Charge: A Text Messaging-based Weight Loss Intervention

NCT ID: NCT03254940

Last Updated: 2025-04-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

534 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-31

Study Completion Date

2023-01-31

Brief Summary

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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.

Detailed Description

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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

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Weight Loss Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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

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

Group Type EXPERIMENTAL

Charge

Intervention Type BEHAVIORAL

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

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

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

Group Type EXPERIMENTAL

Charge

Intervention Type BEHAVIORAL

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

Arm 3: WT-SM-OR-SF-CS

Charge: weekly tracking, self-generated motivational messages, one reminder, specific goal feedback, compare to self

Group Type EXPERIMENTAL

Charge

Intervention Type BEHAVIORAL

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

Arm 4: WT-SM-OR-SF-CG

Charge: weekly tracking, self-generated motivational messages, one reminder, specific goal feedback, compare to group

Group Type EXPERIMENTAL

Charge

Intervention Type BEHAVIORAL

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

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

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

Group Type EXPERIMENTAL

Charge

Intervention Type BEHAVIORAL

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

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

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

Group Type EXPERIMENTAL

Charge

Intervention Type BEHAVIORAL

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

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

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

Group Type EXPERIMENTAL

Charge

Intervention Type BEHAVIORAL

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

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

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

Group Type EXPERIMENTAL

Charge

Intervention Type BEHAVIORAL

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

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

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

Group Type EXPERIMENTAL

Charge

Intervention Type BEHAVIORAL

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

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

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

Group Type EXPERIMENTAL

Charge

Intervention Type BEHAVIORAL

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

Arm 11: WT-EM-OR-SF-CS

Charge: weekly tracking, expert-generated motivational messages, one reminder, specific goal feedback, compare to self

Group Type EXPERIMENTAL

Charge

Intervention Type BEHAVIORAL

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

Arm 12: WT-EM-OR-SF-CG

Charge: weekly tracking, expert-generated motivational messages, one reminder, specific goal feedback, compare to group.

Group Type EXPERIMENTAL

Charge

Intervention Type BEHAVIORAL

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

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

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

Group Type EXPERIMENTAL

Charge

Intervention Type BEHAVIORAL

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

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

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

Group Type EXPERIMENTAL

Charge

Intervention Type BEHAVIORAL

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

Arm 15: WT-EM-MR-SF-CS

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

Group Type EXPERIMENTAL

Charge

Intervention Type BEHAVIORAL

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

Arm 16: WT-EM-MR-SF-CG

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

Group Type EXPERIMENTAL

Charge

Intervention Type BEHAVIORAL

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

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

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

Group Type EXPERIMENTAL

Charge

Intervention Type BEHAVIORAL

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

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

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

Group Type EXPERIMENTAL

Charge

Intervention Type BEHAVIORAL

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

Arm 19: DT-SM-OR-SF-CS

Charge: daily tracking, self-generated motivational messages, one reminder, specific goal feedback, compare to self.

Group Type EXPERIMENTAL

Charge

Intervention Type BEHAVIORAL

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

Arm 20: DT-SM-OR-SF-CG

Charge: daily tracking, self-generated motivational messages, one reminder, specific goal feedback, compare to group

Group Type EXPERIMENTAL

Charge

Intervention Type BEHAVIORAL

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

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

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

Group Type EXPERIMENTAL

Charge

Intervention Type BEHAVIORAL

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

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

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

Group Type EXPERIMENTAL

Charge

Intervention Type BEHAVIORAL

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

Arm 23: DT-SM-MR-SF-CS

Charge: daily tracking, self-generated motivational messages, multiple reminders, specific goal feedback, compare to self.

Group Type EXPERIMENTAL

Charge

Intervention Type BEHAVIORAL

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

Arm 24: DT-SM-MR-SF-CG

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

Group Type EXPERIMENTAL

Charge

Intervention Type BEHAVIORAL

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

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

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

Group Type EXPERIMENTAL

Charge

Intervention Type BEHAVIORAL

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

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

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

Group Type EXPERIMENTAL

Charge

Intervention Type BEHAVIORAL

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

Arm 27: DT-EM-OR-SF-CS

Charge: daily tracking, expert-generated motivational messages, one reminder, specific goal feedback, compare to self

Group Type EXPERIMENTAL

Charge

Intervention Type BEHAVIORAL

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

Arm 28: DT-EM-OR-SF-CG

Charge: daily tracking, expert-generated motivational messages, one reminder, specific goal feedback, compare to group

Group Type EXPERIMENTAL

Charge

Intervention Type BEHAVIORAL

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

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

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

Group Type EXPERIMENTAL

Charge

Intervention Type BEHAVIORAL

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

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

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

Group Type EXPERIMENTAL

Charge

Intervention Type BEHAVIORAL

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

Arm 31: DT-EM-MR-GF-CS

Charge: daily tracking, expert-generated motivational messages, multiple reminders, specific goal feedback, compare to self

Group Type EXPERIMENTAL

Charge

Intervention Type BEHAVIORAL

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

Arm 32: DT-EM-MR-GF-CG

Charge: daily tracking, expert-generated motivational messages, multiple reminders, specific goal feedback, compare to group.

Group Type EXPERIMENTAL

Charge

Intervention Type BEHAVIORAL

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

Interventions

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Charge

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gary G Bennett, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Duke University

Durham, North Carolina, United States

Site Status

Countries

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United States

References

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Reference Type DERIVED
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Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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D0752

Identifier Type: -

Identifier Source: org_study_id

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