DT-SM-OR-SS-CGExperimental: Arm 19: DT-SM-OR-SF-CSExperimental: Arm 20: DT-SM-OR-SF-CGExperimental: Arm 21: DT-SM-MR-SS-CSExperimental: Arm 22: DT-SM-MR-SS-CGExperimental: Arm 23: DT-SM-MR-SF-CSExperimental: Arm 24: DT-SM-MR-SF-CGExperimental: Arm 25: DT-EM-OR-SS-CSExperimental: Arm 26: DT-EM-OR-SS-CGExperimental: Arm 27: DT-EM-OR-SF-CSExperimental: Arm 28: DT-EM-OR-SF-CGExperimental: Arm 29: DT-EM-MR-SS-CSExperimental: Arm 30: DT-EM-MR-SS-CGExperimental: Arm 31: DT-EM-MR-GF-CSExperimental: Arm 32: DT-EM-MR-GF-CGTotal
Mean34.1 ± 633.2 ± 5.930.6 ± 2.832.7 ± 6.234.9 ± 7.233.9 ± 7.232.4 ± 7.535.9 ± 7.336.9 ± 8.332.1 ± 5.234.4 ± 7.233.7 ± 4.435.8 ± 5.432.5 ± 5.736.7 ± 6.432.8 ± 4.932.1 ± 4.634.9 ± 6.132.9 ± 5.632.8 ± 4.633.6 ± 5.536.2 ± 7.933.9 ± 6.634.4 ± 5.433.4 ± 5.536.3 ± 6.433.4 ± 6.232.5 ± 6.136.6 ± 7.134.3 ± 3.732.0 ± 4.834.6 ± 7.733.9 ± 6.1
Personal income
Personal income(Participants)Experimental: Arm 1: WT-SM-OR-SS-CSExperimental: Arm 2: WT-SM-OR-SS-CGExperimental: Arm 3: WT-SM-OR-SF-CSExperimental: Arm 4: WT-SM-OR-SF-CGExperimental: Arm 5: WT-SM-MR-SS-CSExperimental: Arm 6: WT-SM-MR-SS-CGExperimental: Arm 7: WT-SM-MR-SF-CSExperimental: Arm 8: WT-SM-MR-SF-CGExperimental: Arm 9: WT-EM-OR-SS-CSExperimental: Arm 10: WT-EM-OR-SS-CGExperimental: Arm 11: WT-EM-OR-SF-CSExperimental: Arm 12: WT-EM-OR-SF-CGExperimental: Arm 13: WT-EM-MR-SS-CSExperimental: Arm 14: WT-EM-MR-SS-CGExperimental: Arm 15: WT-EM-MR-SF-CSExperimental: Arm 16: WT-EM-MR-SF-CGExperimental: Arm 17: DT-SM-OR-SS-CSExperimental: Arm 18: DT-SM-OR-SS-CGExperimental: Arm 19: DT-SM-OR-SF-CSExperimental: Arm 20: DT-SM-OR-SF-CGExperimental: Arm 21: DT-SM-MR-SS-CSExperimental: Arm 22: DT-SM-MR-SS-CGExperimental: Arm 23: DT-SM-MR-SF-CSExperimental: Arm 24: DT-SM-MR-SF-CGExperimental: Arm 25: DT-EM-OR-SS-CSExperimental: Arm 26: DT-EM-OR-SS-CGExperimental: Arm 27: DT-EM-OR-SF-CSExperimental: Arm 28: DT-EM-OR-SF-CGExperimental: Arm 29: DT-EM-MR-SS-CSExperimental: Arm 30: DT-EM-MR-SS-CGExperimental: Arm 31: DT-EM-MR-GF-CSExperimental: Arm 32: DT-EM-MR-GF-CGTotal
Missing0102000011012010003110101201010020
Less than $25,00062214264501434543213321743801432100
$25,000 through $49,99926447633866455335512425242248365135
$50,000 and greater9711105781041011766991091011101288910712771010279
07

Study locations

1 site
  • Duke University
    Durham, North Carolina 27708, United States
08

References and documents

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 ↗
  • 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. PubMed 21672170 ↗
  • 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. PubMed 22944150 ↗
  • 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. PubMed 24246427 ↗
  • 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. PubMed 33459600 ↗

Study documents

  • Protocol, analysis plan and consent form · Jan 21, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03254940
Lead sponsor
Duke University
Responsible party
Sponsor
First posted
Aug 21, 2017
Start date
Jan 31, 2018
Primary completion
Jun 29, 2019
Completion
Jan 31, 2023
Results posted
Apr 10, 2025
Last update
Apr 10, 2025

Study contacts

Gary G Bennett, PhD
principal investigator · Bishop-MacDermott Family Professor of Psychology, Global Health & Medicine

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
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